A Randomized, Double-blind, Multicenter Integrated Phase I/III Study in Postmenopausal Women With Osteoporosis to Compare the Pharmacokinetics, Pharmacodynamics, Efficacy, Safety and Immunogenicity of GP2411 (Proposed Biosimilar Denosumab) and Prolia® (EU-authorized)

This study was conducted to assess if there were any clinically meaningful differences in pharmacokinetics (PK), pharmacodynamics (PD), efficacy, safety, or immunogenicity between GP2411 (proposed biosimilar denosumab) and EU-authorized Prolia® (denosumab).

开始日期2019-07-02

申办/合作机构

Sandoz Group AG

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100 项与地舒单抗生物类似药 (Novartis) 相关的临床结果

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100 项与地舒单抗生物类似药 (Novartis) 相关的专利（医药）

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项与地舒单抗生物类似药 (Novartis) 相关的文献（医药）

2024-08-05·JOURNAL OF BONE AND MINERAL RESEARCH

Correction to: Equivalence trial of proposed denosumab biosimilar GP2411 and reference denosumab in postmenopausal osteoporosis: the ROSALIA study

2024-04-19·Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research

Equivalence trial of proposed denosumab biosimilar GP2411 and reference denosumab in postmenopausal osteoporosis: the ROSALIA study

Article

作者: Vogg, Barbara ; Banerjee, Samik ; Jeka, Sławomir ; Schwebig, Arnd ; Żuchowski, Paweł ; Poetzl, Johann ; Eastell, Richard ; Sekhar, Susmit ; Dokoupilová, Eva ; Body, Jean-Jacques ; Krivtsova, Natalia ; Kivitz, Alan

Abstract:

Denosumab is a monoclonal antibody used to reduce risk of fractures in osteoporosis. ROSALIA was a multicenter, double-blind, randomized, integrated phase I/phase III study comparing the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and safety of proposed biosimilar denosumab GP2411 with reference denosumab (REF-DMAb) (Prolia®; Amgen). Postmenopausal women with osteoporosis were randomized 1:1 to 2 60-mg doses of GP2411 or REF-DMAb, one at study start and one at week 26. At week 52, the REF-DMAb group was re-randomized 1:1 to a third dose of REF-DMAb or switch to GP2411. The primary efficacy endpoint was percentage change from baseline (%CfB) in LS-BMD at week 52. Secondary efficacy endpoints were %CfB in LS-BMD, FN-BMD, and TH-BMD at weeks 26 and 78 (and week 52 for FN-BMD and TH-BMD). Primary PK and PD endpoints were the area under the serum concentration–time curve extrapolated to infinity and maximum drug serum concentration at week 26, and the area under the effect–time curve of the %CfB in serum CTX at week 26. Secondary PK and PD endpoints included drug serum concentrations and %CfB in serum CTX and P1NP during the study period. Similar efficacy was demonstrated at week 52, with 95% CIs of the difference in %CfB in LS-BMD between treatment groups fully contained within prespecified equivalence margins. Similarity in PK and PD was demonstrated at week 26. Immunogenicity was similar between groups and was not impacted by treatment switch. The rate of new vertebral fractures was comparable. Treatment-emergent adverse events were comparable between groups (63.6% [GP2411/GP2411]; 76.0% [REF-DMAb/REF-DMAb]; 76.6% [REF-DMAb/GP2411]). In conclusion, ROSALIA showed similar efficacy, PK and PD, and comparable safety and immunogenicity of GP2411 to REF-DMAb in postmenopausal osteoporosis.

2024-02-01·Expert opinion on biological therapy

Pharmacokinetics and pharmacodynamics of the proposed biosimilar denosumab GP2411 and reference denosumab in healthy males

Article

作者: Sekhar, Susmit ; Schwebig, Arnd ; El Galta, Rachid ; Vogg, Barbara ; Poetzl, Johann ; Fuhr, Rainard

BACKGROUND:

This Phase I study compared the pharmacokinetic (PK) and pharmacodynamic (PD) similarity of GP2411 proposed denosumab biosimilar to reference denosumab (a monoclonal antibody for specific pro-resorptive conditions).

RESEARCH DESIGN AND METHODS:

Healthy males (28-65 years, 50-90 kg) were randomized to a single sub-therapeutic subcutaneous injection of 35 mg GP2411, EU-Xgeva® or US-Xgeva®, and followed for 39 weeks. The primary endpoints were AUC_inf, AUC_last, and C_max.

RESULTS:

Four hundred ninety-two participants completed treatment. The 90% confidence intervals (CIs) (AUC_inf, AUC_last, and C_max) and 95% CI of the geometric mean ratios of AUEC of % change from baseline in serum CTX were fully contained within the prespecified equivalence margins (0.80, 1.25), demonstrating similarity. The occurrence of treatment-emergent adverse events (TEAEs) with GP2411, EU-Xgeva® and US-Xgeva® was similar (72.9%, 76.0%, and 71.0% of participants, respectively). Most were Grade 1 or 2, <30% were treatment-related, and there was only one TEAE-related study discontinuation. Rates of positive anti-drug antibodies (ADAs) were similar (57.8%, 64.9%, and 69.1% of participants respectively), but immunogenicity was only borderline detectable and of very low magnitude. Ninety-nine percent of positive ADAs were transient.

CONCLUSION:

GP2411 demonstrated similarity with EU-Xgeva® and US-Xgeva® in PK, PD, safety, and immunogenicity in this population.

CLINICAL TRIAL REGISTRATION:

EudraCT 2019-001651-39.

项与地舒单抗生物类似药 (Novartis) 相关的新闻（医药）

2025-11-13

·动脉网

山德士签署全球许可协议，将商业化乳腺癌生物类似药帕妥珠单抗 Sandoz signs global license agreement to commercialize breast cancer biosimilar pertuzumab

