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更新于：2025-03-20
Bevacizumab-awwb
贝伐珠单抗生物类似药（安进）
更新于：2025-03-20
概要
基本信息
原研机构 |
非在研机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)终止 |
特殊审评- |
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结构/序列
Sequence Code 41632H
来源: *****
Sequence Code 41637L
来源: *****
关联
10
项与 贝伐珠单抗生物类似药（安进） 相关的临床试验JPRN-jRCTs031220724
A Phase2 study to investigate the efficacy and safety of Atezolizumab and bevacizumab with live bacterial product for unresectable HCC
开始日期2023-08-25 |
申办/合作机构- |
NCT05180422
A Phase I/II Study of AMG 510 in Combination With MVASI in Patients With Advanced, Unresectable or Metastatic KRAS G12C Mutant NSCLC With Asymptomatic Brain Metastasis.
This is a multicenter, non-randomized, open-label, phase I/II study to evaluate the safety and tolerability of AMG 510 plus MVASI in subjects with advanced KRAS p.G12C mutant non-small cell lung cancer (NSCLC) with small, untreated brain metastases.
开始日期2022-06-15 |
申办/合作机构  CRITERIUM, Inc. [+1] |
NCT04466917
A Randomized, Double-blind, Phase 3 Bridging Study Evaluating the Safety and Efficacy of ABP 215 Compared With Bevacizumab in Chinese Subjects With Advanced Non-Squamous Non-Small Cell Lung Cancer
The purpose of this research study is to assess the efficacy and safety of ABP 215 compared to Bevacizumab in Chinese patients with advanced non-small cell lung cancer (NSCLC).
开始日期2021-05-15 |
申办/合作机构  Amgen, Inc. [+1] |
100 项与 贝伐珠单抗生物类似药（安进） 相关的临床结果
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100 项与 贝伐珠单抗生物类似药（安进） 相关的转化医学
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100 项与 贝伐珠单抗生物类似药（安进） 相关的专利（医药）
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18
项与 贝伐珠单抗生物类似药（安进） 相关的文献（医药）2025-01-02·Expert Opinion on Drug Safety
Safety of marketed biosimilar monoclonal antibody cancer treatments in the US: a disproportionality analysis using the food and drug administration adverse event reporting system (FAERS) database
Article
作者: Xue, Xiangzhong ; Qian, Jingjing
2024-12-01·Value in Health
Cost-Effectiveness Analysis of Bevacizumab Biosimilars Versus Originator Bevacizumab for Metastatic Colorectal Cancer: A Comparative Study Using Real-World Data
Article
作者: Chan, Kelvin K W ; Lu, Brandon ; Mercer, Rebecca E ; Nguyen, Lena ; Muñoz, Caroline ; Adamic, Andrea ; Beca, Jaclyn M ; Dvorani, Erind
2024-12-01·Clinical & Experimental Ophthalmology
Bevacizumab biosimilar (bevacizumab‐awwb) is safe in the treatment of retinopathy of prematurity
Letter
作者: Hong, Zixin ; Shah, Shaheen ; Dai, Shuan ; Sheth, Shivanand ; Liu, Cindy Yue‐Ying
69
项与 贝伐珠单抗生物类似药（安进） 相关的新闻（医药）2025-03-06
·医药魔方
趵突飞雪漱石冷，明湖揽月荷香清。泉涌星垂、柳浪闻莺的三月人间在晨钟暮鼓间蓦然苏醒。岁月凝眸，仿若繁花，长路未央，残阳如血，寒鸦掠水惊起戍旗卷云，华灯初上的灯火阑珊中梦回吹角连营，三分剑气凝成醉卧沙场的残篇，七分柔肠化作挼碎梅英的旧笺。流年回溯，仿若千帆，青春恰时来，策马正少年。
整体概况
2024年全球生物药市场规模达到了6200亿美元，占到全球医药整体市场的大约40%，预计将在五年后的2030年将突破万亿美元大关。近年来以欧美为主的全球生物类似药市场规模不断扩大，随着未来几年内乌司奴单抗、地舒单抗以及阿柏西普等多个重磅分子专利限制的陆续解除，全球生物类似药又将进入一个新的高速发展期。从多家机构最新的预测来看，当前全球生物类似药整体规模在300亿美元左右，未来十年的预期复合增长率有望接近20%。
全球生物类似药市场规模与增速预测
2024年全球销售额TOP100药品中，以单抗为代表的大分子药物占据半壁江山。除去疫苗产品外，2024年全球销售额TOP20生物产品均为单抗和抗体融合蛋白；入围门槛进一步提高至40亿美元，其中七成产品全球销售收入在50亿美元以上，6个产品突破了百亿大关；K药以绝对优势稳居药王宝座，利生奇珠单抗和阿达木单抗的销售收入排名相比上年分别上升5和下降6位，成为TOP20中名次变化最大的产品；法瑞西单抗以68%的增速在获批上市第三年便杀入榜单，完美诠释了生如夏花之绚烂；卸下王冠的阿达木单抗在四面楚歌之中进一步加速凋零，38%的降幅再次跌出新高；2023年的TOP20守门员阿巴西普在2024年以一位之差跌出榜单，法瑞西单抗之外的其余19个产品均为2023年在榜产品；
2024年全球销售额TOP20生物药
（非疫苗类）
从地域上看，美国市场处于绝对核心地位，榜单中九成产品的美国市场收入全球占比在50%以上；产品主要分布在肿瘤和自免领域，榜单中唯二尚未在中国市场上市的奥瑞珠单抗和利生奇珠单抗两个产品已经处于注册审评之中；八成产品在2010年及之后获批，其中获批时间最早的依那西普距今已有25年，凭借美国市场潜水艇专利对生物类似药的限制依然年年上榜，2022年获批的法瑞西单抗成为榜单中最年轻的后来者。
2024年美国医药市场整体规模再创新高已逼近8000亿美元，以50%的占比继续领跑全球，蓬勃发展的生物药品在整体销售额中的占比达到了51%，IQVIA预计将在2033年达到6800亿美元的规模，份额占比增长至58%。
在经历了2023年的小幅下滑后，2024年的美国生物类似药市场开始回暖，最终以90亿美元圆满收官，主要得益于阿达木单抗逐步扭转初期颓势，罗氏抗肿瘤三件套等老产品实现间歇性复苏，以及托珠单抗和阿柏西普两个新产品的小幅助力。在收入贡献方面，阿达木单抗生物类似药产品群相比上年实现了近10亿美元的增量，成为最大功臣，聚乙二醇化非格司亭和雷珠单抗是另外两个增量在1亿美元以上的单品集群，英夫利昔单抗下滑超1亿美元，成为最大的反作用力。从各生物类似药产品集群整体收入占比来看，贝伐珠单抗顶着生物类似药最高渗透率光环排名榜首，利妥昔单抗和英夫利昔单抗紧随其后，三个产品群的份额均超过了15%，托珠单抗和阿柏西普两个新产品限于上市时间过短整体占比均未超过1%。
过去的2024年，美国生物类似药历史申报总数量成功破百，转瞬间距离首个生物类似药获批已经即将十年；地舒单抗、阿柏西普和依库珠单抗三个分子的首个生物类似药顺利获批，带动获批分子总数量增加至17个；非格司亭和贝伐珠单抗两个分子的生物类似药份额逼近90%，挑战不可能的脚步从未停歇；阿柏西普首个生物类似药冒险上市，时隔多年以后安进再次用相信的力量诠释了“因为懂得，所以勇敢”。回首远眺，似乎没有那么多惊天地泣鬼神，或许这就是燎原星火的点点滴滴吧。微弱，却足以在黑暗中指引方向。
获批&上市
2024年美国共有18个生物类似药产品获批，这一数字相当于过去四年获批数量之和，刷新了2019年10个产品申报的历史记录。18个获批产品共涉及乌司奴单抗等8个分子以及Amgen等10家公司，其中地舒单抗、阿柏西普和依库珠单抗均为首次有生物类似药获批；Alvotech与Teva合作的首个高浓度阿达木单抗生物类似药Simlandi等6个产品在获批的同时被授予可互换资格；Samsung Bioepis、 Pfizer、Sandoz和Amgen四大巨头合计赢得8个获批产品，Alvotech、Accord、Formycon和Tanvex四家公司均是首次有生物类似药在美获批，历史累计生物类似药获批产品涉及公司数量达到了20家。
2024年美国生物类似药获批一览
从获批位次看，Simlandi成为第10个获批的阿达木单抗生物类似药， Hercessi成为第6个获批的曲妥珠单抗生物类似药， Nypozi成为第4个获批的非格司亭生物类似药，Jubbonti/Wyost则成为首个获批的地舒单抗生物类似药，另有6个乌司奴单抗、5个阿柏西普和2个依库珠单抗生物类似药获批。
从审评时长看，全部18个获批产品的平均审评时长为585天，其中Tanvex Biopharma（泰福生技）的非格司亭生物类似药Nypozi以2100天的审评时间打破了此前由Amneal在售的另一非格司亭生物类似药Releuko保持的1693天的单品历史最长审评时间记录，该产品在2018年9月首次申报后先后分别于2019年9月、2021年5月和2023年2月收到了三次CRL，同时在一定程度上也受到了新冠疫情期间FDA出行不便导致审计延迟的影响；Ahzantive等3个阿柏西普以及Otulfi等3个乌司奴单抗生物类似药在一个审评周期内获批。截至2024年底，除去仅有一个样本的阿法依泊汀外，在至少有两家生物类似药获批的分子中，非格司亭和聚乙二醇化非格司亭分别以1100天和738天的生物类似药平均审评时长排名前两位，其余分子生物类似药的平均审评时长分布在400-550天之间，目前仅有样本量较小的雷珠单抗和甘精胰岛素两个分子的全部生物类似药在一个周期内完成审评。
从上市情况看，2024年仅有4个生物类似药上市，相比于上年13个产品上市的历史最高记录发生了明显下降， 其中阿达木单抗生物类似药上市数量达到了10个，托珠单抗的首仿和二仿生物类似药全部在获批当年及实现上市。Amgen的Pavblu是在诉讼尚未最终定论情况下的冒险上市，复制了当年其贝伐珠单抗Mvasi和曲妥珠单抗生物类似药Kanjinti冒险首仿上市的案例。
2024年美国生物类似药上市一览
从申报数量看，2024财年共有19个生物类似药BLA首次向FDA申报，与去年持平，共同保持着单年生物类似药BLA申报数量的历史记录，主要源于以地舒单抗、阿柏西普和乌司奴单抗为代表的新一代重磅生物类似药进入集中申报期。
截至2024年底，美国以351(K)途径申报的生物类似药获批和上市数量已经分别达到了63个和42个。从产品类型看，共涉及维持治疗、抗肿瘤、自体免疫、胰岛素和眼科五大领域的17个分子，其中数量最多的阿达木单抗共有10个生物类似药获批并已全部上市，成为当下竞争最为激烈的产品，数量最少的阿法依泊汀只有1个生物类似药获批并上市；从公司看，共涉及包括了原研创新型、专注研发型以及大型仿制药公司在内的20家公司，其中Samsung Bioepis 、Pfizer、Amgen和Sandoz均以8个产品获批并列排名产品获批数量第一，Pfizer以7个产品上市的战绩排名产品上市数量榜首；阿达木单抗等8个分子实现了全部获批生物类似药均已上市，获批未上市的21个生物类似药有18个受限于专利，其余则主要因为商业化策略暂未上市或放弃上市。
市场渗透&价格变化
生物类似药在美国市场的渗透逐步加深，2024年共有12款分子有生物类似药在售，其中阿柏西普和托珠单抗在2024年首次迎来生物类似药上市，其余10个分子的首款生物类似药上市时间均已超过一年。12个分子对应的生物类似药产品市场销量份额相比上年均取得了不同程度的增长，但整体来看增速已经明显放缓，渗透速度在不同的疾病领域也存在较为明显的差异。
从具体数字看，7个分子的生物类似药在市销售时间已超过3年，并且2023年的整体市场份额超过40%，其中贝伐珠单抗和非格司亭两个分子的生物类似药市场占比均突破了85%，进一步刷新历史最高记录；7个分子的生物类似药数量超过3家，阿达木单抗的在售生物类似药数量更是达到了10个，继续保持着最高数量记录；2022年新上市的雷珠单抗生物类似药在去年将整体市场份额提升了27%，成为了2024年渗透幅度增长最大的产品。阿法依伯汀多年来只有一家生物类似药与原研产品竞争，其份额6年来一直未能突破50%。聚乙二醇化非格司亭采取了跟进生物类似药同步降价的策略，但市场格局在过去一年里发生了较大的变化，生物类似药历时6年终于在份额上过半，以15%的增幅来到了57%；英夫利昔单抗在2022年实现了重大突破后开始放缓步伐，过去一年里四家生物类似药的市场份额增长不足1%，成为了2024年渗透最慢的产品；安进的阿柏西普生物类似药Pavblu冒险上市后，仅用时3个月便拿到了22%的市场份额，成为2024年生物类似药渗透最快的单品。
从具体单品份额排名看，美国首个生物类似药Zarxio 经历小幅下滑但依然以51%的份额排名榜首，但与紧随前后的贝伐珠单抗首仿产品Mvasi的差距已经不足1%。雷珠单抗生物类似药Cimerli超越没有其他生物类似药竞争的阿法依伯汀首仿产Retacrit，以44%的份额排名第三；各药物分子份额排名榜首的12个生物类似药中，有8个为首仿产品，3个为二仿产品，仅有Sandoz的阿达木单抗生物类似药上市位次在前三开外，但其有着扎堆上市以及竞品初期普遍遇阻的特殊性。阿达木单抗的首仿产品Amjevita以及其他上市位次早于Sandoz的产品未能将上市早的优势转化成领先份额；上市时间较短的托珠单抗首仿产品Tyenne以不足1%的份额排名全部首仿产品末尾。总体来看，上市越早份额越大依然是生物类似药市场的金科玉律，而上市后的市场份额取决于各分子产品特点以及竞品数量等多重因素，虽然弯道超车并非完全没有可能，但相比小分子仿制药而言难度不言而喻。
价格方面，多个产品2024年的降价幅度相比前一年有所减缓，部分产品出现了小幅涨价。从具体产品看，曲妥珠单抗的五仿产品Kanjiti的降幅达到了38%，成为过去一年里降幅最大的生物类似药单品；与当前各分子原研产品价格相比，曲妥珠单抗生物类似药ASP价格（平均销售价格）的达到了最低的18%，聚乙二醇化非格司亭、阿法依泊汀和雷珠单抗三个产品则出现了原研价格全部低于生物类似药价格的独特场景，7个分子当前最低生物类似药产品ASP价格相比于生物类似药上市之前的原研品价格降幅在36%-94%之间，6个产品的降幅超过了75%，其中原研采取价格跟进策略的聚乙二醇化非格司亭的价格降幅最大，达到了94%，2022年上市的雷珠单抗产品降幅最小，仅有36%；
从原研自身价格变化来看，各分子均发生了一定程度的下降，生物类似药上市之前ASP价格平均增幅最大的聚乙二醇化非格司亭原研产品Neulasta在生物类似药进入后不断疯狂跟进，以95%的降幅蝉联原研品降价冠军；英夫利昔单抗原研产品Remicade和雷珠单抗原研产品Lucentis分别以63%和56%的降幅紧随其后；非格司亭原研产品Neupogen多年来的降幅不足2%，成为了价格最为稳定的原研产品，Amgen同时作为非格司亭和聚乙二醇化非格司亭两个产品的原研公司采取了两套截然不同的价格策略，深刻的诠释了“以不变应万变“和“唯一不变的就是变化”。
美国生物类似药涉产品价格变化一览
策略&管线
城中桃李愁风雨，春在溪头荠菜花。过去一年里，有看破红尘、不破不立的转身告别，也有越过山丘才发现无人等候的骑虎难下，还有小荷才露尖尖角的跃跃欲试，当然更多的还是千磨万击还坚劲的执着坚守。总体来看针对美国市场的生物类似药研发热度依然保持在较高的水平上，纷繁复杂的形势变化和诸多不确定因素交织在一起，对或早或晚的入局者提出了新的考验和挑战，或许真正的路并不在地图上，而在罗盘指向的远方。
随着与老铁Alvotech合作的阿达木单抗生物类似药Simlandi以及乌司奴单抗生物类似药Selarsdi分别在2024年5月和2025年2月的上市，Teva目前在售的生物类似药数量达到了4个，其中利妥昔单抗和曲妥珠单抗两个产品均来自于生物药巨头Celltrion。Celltrion在2023年转型独立销售基本上断掉了两家未来在美直接合作生物类似药的这条线，现有两个合作产品在协议到期后的未来也有些破朔迷离。对于秉持外部合作为主并结合少量自研的生物类似药开发策略的Teva而言，在目前处于研发晚期的自研产品数量相对较少的情况下迫切需要与更多不具备美国市场销售能力的其他外部研发和生产型合作伙伴建立合作。
Teva在2024年先后与Mabxience达成了两项针对美国市场的生物类似药产品合作，刚刚又在今年1月宣布与Samsung Bioepis达成美国市场依库珠单抗的合作，新的朋友圈开始逐步拓展。目前已获批等待上市的只有依库珠单抗一个产品，此前Samsung Bioepis已经与Alexion达成了针对依库珠单抗的和解。目前处于FDA审评阶段的共有与Alvotech合作的戈利木单抗和阿柏西普以及自研的地舒单抗三个产品，奥马珠单抗和维得利珠单抗两个产品也有望在近两年申报，还有8个处于临床前阶段的自研和合作项目，短期看产品管线还算丰富。
Sandoz在过去一年里依然向着生物类似药全球领导者的目标努力前行着，按照其不把鸡蛋都放到一个篮子里的策略，在产品选择上既布局了包括地舒单抗、阿达木单抗和乌司奴单抗在内的重磅大药，也入局了包括了向那他珠单抗这种竞争有限但有着REMS等特殊要求的小众产品。另一方面，在本身具备强劲研发能力的同时，Sandoz也积极地拓展外部合作争取更加经济和快速的尽早入市机会。
截止去年底，Sandoz在美国共有非格司亭、阿达木单抗、雷珠单抗和聚乙二醇化非格司亭四个生物类似药在售，其中前三个产品均以绝对优势占据市场份额榜首。Sandoz与Samsung Bioepis合作的乌司奴单抗生物类似药Pyzchiva刚刚于今年2月底在美上市，在售产品线得到了进一步丰富。在过去一年里，Sandoz拿到了地舒单抗和阿柏西普两个重磅产品生物类似药的获批，其中前者按照与Amgen的和解条件可于今年5月31日上市，后者的上市时间还要视诉讼情况而定，并无冒险上市的打算。另外两个已经获批的依那西普和那他珠单抗受专利影响暂时还无法上市。Sandoz与EirGenix合作的曲妥珠单抗和与甘李合作的胰岛素系列生物类似药产品受到审评缺陷影响目前暂未获批，与百奥泰合作的贝伐珠单抗生物类似药产品Avzivi虽已获批但迟迟未能上市。在研管线中，OK双药均已处于III期临床阶段，另有19个处于研发早期阶段的产品，产品线的丰富程度无人能出其右。
Amgen的2024年很忙碌，在求人不如求己策略的指引下，还是依托于自身研发 走着“一边告别人、一边被别人告”的老戏路，还措不及防的时隔多年又投了个冒险上市的炸弹。作为原告，Amgen在过去一年里先后就地舒单抗告了Celltrion、Fresenius、Samsung Bioepis和Accord四家，其中跟Celltrion和2023年便开打的Sandoz达成了和解；作为被告，Amgen陷入了Regeneron的阿柏西普诉讼大战，在形势并不明朗的前提下独一家选择了冒险上市，在上市短短两个月便赚取了高额利润，同时也借此给原研进一步施压。正反通吃的双面力量使得Amgen有底气在攻防大战不按常理出牌。Amgen在过去一年获批了依库珠单抗和阿柏西普两个产品，前者按照和解协议可于今年3月1日上市，加之已于今年1月份首仿上市的乌司奴单抗生物类似药Wezlana，目前Amgen在美获批的8个生物类似药已经全部上市，其中6个为首仿上市。过人的上市速度除了得益于本身较早的启动和出众的研发能力外，凭借在专利诉讼领域知己知彼的洞察力在工艺开发之初便完善布局从而争取到优于其他竞争对手的和解条件是其成功的又一法宝。从后续管线产品来看，OK双药和奥瑞珠单抗生物类似药均已处于III期临床阶段，都具备拿下首仿的可能性。
亚洲生物类似药巨头Celltrion在2023年顺利搭建完成了美国市场生物类似药的销售体系，并从贝伐珠单抗生物类似药Vegzelma开始全面转为自售。除了早期不具备自售能力时分别与Pfizer和Teva合作的英夫利昔单抗、利妥昔单抗和曲妥珠单抗三个分子的生物类似药之外，剩余已上市产品均已实现了由其美国公司进行自售。目前Celltrion已获批产品数量已经达到了7个，3月份即将迎来其乌司奴单抗生物类似药Steqeyma的和解上市。刚刚于今年1月份获批的托珠单抗预计最快也将于今年上半年上市。从产品位次而言，Celltrion在英夫利昔单抗和利妥昔单抗两个产品上为首仿生物类似药上市，其余产品上市位次均在三仿之后。从后续管线产品来看，Celltrion除了目前已经处于FDA审评中的奥马珠单抗、地舒单抗和阿柏西普以外，还拥有达雷妥尤单抗、帕博利珠单抗、司库奇尤单抗和奥瑞珠单抗四个已经处于III期临床阶段的在研生物类似药，其中达雷妥尤单抗和司库奇尤单抗均为目前所知的针对美国市场进行研发的进度最快的生物类似药。
Samsung Bioepis在与Organon和Biogen进行生物类似药的合作基础上，2024年在美国市场又新增了Sandoz这一合作伙伴，今年1月又与Teva就依库珠单抗生物类似药达成合作。作为典型的研发型公司，其在生产上依托于其母公司Samsung Biologics，在美国当地的销售上只能依托于具备商业化销售能力的其他合作伙伴，与Celltrion相比尚未完成打通最后一公里的转变，看似不远但实际上并不简单。加上2月份刚刚获批的地舒单抗，Samsung Bioepis当前已经拥有9个获批产品，成为拥有获批生物类似药数量最多的公司，9个产品中的5个已经上市，其中雷珠单抗生物类似药是其中唯一的首仿产品，其余4个产品受限于专利尚未上市。从后续管线产品来看，已经申报多年的贝伐珠单抗生物类似药至今仍未获批，进度最快的帕博利珠单抗生物类似药已经进入III期临床阶段。
继承了Viatris原班销售团队的Biocon
Biologics在2024年进入了新的独立销售周期，完成交接后在美国市场生物类似药策略也有所变化，从此前的自研自产逐步向自研与外部引进相结合的混合业务模式转变。全年共有乌司奴单抗和阿柏西普两个产品获批，在售产品数量仍为4个，其中聚乙二醇化非格司亭和甘精胰岛素两个产品为首仿生物类似药。Biocon Biologics包括已获批产品在内的全球生物类似药管线产品总数量达到了20个（包括了6个未披露名称的早期项目），针对美国市场的门冬胰岛素和贝伐珠单抗等三个产品目前仍处于FDA审评过程中，后续的地舒单抗已经处于待申报状态，帕妥珠单抗处于III期临床中。
Coherus在2024选择了退场，有些意料之外但又情理之中，在圈子里的时光还是创造了一些带着胜利光环的辉煌。随着先后将雷珠单抗、阿达木单抗和聚乙二醇化非格司亭三个产品先后转让给Sandoz、Meitheal和Accord，快速补充了现金流，未来将聚焦抗肿瘤创新药领域。所有失去的，终将以另一种方式归来。Accord在经历了十年前的失望之旅后，最终在去年成功接手了由Coherus转让的聚乙二醇化非格司亭生物类似药产品Udenyca，也算是弥补了当年报而不批的遗憾，同时其与复宏汉霖合作的曲妥珠单抗生物类似药也将在今年迎来上市。
Amneal的美国市场在售生物类似药产品数量已经达到了3个，在当前众多生物类似药竞争者中与Fresenius一道成为小分子仿制药头部药企的代表，其与mAbxience合作的地舒单抗已经完成了III期临床试验，处于待申报状态，与战略伙伴Kashiv BioSciences合作的奥马珠单抗已经处于III期临床阶段。
Fresenius的托珠单抗在去年首仿上市，但总体来其与聚乙二醇化非格司亭和阿达木单抗三个产品的份额都还比较有限，去年获批的乌司奴单抗生物类似药Otulfi尚未上市，目前在研管线中的利妥昔单抗和地舒单抗两个生物类似药产品均已处于FDA审评阶段。Hikma的地舒单抗和乌司奴单抗两个生物类似药产品终于在去年完成了申报，管线中暂时没有披露的新产品加入；Lupin处于FDA审评中的聚乙二醇化非格司亭生物类似药仍未获批，雷珠单抗已经完成了III期临床试验。
中国军团中百奥泰的贝伐珠单抗和托珠单抗两个生物类似药产品已经获批，其中与Biogen合作的托珠单抗已经于去年二仿上市；复宏汉霖的曲妥珠单抗生物类似药预计将于今年上市，其地舒单抗和帕妥珠单抗生物类似药也已经处于FDA审评阶段；甘李与Sandoz合作的甘精、门冬、赖脯三大胰岛素生物类似药均已处于FDA审评阶段；健友自研的非格司亭、聚乙二醇化非格司亭和促卵胞素以及与通化东宝于2023年达成合作的三大胰岛素的生物类似药产品目前均还处于临床阶段，未来将由其美国子公司Meitheal进行商业化销售。
美国市场生物类似药竞争公司管线产品一览
整体来看，上述各家公司的在审产品中仍包含了少量美国市场已有生物类似药上市多年的老分子产品，这些产品申报时间相对较早但限于自身问题尚未获批，例如Samsung Bioepis于2019年申报的贝伐珠单抗生物类似药，Lupin于2021年申报的聚乙二醇化非格司亭生物类似药；近几年内即将有生物类似药登陆市场的阿柏西普、地舒单抗以及乌司奴单抗三大重磅分子产品已有多家申报，各家进度存在一定差距，既有已经获批的，也有即将进行申报的，但总体上围绕该类第三波重磅生物药的生物类似药研发基本已经告一段落，以OK双药为代表的第四波重磅生物药产品的竞争开始逐渐浮出水面，进度较快的已经进入III期临床阶段。
除了上述重磅大产品外，各家管线中也包括了奥马珠单抗、司库奇尤单抗单抗和帕妥珠单抗等多个位列TOP50的次重磅产品，这些产品在销售额上略低于上述重磅产品但也属于大药范畴，针对此类次重磅产品的竞争相对缓和。面对生物类似药的激烈竞争，原研产品也在采取多种措施积极防御，例如多个产品已经或即将推出皮下注射版本产品逐步替代原传统静脉注射产品，通过更晚的专利保护在生物类似药进入市场之前占得先机，这些都对生物类似药的立项选择提出了新的挑战。
诉讼进展
BPCIA诉讼大战在2024年迎来了第12个年头，随着生物类似药BLA申报数量再创新高，2024年8起的诉讼案件数量也创下了近6年来的新高。截至2024年底，美国历史累计BPCIA诉讼数量已经达到了69起，其中包括了一些双方针对同一产品在不同地区或针对不同专利发起的同源性诉讼。
过去的2024年里共有三起诉讼落下帷幕，均已和解告终。其中两起于2023年发起、一起于2024年发起，共涉及地舒单抗、依库珠单抗和利妥昔单抗三个分子，其中两个产品已经获批待上市，平均和解时间为255天；2024年之前的诉讼仍有六起尚未了结，分别涉及阿柏西普和那他珠单抗；2024年发起的八起诉讼中共有四起针对地舒单抗、三起针对阿柏西普，另外一起涉及依库珠单抗，其中依库珠单抗为首次涉及BPCIA诉讼。七起诉讼的原告方共涉及Amgen、Alexion和Regeneron三家公司，被诉方涉及Sandoz等六家公司，诉讼涉及的专利数量平均为30个，其中最多的为Sandoz阿柏西普的诉讼，涉及专利数量均达到了46个。
从范围上看，2013年-2024年间在负责初审的地区法院层级总共由Amgen、Genentech、Janssen、Abbvie、Biogen、Alexion和Regeneron七家原研药公司针对目前有生物类似药获批的16个分子向Celltrion等近20家集团公司提起诉讼，共涉及50余个生物类似药（部分未获批）；从时间看，2017（11起）和2018（12起）两年成为诉讼发起最为集中的时间段，占据了全部诉讼数量的三分之一，2013年仅有一起诉讼提出；从公司表现看，Genentech以提出18起诉讼的数量排名原告第一，同时分饰原告和被告两角的Amgen和Celltrion均以承接10起诉讼的战绩排名被告第一， Sandoz以被诉9起的数量紧随其后；从耗时看，Sandoz的非格司亭生物类似药Zarxio和Celltrion的英夫利昔单抗生物类似药Inflectra从最初被诉到最终胜诉均历时近五年，成为拉锯时间最长的生物类似药产品，Sandoz的阿达木单抗生物类似药Hyrimoz从被诉到最终与原研和解仅历时2个月，成为诉讼耗时最短的产品；从结果看绝大多数诉讼均以和解告终。
在专利诉讼之外的第二战场，2024年美国各公司针对阿柏西普等多个产品共发起了11件IPR多方复审，从数量上来看是近十年来除了2020（受疫情影响）的最低，历史单年IPR最高数量出现在2017年，发起数量已接近90件；从涉及产品看，曲妥珠单抗原研产品Herceptin（18%）、利妥昔单抗原研产品Rituxan（15%）和阿柏西普原研产品Eylea（14%）成为累计IPR数量最多的产品，近两年年来针对帕博利珠单抗和度普利尤单抗等尚无生物类似药获批的新分子的IPR数量开始逐渐增多；从被无效专利类型看，应用专利被挑战次数已经超过了100起，以绝对优势领先其他类型专利。