Sandoz the global leader in affordable medicines, today announced the signing of a global license agreement to commercialize a proposed biosimilar of oncology medicine pertuzumab. 山德士是负担得起的药物的全球领导者，今天宣布签署了一项全球许可协议，以商业化一种拟议的肿瘤药物帕妥珠单抗的生物类似药。The agreement with EirGenix Inc. (EirGenix Inc., 6589.TW) is milestone-based, including an upfront payment and further potential incentives dependent upon market performance. The reference medicine market is worth an estimated USD 4.1 billion1 in global sales, and pertuzumab will join the deep Sandoz pipeline with the strategic objective to capitalize on a projected ~USD 300 billion biosimilar market opportunity over the next 10 years2. . 与喜康生物制药股份有限公司（EirGenix Inc.，6589.TW）的协议基于里程碑，包括首付款以及取决于市场表现的进一步潜在激励。参考药品市场全球销售额估计达41亿美元1，而pertuzumab将加入山德士深厚的在研产品线，其战略目标是利用未来10年内预计约3000亿美元的生物类似药市场机会2。Under the terms of the agreement, Sandoz has exclusive worldwide commercial rights to a biosimilar of pertuzumab, excluding certain countries in Asia*, while EirGenix Inc. will be responsible for development, manufacturing and supply. The medicine has already completed a human pharmacokinetic similarity clinical study.. 根据协议条款，山德士在全球范围内对帕妥珠单抗生物类似药拥有独家商业权利，但某些亚洲国家*除外，而台康生技将负责该药物的开发、生产和供应。该药物已经完成了一项人体药代动力学相似性临床研究。Richard Saynor, CEO of Sandoz, said: “According to the latest estimates, up to 2.3 million patients worldwide are diagnosed with breast cancer each year and, of these cases, approximately 15% to 20% are HER2-positive breast cancer3. 山德士首席执行官理查德·赛诺表示：“根据最新的估算，全球每年约有230万名患者被诊断出患有乳腺癌，其中大约15%至20%的病例为HER2阳性乳腺癌。“This agreement underscores our commitment to expand patient access, as well as support healthcare systems by offering high quality and more affordable treatment options. It also enhances our biosimilar oncology portfolio and complements our pipeline, given that the combination of pertuzumab and trastuzumab represents the standard of care in this field.”. “该协议重申了我们扩大患者获取渠道的承诺，同时也通过提供高质量且更实惠的治疗选择来支持医疗系统。鉴于帕妥珠单抗和曲妥珠单抗的组合代表了该领域的治疗标准，这项协议还增强了我们的生物类似药肿瘤学产品组合，并补充了我们的研发管线。”The reference medicine Perjeta®** is a humanized IgG1 monoclonal antibody that is used in combination with other therapies, including trastuzumab, to treat HER2-positive early breast cancer and HER2-positive metastatic or locally recurrent unresectable breast cancer4,5. 参考药物Perjeta®**是一种人源化的IgG1单克隆抗体，与包括曲妥珠单抗在内的其他疗法联合使用，用于治疗HER2阳性早期乳腺癌和HER2阳性转移性或局部复发不可切除的乳腺癌4,5。The agreement strengthens the collaboration between Sandoz and EirGenix Inc, with an existing agreement already in place for worldwide commercialization*** of the proposed biosimilar trastuzumab, in both 150 mg and 420 mg forms. Studies also show that a combination of pertuzumab and trastuzumab deruxtecan could become a new first-line standard for HER2-positive metastatic breast cancer6, with a biosimilar of trastuzumab deruxtecan currently in the Sandoz pipeline. . 该协议加强了山德士与永昕生物医药股份有限公司之间的合作，双方已就拟议的生物类似药曲妥珠单抗（包括150毫克和420毫克两种形式）的全球商业化达成现有协议。研究还表明，帕妥珠单抗与曲妥珠单抗 deruxtecan 的联合用药可能成为 HER2 阳性转移性乳腺癌的新一线标准治疗，而曲妥珠单抗 deruxtecan 的生物类似药目前正处于山德士的研发管线中。Sandoz is committed to helping millions of patients access critical and potentially life-changing biologic medicines sustainably and affordably, with a leading global portfolio comprising 11 marketed biosimilars and a further 27 assets in various stages of development. The marketed biosimilar oncology portfolio includes Rixathon®, Zarzio®, Ziextenzo® and Binocrit®. 山德士致力于以可持续且可负担的方式，帮助数百万患者获得关键且可能改变生活的生物药物。公司拥有领先的全球产品组合，包括11种已上市的生物类似药，以及另外27种处于不同开发阶段的产品。已上市的生物类似药肿瘤产品组合包括Rixathon®、Zarzio®、Ziextenzo®和Binocrit®。Sandoz also launched Wyost®/Jubbonti® (denosumab) in the US in June 2025 and expects to launch in Europe in the fourth quarter of 2025.. 山德士公司还于2025年6月在美国推出了Wyost®/Jubbonti®（地诺单抗），并预计在2025年第四季度在欧洲推出。* Countries out of scope: Taiwan, China, Macau, Korea, Mongolia, Brunei, Cambodia, Indonesia, Laos, Myanmar, the Philippines and Japan * 超出范围的国家/地区：台湾、中国、澳门、韩国、蒙古、文莱、柬埔寨、印度尼西亚、老挝、缅甸、菲律宾和日本** Perjeta® is a registered trademark of Roche ** Perjeta® 是罗氏的注册商标*** Under this agreement, Sandoz holds the right to commercialize the medicine globally except in Russia, China, Taiwan, Australia, and some other Asian and South American countries 根据该协议，山德士拥有在全球范围内商业化这种药物的权利，但俄罗斯、中国、台湾、澳大利亚和一些其他亚洲及南美国家除外。Disclaimer 免责声明This Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. 本媒体发布包含前瞻性声明，这些声明对未来业绩不提供任何保证。这些声明是基于管理层在作出声明时对未来事件和业务表现的看法和假设。它们受风险和不确定性的影响，包括但不限于未来的全球经济状况、汇率、法律规定、市场状况、竞争对手的活动以及其他超出山德士控制范围的因素。Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly revise any forward-looking statements, except as required by law.. 如果这些风险或不确定性中的一个或多个成为现实，或者基本假设被证明不正确，实际结果可能与预测或预期的结果有重大差异。每项前瞻性声明仅适用于该声明的日期，山德士没有义务公开修订任何前瞻性声明，除非法律要求。References 参考文献About Sandoz 关于山德士 Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in affordable medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 900 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. 山德士（SIX：SDZ；OTCQX：SDZNY）是全球平价药品的领导者，其增长战略由其宗旨驱动：为患者开拓药品获取渠道。来自100个国籍的两万多名员工齐心协力，确保山德士提供9亿次患者治疗，创造显著的全球医疗成本节约以及更大的社会影响。Its leading portfolio of approximately 1,300 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. 其约1300种产品组合涵盖了从普通感冒到癌症的疾病。山德士总部位于瑞士巴塞尔，历史可追溯至1886年。其突破性创新的历史包括：1929年的钙尔奇、1951年全球首款口服青霉素，以及2006年全球首款生物类似药。In 2024, Sandoz recorded net sales of USD 10.4 billion. . 2024年，山德士的净销售额为104亿美元。Contacts 联系人Global Media Relations contacts 全球媒体关系联系人Global.MediaRelations@sandoz.com 全球媒体关系@sandoz.comAlexis Kalomparis 亚历克西斯·卡洛姆帕里斯+41 792 790285 +41 792 790285Chris Lewis 克里斯·刘易斯+49 174 244 9501 +49 174 244 9501Gregor Rodehueser 格雷戈尔·罗德赫瑟+49 170 574 3200 +49 170 574 3200Investor Relations contacts 投资者关系联系人Investor.Relations@sandoz.com 投资者关系@sandoz.comCraig Marks 克雷格·马克斯+44 7818 942 383 +44 7818 942 383Silvia Siegfried 西尔维娅·齐格弗里德+41 79 795 9061 +41 79 795 9061Source: sandoz.com 来源：sandoz.com