产品表现
阿达木单抗（Adalimumab）
原研产品/公司：Humira/Abbvie
美国获批时间：2002/12
竞争难度：★★★★★
2023年美国市场迎来阿达木单抗生物类似药的组团集体上市，经历了这场相比预期并不算猛烈的暴风雨洗礼后，Humira在过去一年迎来了更严峻的挑战，先后被CVS Caremark、Express Scripts和Optum三大PBM从商业保险药品目录中剔除，被各显神通的多个生物类似药所取代。Humira在美国市场开始受到全面冲击的形势下最终交出了89.93亿美元的答卷，在上年走下王座后进一步下跌38%，极有可能在2025年跌破50亿美元。
2024年，Humira美国市场收入为71.42亿美元（-41%），在其全球总收入中的占比下降至近五年来最低的79%。不过瘦死的骆驼比马大，美国依然是Humira当下仍需仰仗的最大市场。在去年Humira销量突破1100万支的基础上，2024年包括10家生物类似药在内的美国市场总销量出现了8%的小幅下滑，Humira的市场份额开始出现明显萎缩，截至去年12月底已降至71%。从包装形式看，注射笔产品的份额稳定的维持在90%；从规格看，100mg/ml高浓度产品的份额达到了87%，几乎全部被40mg/0.4ml的主流规格所占据。
随着Teva和Alvotech联手开发的Simlandi在去年5月上市，已经获批的全部10个阿达木单抗生物类似药均已登陆美国市场。各家为了上量各出绝招，在价格方面，Amgen等7家公司推出了高低两种价格方案，Organon等3家公司只提供了一种低价WAC方案，一年下来境遇也不尽相同。CVS于2023年8月成立了与生产商直接合作进行生物类似药销售的子公司Codavis，随后宣布与Sandoz就该产品达成合作，从2024年开始供应，凭借近水楼台先得月的渠道优势，Sandoz产品Hyrimoz在去年CVS宣布将Humira剔除出主要商品目录后开始迅速置换上量，同时还被Express Scripts等其他主要PBM覆盖，连同其他渠道的当前总体份额已达到22%，远远甩开其他生物类似药。
BI的Cyltezo虽然贵为首个被FDA授予自动互换资格的阿达木单抗生物类似药，但其销售并不如意，当前市场份额不足1%，为了扭转颓势于去年对其Cyltezo销售团队进行了优化裁员，同时宣布与GoodRx合作，提供相比原研WAC产品价格92%的折扣。虽然其也与Cigna旗下的Quallent建立了合作，但奈何并非独家，上量速度相对较慢。
Celltrion于2023年底先后与PBM公司Ventegra、和连锁药房CarePartners达成了合作，随后又将业务拓展至OptumRx和Costco，目前已经覆盖了全美50%以上的保险业务市场，尽管如此其份额也未突破1%，目前Celltrion还在与Rani Therapeutics合作共同开发口服版阿达木单抗生物类似药RT-105。
Coherus在退圈之前于去年6月将其该产品生物类似药Yusimry以4000万美元的转让给了Meitheal，未来将由Meitheal继续负责该产品商业化销售。综合各家表现来看，除了Sandoz的一枝独秀以外，其他各家份额均相对比较有限，全年销量占比超过1%的仅有Organon一家。
总体来看，2024年是阿达木单抗生物类似药迎来转折的关键一年，截至2024年12月的生物类似药市场整体份额已经升至30%，相比上市元年已经实现了大幅超越，随着多家PBM策略的进一步调整和合作模式的更加多元化，生物类似药的未来依然值得期待。
贝伐珠单抗 (Bevacizumab)
原研产品/公司：Avastin/Roche
美国获批时间：2004/02
竞争难度：★★★★☆
2024年贝伐珠单抗原研产品Avastin在欧美两大市场的下滑速度有所缓和，均为自2020年全面下滑以来的最低，日本市场则因为政府限价创造了近40%的历史最大降幅记录，最终全球收入进一步下滑至12.33亿瑞士法郎（约合14亿美元），整体降幅达到了22%（以恒定汇率计为17%），刷新了历史新低。
2024年，原研产品Avastin美国市场销售收入为3.83亿瑞士法郎（约合4.35亿美元），相比上年下滑了21%，美国市场在全球收入中的区域占比继续维持在31%左右。美国市场贝伐珠单抗的2024年整体销量小幅增长至248万支（+2%），其中生物类似药占比达到了历史最高的88%，目前共有4家生物类似药产品在市销售。
Amgen的贝伐珠单抗首仿生物类似药Mvasi以51%的全年平均份额占据销量榜首位置，但销售额受限于激烈竞争造成的价格下滑已下降至4.49亿美元（-12%）；Pfizer的二仿产品Zirabev继续位列次席，份额由上年的36%降至27%（自2024年起Pfizer将全部抗肿瘤生物类似药收入进行合并报告，不再公布单一生物类似药产品收入。Zirabev的2023年美国市场收入为3.04亿美元）；Amneal和Celltrion分别于2022年和2023年上市的生物类似药Alymsys和Vegzelma份额相比上年均分别提升了3个百分点，继续位列三四位。
从规格看，100mg/4ml产品的销量份额维持在53%左右，相比400mg/16ml的大规格产品略占优势；在价格方面，Vegzelma相比上年大幅下降，降幅达到了30%，其余三个生物类似药的价格相对变化不大，其中Mvasi和Zirabev两个产品的价格相比上一年的大幅下滑有所回升。当前最低平均销售价格（来自Zirabev）为17.5美元/10mg（-50%），相当于原研品价格的25%，原研产品Avastin的价格小幅下降至69美元/10mg（-1.2%）。
Sandoz和百奥泰合作的Avzivi 虽然早在2022年底便已获批成为美国第五个获批的贝伐珠单抗生物类似药，但截至目前仍未上市，获批效期过短的问题在一定程度上可能对其商业化销售造成了一定影响。
Biocon的BMAB-100 (2020年3月接受审评)、Centus的FKB238（2019年11月接受审评）以及Samsung Bioepis的SB8 (2019年11月接受审评)三个贝伐珠单抗生物类似药历时多年仍未获批。
曲妥珠单抗 (Trastuzumab)
原研产品/公司：Herceptin/Roche
美国获批时间：1998/09
竞争难度：★★★★★
面对生物类似药和同领域创新药双重重压的曲妥珠单抗原研产品Herceptin在过去的一年交出了13.81亿瑞士法郎（约合15.7亿美元）的答卷，全球销售额整体降幅达到了15%，（以恒定汇率计为11%），迎来了2017年全球销售峰值过后的七连跌，下滑幅度相比此前几年有所放缓。
2024年，原研产品Herceptin美国市场销售继续下滑至2.65亿瑞士法郎（约合3亿美元），20%的降幅为近五年来最低，美国市场在全球收入中的占比降至历史最低的19.2%。2024年的美国曲妥珠单抗生物类似药之争依然延续着五强争霸的格局，全年生物类似药市场整体销量份额进一步提升至74%。2024年该产品的整体美国市场销量继续下滑至101万支（-6%），420mg大规格产品份额进一步增长至51%。
Amgen的Kanjinti作为首仿产品在2024年表现相对平稳，以29%的份额继续领跑生物类似药，其美国市场销售额跌破1亿美元，在2024年报中也不再单独报告单品收入；Pfizer的三仿产品Trazimera以22%的销量份额排名生物类似药第二，Biocon的二仿产品Ogivri份额提升至16%，依然位列第三，Organon和Teva的两个生物类似药销量份额均未超过5%；在价格方面，Kanjinti在经历了上年的暴跌之后开始触底反弹回升，Trazimera的价格也有所增长，提升至12.8美元/10mg，为当前最低平均销售价格，相当于原研品价格的17.6%，原研产品Herceptin的平均销售价格小幅下降至72.7美元/10mg（-4%）。
复宏汉霖与Accord合作的Hercessi于去年4月获批，成为美国第六个获批的曲妥珠单抗生物类似药，上市批产品已于去年11月底发往美国。截至目前，Sandoz与Eirgenix合作的EGI014 (2021年12月申报 )以及Tanvex的TX-05(2021年10月接受审评) 两个曲妥珠单抗生物类似药产品目前仍处于FDA审评过程中，其中TX-05刚刚于今年1月收到来自FDA的第二次CRL。未来美国市场该产品生物类似药数量预计将接近10家，竞争进一步白热化。
利妥昔单抗（Rituximab）
原研产品/公司：Rituxan /Roche
美国获批时间：1997/11
竞争难度：★★★☆☆
利妥昔单抗原研产品Mabthera/Rituxan ( 分别用于欧洲和美国市场)在2024年紧随Avastin和Herceptin的步伐同步下滑，全球销售额降至13.8亿瑞士法郎（约合15.7亿美元），降幅达到了15%（以恒定汇率计为13%），预计明年该数字将跌破10亿美元。
2024年，原研产品Rituxan美国市场销售收入为8.42亿瑞士法郎（约合9.6亿美元），相比2023年下滑了15%，占到了原研产品全球销售额的61%；利妥昔单抗生物类似药的整体销量占比进一步增加至80%， 目前共有三家生物类似药在售。2024年该产品的整体美国市场销量为221万支（+3%），相比上年略有提升，约55%的份额来自于100mg/10ml的小规格产品。
作为比首仿晚两个月上市的二仿产品，Pfizer的Ruxience以37%的全年份额继续领跑，3.08亿的美国市场销售额相比上年下降了24%，Teva的首仿产品Truxima排名第二，其份额升至32%，进一步缩小了与Ruxience的差距，于2021年最晚上市的Amgen的Riabni份额提升至11%。在价格方面，持续降价的Ruxience在去年有所止血，其平均销售价格提升至17.5美元/10mg，仍为目前该产品的生物类似药最低价格，相当于原研品价格的24%，原研产品Rituxan的价格小幅下降至72美元/10mg（-3%）。
除当前在市销售的3家外，后续针对美国市场的竞品相对比较匮乏，目前处于FDA审评中的生物类似药仅剩Dr Reddy’s和Fresenius合作的产品DRL_RI，该产品于2023年7月被FDA接受审评，在去年4月收到了FDA的CRL，缺陷主要涉及生产场地检查，短期内该产品的竞争将维持在原研产品以及3-4个生物类似药之间。
非格司亭（Filgrastim）
原研产品/公司：Neupogen/Amgen
美国获批时间：1991/02
竞争难度：★★★☆☆
限于销售额过小已于2023年开始不再Amgen年报中单独报告销售收入的非格司亭原研品Neupogen在2024年与该分类中包括6个生物类似药在内的另外10个产品一起取得了13.45亿美元的全球销售额，从趋势看Neupogen全球销售额已跌破一亿美元，在众多已有生物类似药上市的原研产品中表现最为惨淡。
2024年，该产品的美国整体市场量约223万支，相比上年小幅下滑（-4%），其中预冲注射器产品占比增长至86%；从市场竞争来看，除去Teva以351(a)途径获批的Granix外，过去一年依然延续着Sandoz、Pfizer和Amneal三家仿制药竞争的局面。生物类似药的整体销量份额进一步小幅提升至84%（不含Granix），生物类似药渗透率最高分子的光环被贝伐珠单抗所取代，其中Sandoz的首仿产品Zarxio依旧份额稳居榜首，但相比上年出现了一定幅度的下滑将至51%。Pfizer的二仿产品Nivestym进一步将份额提升至27%。2022年最晚上市的Releuko排名末尾，份额又上年的不足1%增加至5%；
从价格看，原研产品Neupogen的价格相较于仿制药上市前几乎没有大的变化，当前最低平均销售价格（来自Nivestym）已降至0.21美元/1mcg（-3%），相当于原研品价格的23%，Zarxio继上年后再度实现了价格增长，相比上年价格提升了14%，Neupogen价格基本与去年持平。除去去年刚有生物类似药上市的托珠单抗和依那西普外，非格司亭在美国市场所有已有生物类似药上市的分子中销售额排名垫底。
Tanvex的ANDA历时近6年终于获批，预计将于今年上市，目前看后续已暂无其他以美国市场为目标的处于晚期的在研非格司亭生物类似药，考虑到整体市场的持续萎缩，预计该分子下生物类似药的数量很可能将定格在4家。
聚乙二醇化非格司亭（PEG-filgrastim/PEG-GCSF）
原研产品/公司：Neulasta/Amgen
美国获批时间：2002/01
竞争难度：★★★★★
随着Coherus自动注射器产品在去年的退出，Amgen美国市场最后的防御体系开始遭遇猛烈冲击，
选择不断跟进与生物类似药硬扛价格争取以价保量的原研产品Neulasta在2024年的全球销售额继续暴跌至4.31亿美元（-49%），其中美国市场收入占比下降至74%。
2024年Neulasta美国市场销售额降至3.18亿美元（-55%），在全球销售额中的占比下滑至74%。市场总量下滑至130万支（-4%），自动注射器产品份额进一步下降至34%，其中的95%依然被Amgen占据，占据另外6%份额的预充注射器产品之争在原研公司Amgen与Coherus等6家生物类似药公司之间展开。接替Viatris开始独立进行销售的Biocon将首仿产品Fulfila全年份额提升至36%，以微弱优势占据预充注射器产品榜首，Coherus的二仿产品Udenyca以1%的差距紧随其后，原研产品Neulasta份额下滑至16%，Pfizer的四仿产品Nyvepria以8%的份额排名第四，Sandoz的三仿产品Ziextenzo以及Fresenius和Amneal于2023年新上市的Stimufend和Fylnetra三个生物类似药的份额均未超过3%。将预充注射器、注射笔和自动注射器三种形式产品的销量合并计算，2024年该产品生物类似药的整体份额突破一半达到了54%。
在价格方面，原研产品Neulasta最新平均销售价格已降至226美元（-61%），相比生物类似药进入市场前的价格降幅达到了95%，已经低于277美元/支的当前生物类似药最低平均销售价格（来自Ziextenzo），Neulasta也成为了目前有生物类似药上市的分子中降价幅度最大且价格低于全部生物类似药的原研产品，其余4个生物类似药的平均销售价格均保持在1300美元/支以上。
Coherus于去年2月在美国正式上市了自动注射器产品UDENYCA® ONBODY™ ，成为了首个与原研Neulsata Onpro直接竞争的生物类似药产品，注射时间仅为5分钟，加之已经于2023年5月推出的独有的注射笔产品UDENYCA® Autoinjector以及各家均有的预充注射器产品，成为了目前集齐全部三种形式产品的公司。随着Coherus于去年12月完成转让交易，未来该产品将由Accord进行商业化销售。
Lupin的该产品生物类似药目前仍处于FDA审评中，其审评时间已近4年仍未获批。Aurobindo已明确将在美国申报该产品，加之处于临床阶段的Tanvex的TX-04, 未来该产品美国市场生物类似药数量极有可能达到10家。在目前市场高度内卷的激烈态势下，未来竞争将更加白热化。
英夫利昔单抗（Infliximab）
原研产品/公司：Remicade/J&J
美国获批时间：1998/08
竞争难度：★★★☆☆
随着美国等全球多个市场生物类似药渗透的不断加强，2024年Remicade的销量和价格持续同步下滑，全球销售额降至18.16亿美元（-21%），下滑幅度与去年持平。