生物类似药抗体药物偶联物引进/卖出

2025-11-12

·格隆汇

2025年11月12日全球新药进展早知道

药物研发进展1. 诺华BTK抑制剂获FDA批准，治疗慢性自发性荨麻疹11月10日，诺华宣布其BTK抑制剂「瑞米布替尼片」已获美国FDA批准，用于治疗在接受H1抗组胺药治疗后仍有症状的成人慢性自发性荨麻疹（CSU）患者。瑞米布替尼片为每日两次口服片剂，无需注射和实验室监测。根据新闻稿介绍，该产品是首个获FDA批准用于治疗CSU的BTK抑制剂。瑞米布替尼片通过靶向阻断BTK信号通路来抑制肥大细胞中组胺及其他促炎介质的释放，为CSU治疗提供了全新的选择。瑞米布替尼片CSU适应症的获批是基于3期REMIX-1和REMIX-2临床试验的结果，这些试验纳入了在二代H1抗组胺药治疗下仍有症状的患者。瑞米布替尼片在第12周相较安慰剂在瘙痒（ISS7）、风团（HSS7）以及每周荨麻疹活动度（UAS7）的基线变化方面显示出优效性。2. 复宏汉霖宣布地舒单抗获英国批准上市11月11日，复宏汉霖宣布，英国药品和健康产品管理局（MHRA）已批准地舒单抗注射液（60 mg/mL）BILDYOS®（denosumab）和地舒单抗注射液（120mg/1.7mL）BILPREVDA®（denosumab）的上市许可，两款产品分别为PROLIA®（地舒单抗）和XGEVA®（地舒单抗）的生物类似药，覆盖原研药在英国已获批的所有适应症。此前在2022年，复宏汉霖与Organon签订许可与供应协议，授予Organon对包括BILDYOS 和BILPREVDA在内的多个生物类似药在除中国以外的全球区域的独家商业化权益。3. 华东医药PDE4抑制剂新适应症在华申报上市11月11日，CDE官网显示，华东医药从Arcutis Biotherapeutics引进的罗氟司特乳膏（商品名：ZORYVE）新适应症上市申请获受理，推测适应症为特应性皮炎。此前于10月底，罗氟司特乳膏0.3%上市许可申请已获CDE受理，适应症为：适用6岁及以上斑块状银屑病患者的局部外用治疗，包括间擦部位。罗氟司特乳膏是一种高活性和高选择性的非类固醇类磷酸二酯酶-4（PDE4）抑制剂，中美华东与Arcutis于2023年8月签署合作协议引进，拥有该产品在大中华区及东南亚的独家许可，包括开发、注册、生产及商业化权益。该交易首付款为3000万美元，里程金为6425万美元。4. 石药集团「帕妥珠单抗」在华申报上市，国内第5款11月11日，CDE官网显示，石药集团帕妥珠单抗注射液上市申请获受理，用于治疗HER2阳性乳腺癌。这是国内第5款申报上市的帕妥珠单抗生物类似药。帕妥珠单抗是一款HER2单抗，通过靶向HER2的细胞外二聚体化结构域（亚结构域II），阻断HER2与其他HER2家族成员（包括EGFR、HER3和HER4）生成配体依赖型异源二聚体，从而阻断信号通路，抑制肿瘤细胞生长。原研由罗氏开发，最早2012年在美国获批上市，虽然受到生物类似药冲击，但2024年销售额还有40.97亿美元。5. 默沙东口服PCSK9抑制剂关键三期临床成功11月10日，默沙东公布了其关键性3期CORALreef HeFH研究的初步结果。在该试验中，每日一次口服的在研PCSK9抑制剂enlicitide decanoate在治疗24周时，使异质性家族性高胆固醇血症（HeFH）成人患者的低密度脂蛋白胆固醇（LDL-C）水平较安慰剂显著降低了59.4%（95% CI：-65.6，-53.2；p<0.001），达成主要终点。其疗效幅度及安全性表现与此前关键性3期CORALreef Lipids研究中观察到的结果一致。新闻稿指出，enlicitide decanoate有望成为首款可提供类似抗体疗效的口服PCSK9抑制剂。6. 反义寡核苷酸疗法关键三期临床结果积极，每月一针长效降脂11月10日，Ionis Pharmaceuticals宣布，其在严重高甘油三酯血症（sHTG）患者中开展的CORE和CORE2关键性3期研究取得了积极结果。研究显示，olezarsen在6个月时实现了高达72%经安慰剂校正的空腹甘油三酯（TG）平均水平显著降低，且这一降幅在12个月时仍然得以维持。同时，olezarsen还将急性胰腺炎事件风险显著降低了85%，安全性和耐受性表现良好。值得注意的是，这一结果同步发表于《新英格兰医学杂志》（NEJM）。根据新闻稿，这是首次在研治疗方案可在sHTG患者中显著降低急性胰腺炎事件发生率。Olezarsen是一种反义寡核苷酸疗法，旨在抑制机体产生载脂蛋白C-III。美国FDA于2024年2月授予该疗法孤儿药资格和突破性疗法认定（BTD），并在12月批准其用于作为饮食控制的辅助治疗，以降低家族性乳糜微粒血症综合征成人患者的甘油三酯。7. 百济神州CDK2 PROTAC启动美国一期临床11月10日，百济神州在Clinicaltrials.gov网站上注册了BG-75098单药或联合治疗晚期实体瘤的国际化一期临床试验。该一期临床计划入组105例晚期实体瘤患者。联合治疗方案包括联合CDK4抑制剂BGB-43395和氟维司群。根据百济神州2025年研发日上披露的信息，BG-75098为一款CDK2 CDAC，也是潜在同类首创的CDK2降解剂，具有更优的强效性、选择性和PK特征。百济神州将CDK2 CDAC作为乳腺癌/妇科肿瘤领域又一个潜在核心产品，尽管其已经布局了选择性的CDK4、CDK2抑制剂。行业资讯1. 超8.6亿美元！斯丹赛CAR-T出海11月10日，Lyell Immunopharma（Nasdaq:LYEL）宣布已通过从Innovative Cellular Therapeutics（ICT，斯丹赛生物）获得LYL273（前身为GCC19CART）的全球权利来加强其实体瘤管线。LYL273是一种新型的自体鸟苷酸环化酶-C（GCC）靶向CAR-T细胞治疗候选产品，用于治疗转移性癌症（mCRC）和其他表达GCC的癌症。根据最终许可协议的条款，Lyell将获得LYL273在中国大陆、香港、澳门和台湾地区以外的独家全球权利，用于研究、开发、生产和商业化LYL273。斯丹赛将获得4000万美元的首付款和190万股Lyell普通股。斯丹赛还有资格获得额外的现金和股权对价，以及未来净销售额的分层特许权使用费。额外现金对价包括潜在的3000万美元临床里程碑付款，最高1.15亿美元的后期监管里程碑付款，以及最高6.75亿美元的商业销售里程碑付款。