2024年，Remicade美国市场销售额为11.1亿美元（-14%），下滑幅度低于往年，在全球销售额中占比增加至61%，，英夫利昔单抗美国整体市场销售量小幅增长至1014万支（+1%），生物类似药增速有所放缓，整体份额小幅增加至49%，原研依然占据着半壁江山。
目前共有Pfizer的Inflectra、Organon的Renflexis以及Amgen的Avsola三家生物类似药在售，各家销量份额相比于2023年变化不大，首仿产品Inflectra以27%份额继续排在首位， 销售额达到了2.68亿美元，Avsola和Renflexis份额均在10%左右，位列二三位。
整体市场价格依然保持了持续下滑的趋势，当前生物类似药的最低平均销售价格（来自Inflectra）进一步降至9.11美元/10mg（-23%），相当于原研品价格的32%，原研产品Remicade的价格小浮下降至28.8美元/10mg（-5%），当前生物类似药最低平均销售价格相比首仿上市时原研价格已经下降了88%。Celltrion于去年3月上市了其皮下注射版英夫利昔单抗产品Zymfentra，凭借其相比生物类似药的高价，在全年销量不足1万支的情况下依然取得了千万级别的销售收入，该产品当前平均销售价格为246美元/10mg，相当于生物类似药整体平均销售价格的15倍。
目前暂时已无其他进展较快的潜在竞争对手在短期内寻求在美申报英夫利昔单抗生物类似药。
阿法依伯汀/依泊汀α（Epoetin Alfa）
原研产品/公司：Epogen &Procrit /Amgen
美国获批时间：1989/06
竞争难度：★★☆☆☆
安进负责的阿法依伯汀美国市场部分2024年销售额进一步大幅下滑至1.25亿美元(-45%)，J&J负责的美国及全球其他市场部分因销售额过低自2022年起已不在财报中单独列出。
自Pfizer的生物类似药Retacrit于2018年底上市以来，一直未有新的生物类似药获批，2024年该产品的美国市场整体销量下滑至669万支，Retacrit的全年市场份额继续保持在43%，年报自2024年起不再单独报告其收入，其当前平均销售价格在过去一年小幅降至0.71美元/100units（-2%），原研产品价格出现了27%的降幅，当前平均销售价格0.61美元/100units，已经低于生物类似药Retacrit。
暂时没有更多关于后续有计划在美国市场开发该产品生物类似药的其他公司的相关进展报道，考虑到该产品整体市场的不断萎缩，预计未来很难有新的生物类似药产品寻求进入美国市场，两个原研品与一个生物类似药竞争的局面仍将继续维持下去。
甘精胰岛素（Insulin Glargine）
原研产品/公司：Lantus /Sanofi
美国获批时间：2000/04
竞争难度：★★★☆☆
得益于美国市场竞品出现供应问题，2024年甘精胰岛素原研产品Lantus的全球销售取得了意外的增长，整体销售额为16.28亿欧元（折合18亿美元），取得了14.6%的增长，暂时止住了自2016年以来的8连跌。
2024年，Lantus美国市场大涨127%，销售额增长至6.38亿欧元（折合7亿美元），在全球销售额中占比由20%增加至39%，美国市场甘精胰岛素注射液整体销量小幅增加至1.2亿支，当前竞争在Eli Lilly、Biocon和原研Sanofi三家之间展开。Sanofi共有原研产品Lantus、升级产品Toujeo以及于2022年推出的非品牌版本三种甘精胰岛素产品。Toujeo成分与Lantus相同但释放活性成分更平缓，低血糖发生率显著降低，但临床的不可替代性相对较低。Biocon于去年正式接手Viatris开始销售具有可互换资格的生物类似药Semglee以及其非品牌版本产品。Eli Lilly在之前销售的以化药NDA获批并完成BLA转换的Basaglar基础上于2023年上市了同样具有可互换资格的生物类似药Rezvoglar，目前已经拥有两款甘精胰岛素产品在市销售。
2024年，生物类似药的份额维持在12%，渗透速率较慢，此前各家受《通胀削减法案》的影响均进行了不同程度的降价以响应将患者每月的胰岛素自付费用限制在35美元的要求，从当前的WAC价格看，Lantus和Semglee非品牌版本产品的价格维持在34美元/1000IU和30美元/1000IU。
Sandoz和甘李合作的甘精胰岛素生物类似药已经于2023年2月被FDA接受审评，目前仍处于FDA审评过程中；健友与通化东宝于2023年达成战略合作，共同推进甘精、门冬、赖脯三种胰岛素注射液在美国市场的开发和生产。
雷珠单抗（Ranibizumab）
原研产品/公司：Lucentis/Roche
美国获批时间：2000/04
竞争难度：★★★☆☆
原研产品Lucentis在同领域其他创新药竞品及生物类似药的激烈竞争下不断萎缩，2024年的全球销售额最终以39%的历史最大跌幅定格在12.1亿美元，负责美国市场销售的Roche和美国外其他市场销售的Novartis分别贡献了其中的14%和86%。
2024年Lucentis美国市场销售额为1.44亿瑞士法郎（折合1.64亿美元）， 降幅达到了历史最高的67% ，市场总量进一步下降至77.5万支(-18%)，预充注射器装产品的份额在目前只有瓶装产品的生物类似药竞争下从2022年的99%下滑至目前的47%。Samsung Bioepis的雷珠单抗首仿产品Byooviz以及Coherus在去年初转让给Sandoz的二仿产品Cimerli于2022年6月和10月相继上市后在2024年里进一步渗透，将生物类似药的整体份额提升至53%，其中Cimerli的份额达到了44%。
在价格方面，当前原研产品Lucentis最新的平均销售价格已降至117美元/0.1mg（-34%），相比生物类似药上市之前的自身价格已经下降了56%，已经低于117美元/0.1mg（-33%）的当前生物类似药最低平均销售价格（来自Cimerli），成为了另一个价格低于当前在市的全部生物类似药的原研产品。
出于战略层面考虑，Coherus在去年1月将视为非核心资产的Cimerli以1.7亿美元的首付款转让给了Sandoz，未来将更加专注于肿瘤领域的创新药产品，收购于去年3月初完成，BLA已转移至Sandoz名下，Sandoz借此在阿柏西普的基础上补强了自身的眼科生物类似药产品线；
三大联盟之一的Xbrane/Stada在此前终止了与Bausch + Lomb在美国市场的合作后于去年5月又和Valorum达成合作，授权许可费最高可达4500万美元，其BLA先后两次收到CRL，最近一次回复于去年12月底完成，有望于今年中旬获批。Lupin于去年4月宣布其LUBT010已经顺利完成了针对美国市场的III期临床试验，但截至目前仍未申报。
托珠单抗（Ranibizumab）
原研产品/公司：ACTEMRA/Roche
美国获批时间：2010/01
竞争难度：★★★☆☆
随着Biogen和Fresenius各自生物类似药在去年在美上市，托珠单抗成为美国市场又一面临生物类似药竞争的新分子。该产品上市以来全球销售额持续增长并于2021年达到35.62亿瑞士法郎（约合44.4亿美元）的销售峰值，随后受2022疫情和2023欧洲托珠单抗生物类似药上市影响开始出现下滑。2024年其全球收入为26.45亿瑞士法郎（约合30亿美元），与上年基本持平。
2024年，原研产品Actemra美国市场销售收入为13.31亿瑞士法郎（约合15亿美元），相比2023年增长了9%，占到了原研产品全球销售额的50.3%。2024年该产品的整体美国市场销量为179万支（+12%），保持持续增长状态，约49%的份额来自于162mg/0.9ml的皮下注射产品，其余来自于三个规格的静脉注射产品，静脉注射产品包装为西林瓶，皮下注射产品包装为预充式注射器和注射笔。目前共有两家生物类似药在售，分别为Biogen的Tofidence以及Fresenius的Tyenne，两个产品均为去年上市，合计份额不足市场总量的1%。当前最低平均销售价格（来自Tyenne）为4.1美元/1mg，相当于原研品价格的73%。
Celltrion的托珠单抗生物类似药Avtozma已于今年1月底在美获批，预计将于今年上半年上市；Dr Reddy’s的托珠单抗生物类似药DRL_TC目前处于III期临床阶段。
未来展望
花开花落，又是一年，时光的脚步从不停歇, 留下了岁月的痕迹和那些难忘的回忆。再过几天即将迎来美国市场首个351(K)途径获批的生物类似药Zarxio的十周年纪念日。回首往昔，寸步不让的诉讼大战、出其不意的冒险上市、万众瞩目的组团PK……一幕幕划过脑海，不屈的信念和进击的力量早已刻在了这十年光阴的每一天，在逆风中逐渐成长，在未知中不断探索，在挑战中持续突破，一切都是崭新的。
在研发方面，针对一系列爆品的群雄逐鹿激战正酣，短期内的重磅大药依然是各家追逐的首要目标，但也必须意识到肉多狼也多的潜在风险并警惕原研公司推出升级产品的最后一搏，一旦无法获得较为靠前的顺位并与后者拉开差距，竞争难度将明显增大。目前尚未有生物类似药开发的可选分子还有不少，纵观各家产品管线，部分规模不及巨头体量的中小型公司开始更加务实的将未来的管线产品选择放在了一些市场体量相对较小的低竞争分子上面以避开与多家实力更强的竞争对手之间的直接冲突，例如Lupin早期管线中的培塞利珠单抗和美泊利单抗等产品。肿瘤和自身免疫两大领域依然是接下来最为火爆的战区，相比于慢性病用药，生物类似药在抗肿瘤领域的渗透速度明显更快，接受度也更高。很多时候在研发水平硬实力之外，明晰的开发思路和策略以及全面的考量和布局显得更为重要，2025年将迎来乌司奴单抗和地舒单抗两大分子多个生物类似药产品的全面上市，生物类似药的美国市场整体规模将突破百亿美元大关。
在竞争方面，除了采取差异化策略推出升级产品限制生物类似药竞争以外，越来越多的原研公司开始一改往日孤傲的刻板印象走下神坛与生物类似药竞品真刀真强拼价格，再持续推出重磅新品抵消原有核心产品专利悬崖带来的冲击越来越慢、越来越难的情况下，价格战也未尝不是一条可以选择的道路。生物类似药在内部竞争的同时所面临的来自原研产品的压力加大，产品的高价格红利期越来越短，不可能一直赚钱但却真的可能一直不怎么赚钱，单靠一个产品孤注一掷同样变得越发不现实，多年审评不过的案例越来越多，从长远看对入局者依托于自身实际、科学的建立与自身策略相匹配的可持续性研发管线的要求逐渐增加，不确定性一直都在，敢于拥抱不确定性并在其中寻找和把握确定性或许将成为在破局之路杀出重围的关键。
在合作方面，其实圈子就那么大，生物类似药相比小分子化药特别是在研发和销售端针对限定市场可以选择的合作伙伴更加有限，现有各项合作的达成基本都是圈子里有限可选项之间的各种连线组合。相比于研发端，在销售端可选的数量则更少，有时限于可选方在产品领域匹配度、市场竞争形式和反选资源丰富程度的考虑，找到一个合适的商业化合作伙伴确实不容易。Case的大小取决于销售伙伴能够在限定时间内赚到的多少，有时几个月的差距就会带来数千万美元授权许可费的滑落，不管做哪个，快总没错。对于销售商而言，在考虑产品引进时的可选项则更加丰富，同一产品针对不同市场选择不同合作伙伴和有晚期哪怕贵点绝不选早期以最大提速同时规避风险的策略和案例在近年来愈发常见，不管要哪个，慢就不行。
在注册方面，生物类似药产品申报数量在2024财年继续维持在了高点，考虑到当前已经完成III期临床研究但尚未申报以及将于2026年完成临床研究的产品数量，在经历了过去两年针对多个重磅大产品的申报潮之后可能会在2025年申报数量上出现一定的减少。新的一年里BsUFAIII（生物类似药用户付费法案）将进入实施周期内的第三个财年，2025财年生物类似药申请费和项目费相比上一财年发生了近一半的增幅，临床类和非临床类产品申请费分别增加至1471118美元和735559美元，项目费增加至256168美元，包括初始BPD费、年度BPD费用和再激活费的开发费(BPD)与上一财年保持齐平。
在监管方面，FDA对于生物类似药申报必须需要完整III期临床研究数据的要求也在悄然转变，两家研发型公司Xbrand和Formycon先后披露了其在与FDA分别就其纳武利尤单抗和帕博利珠单抗简化临床研究方案进行沟通后得到的积极性意见。其中Xbrane 公司的开发计划包括一项单一临床试验，与采用单独的I期和III期试验的传统方法相比，该计划将临床开发预算至少减少了60%，从约1.2 亿美元降至 5000万美元或更低；Formycon则在沟通后终止了其正在进行的III 期临床试验，可以通过正在进行的针对黑色素瘤适应症的平行研究数据，结合全面的分析项目充分证明其生物类似药与原研产品在治疗效果上的可比性，终止 III 期临床试验可能在未来几年节省高达数千万欧元的投资。从大趋势来看，FDA针对生物类似药的监管政策更加灵活，两家公司的案例也给更多其他生物类似药研的开发者提供了非常好的启示，使得未来研究提速的同时节省大量费用逐步常态化成为可能。
在政策方面，通胀削减法案（IRA法案）进一步助力生物类似药，美国政府通过取消可互换性限制、优化报销结构、加速审批流程和限制原研专利诉讼数量等措施，显著推动了生物类似药的发展。美国医保局取消了生物类似药替换原研药时需获得CMS提前批准的要求。此前，只有被认定为可互换的生物类似药才能直接替换原研药，而新规则允许所有生物类似药在无需额外审批的情况下进行替换；Medicare Part B对生物类似药的报销比例提高了两个百分点（在平均销售价格基础上加8%）以鼓励医疗服务提供者开具生物类似药处方；美国参议院通过一项法案，旨在通过限制制药商在针对潜在生物仿制药竞争对手的侵权诉讼中可以主张的专利数量来遏制专利制度的滥用；若两年年内有生物类似药上市，原研药可以延迟药价谈判，一定程度上平衡了原研药和生物类似药的市场环境……
心之所向，无问西东。纵使桃李凋零处风雨未歇，那些穿越周期的新芽，终将在荆棘丛生的赛道上，拓出一片可期的春色。
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生物类似药疫苗专利到期加速审批上市批准
2025-02-05
After recent launches of biosimilar versions of Regeneron and Bayer's Eylea and Johnson & Johnson's Stelara, Amgen sees its biosimilar sales nearly doubling from $2.2 billion in 2024 to $4 billion by the end of the decade.
Less than a decade since it secured its first FDA approval for a biosimilar, Amgen’s portfolio of the copycat drugs is growing and making strong contributions to the company’s top line.In 2024, when Amgen generated $33.4 billion in revenue, more than $2.2 billion came from sales of its biosimilars. It was a 16% increase from Amgen’s biosimilar sales in 2023 and the company appears ready to top that figure this year.Less than three months ago, Amgen became the first company in the U.S. to launch a biosimilar version of Regeneron and Bayer’s eye disease blockbuster Eylea. Then last month, Amgen brought to the market a knockoff of Johnson & Johnson immunology powerhouse Stelara.In the last nine weeks of last year, Amgen’s Eylea biosimilar, Pavblu, generated $31 million in sales.“The current feedback from retina specialists that we’ve been talking to is very enthusiastic, very positive,” Murdo Gordon, Amgen’s global commercial operations chief, said Tuesday during a quarterly conference call. “They are pleased that Amgen is bringing yet another high-quality biosimilar in a very easy-to-use prefilled syringe.”Reiterating the words of Amgen CEO Robert Bradway, Gordon added the importance the company places on being in the “first wave” when it launches a biosimilar, as was the case with Pavblu and its Stelara copycat Wezlana. “That represents an opportunity that we will capitalize on,” Gordon said. Being first was beneficial for Amgen with its version of AbbVie’s mega-blockbuster Humira. Amjevita was first to the market when it launched in Europe in 2018 and in the U.S., where it debuted in January of 2023.Amjevita sales reached $763 million last year, a 22% bump from 2023. Meanwhile, Amgen’s sales of Mvasi—a biosimilar version of Roche’s Avastin—are finally starting to fade, falling 9% last year to $727 million.Soon to fill the void will be Bkemv, which is Amgen’s copycat of AstraZeneca’s Soliris. It is set to launch in the second quarter of this year, according to an Amgen investor presentation (PDF). Amgen also expects in the second quarter to read out a phase 3 trial of its biosimilar edition of Bristol Myers Squibb’s cancer immunotherapy Opdivo.In the works further down the pipeline are biosimilar versions of Merck’s cancer superstar Keytruda and Roche’s multiple sclerosis blockbuster Ocrevus. Amgen’s chief financial officer Peter Griffith added that the company expects biosimilar sales to reach $4 billion by the end of the decade.“We’ve built what we think, obviously, is an industry-leading biosimilar franchise,” Griffith said. “We operate very efficiently. We leverage the broader Amgen footprint, including manufacturing and operations.”
上市批准临床3期生物类似药
2025-02-04
THOUSAND OAKS, Calif., Feb. 4, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the fourth quarter and full year of 2024 versus comparable periods in 2023.
"Robust growth in sales and earnings throughout 2024 reflects the momentum of our business. With strong performance globally, we are investing heavily in our rapidly advancing pipeline to deliver innovative therapies across our four therapeutic areas," said Robert A. Bradway, chairman and chief executive officer.
Key results include:
For the fourth quarter, total revenues increased 11% to $9.1 billion in comparison to the fourth quarter of 2023.
Product sales grew 11%, primarily driven by 14% volume growth. Excluding sales from our Horizon Therapeutics (Horizon) acquisition, product sales grew 10%, driven by volume growth of 15%.
Ten products delivered at least double-digit sales growth in the fourth quarter, including Repatha® (evolocumab), BLINCYTO® (blinatumomab), TEZSPIRE® (tezepelumab-ekko), EVENITY® (romosozumab-aqqg) and TAVNEOS® (avacopan).
Our performance included $1.2 billion of sales from our rare disease products, driven by several first-in-class, early-in-lifecycle medicines, including TEPEZZA® (teprotumumab-trbw), KRYSTEXXA® (pegloticase), UPLIZNA® (inebilizumab-cdon) and TAVNEOS®.
For the full year, total revenues increased 19% to $33.4 billion in comparison to the full year of 2023.
Product sales grew 19%, primarily driven by 23% volume growth, partially offset by 2% lower net selling price. Excluding sales from our Horizon acquisition, product sales grew 7%, driven by volume growth of 11%.
Ten products delivered at least double-digit sales growth for the full year, including Repatha®, TEZSPIRE®, EVENITY®, BLINCYTO® and TAVNEOS®.
21 products achieved record sales for the full year.
GAAP earnings per share (EPS) decreased 18% from $1.42 to $1.16 for the fourth quarter, primarily driven by mark-to-market losses on our equity investments, partially offset by higher revenues. For the full year, GAAP EPS decreased 39% from $12.49 to $7.56, primarily driven by higher operating expenses, including amortization expense from Horizon acquisition-related assets and incremental operating expenses from Horizon, and overall mark-to-market losses on our equity investments in 2024, partially offset by higher revenues.
For the fourth quarter, GAAP operating income increased from $1.3 billion to $2.3 billion, and GAAP operating margin increased 10.3 percentage points to 26.5%. For the full year, GAAP operating income decreased from $7.9 billion to $7.3 billion, and GAAP operating margin decreased 6.6 percentage points to 22.7%.
Non-GAAP EPS increased 13% from $4.71 to $5.31 for the fourth quarter, driven by higher revenues, partially offset by higher operating expenses. For the full year, non-GAAP EPS increased 6% from $18.65 to $19.84, driven by higher revenues, partially offset by higher operating expenses, including incremental operating expenses from Horizon, and higher interest expense.
For the fourth quarter, non-GAAP operating income increased from $3.7 billion to $4.0 billion, and non-GAAP operating margin decreased 0.4 percentage points to 46.3%. For the full year, non-GAAP operating income increased from $13.4 billion to $15.0 billion, and non-GAAP operating margin decreased 2.9 percentage points to 46.9%.
The Company generated $10.4 billion of free cash flow for the full year versus $7.4 billion in 2023, driven by business performance and timing of working capital items, primarily collections, partially offset by higher net interest expense.
References in this release to "non-GAAP" measures, measures presented "on a non-GAAP basis," "free cash flow" (computed by subtracting capital expenditures from operating cash flow), "EBITDA, or earnings before interest, taxes, depreciation and amortization" (computed by adding interest expense, provision for income taxes, and depreciation and amortization expense to GAAP net income) and "debt leverage ratio" (calculated as the ratio of GAAP total debt to EBITDA) refer to non-GAAP financial measures. Adjustments to the most directly comparable GAAP financial measures and other items are presented on the attached reconciliations. Refer to Non-GAAP Financial Measures below for further discussion.