上市批准生物类似药临床3期引进/卖出

2025-10-24

·东楠逸锦

【深度】安进公司专利悬崖挑战与战略转型

引言安进公司（Amgen Inc.）作为全球领先的生物技术公司，正面临着前所未有的专利悬崖挑战。截至 2025 年 10 月 21 日，公司股价为 300.18 美元，总市值达 1616.05 亿美元(1)，位列全球第 14 大制药公司。然而，这家成立于 1980 年、拥有超过 21,000 名员工的行业巨头，其核心产品组合正处于关键的专利到期期。专利悬崖的严峻性不容忽视。根据最新数据，2025-2030 年间，全球将有价值约 3500 亿美元的药物失去专利保护，其中前 20 大制药公司承担了 80% 的收入损失风险(149)。对安进而言，其九款核心产品将在 2021-2030 年间陆续失去专利保护，其中Prolia/Xgeva 和 Otezla 合计占公司 2025 年预计总收入的 41%(125)。更令人担忧的是，公司面临 67% 的收入风险，前四大产品均面临专利到期威胁(132)。本研究旨在深入分析安进公司如何应对这一关键挑战，重点关注其核心产品专利到期后的市场影响、生物类似药竞争格局，以及公司的战略转型措施。通过对公司财务数据、产品管线、研发投入和并购策略的全面评估，我们将揭示安进能否成功跨越专利悬崖，维持其在生物技术领域的领导地位。一、安进核心产品专利到期全景图 1.1 专利到期时间轴与市场分布安进的专利悬崖呈现出集中爆发的特征，主要集中在 2025-2028 年这一关键时期。根据最新的专利到期数据，各核心产品的专利保护情况如下：已到期产品： •Enbrel（依那西普）：物质专利于 2012 年到期，但通过制剂和制备方法专利的扩展，目前活性组分制备专利期已延长至 2029 年，制剂专利期最长延长至 2034 年(12)。在美国市场，Enbrel 的新专利将于 2028 年 11 月 22 日到期，届时该药物将已上市 30 年(16)。 2025 年到期产品： •Prolia/Xgeva（地诺单抗）：主要专利已于 2025 年 2 月到期(6)。在美国，专利到期日为 2025 年 2 月 19 日；在欧洲，除法国、意大利、西班牙和英国外，其他国家已于 2022 年 6 月 25 日到期，而这四个主要市场将在 2025 年到期。 •Kyprolis（卡非佐米）：治疗方法专利已于 2025 年 4 月 14 日到期，而化合物专利将于 2027 年 12 月 7 日到期(19)。 2026-2028 年到期产品： •Xgeva：作为地诺单抗的另一个品牌，将于 2026 年到期(101)。 •Otezla（阿普米司特）：专利原定于 2024 年到期，但获得了超过 3 年的专利延期，现定于 2028 年 2 月 16 日到期(23)。法院裁决阻止了仿制药制造商在 2028 年前销售仿制药(8)。 •Enbrel：核心专利将于 2028 年到期(101)。 •Repatha（依洛尤单抗）：专利将于 2028 年 8 月到期(29)。 1.2 生物类似药获批与上市情况随着专利到期，生物类似药的竞争格局正在快速形成。截至 2025 年 6 月，安进核心产品的生物类似药获批情况如下：地诺单抗（Prolia/Xgeva）生物类似药： •Sandoz 的 Jubbonti®/Wyost® 已于 2025 年 6 月 2 日在美国上市，成为首个获批的可互换生物类似药(72)。根据与安进的和解协议，Sandoz 可于 2025 年 5 月 31 日或更早上市(76)。 •在欧洲，已有三家公司的生物类似药获批：Celltrion 的 Stoboclo®/Ozenvelt®（2025 年 2 月）、Samsung Bioepis 的 Obodence™和 Xbryk™（2025 年 2 月）以及 Sandoz 的产品（2024 年 5 月）(74)。依那西普（Enbrel）生物类似药： •Sandoz 的 Erelzi® 早在 2016 年 8 月就获得了 FDA 批准，但由于专利诉讼，预计要到 2029 年才能在美国上市(50)。 •Samsung Bioepis 的 Eticovo® 于 2019 年 4 月获批，但同样受到专利限制。其他产品的生物类似药进展： •Repatha：已有生物类似药在研，如 Henlius 开发的 evolocumab 生物类似药，但仍在专利保护期内(78)。 •Blincyto：Teva 和武田正在开发生物类似药，计划 2026 年进入市场，目前正在进行分子验证研究(84)。二、专利到期对核心产品的市场冲击分析 2.1 Enbrel：从巅峰到衰退的转折 Enbrel 作为安进的明星产品，其市场表现的变化最能体现专利到期和生物类似药竞争的影响。根据公司财报数据，Enbrel 的销售趋势呈现出明显的下滑态势： •2022 年：销售额 36.97 亿美元(122) •2023 年：销售额 36.97 亿美元(122) •2024 年：销售额 33.2 亿美元，同比下降 10%(63) •2025 年 Q1：销售额 5.1 亿美元，同比下降 10%(124) •2025 年 Q3：销售额 8.25 亿美元，同比下降 20%，主要由 13% 的销售扣除和 12% 的价格下降驱动(115) 欧洲市场的惨烈教训为美国市场提供了预警。在欧洲，安进已经失去了约 25% 的市场份额给 Samsung Bioepis 的生物类似药。法国市场的数据更为惊人，etanercept 生物类似药的渗透率已达 74%。价格方面，欧洲市场的生物类似药竞争导致 Enbrel 和同类产品价格下降了 30%-50%(66)。辉瑞作为 Enbrel 的共同开发者，其分得的收入也呈现下滑趋势。2024 年辉瑞从 Enbrel 分得 6.90 亿美元，同比下降 17%(58)，这进一步印证了该产品面临的市场压力。 2.2 Prolia/Xgeva：下一个面临冲击的重磅产品 Prolia 和 Xgeva 作为地诺单抗的两个品牌，合计占安进 2023 年销售额的 22% 以上(1)，是公司的第一大收入来源。2024 年的数据显示： •Prolia 全年销售额 40.48 亿美元(122) •2025 年 Q4 销售额 12 亿美元，全年 37.9 亿美元 •2025 年 Q1 销售额 11.7 亿美元，同比增长 5% 然而，随着 2025 年 2 月专利到期和 Sandoz 生物类似药的上市，Prolia/Xgeva 的销售前景堪忧。安进管理层在 2025 年 Q1 财报会议上明确指出，预计 2025 年下半年将出现销售侵蚀(128)。考虑到 Enbrel 在欧洲市场的经验，Prolia/Xgeva 可能面临类似的市场份额损失。 2.3 其他核心产品的风险评估除了 Enbrel 和 Prolia/Xgeva，安进的其他核心产品也面临不同程度的专利到期风险： Otezla（阿普米司特）： •2024 年销售额 21.88 亿美元(122) •占 2024 年产品销售额的 6.73% •虽然专利延期至 2028 年，但已面临激烈的市场竞争，2024 年销售额下降 3%，主要由 8% 的价格下降驱动 Repatha（依洛尤单抗）： •2024 年销售额 22.2 亿美元，同比增长 36%(121) •占 2024 年产品销售额的 7.58% •作为 PCSK9 抑制剂，技术结构相对清晰，未来可能面临生物类似药挑战(77) Kyprolis（卡非佐米）： •2024 年销售额 14.03 亿美元(122) •占 2024 年产品销售额的 4.32% •虽然治疗方法专利已到期，但化合物专利保护至 2027 年 12 月，短期内风险相对可控三、安进的战略应对：多管齐下的转型之路 3.1 重磅收购：通过外延式增长填补专利悬崖面对专利悬崖，安进采取了激进的并购策略。2023 年 10 月，公司以 278 亿美元收购 Horizon Therapeutics，这是安进历史上最大的一笔收购(101)。这笔交易的战略意图十分明确：通过获得罕见病药物来弥补核心产品专利到期带来的收入损失。 Horizon 带来的核心资产： •Tepezza（teprotumumab-trbw）：甲状腺眼病治疗药物，2024 年销售额达 18.5 亿美元(139)，成为安进新的增长引擎。2024 年 Q4 销售额 4.6 亿美元，全年近 19 亿美元(114)。 •Krystexxa（pegloticase）：痛风治疗药物，2024 年 Q3 销售额 3.1 亿美元，同比增长 116%。安进在全球静脉用 pegloticase 市场占据 60-65% 的份额(119)。 •Uplizna（inebilizumab-cdon）：视神经脊髓炎谱系疾病治疗药物，2024 年 Q4 销售额 1.01 亿美元，全年 3.79 亿美元。 •Tavneos（avacopan）：抗中性粒细胞胞浆抗体相关性血管炎治疗药物，2024 年 Q4 销售额 8100 万美元，全年 2.96 亿美元，同比增长 111%。通过这笔收购，安进在 2024 年 Q3 实现了 12 亿美元的罕见病产品销售额，这些产品大多处于生命周期早期，有望在未来几年持续增长(115)。 3.2 创新研发：押注下一代重磅产品在内部研发方面，安进展现出了强大的创新能力和资金实力。2024 年，公司研发投入达到创纪录的 60 亿美元，同比增长 25%(108)。公司的研发策略结合了人类遗传学、蛋白质工程和人工智能等前沿技术(106)。最具潜力的在研产品：MariTide（AMG 133） MariTide 是安进在减肥药市场的重磅赌注。作为一种长效肽 - 抗体偶联物，每月或更少频率给药，在 2025 年 6 月公布的 Phase 2 研究中展现出令人瞩目的效果： •非糖尿病肥胖患者：52 周平均体重减轻高达 20%，安慰剂组仅为 2.6% •糖尿病肥胖患者：52 周平均体重减轻高达 17%，安慰剂组仅为 1.4% •更重要的是，52 周时体重减轻尚未达到平台期，提示有进一步减重潜力 MariTide 的差异化优势在于其给药频率。与诺和诺德的 Wegovy（每周注射）相比，MariTide 的每月给药方案有望显著提高患者依从性。目前，公司正在进行 72 周的 Phase 3 MARITIME 慢性体重管理研究，并计划在 2025 年启动动脉粥样硬化性心血管疾病、心力衰竭和阻塞性睡眠呼吸暂停的 Phase 3 研究。其他重要研发进展： •IMDELLTRA（tarlatamab-dlle）：2024 年 5 月获得 FDA 加速批准用于广泛期小细胞肺癌，2024 年 Q3 销售额 3600 万美元，季度环比增长 200%(110) •Tezspire（tezepelumab-ekko）：哮喘治疗药物，2024 年 Q3 销售额 2.69 亿美元，同比增长 67% •Evenity（romosozumab-aqqg）：骨质疏松治疗药物，2024 年 Q3 销售额 3.99 亿美元，同比增长 30% 3.3 生物类似药布局：从防守到进攻面对生物类似药的威胁，安进采取了 **"以其人之道还治其人之身"** 的策略，积极布局生物类似药业务。公司利用其在生物制剂领域的丰富经验，开发了多款生物类似药： •2024 年，安进的生物类似药销售额达到 7 亿美元，同比增长 35% •成功推出了强生 Stelara 的生物类似药 Wezlana，标志着公司在生物类似药领域的突破(140) •继续扩大在肿瘤学和自身免疫疾病领域的生物类似药组合这种策略不仅能够部分抵消原研药专利到期的影响，还能为公司开辟新的收入来源。 3.4 产品组合优化：聚焦高增长领域安进正在重新平衡其产品组合，减少对即将失去专利保护产品的依赖，加大对高增长领域的投入：重点发展领域： 1.罕见病：通过 Horizon 收购，罕见病已成为公司重要的增长引擎。预计到 2030 年，罕见病药物可能贡献公司收入的 25%(126)。 2.肿瘤学：IMDELLTRA、Blincyto 等创新产品展现出强劲增长势头。2024 年，10 个产品实现双位数增长，包括多款肿瘤药物(116)。 3.代谢疾病：MariTide 有望在 2030 年达到 1000 亿美元的肥胖药物市场中占据重要份额。产品生命周期管理： •为即将到期的产品寻找新适应症，如 Otezla 在 2024 年获批用于中重度斑块型银屑病(89) •开发新剂型和给药方案，如 Enbrel 的每周给药方案(44) •通过价格策略和患者支持项目维持市场份额四、财务影响的量化评估与前景展望 4.1 专利悬崖的财务冲击预测基于各产品的销售占比和专利到期时间，我们可以对安进未来几年的财务影响进行量化分析：短期影响（2025-2026 年）： •Prolia/Xgeva 占 2025 年预计收入的 22% 以上(1)，随着生物类似药上市，预计将出现 30-50% 的销售下滑 •Enbrel 占 2024 年销售额的 10.3%(121)，已呈现加速下滑趋势，2025 年 Q1 同比下降 10%(124) •管理层预计 2025 年下半年将出现明显的销售侵蚀，但新增长将抵消大部分损失中长期影响（2027-2030 年）： •到 2030 年，安进面临 67% 的收入风险，前四大产品均将失去专利保护(132) •九款产品将在 2021-2030 年间失去专利保护，累计影响可能超过 100 亿美元 4.2 新增长引擎的贡献评估尽管面临专利悬崖，安进的新增长引擎正在加速运转： 2024 年业绩亮点： •总收入 334.24 亿美元，同比增长 19%(123) •产品销售增长 19%，主要由 23% 的销量增长驱动(123) •21 个产品创下销售记录(123) •自由现金流 104 亿美元，同比增长 41%(123) 2025 年展望：公司对 2025 年保持谨慎乐观，预计： •总收入 343-357 亿美元 •非 GAAP 每股收益 20.00-21.20 美元 •生物类似药销售额预计达到 10 亿美元以上 4.3 关键成功因素与风险提示成功跨越专利悬崖的关键因素： 1.MariTide 的市场成功：作为潜在的重磅产品，MariTide 需要在 2026-2027 年成功上市并快速放量，以弥补 Enbrel 和 Prolia/Xgeva 的收入损失。 2.罕见病产品的持续增长：Tepezza、Krystexxa 等产品需要保持高速增长，特别是 Tepezza 需要从目前的 18.5 亿美元增长到 30 亿美元以上。 3.生物类似药业务的扩张：需要从目前的 7 亿美元增长到 20 亿美元以上，成为重要的收入来源。 4.研发管线的执行力：需要持续推出创新产品，特别是在肿瘤学和罕见病领域。主要风险因素： 1.竞争加剧：在肥胖药物市场，诺和诺德和礼来已经建立了强大的先发优势，MariTide 面临激烈竞争。 2.监管风险：新药审批的不确定性，特别是对于创新药物如 MariTide。 3.执行风险：大规模并购的整合挑战，以及新产品上市的商业化风险。 4.宏观环境：美国《通胀削减法案》的价格谈判压力，可能影响新产品的定价策略。结语安进公司正站在一个关键的十字路口。专利悬崖的挑战是严峻的，2025-2028 年间，公司将失去多款核心产品的专利保护，预计将影响超过 100 亿美元的年收入。Enbrel 在欧洲市场的教训表明，生物类似药的冲击可能比预期更加猛烈。然而，安进的应对策略是全面而富有远见的。通过 278 亿美元收购 Horizon，公司成功获得了 Tepezza 等极具潜力的罕见病药物；通过 60 亿美元的研发投入，培育了 MariTide 等下一代重磅产品；通过生物类似药布局，实现了从防守到进攻的转变。