Product Sales Performance
General Medicine
Repatha® (evolocumab) sales increased 45% year-over-year to $606 million in the fourth quarter, primarily driven by volume growth. Full year sales increased 36%, primarily driven by 43% volume growth, partially offset by 10% lower net selling price. For 2025, we expect lower declines in net selling price.
EVENITY® (romosozumab-aqqg) sales increased 36% year-over-year to $431 million in the fourth quarter and 35% for the full year, driven by volume growth.
Prolia® (denosumab) sales increased 5% year-over-year to $1.2 billion in the fourth quarter and 8% for the full year, driven by volume growth. For 2025, we expect sales erosion driven by biosimilar competition.
Rare Disease
Except for TAVNEOS®, the products listed below were added through the acquisition of Horizon on Oct. 6, 2023.
TEPEZZA® (teprotumumab-trbw) generated $460 million of sales in the fourth quarter and $1.9 billion for the full year. TEPEZZA is the first and only approved treatment for thyroid eye disease (TED) in the U.S. and Japan.
KRYSTEXXA® (pegloticase) generated $346 million of sales in the fourth quarter and $1.2 billion for the full year. KRYSTEXXA is the first and only FDA-approved treatment for chronic refractory gout.
UPLIZNA® (inebilizumab-cdon) generated $101 million of sales in the fourth quarter and $379 million for the full year. UPLIZNA is used to treat adults with neuromyelitis optica spectrum disorder (NMOSD).
TAVNEOS® (avacopan) generated $81 million of sales in the fourth quarter. Sales increased 84% year-over-year in the fourth quarter and 111% for the full year, primarily driven by volume growth. TAVNEOS is a first-in-class treatment for severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (ANCA-associated vasculitis).
Ultra-Rare products, which consist of
RAVICTI® (glycerol phenylbutyrate),
PROCYSBI® (cysteamine bitartrate),
ACTIMMUNE®
(interferon gamma-1b),
QUINSAIR® (levofloxacin) and
BUPHENYL® (sodium phenylbutyrate), generated $214 million of sales in the fourth quarter and $758 million for the full year.
Inflammation
TEZSPIRE® (tezepelumab-ekko) sales increased 67% year-over-year to $296 million in the fourth quarter and 71% for the full year, primarily driven by volume growth.
Otezla® (apremilast) sales decreased 1% year-over-year to $624 million in the fourth quarter, driven by 7% lower net selling price, partially offset by 5% volume growth. Sales decreased 3% for the full year, primarily driven by 8% lower net selling price, partially offset by 3% volume growth.
Enbrel® (etanercept) sales were flat year-over-year at $1.0 billion in the fourth quarter as 7% favorable changes to estimated sales deductions were offset by lower net selling price. Full year sales decreased 10%, driven by lower net selling price. For 2025, we expect continued declining net selling price and relatively flat volumes.
We expect Otezla and Enbrel to follow the historical pattern of lower sales in the first quarter relative to subsequent quarters due to the impact of benefit plan changes, insurance reverification and increased co-pay expenses as U.S. patients work through deductibles.
AMJEVITA®/AMGEVITA™ (adalimumab) sales increased 84% year-over-year to $294 million in the fourth quarter and 22% for the full year, driven by volume growth, partially offset by lower net selling price.
Oncology
BLINCYTO® (blinatumomab) sales increased 58% year-over-year to $381 million in the fourth quarter and 41% for the full year, primarily driven by volume growth.
Vectibix® (panitumumab) sales decreased 2% year-over-year to $246 million in the fourth quarter, driven by 5% unfavorable foreign exchange impact and 4% lower volume, partially offset by higher net selling price. Sales increased 6% for the full year, driven by 8% higher net selling price and 4% volume growth, partially offset by unfavorable foreign exchange impact.
KYPROLIS® (carfilzomib) sales increased 6% year-over-year to $372 million in the fourth quarter and 7% for the full year, driven by volume growth outside the U.S.
LUMAKRAS®/LUMYKRAS™ (sotorasib) sales increased 10% year-over-year to $85 million in the fourth quarter, primarily driven by volume growth. Sales increased 25% for the full year, driven by volume growth and favorable changes to estimated sales deductions.
XGEVA® (denosumab) sales increased 6% year-over-year to $561 million in the fourth quarter, driven by volume growth. Sales increased 5% for the full year, driven by higher net selling price. For 2025, we expect sales erosion driven by biosimilar competition.
Nplate® (romiplostim) sales decreased 13% year-over-year to $337 million in the fourth quarter. Excluding a fourth quarter 2023 U.S. government order of $62 million, Nplate sales grew 4% year-over-year in the fourth quarter, driven by volume growth. Full year sales decreased 1%. U.S. government orders were $128 million in 2024 compared to $286 million in 2023. Excluding these U.S. government orders, Nplate sales grew 12% year-over-year for the full year, driven by 8% volume growth and 6% higher net selling price.
IMDELLTRA® (tarlatamab-dlle) generated $67 million of sales in the fourth quarter. Sales increased 86% quarter-over-quarter, driven by volume growth and inventory levels. IMDELLTRA is the first and only FDA-approved bispecific T-cell engager (BiTE
®) therapy for the treatment of extensive-stage small cell lung cancer (ES-SCLC).
MVASI® (bevacizumab-awwb) sales decreased 8% year-over-year to $173 million in the fourth quarter and 9% for the full year.
Established Products
Our established products, which consist of
EPOGEN® (epoetin alfa),
Aranesp® (darbepoetin alfa),
Parsabiv® (etelcalcetide) and
Neulasta® (pegfilgrastim), generated $500 million of sales in the fourth quarter. Sales decreased 29% year-over-year for the fourth quarter, driven by volume declines, unfavorable changes to estimated sales deductions and lower net selling price. Sales decreased 19% for the full year, driven by volume declines, lower net selling price and unfavorable changes to estimated sales deductions.
Product Sales Detail by Product and Geographic Region
Operating Expense, Operating Margin and Tax Rate Analysis
On a GAAP basis:
Total Operating Expenses decreased 2% year-over-year for the fourth quarter and increased 29% for the full year.
Cost of Sales as a percentage of product sales decreased 4.0 percentage points for the fourth quarter primarily driven by lower amortization expense from the fair value step-up of inventory acquired from Horizon, partially offset by changes in our sales mix, and higher profit share and royalty expense. For the full year, cost of sales as a percentage of product sales increased 8.7 percentage points driven by higher amortization expense from Horizon acquisition-related assets and, to a lesser extent, higher profit share and royalty expense, partially offset by the Puerto Rico excise tax.
Research & Development (R&D) expenses increased 12% for the fourth quarter driven by higher spend in later-stage clinical programs, partially offset by lower research and early pipeline spend. R&D expenses increased 25% for the full year driven by higher spend in later-stage clinical programs and marketed products support, including spend from Horizon-acquired programs.
Selling, General & Administrative (SG&A) expenses decreased 17% for the fourth quarter primarily driven by lower Horizon acquisition-related expenses. SG&A expenses increased 15% for the full year primarily driven by expenses from the acquired Horizon business and other commercial expenses, partially offset by lower Horizon acquisition-related expenses incurred in 2024.
Other operating expenses for the full year primarily consisted of impairment charges associated with in-process R&D (IPR&D) intangible assets related to our Teneobio, Inc. acquisition in 2021 and expenses related to cost-savings initiatives incurred in 2024.
Operating Margin as a percentage of product sales increased 10.3 percentage points to 26.5% for the fourth quarter and decreased 6.6 percentage points to 22.7% for the full year.
Tax Rate increased 9.8 percentage points in the fourth quarter and decreased 3.2 percentage points for the full year. The fourth quarter tax rate increase was related to deferred tax adjustments associated with the U.S. minimum tax on the earnings of our foreign subsidiaries and prior year favorable items, partially offset by the change in earnings mix as a result of the fourth quarter 2024 unrealized losses on our strategic equity investments (primarily BeiGene). The full year tax rate decrease was due to the change in earnings mix, including the net unrealized impacts of our strategic equity investments (primarily BeiGene), partially offset by the deferred tax adjustments associated with the U.S. minimum tax on the earnings of our foreign subsidiaries.
On a non-GAAP basis:
Total Operating Expenses increased 11% year-over-year for the fourth quarter and increased 24% for the full year.
Cost of Sales as a percentage of product sales increased 1.3 percentage points for the fourth quarter driven by changes in our sales mix, and higher profit share and royalty expense. Cost of sales as a percentage of product sales increased 0.9 percentage points for the full year driven by higher profit share and royalty expense, partially offset by the Puerto Rico excise tax.
R&D expenses increased 14% for the fourth quarter driven by higher spend in later-stage clinical programs, partially offset by lower spend in research and early pipeline. R&D expenses increased 25% for the full year driven by higher spend in later-stage clinical programs and marketed products support, including spend from Horizon-acquired programs.
SG&A expenses increased 3% for the fourth quarter driven by higher general and administrative expenses. SG&A expenses increased 23% for the full year primarily driven by expenses from the acquired Horizon business and other marketed product expenses.
Operating Margin as a percentage of product sales decreased 0.4 percentage points to 46.3% for the fourth quarter and decreased 2.9 percentage points to 46.9% for the full year.
Tax Rate decreased 1.1 percentage points for the fourth quarter and decreased 2.0 percentage points for the full year. The fourth quarter tax rate decrease was primarily due to the change in earnings mix and net favorable items as compared to the prior year. The full year tax rate decrease was primarily due to the change in earnings mix as a result of the inclusion of the Horizon business and net favorable items as compared to the prior year.
Cash Flow and Balance Sheet
The Company generated a record $4.4 billion of free cash flow in the fourth quarter of 2024 versus $0.3 billion in the fourth quarter of 2023, driven by timing of tax payments, timing of working capital, primarily collections, lower transaction expenses compared to the fourth quarter of 2023, which included significant costs tied to the closing of the Horizon acquisition, and business performance. The Company generated $10.4 billion of free cash flow for the full year 2024 versus $7.4 billion in 2023.
The Company's fourth quarter 2024 dividend of $2.25 per share was declared on October 25, 2024, and was paid on December 9, 2024, to all stockholders of record as of November 18, 2024, representing a 6% increase from the same period in 2023.
During the fourth quarter, there were no repayments or extinguishments of debt. For the full year 2024, the Company reduced principal debt outstanding by $4.5 billion.
For the fourth quarter and full year, the Company repurchased 0.7 million shares of common stock at a total cost of $200 million.
Cash and investments totaled $12.0 billion and debt outstanding totaled $60.1 billion as of December 31, 2024. Debt leverage was approximately 4.5 times EBITDA as of December 31, 2024.
2025 Guidance
For the full year 2025, the Company expects:
Total revenues in the range of $34.3 billion to $35.7 billion.
On a
GAAP basis, EPS in the range of $10.89 to $12.14, and a
tax rate in the range of 11.0% to 12.5%.
On a
non-GAAP basis, EPS in the range of $20.00 to $21.20, and a
tax rate in the range of 15.0% to 16.0%.
Capital expenditures to be approximately $2.3 billion.
Share repurchases not to exceed $500 million.
Fourth
Quarter Product and Pipeline Update
The Company provided the following updates on selected product and pipeline programs:
General Medicine
MariTide (maridebart cafraglutide, AMG 133)
MariTide is a differentiated peptide-antibody conjugate that activates the glucagon like peptide 1 (GLP-1) receptor and antagonizes gastric inhibitory polypeptide receptor (GIPR).
In November 2024, data were presented from Part 1 of a Phase 2 chronic weight management study in adults who are living with overweight or obesity, with or without Type 2 diabetes mellitus. MariTide demonstrated robust weight loss at 52 weeks without a weight loss plateau, significant improvements in cardiometabolic parameters, and is the first obesity treatment with monthly or less frequent dosing to demonstrate safe and effective weight loss in a Phase 2 study.
Part 2 of the Phase 2 chronic weight management study is ongoing in adults who are living with overweight or obesity, with or without Type 2 diabetes mellitus. Data readout is anticipated in H2 2025.
A Phase 2 study investigating MariTide for the treatment of Type 2 diabetes mellitus is enrolling adults living with and without obesity. Data readout is anticipated in H2 2025.
Planning for MARITIME, a broad Phase 3 program across multiple indications remains on track with the first studies expected to begin in H1 2025.
AMG 513
A Phase 1 study of AMG 513 in people living with obesity was placed on clinical hold by the U.S. Food and Drug Administration (FDA). Discussions are underway on a path forward to reopen the study.
Olpasiran (AMG 890)
Olpasiran is a potentially best-in-class small interfering ribonucleic acid (siRNA) molecule that reduces lipoprotein(a) (Lp(a)) synthesis in the liver.
The OCEAN(a)-Outcomes trial, a Phase 3 cardiovascular (CV) outcomes study, is ongoing in patients with atherosclerotic CV disease and elevated Lp(a).
A Phase 3 CV outcomes study in patients with elevated Lp(a) and at high risk for a CV event is expected to be initiated in H2 2025 / H1 2026.