更重要的是，公司正在从一家以成熟产品为主的传统生物技术公司，转型为以创新和罕见病为驱动的新型生物制药企业。对投资者的建议：安进的股票在短期内可能面临波动，特别是 2025 年下半年 Prolia/Xgeva 生物类似药全面上市后。但从长期来看，公司的转型战略是正确的。建议投资者关注以下几个关键指标：(1) MariTide 的临床进展和商业化前景；(2) Tepezza 等罕见病产品的增长轨迹；(3) 生物类似药业务的扩张速度；(4) 研发管线中其他创新产品的进展。对行业观察者的启示：安进的转型之路为整个生物技术行业应对专利悬崖提供了重要借鉴。成功的关键在于：(1) 提前布局，通过并购快速获得新的增长引擎；(2) 持续创新，保持强大的研发能力；(3) 灵活应变，在生物类似药时代找到新的商业模式；(4) 聚焦优势，在核心治疗领域建立领导地位。对公司管理层的建议： 1.加快 MariTide 的开发和上市进程，确保其成为新的增长支柱。 2.深化与医疗机构和支付方的合作，确保新产品的市场准入。 3.优化成本结构，提高运营效率，为转型期提供财务缓冲。 4.加强人才管理，特别是在创新研发和商业化领域吸引顶尖人才。总的来说，虽然专利悬崖是安进面临的最大挑战，但公司已经展现出了强大的战略定力和执行能力。如果能够成功执行既定战略，安进有望在 2030 年后以一个更加强大和多元化的姿态出现在全球生物制药舞台上。正如公司 CEO Robert Bradway 所说："2024 年销售和收益的强劲增长反映了我们业务的发展势头。凭借全球强劲表现，我们正在大力投资快速推进的管线，专注于在四个治疗领域提供创新疗法。"(123) 这种信心并非毫无根据，而是建立在扎实的战略布局和执行能力之上。参考资料 [1] Biotech Moat Overview | June 1(pdf) https://www.morningstar.com/content/cs-assets/v3/assets/blt4eb669caa7dc65b2/blt73f6a3d6d16ac04a/Biotech_Moat_Report.pdf?refid=cvent_2023_archive [2] Patent Expiration https://www.drugpatentwatch.com/blog/category/patent-expiration/ [3] Patent Cliff: Can small healthcare firms dictate terms for bigger Pharma on the M&A deals? https://www.acuitykp.com/blog/patent-cliff/ [4] Amgen Update on Patent Litigation Related to Sandoz 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2025-2029年关键生物制剂药物专利到期盘点_CPHI制药在线移动官网 https://m.cphi.cn/news/show-285728.html [36] Top 10 drugs with patents due to expire in the next five years https://www.proclinical.com/blogs/2024-2/top-10-drugs-with-patents-due-to-expire-in-the-next-5-years [37] Biosimilar boom ahead: Patent expirations set to reshape the global biologics market https://www.biospectrumasia.com/analysis/29/25972/biosimilar-boom-ahead-patent-expirations-set-to-reshape-the-global-biologics-market.html [38] BLINCYTO Drug Profile https://www.drugpatentwatch.com/p/biologics/tradename/BLINCYTO [39] Onyx Pharms Amgen Company Profile https://www.drugpatentwatch.com/p/applicant/Onyx+Pharms+Amgen [40] MEMORANDUM in Support re 490 MOTION for Summary Judgment That The Claims Of Patents-In-Suit Are Invalid For Double Patenting Over Amgen 016 Patent filed by F for Amgen Inc. v. F. Hoffmann-LaRoche LTD et al :: Justia Dockets & Filings(pdf) https://cases.justia.com/federal/district-courts/massachusetts/madce/1:2005cv12237/100734/491/0.pdf [41] Amgen Update on Patent Litigation Related to Sandoz Denosumab Biosimilar Products https://www.amgen.com/newsroom/company-statements/amgen-update-on-patent-litigation-related-to-sandoz-denosumab-biosimilar-products [42] U.S. Biosimilar Landscape Deve(pdf) https://www.amerisourcebergen.com/-/media/assets/corporate/global/campaign-pages/cencora-biosimilars-usmarketlandscape-jul25.pdf [43] Medicare Price Negotiations Will Slow Biosimilar Momentum, Widening Market Gap https://www.centerforbiosimilars.com/view/medicare-price-negotiations-will-slow-biosimilar-momentum-widening-market-gap [44] FDA Approves ENBREL for Once-Weekly Dosing https://www.amgen.com/newsroom/press-releases/2003/10/fda-approves-enbrel-for-once-weekly-dosing [45] Pearce IP BioBlast® for the week ending 3 October 2025 https://www.pearceip.law/2025/10/09/pearce-ip-bioblast-for-the-week-ending-3-october-2025/ [46] 专利战升级背后:安进三星再次对簿公堂，生物类似药市场生变?_手机新浪网 https://finance.sina.cn/stock/relnews/us/2024-08-23/detail-inckryae1111936.d.html [47] Amgen Raises Forecast for Year Even as Biosimilars Encroach https://www.ndtvprofit.com/business/amgen-raises-forecast-even-as-biosimilars-encroach-on-top-drugs [48] The Value of Biosimilars and Amgen's Commitment https://wwwext.amgen.com/science/biosimilars/value-of-biosimilars-and-amgens-commitment [49] [重磅]Enbrel生物类似药Erelzi获FDA批准上市 https://m.sohu.com/a/112882965_465956/ [50] Approval and launch dates for US biosimilars https://gabionline.net/reports/Approval-and-launch-dates-for-US-biosimilars [51] Lupin to launch etanercept and pegfilgrastim biosimilars in the US https://gabionline.net/biosimilars/news/Lupin-to-launch-etanercept-and-pegfilgrastim-biosimilars-in-the-US [52] Etanercept biosimilar - Sandoz https://adisinsight.springer.com/drugs/800038107 [53] 中年安进，如何安全度过专利悬崖期? // • 第一核心支柱Prolia将在2025年下半年迎接生物类似药的竞争; • 第二大核心支柱Enbrel增速放缓，... https://xueqiu.com/4376152234/343318494 [54] AMGEN REPORTS THIRD QUARTER FINANCIAL RESULTS https://www.amgen.com/newsroom/press-releases/2023/10/amgen-reports-third-quarter-financial-results [55] Amgen, Merck, Teva Provide First-Quarter Biosimilars Info https://www.centerforbiosimilars.com/view/amgen-merck-teva-provide-first-quarter-biosimilars-reports [56] Amgen Raises Forecast for Year Even as Biosimilars Encroach https://www.ndtvprofit.com/business/amgen-raises-forecast-even-as-biosimilars-encroach-on-top-drugs [57] AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS https://investors.amgen.com/news-releases/news-release-details/amgen-reports-fourth-quarter-and-full-year-2024-financial [58] 2024年全球制药巨头自免业务排名TOP10 https://www.phirda.com/artilce_37907.html?module=trackingCodeGenerator [59] AMGEN REPORTS THIRD QUARTER 2024 FINANCIAL RESULTS https://www.amgen.com/newsroom/press-releases/2024/10/amgen-reports-third-quarter-2024-financial-results [60] Amgen's 2013 Revenues Increased 8 Percent To $18.7 Billion And Adjusted Earnings Per Share (EPS) Increased 17 Percent To $7.60 https://www.amgen.com/newsroom/press-releases/2014/01/amgens-2013-revenues-increased-8-percent-to-187-billion-and-adjusted-earnings-per-share-eps-increased-17-percent-to-760 [61] AMGEN REPORTS THIRD QUARTER 2024 FINANCIAL RESULTS https://www.amgen.com/newsroom/press-releases/2024/10/amgen-reports-third-quarter-2024-financial-results [62] Amgen 2024: Building a portfolio with longevity https://www.pharmalive.com/amgen-2024-building-a-portfolio-with-longevity/ [63] 安进2024年财报:业绩超预期，多样化药物组合推动高增长_财富号_东方财富网 https://caifuhao.eastmoney.com/news/20250207185319444019870 [64] AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS https://investors.amgen.com/news-releases/news-release-details/amgen-reports-fourth-quarter-and-full-year-2024-financial [65] Drug Price Trends for ENBREL https://www.drugpatentwatch.com/p/drug-price/drugname/ENBREL [66] 生物类似药欧美市场两重天-四川省医药行业协会 http://scyyhyxh.com/list_51/8209.html [67] +44 20 8123 2220 info@marketpu(pdf) https://pdf.marketpublishers.com/la_merie/competitor-analysis-biosimilar-n-biosuperior-anti-tnf-antibodies-2016-update.pdf [68] Eye on Pharma: Korean Drugmakers’ Impact in Europe; New Denosumab, Eculizumab Deals https://www.centerforbiosimilars.com/view/eye-on-pharma-korean-drugmakers-impact-in-europe-new-denosumab-eculizumab-deals [69] Korean drugmakers control more than half of European biosimilar market https://openkorea.org/feeds/news/korean-drugmakers-control-more-than-half-of-european-biosimilar-market/ [70] Biosimilars’ Power or Not? https://www.dcatvci.org/features/biosimilars-power-or-not/ [71] SAT0161 PRELIMINARY REAL WORLD DATA ON SWITCHING PATTERNS BETWEEN ETANERCEPT, ITS RECENTLY MARKETED BIOSIMILAR COUNTERPART AND ITS COMPETITOR ADALIMUMAB, USING SWEDISH PRESCRIPTION REGISTRY(pdf) http://gooa.las.ac.cn/apipaperc/api/paper/pdfdown?wid=JA202307270024340WH&roid=RO202307270024340WH [72] New denosumab and ustekinumab biosimilar launches in US, Canada and Japan https://gabionline.net/pharma-news/new-denosumab-and-ustekinumab-biosimilar-launches-in-us-canada-and-japan [73] Sandoz launches first and only interchangeable denosumab biosimilars in US, providing new affordable treatment options for over 10 million patients[1] https://www.thesudburystar.com/globe-newswire/sandoz-launches-first-and-only-interchangeable-denosumab-biosimilars-in-us-providing-new-affordable-treatment-options-for-over-10-million-patients1 [74] CuraTeQ Biologics Completes Biosimilar Denosumab Phase I Trial https://www.pearceip.law/2025/04/10/curateq-biologics-completes-biosimilar-denosumab-phase-i-trial/ [75] Amgen Expands US BPCIA Denosumab Litigation to include Biocon https://www.pearceip.law/2025/06/30/amgen-expands-us-bpcia-denosumab-litigation-to-include-biocon/ [76] Amgen Update on Patent Litigation Related to Sandoz Denosumab Biosimilar Products https://www.amgen.com/newsroom/company-statements/amgen-update-on-patent-litigation-related-to-sandoz-denosumab-biosimilar-products [77] 2025-2029年关键生物制剂药物专利到期盘点_CPHI制药在线移动官网 https://m.cphi.cn/news/show-285728.html [78] Lesser-Known Biosimilar Candidates to Watch For https://www.centerforbiosimilars.com/view/lesser-known-biosimilar-candidates-to-watch-for [79] SEC Filings | Amgen Inc.(pdf) https://amgen-investors.functionize.com/static-files/0000318154-21-000005.pdf;%20filename_=UTF-8''0000318154-21-000005.pdf [80] Competition and price among brand-name drugs in the same class: A systematic review of the evidence https://pmc.ncbi.nlm.nih.gov/articles/PMC6667132/ [81] KYPROLIS Drug Patent Profile https://www.drugpatentwatch.com/p/tradename/KYPROLIS [82] BRIEF—China’s Hansoh files for approval of generic Kyprolis https://www.thepharmaletter.com/in-brief/brief-china-s-hansoh-files-for-approval-of-generic-kyprolis [83] Amgen Data To Be Presented At ASCO 2016 Demonstrates More Insights Into Treatment Options For Patients https://www.amgen.com/newsroom/press-releases/2016/05/amgen-data-to-be-presented-at-asco-2016-demonstrates-more-insights-into-treatment-options-for-patients [84] Blincyto Market Size, Share, Growth, and Industry Analysis, By Type (IV Infusion), By Application (B-cell Acute Lymphoblastic Leukemia (ALL), Relapsed/Refractory Cancer), Regional Insights and Forecast to 2033 https://www.marketgrowthreports.com/market-reports/blincyto-market-113987 [85] AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS https://www.amgen.com/newsroom/press-releases/2025/02/amgen-reports-fourth-quarter-and-full-year-2024-financial-results [86] Pipeline Report: Oncology Biosimilars to Advance in 2020 https://www.centerforbiosimilars.com/view/pipeline-report-oncology-biosimilars-to-advance-in-2020 [87] Stivarga (regorafenib) https://veri.larvol.com/news/stivarga-regorafenib/drug [88] Amgen Announces Top-Line Results of Vectibix® (panitumumab) Phase 3 Head-to-Head Study Against Erbitux® (cetuximab) in Metastatic Colorectal Cancer https://www.amgen.com/newsroom/press-releases/2013/05/amgen-announces-topline-results-of-vectibix-panitumumab-phase-3-headtohead-study-against-erbitux-cetuximab-in-metastatic-colorectal-cancer [89] Advancing Health Through Innov(pdf) https://www.fda.gov/files/drugs/published/new-drug-therapy-2025-annual-report.pdf [90] Otezla (apremilast) https://www.pharmakb.com/drug-report/apremilast [91] Otezla上市多久? - 1健康 https://www.jiankang1.com/ask/a179602.html [92] OTEZLA Drug Patent Profile https://www.drugpatentwatch.com/p/tradename/OTEZLA [93] Amgen History https://www.amgen.com/about/amgen-history [94] Only 1 patent barrier remains for launch of Amgen's Otezla generics in Korea https://www.koreabiomed.com/news/articleViewAmp.html?idxno=20115 [95] RESULTS FROM AMGEN'S PHASE 2 OBESITY STUDY OF MONTHLY MARITIDE PRESENTED AT THE AMERICAN DIABETES ASSOCIATION 85TH SCIENTIFIC SESSIONS https://www.amgen.com/newsroom/press-releases/2025/06/results-from-amgens-phase-2-obesity-study-of-monthly-maritide-presented-at-the-american-diabetes-association-85th-scientific-sessions [96] 安进AMG 133公布II期结果:52周减重20% - 医药产业专区 - 生物谷 https://news.bioon.com/article/9da785381257.html [97] maridebart cafraglutide (AMG 133) Trials - LARVOL Sigma http://sigma.larvol.com/sigma/product.php?e1=856617&sourcepg=TZP&tab=ott [98] AMGEN PROVIDES STATEMENT ON MARITIDE PHASE 1 DATA https://www.amgen.com/newsroom/press-releases/2024/11/amgen-provides-statement-on-maritide-phase-1-data [99] Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AMG 133 in Adult Subjects With Overweight or Obesity, With or Without Type 2 Diabetes Mellitus https://ctv.veeva.com/study/dose-ranging-study-to-evaluate-the-efficacy-safety-and-tolerability-of-amg-133-in-adult-participan [100] Amgen's big reveal of obesity data falls a little flat https://pharmaphorum.com/news/amgens-big-reveal-obesity-data-falls-little-flat [101] 278亿美元超级并购之后，安进仍陷“专利悬崖”之困_财经头条 https://cj.sina.cn/articles/view/6066470577/16996feb1027016dgk [102] Queen Mary Knowledge Group\nTh(pdf) https://www.qmbfs.com/s/Week-9-MA-2023.pdf [103] Amgen concludes $27.8bn acquisition of Horizon Therapeutics https://www.practical-patient-care.com/news/amgen-concludes-27-8bn-acquisition-of-horizon-therapeutics/ [104] Amgen buys Horizon for $27.8 billion in bold step into the rare disease market https://www.cphi-online.com/news/amgen-buys-horizon-for-27-8-billion-in-bold-step-into-the-rare-disease-market/ [105] IMDELLTRA® SIGNIFICANTLY REDUCED RISK OF DEATH BY 40% IN SMALL CELL LUNG CANCER PATIENTS https://www.amgen.com/newsroom/press-releases/2025/06/imdelltra-significantly-reduced-risk-of-death-by-40-in-small-cell-lung-cancer-patients [106] Research & Development Strategy https://www.amgen.com/science/research-and-development-strategy [107] Amgen's Strategic Momentum at the Bank of America Healthcare Conference: Key Takeaways for Investors https://www.ainvest.com/news/amgen-strategic-momentum-bank-america-healthcare-conference-key-takeaways-investors-2505/ [108] Amgen 2025: The future of American science and innovation