Repatha
VESALIUS-CV, a Phase 3 CV outcomes study of Repatha, is ongoing in patients at high CV risk without prior myocardial infarction or stroke. Data readout is event driven and anticipated in H2 2025.
EVOLVE-MI, a Phase 4 study of Repatha administered within 10 days of an acute myocardial infarction to reduce the risk of CV events, is ongoing.
Rare Disease
TAVNEOS
A Phase 3, open-label study of TAVNEOS in combination with rituximab or a cyclophosphamide-containing regimen is enrolling patients from 6 years to < 18 years of age with active ANCA-associated vasculitis (Granulomatosis with Polyangiitis (GPA) / Microscopic Polyangiitis (MPA)).
TEPEZZA
Regulatory review is underway in multiple additional geographies including with the European Medicines Agency (EMA) where approval is anticipated in H2 2025.
A Phase 3 study of TEPEZZA in Japan is enrolling patients with chronic or low clinical activity score TED.
A Phase 3 study evaluating the subcutaneous route of administration of teprotumumab is enrolling patients with TED.
KRYSTEXXA
Data were presented in November 2024 from the AGILE study evaluating the safety, tolerability and efficacy of KRYSTEXXA administered with a shorter infusion duration in patients with uncontrolled gout receiving methotrexate as co-administration:
Safety and efficacy data from the 60-minute infusion duration cohort of the AGILE trial are similar to the MIRROR randomized clinical trial and current administration of KRYSTEXXA with methotrexate over at least 120 minutes.
U.S. Regulatory filing for AGILE is underway.
UPLIZNA
In January 2025, the FDA granted UPLIZNA Orphan Drug Designation for the treatment of generalized myasthenia gravis (gMG) based upon data from the Phase 3 MINT study. Regulatory filing activities are underway with submission anticipated to be complete in H1 2025.
In November 2024, data were presented and simultaneously published in the New England Journal of Medicine from the Phase 3 MITIGATE study evaluating UPLIZNA compared to placebo in patients with immunoglobin G4-related disease (IgG4-RD). In this study, UPLIZNA demonstrated a statistically significant 87% reduction in IgG4-RD flares, this primary endpoint and all key secondary endpoints were met. The safety results in the placebo-controlled period were consistent with the established safety profile of UPLIZNA.
The FDA accepted the regulatory submission for the Phase 3 MITIGATE study under priority review with a Prescription Drug User Fee Act (PDUFA) action date of April 3, 2025.
Dazodalibep
Dazodalibep is a fusion protein that inhibits CD40L.
Two Phase 3 studies of dazodalibep in Sjögren's disease are enrolling patients. The first study is in patients with moderate-to-severe systemic disease activity, and the second study is in patients with moderate-to-severe symptomatic burden and low systemic disease activity.
Daxdilimab
Daxdilimab is a fully human monoclonal antibody targeting immunoglobulin-like transcript 7 (ILT7).
A Phase 2 study of daxdilimab is ongoing in patients with moderate-to-severe active primary discoid lupus erythematosus refractory to standard of care.
A Phase 2 study of daxdilimab is ongoing in patients with dermatomyositis and antisynthetase inflammatory myositis.
Fipaxalparant
Fipaxalparant is a lysophosphatidic acid receptor 1 (LPAR1) antagonist.
A Phase 2 study of fipaxalparant in patients with diffuse cutaneous systemic sclerosis is complete. The study did not meet the primary or secondary endpoints. Further development of fipaxalparant in this indication will be discontinued.
Inflammation
TEZSPIRE
The Company is planning to initiate Phase 3 studies in patients with moderate-to-very severe chronic obstructive pulmonary disease (COPD) and a BEC ≥ 150 cells/µl. Study initiation is anticipated in H1 2025.
In December, the Company announced positive top-line results from the Phase 3 WAYPOINT trial in patients with chronic rhinosinusitis with nasal polyps:
Patients treated with TEZSPIRE had a statistically significant and clinically meaningful reduction in the size of nasal polyps and reduced nasal congestion compared to placebo.
The safety profile and tolerability of TEZSPIRE in the trial were consistent with the known profile of the medicine.
Regulatory submission is anticipated in H1 2025.
A Phase 3 study of TEZSPIRE is enrolling patients with eosinophilic esophagitis.
In severe asthma, the WAYFINDER Phase 3b study is complete and the PASSAGE Phase 4 real-world effectiveness study is ongoing. The SUNRISE Phase 3 study will be discontinued due to limited enrollment.
Rocatinlimab (AMG 451/KHK4083)
Rocatinlimab is a first-in-class T-cell rebalancing monoclonal antibody targeting the OX40 receptor.
The eight study ROCKET Phase 3 program evaluating rocatinlimab in patients with moderate-to-severe atopic dermatitis (AD) has enrolled over 3300 patients. Enrollment is now complete in seven studies.
Key milestones from the ROCKET Phase 3 program:
ROCKET SHUTTLE is a 24-week study evaluating rocatinlimab in combination with topical corticosteroids and/or topical calcineurin inhibitors in adult patients with moderate-to-severe AD. Data readout is anticipated in H1 2025.
ROCKET IGNITE is a 24-week study evaluating rocatinlimab monotherapy in adult patients with moderate-to-severe AD. Data readout is anticipated in H1 2025.
ROCKET ASCEND is a study evaluating rocatinlimab maintenance therapy in adult and adolescent patients with moderate-to-severe AD. Data readout is anticipated in H2 2025.
ROCKET ASTRO is a 52-week study evaluating rocatinlimab in adolescent patients with moderate-to-severe AD. Data readout is anticipated in H2 2025.
A Phase 2 study of rocatinlimab is enrolling patients with moderate-to-severe asthma.
A Phase 3 study of rocatinlimab is enrolling patients with prurigo nodularis.
Otezla
In November 2024, we made six data presentations at the American College of Rheumatology (ACR). Notable highlights include:
Otezla reduces axial inflammation in patients with psoriatic arthritis (PsA) as assessed by CANDEN Magnetic Resonance Imaging Scoring, results From the Phase 4 MOSAIC study.
FOREMOST oligoarticular PsA data presentations (4 posters), including 48-week data and data at 16 weeks showing that Otezla was associated with fewer patients progressing from < 4 to > 4 active joints when compared to placebo suggesting that Otezla reduced the progression from oligoarticular to polyarticular PsA.
Blinatumomab
Blinatumomab is a BiTE molecule targeting CD19.
A Phase 2 study of blinatumomab in autoimmune disease was initiated in patients with systemic lupus erythematosus (SLE).
Inebilizumab
Inebilizumab is a monoclonal antibody targeting CD19.
A Phase 2 study of inebilizumab in autoimmune disease was initiated in patients with SLE.
Ordesekimab (AMG 714/PRV-015)
Ordesekimab is a monoclonal antibody that binds interleukin-15.
A Phase 2b study of ordesekimab, conducted by Provention Bio, a Sanofi Company, in patients with nonresponsive celiac disease was completed as planned and did not meet primary or secondary endpoints. No safety concerns were noted.
AMG 104 (AZD8630)
AMG 104 is an inhaled anti-thymic stromal lymphopoietin (TSLP) fragment antigen-binding (Fab).
A Phase 2 study is enrolling patients with asthma.
Oncology
BLINCYTO
In December 2024, data from a Phase 3 study (AALL1731) conducted by the Children's Oncology Group, were presented and simultaneously published in the New England Journal of Medicine. These data demonstrated that BLINCYTO added to chemotherapy significantly improves disease-free survival in newly diagnosed pediatric patients with National Cancer Institute standard risk B-cell precursor acute lymphoblastic leukemia (B-ALL) of average or higher risk of relapse.
Golden Gate, a Phase 3 study of BLINCYTO alternating with low-intensity chemotherapy, is enrolling older adult patients with newly diagnosed Philadelphia chromosome (Ph)-negative B-ALL.
A Phase 1/2 study of subcutaneous blinatumomab is ongoing in the dose-expansion and optimization phase in adult patients with relapsed or refractory Ph-negative B-ALL. The Company is planning to advance blinatumomab subcutaneous administration to a potentially registration-enabling Phase 2 portion of this study with initiation in H2 2025.
IMDELLTRA
IMDELLTRA is a first-in-class delta-like ligand 3 (DLL3) targeting BiTE molecule.
In 2024, IMDELLTRA received accelerated approval in the U.S. for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Marketing authorizations have subsequently been granted in Japan and in additional countries, including Canada, Brazil, Israel and Great Britain.
The Company is advancing a comprehensive, global clinical development program across extensive-stage and limited-stage small cell lung cancer (SCLC):
DeLLphi-304, a Phase 3 study of IMDELLTRA in second-line ES-SCLC, is ongoing. Data readout is anticipated in H1 2025.
DeLLphi-305, a Phase 3 study of IMDELLTRA and durvalumab is enrolling patients with first-line ES-SCLC in the maintenance setting.
DeLLphi-306, a Phase 3 study of IMDELLTRA following concurrent chemoradiation therapy, is enrolling patients with limited-stage SCLC.
DeLLphi-308, a Phase 1b study evaluating subcutaneous tarlatamab, is enrolling patients with second line or later ES-SCLC.
DeLLphi-309, a Phase 2 study evaluating alternative intravenous dosing regimens in second-line ES-SCLC, was initiated.
DeLLphi-303, a Phase 1b study of IMDELLTRA in combination with a programmed cell death protein ligand-1 (PD-L1) inhibitor, carboplatin and etoposide or separately in combination with PD-L1 alone, is ongoing in patients with first-line ES-SCLC.
Xaluritamig (AMG 509)
Xaluritamig is a first-in-class bispecific T-cell engager targeting six-transmembrane epithelial antigen of prostate 1 (STEAP1).
A Phase 3 study of xaluritamig is enrolling patients with metastatic castrate resistant prostate cancer (mCRPC) who have previously been treated with taxane-based chemotherapy.
A Phase 1 monotherapy dose-expansion study of xaluritamig is enrolling mCRPC patients who have not yet received taxane-based chemotherapy and to enroll patients in a fully outpatient treatment setting to further improve administration convenience.
A Phase 1 combination of xaluritamig with enzalutamide or abiraterone is enrolling patients with mCRPC in dose-escalation and dose-expansion respectively.
A Phase 1b study evaluating neoadjuvant xaluritamig therapy prior to radical prostatectomy is enrolling patients with newly diagnosed localized intermediate or high–risk prostate cancer.
A Phase 1b study of xaluritamig is enrolling patients with high-risk biochemically recurrent prostate cancer after definitive therapy.
AMG 193
AMG 193 is a first-in-class small molecule methylthioadenosine (MTA)-cooperative protein arginine methyltransferase 5 (PRMT5) inhibitor.
A Phase 2 study evaluating the efficacy, safety, tolerability and pharmacokinetics of AMG 193 is enrolling patients with methylthioadenosine phosphorylase (MTAP)-null previously treated advanced non-small cell lung cancer (NSCLC).
A Phase 1/1b/2 study of AMG 193 is enrolling patients with advanced MTAP-null solid tumors in the dose-expansion portion of the study.
A Phase 1b study of AMG 193 alone or in combination with other therapies is enrolling patients with advanced MTAP-null thoracic malignancies.
A Phase 1b study of AMG 193 in combination with other therapies is enrolling patients with advanced MTAP-null gastrointestinal, biliary tract, and pancreatic cancers.
A Phase 1/2 study of AMG 193 in combination with IDE397, an investigational methionine adenosyltransferase 2A (MAT2A) inhibitor, is enrolling patients with advanced MTAP-null solid tumors.
Bemarituzumab
Bemarituzumab is a first-in-class fibroblast growth factor receptor 2b (FGFR2b) targeting monoclonal antibody.
FORTITUDE-101, a Phase 3 study of bemarituzumab plus chemotherapy, is ongoing in patients with first-line gastric cancer. Data readout is anticipated in H1 2025.
FORTITUDE-102, a Phase 1b/3 study of bemarituzumab plus chemotherapy and nivolumab is ongoing in patients with first-line gastric cancer. Phase 3 data readout is anticipated in H2 2025.
FORTITUDE-103, a Phase 1b/2 study of bemarituzumab plus oral chemotherapy regimens with or without nivolumab, is enrolling patients with first-line gastric cancer.
FORTITUDE-301, a Phase 1b/2 basket study of bemarituzumab monotherapy, is ongoing in patients with solid tumors with FGFR2b overexpression.
LUMAKRAS/LUMYKRAS
In January 2025, the FDA approved LUMAKRAS in combination with Vectibix as a targeted, biomarker-driven combination therapy for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
CodeBreaK 301, a Phase 3 study of LUMAKRAS in combination with Vectibix and FOLFIRI, is enrolling patients with first-line KRAS G12C–mutated CRC.
Regulatory review by the EMA of the CodeBreaK 200 Phase 3 study of adults with previously treated locally advanced or metastatic KRAS G12C–mutated NSCLC concluded with the conditional status of marketing authorization maintained.
CodeBreaK 202 (CB202), a Phase 3 study of LUMAKRAS plus chemotherapy vs. pembrolizumab plus chemotherapy, is enrolling patients with first-line KRAS G12C–mutated and PD-L1 negative advanced NSCLC.