https://www.pharmalive.com/amgen-2025-the-future-of-american-science-and-innovation/ [109] Fighting the World's Toughest Diseases https://www.amgen.com/fighting-the-worlds-toughest-diseases [110] FDA grants accelerated approval to tarlatamab-dlle for extensive stage small cell lung cancer https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer#:~:text=On [111] Oncology (Cancer) / Hematologic Malignancies Approval Notifications https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications [112] FDA Approves Tarlatamab for Extensive-Stage Small Cell Lung Cancer https://www.medscape.com/viewarticle/fda-approves-tarlatamab-extensive-stage-small-cell-lung-2024a10009ds?src=rss [113] Immunotherapy Drug Tarlatamab Approved for Advanced Small Cell Lung Cancer https://www.cancertodaymag.org/cancer-talk/immunotherapy-drug-tarlatamab-approved-for-advanced-small-cell-lung-cancer/ [114] 安进强劲业绩背后，减肥药开发按下暂停键|仿制药|减肥药开发|安进|治疗|知名企业_手机网易网 http://m.163.com/news/article/JNL90Q6M055619KF.html [115] AMGEN REPORTS THIRD QUARTER 2024 FINANCIAL RESULTS https://www.amgen.com/newsroom/press-releases/2024/10/amgen-reports-third-quarter-2024-financial-results [116] AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS https://www.amgen.com/newsroom/press-releases/2025/02/amgen-reports-fourth-quarter-and-full-year-2024-financial-results [117] Amgen quarterly profit slips, obesity data on track for late 2024 https://www.streetinsider.com/dr/news.php?id=23558679 [118] Amgen quarterly profit rises 15% as Horizon deal boosts results https://www.xmza.com/research/markets/allNews/reuters/amgen-quarterly-profit-rises-15-as-horizon-deal-boosts-results-53758299 [119] Intravenous Pegloticase Market Size, Production, Sales, Average Product Price, Market Share, Import vs Export https://datavagyanik.com/reports/intravenous-pegloticase-market-research-report-analysis-and-forecast-till-2030/ [120] Hyperuricemia Drugs Global Market Report 2024 https://www.giiresearch.com/report/tbrc1619667-hyperuricemia-drugs-global-market-report.html [121] 安进2024年财报:业绩超预期，多样化药物组合推动高增长 2月4日，安进 $安进(AMGN)$1nbsp;公布了2024年财务业绩，超预期，股价随后大涨6.5%。公司2024年总收入同比... https://xueqiu.com/2319443919/322608173 [122] Amgen 2024: Building a portfolio with longevity https://www.pharmalive.com/amgen-2024-building-a-portfolio-with-longevity/ [123] AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS https://investors.amgen.com/news-releases/news-release-details/amgen-reports-fourth-quarter-and-full-year-2024-financial [124] 中年安进，如何安全度过专利悬崖期? // • 第一核心支柱Prolia将在2025年下半年迎接生物类似药的竞争; • 第二大核心支柱Enbrel增速放缓，... https://xueqiu.com/4376152234/343318494 [125] Patent Cliff: Can small healthcare firms dictate terms for bigger Pharma on the M&A deals? https://www.acuitykp.com/blog/patent-cliff/ [126] Amgen's Strategic Resilience Amid Patent Cliffs: Leveraging Acquisitions and Rare Diseases for Long-Term Growth https://www.ainvest.com/news/amgen-strategic-resilience-patent-cliffs-leveraging-acquisitions-rare-diseases-long-term-growth-2506/ [127] Amgen Reports Second Quarter 2019 Financial Results https://investors.amgen.com/news-releases/news-release-details/amgen-reports-second-quarter-2019-financial-results [128] Amgen Q1: Volume-Driven Sales Rise 11%, Cash Flow Doubles Amidst Biosimilar, IRS Tax Threats https://www.panabee.com/news/amgen-q1-quarterly-earnings-2025 [129] Amgen Reports First Quarter 2021 Financial Results https://www.amgen.com/newsroom/press-releases/2021/04/amgen-reports-first-quarter-2021-financial-results [130] Quarterly Newsletter | Amgen Inc.(pdf) https://amgen-investors.functionize.com/static-files/IR%20Newsletter_Q2_2019_Final.pdf [131] Annual Reports | Amgen Inc.(pdf) https://amgen-investors.functionize.com/static-files/2019%20Annual%20Letter_10-K%20Bookmarked.pdf [132] The $183B Impact of Patent Expirations On Biopharma Giants https://www.worldpharmatoday.com/news/the-183b-impact-of-patent-expirations-on-biopharma-giants/ [133] 2025至2030生物相似行业产业运行态势及投资规划深度研究报告.docx-原创力文档 https://m.book118.com/html/2025/0728/6052055203011205.shtm [134] Vizient Report Projects Price Inflation for Originators With Biosimilars in the Pipeline https://www.centerforbiosimilars.com/view/vizient-report-projects-price-inflation-for-originators-with-biosimilars-in-the-pipeline [135] Biosimilars Regulatory Roundup: May 2025 https://www.centerforbiosimilars.com/view/biosimilars-regulatory-roundup-may-2025 [136] 25 High-Value Drugs Losing Patent Protection in 2025: What It Means for Healthcare https://biopharmaapac.com/analysis/60/5727/25-high-value-drugs-losing-patent-protection-in-2025-what-it-means-for-healthcare.html [137] Global Biosimilars Market Size, Share, Growth, Trends & Analysis Report 2025 https://meditechinsights.com/global-biosimilars-market/ [138] The Stelara Biosimilar Price War: How PBM-Affiliated Private Labels Are Reshaping the Market https://www.drugchannels.net/2025/07/the-stelara-biosimilar-price-war-how.html?m=1 [139] 全球前20大制药公司营收最新排名及分析!涉及强生、罗氏、默沙东、辉瑞等-腾讯新闻 https://news.qq.com/rain/a/20250427A0836Y00 [140] With patent losses on the horizon, Amgen refocuses its business strategy https://www.pharmavoice.com/news/amgen-patent-loss-business-strategy-otezla-enbrel-biosimilars/741572/ [141] Amgen's SWOT analysis: stock outlook amid obesity drug race By Investing.com https://www.investing.com/news/swot-analysis/amgens-swot-analysis-stock-outlook-amid-obesity-drug-race-93CH-3846730 [142] Johnson & Johnson Competitors – Top 10 Major Competitors of Johnson & Johnson | Competitors Analysis https://www.managementnote.com/johnson-johnson-competitors/ [143] Amgen: Business Model, SWOT Analysis, and Competitors 2024 https://pitchgrade.com/companies/amgen [144] 讨论详情 - 雪球 https://xueqiu.com/3692999302/346615026/372553727 [145] Biosimilar boom ahead: Patent expirations set to reshape the global biologics market https://www.biospectrumasia.com/analysis/29/25972/biosimilar-boom-ahead-patent-expirations-set-to-reshape-the-global-biologics-market.html [146] Navigating the Recession and Patent Expirations https://www.pharmexec.com/view/navigating-recession-patent-expirations [147] The Patent Cliff is Coming: What It Means for Pharma Investors in 2025 https://www.crispidea.com/pharma-investing-patent-cliff-2025/ [148] Assessing the Biosimilar Void in the U.S. - IQVIA https://www.iqvia.com/es-mx/insights/the-iqvia-institute/reports-and-publications/reports/assessing-the-biosimilar-void-in-the-us [149] Biopharma Trends 2025(pdf) https://web-assets.bcg.com/80/70/7fee493b4991934742b68e87dc3d/biopharma-trends-focusing-on-innovation-amid-complexity-jan-2025.pdf （注：文档部分内容可能由 AI 生成）

专利到期并购生物类似药

100 项与地舒单抗生物类似药 (Novartis) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	M05BX04	DB06643

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
恶性肿瘤体液性高钙血症	澳大利亚	Sandoz Pty Ltd.	2024-08-23
多发性骨髓瘤	澳大利亚	Sandoz Pty Ltd.	2024-08-23
骨癌	欧盟	Sandoz GmbH	2024-05-17
骨癌	冰岛	Sandoz GmbH	2024-05-17
骨癌	列支敦士登	Sandoz GmbH	2024-05-17
骨癌	挪威	Sandoz GmbH	2024-05-17
代谢性骨病	欧盟	Sandoz GmbH	2024-05-16
代谢性骨病	冰岛	Sandoz GmbH	2024-05-16
代谢性骨病	列支敦士登	Sandoz GmbH	2024-05-16
代谢性骨病	挪威	Sandoz GmbH	2024-05-16
骨病	美国	Sandoz, Inc.	2024-03-05
骨转移癌	美国	Sandoz, Inc.	2024-03-05
骨巨细胞瘤	美国	Sandoz, Inc.	2024-03-05
糖皮质激素诱导的骨质疏松症	美国	Sandoz, Inc.	2024-03-05
高钙血症	美国	Sandoz, Inc.	2024-03-05
骨质疏松症	美国	Sandoz, Inc.	2024-03-05
绝经期后骨质疏松	美国	Sandoz, Inc.	2024-03-05
骨质疏松性骨折	美国	Sandoz, Inc.	2024-03-05

未上市

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适应症	最高研发状态	国家/地区	公司	日期
骨折	申请上市	美国	Sandoz International GmbH	2023-02-06

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临床结果

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分期

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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


NCT03974100 (ROSALIA, WCO_IOF_ESCEO2023)	临床3期	绝经期后骨质疏松	527	GP2411	艱衊簾鑰醖糧襯蓋壓衊(繭鏇選窪製蓋鏇淵獵遞) = 壓鏇顧衊鑰鹽遞簾鏇夢獵觸顧範遞觸築艱窪選 (齋齋鬱鬱築憲構夢憲範 ) 更多	积极	2023-05-04
				Reference Denosumab	艱衊簾鑰醖糧襯蓋壓衊(繭鏇選窪製蓋鏇淵獵遞) = 簾製廠獵觸鏇壓顧製壓獵觸顧範遞觸築艱窪選 (齋齋鬱鬱築憲構夢憲範 ) 更多
NCT03974100 (ROSALIA, CTgov)	临床3期	绝经期后骨质疏松	527	GP2411	窪繭憲衊構憲窪鏇蓋鬱(鑰壓鏇餘壓鏇衊獵鬱繭) = 艱夢鏇鑰遞鹹鹹繭獵窪餘觸憲壓網製選膚願鹹 (積築顧顧膚願積膚鑰蓋, 0.2634) 更多	-	2023-03-08
NCT03974100 (GlobeNewswire) 人工标引	临床3期	骨质疏松症	-	Denosumab-GP2411	選鏇糧選顧衊蓋製觸繭(願齋鏇淵觸鏇鏇蓋憲蓋) = ROSALIA study met primary endpoints, confirming proposed biosimilar denosumab matches reference product in terms of pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity in postmenopausal women with osteoporosis 鹹淵鑰鹽淵餘夢繭顧膚 (淵獵鬱憲製鹹窪蓋衊網 )	相似	2022-09-19
				Denosumab