The ongoing CB202 study is being conducted to serve as confirmatory study and to support conversion of accelerated/conditional approval to full approval, in the US, EU and other regions where applicable.
Nplate
The primary analysis of a Phase 3 study of Nplate as supportive care in chemotherapy-induced thrombocytopenia in gastrointestinal malignancies is complete. The Company continues to follow patients through a planned final analysis in H1 2025. Data presentation at a medical congress is anticipated in mid-2025.
Biosimilars
A randomized, double-blind pharmacokinetic similarity study of ABP 206 compared with OPDIVO® (nivolumab) is enrolling patients with resected stage III or stage IV melanoma in the adjuvant setting. Data readout is anticipated in H2 2025.
A randomized, double-blind comparative clinical study of ABP 206 compared with OPDIVO is enrolling patients with treatment-naïve unresectable or metastatic melanoma.
A randomized, double-blind pharmacokinetic similarity study of ABP 234 compared with KEYTRUDA® (pembrolizumab) is enrolling patients with early-stage non-squamous non-small cell lung cancer as adjuvant treatment.
A randomized, double-blind combined pharmacokinetic/comparative clinical study of ABP 234 compared to KEYTRUDA is enrolling patients with advanced or metastatic non-squamous non-small cell lung cancer.
A randomized, double-blind, pharmacokinetic similarity/comparative clinical study of ABP 692 and OCREVUS® (ocrelizumab) was initiated and is currently enrolling patients with relapsing-remitting multiple sclerosis.
TEZSPIRE is being developed in collaboration with AstraZeneca.
AMG 104 is being developed in collaboration with AstraZeneca.
Rocatinlimab, formerly AMG 451/KHK4083, is being developed in collaboration with Kyowa Kirin.
Ordesekimab, formerly AMG 714 and also known as PRV-015, is being developed in collaboration with Provention Bio, a Sanofi Company. For the purposes of the collaboration, Provention Bio conducts a clinical trial and leads certain development and regulatory activities for the program.
Xaluritamig, formerly AMG 509, is being developed pursuant to a research collaboration with Xencor, Inc.
IDE397 is an investigational MAT2A inhibitor from IDEAYA Biosciences.
OPDIVO is a registered trademark of Bristol-Myers Squibb Company.
KEYTRUDA is a registered trademark of Merck & Co., Inc.
OCREVUS is a registered trademark of Genentech, Inc.
Non-GAAP Financial Measures
In this news release, management has presented its operating results for the fourth quarters and full years of 2024 and 2023, in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and on a non-GAAP basis. In addition, management has presented its full year 2025 EPS and tax guidance in accordance with GAAP and on a non-GAAP basis. These non-GAAP financial measures are computed by excluding certain items related to acquisitions, divestitures, restructuring and certain other items from the related GAAP financial measures. Management has presented Free Cash Flow (FCF), which is a non-GAAP financial measure, for the fourth quarters and full years of 2024 and 2023. FCF is computed by subtracting capital expenditures from operating cash flow, each as determined in accordance with GAAP. Management has also presented Earnings Before Interest, Taxes, Depreciation and Amortization (EBITDA) and debt leverage ratio for 2024, both of which are non-GAAP financial measures. EBITDA is computed by adding interest expense, provision for income taxes, and depreciation and amortization expense to GAAP net income. Debt leverage ratio is calculated as the ratio of GAAP total debt to EBITDA.
The Company believes that its presentation of non-GAAP financial measures provides useful supplementary information to and facilitates additional analysis by investors. The Company uses certain non-GAAP financial measures to enhance an investor's overall understanding of the financial performance and prospects for the future of the Company's normal and recurring business activities by facilitating comparisons of results of normal and recurring business operations among current, past and future periods. The Company believes that FCF provides a further measure of the Company's liquidity. The Company believes its debt leverage ratio provides a supplemental operating metric for the full year period as it compares the amount of cash generated by our operations for the year.
The Company uses the non-GAAP financial measures set forth in the news release in connection with its own budgeting and financial planning internally to evaluate the performance of the business, including to allocate resources and to evaluate results relative to incentive compensation targets. The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.
In 2024, Amgen was named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes, among other external recognitions. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average®, and it is also part of the Nasdaq-100 Index®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.
For more information, visit Amgen.com and follow Amgen on X, LinkedIn, Instagram, YouTube and Threads.
Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or Kyowa Kirin Co., Ltd.), the performance of Otezla® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), our acquisitions of Teneobio, Inc., ChemoCentryx, Inc., or Horizon (including the prospective performance and outlook of Horizon's business, performance and opportunities and any potential strategic benefits, synergies or opportunities expected as a result of such acquisition, and any projected impacts from the Horizon acquisition on our acquisition-related expenses going forward), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on our business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. There can be no guarantee that we will be able to realize any of the strategic benefits, synergies or opportunities arising from the Horizon acquisition, and such benefits, synergies or opportunities may take longer to realize than expected. We may not be able to successfully integrate Horizon, and such integration may take longer, be more difficult or cost more than expected. A breakdown, cyberattack or information security breach of our information technology systems could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our environmental, social and governance objectives. The effects of global climate change and related natural disasters could negatively affect our business and operations. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.
CONTACT: Amgen, Thousand Oaks
Elissa Snook, 609-251-1407 (media)
Justin Claeys, 805-313-9775 (investors)
Our GAAP diluted EPS guidance does not include the effect of GAAP adjustments triggered by events that may occur subsequent to this press release such as acquisitions, asset impairments, litigation, changes in fair value of our contingent consideration obligations and changes in fair value of our equity investments.
SOURCE Amgen
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上市批准并购财报临床2期临床结果
100 项与 贝伐珠单抗生物类似药（安进） 相关的药物交易
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研发状态
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10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 转移性乳腺癌 | 挪威 | 2018-01-15 | |
| 转移性乳腺癌 | 欧盟 | 2018-01-15 | |
| 转移性乳腺癌 | 冰岛 | 2018-01-15 | |
| 转移性乳腺癌 | 列支敦士登 | 2018-01-15 | |
| 原发性腹膜癌 | 列支敦士登 | 2018-01-15 | |
| 原发性腹膜癌 | 挪威 | 2018-01-15 | |
| 原发性腹膜癌 | 冰岛 | 2018-01-15 | |
| 原发性腹膜癌 | 欧盟 | 2018-01-15 | |
| 直肠癌 | 挪威 | 2018-01-15 | |
| 直肠癌 | 冰岛 | 2018-01-15 | |
| 直肠癌 | 欧盟 | 2018-01-15 | |
| 复发性铂耐药性卵巢癌 | 列支敦士登 | 2018-01-15 | |
| 复发性铂耐药性卵巢癌 | 冰岛 | 2018-01-15 | |
| 复发性铂耐药性卵巢癌 | 挪威 | 2018-01-15 | |
| 复发性铂耐药性卵巢癌 | 欧盟 | 2018-01-15 | |
| 胶质母细胞瘤 | 美国 | 2017-09-14 | |
| 转移性结直肠癌 | 美国 | 2017-09-14 | |
| 转移性肾细胞癌 | 美国 | 2017-09-14 | |
| 非鳞状非小细胞肺癌 | 美国 | 2017-09-14 | |
| 宫颈癌 | 美国 | 2017-09-14 |
未上市
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 转移性非小细胞肺癌 | 临床前 | - | 2021-05-15 | |
| 非鳞状非小细胞肺癌 | 临床前 | - | 2021-05-15 | |
| 晚期肺非鳞状非小细胞癌 | 临床前 | 中国 | 2021-02-15 | |
| 晚期非小细胞肺癌 | 药物发现 | 美国 | 2013-11-11 | |
| 晚期非小细胞肺癌 | 药物发现 | 澳大利亚 | 2013-11-11 | |
| 晚期非小细胞肺癌 | 药物发现 | 保加利亚 | 2013-11-11 | |
| 结肠癌 | 药物发现 | - | 2006-11-01 | |
| KRAS突变肿瘤 | 药物发现 | - | 2006-11-01 | |
| 肿瘤转移 | 药物发现 | - | 2006-11-01 | |
| 直肠癌 | 药物发现 | - | 2006-11-01 |
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| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
N/A | - | (積艱餘願選積壓鏇構糧) = 醖窪鏇醖壓衊顧製襯壓 觸憲網鬱遞積鹽獵夢餘 (糧鹹鏇觸窪築憲顧鏇築 ) 更多 | - | 2024-09-19 | |||
(積艱餘願選積壓鏇構糧) = 醖鏇餘顧衊構網獵淵糧 觸憲網鬱遞積鹽獵夢餘 (糧鹹鏇觸窪築憲顧鏇築 ) 更多 | |||||||
N/A | 转移性结直肠癌 一线 | 239 | 築餘鬱鑰壓簾憲顧齋繭(積憲襯夢艱鑰襯繭糧醖) = At least one safety event of interest (EOI) was recorded for 26/75 (34.7%) wave 1 and 70/164 (42.7%) wave 2 patients 襯艱糧網壓衊遞繭顧獵 (鹹簾齋膚衊壓夢窪願壓 ) | - | 2023-05-31 | ||
ASCO2022 人工标引  | N/A | 1,445 | (簾顧憲襯簾鏇觸製鬱窪) = 築夢製襯憲夢網餘廠膚 窪鏇襯積構範築積製鑰 (範鑰膚衊鹹襯襯願遞觸 ) 更多 | 非劣 | 2022-06-02 | ||
(簾顧憲襯簾鏇觸製鬱窪) = 夢築膚選鹽廠簾顧壓憲 窪鏇襯積構範築積製鑰 (範鑰膚衊鹹襯襯願遞觸 ) 更多 | |||||||
临床2期 | 47 | (餘網糧範網廠餘襯窪餘) = 構網鬱網淵窪襯積糧顧 鬱艱簾鹹網廠夢獵夢獵 (築膚觸願夢醖繭積繭簾, 蓋鹽糧觸築鹽齋簾製築 ~ 範顧窪網繭簾網繭積簾) 更多 | - | 2020-03-26 | |||
临床3期 | 晚期非小细胞肺癌 VEGF-A isoform | 642 | (餘鏇構夢築網網選窪觸) = 選糧網鹽繭憲構選艱鬱 範夢觸積醖壓範鏇醖簾 (範糧積膚遞蓋選鹽鑰糧 ) | 积极 | 2019-05-26 | ||
Bevacizumab reference product | (餘鏇構夢築網網選窪觸) = 夢積壓蓋衊鏇顧醖醖範 範夢觸積醖壓範鏇醖簾 (範糧積膚遞蓋選鹽鑰糧 ) | ||||||
临床3期 | 642 | (ABP 215) | 鏇壓衊築糧鑰顧餘願夢(網夢壓壓艱醖構範蓋積) = 選艱遞鬱窪壓淵窪鏇選 製顧簾築襯衊網壓糧衊 (鑰糧廠鹽願顧簾繭顧獵, 壓衊鹹網構鬱構衊範選 ~ 憲窪製淵鹽範蓋蓋夢鹹) 更多 | - | 2017-10-19 | ||
(Bevacizumab) | 鏇壓衊築糧鑰顧餘願夢(網夢壓壓艱醖構範蓋積) = 顧鹹願壓衊襯鑰築淵淵 製顧簾築襯衊網壓糧衊 (鑰糧廠鹽願顧簾繭顧獵, 齋壓鏇築鹽醖繭夢衊網 ~ 蓋願窪範醖蓋獵鑰鹽襯) 更多 | ||||||
临床3期 | 非小细胞肺癌 一线 | 642 | 鹽膚獵鹽簾鬱餘簾淵襯(膚淵壓糧獵衊齋蓋憲簾) = During the study, 4 (1.4%) and 7 (2.5%) patients in the ABP 215 and BEV group, respectively, developed binding antibodies; no patient tested positive for neutralizing antibodies. 憲鏇網鏇窪鑰鏇繭憲憲 (夢顧構製憲顧蓋膚壓觸 ) | 积极 | 2017-05-30 | ||
N/A | 非小细胞肺癌 一线 | 642 | (淵構廠選獵襯艱選衊衊) = 醖築顧獵積艱範遞獵範 鹽鹹繭壓鬱糧襯艱餘獵 (憲獵艱網範鏇醖顧獵憲, 0.80 ~ 1.09) 更多 | 积极 | 2016-12-06 | ||
(淵構廠選獵襯艱選衊衊) = 膚夢窪選窪積網夢範鏇 鹽鹹繭壓鬱糧襯艱餘獵 (憲獵艱網範鏇醖顧獵憲 ) 更多 | |||||||
N/A | 三线 | - | (膚廠顧獵艱齋淵鹹選廠) = 選憲鹹襯簾築夢積淵顧 夢蓋鹽網簾餘獵蓋壓鏇 (選築構鬱願網築廠齋網 ) 更多 | - | 2016-12-06 | ||
(膚廠顧獵艱齋淵鹹選廠) = 網網膚積壓構顧膚蓋壓 夢蓋鹽網簾餘獵蓋壓鏇 (選築構鬱願網築廠齋網 ) 更多 | |||||||
临床2/3期 | 641 | Panitumumab + mFOLFOX6 | (範淵襯壓積艱廠繭鏇繭): HR = 0.37 (95% CI, 0.37 ~ 0.54), P-Value = 0.45 | 积极 | 2016-06-29 | ||
Bevacizumab + mFOLFOX6 |
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