A Multicenter, Randomized, Double-blind Study Evaluating the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Multiple Switches Between Humira® (Adalimumab [US]) and ABP 501 Compared With Continued Use of Adalimumab in Subjects With Moderate to Severe Plaque Psoriasis

Study to evaluate pharmacokinetics, efficacy, safety and immunogenicity of multiple switches between Humira® and ABP 501 (new high concentration formulation) compared with continued use of Humira® in participants with moderate to severe plaque psoriasis. This multi-center study is composed of two periods: A lead-in period of treatment with Humira® followed by a randomized two parallel arm period.

开始日期2021-10-04

申办/合作机构

Amgen, Inc.

NCT05909852

/ Completed临床1期

A Randomized, Single-blind, Single-dose, 2-arm, Parallel-group Study to Determine the Pharmacokinetic Comparability of ABP 501 40 mg/0.4 mL (ABP 501-HCF) and ABP 501 40 mg/0.8 mL (ABP 501-LCF) in Healthy Adult Subjects

To determine the pharmacokinetic (PK) comparability of ABP 501 40 mg/0.4 mL (ABP 501-HCF) compared to ABP 501 40 mg/0.8 mL (ABP 501-LCF) following single-dose subcutaneous (SC) injection, as assessed principally by area under the serum concentration-time curve (AUC) from time 0 extrapolated to infinity (AUCinf) and maximum observed serum concentration (Cmax) in healthy adult participants.

开始日期2021-07-23

申办/合作机构

Amgen, Inc.

NCT04131322

/ Terminated临床4期IIT

Loss of Response of Adalimumab Biosimilar Compared With the Loss of Response of Adalimumab Original: Controlled, Randomized, Non-inferiority Open Study. "ADA-SWITCH Study"

Loss of response of the Adalimumab biosimilar compared with the original drug.

开始日期2019-10-10

申办/合作机构

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

100 项与阿达木单抗生物类似药（安进生物）相关的临床结果

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100 项与阿达木单抗生物类似药（安进生物）相关的转化医学

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100 项与阿达木单抗生物类似药（安进生物）相关的专利（医药）

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项与阿达木单抗生物类似药（安进生物）相关的文献（医药）

2026-01-01·Crohns & Colitis 360

Effectiveness and safety of adalimumab biosimilar in bio-naive patients with inflammatory bowel disease: a real-life multicenter observational study comparing ABP501, SB5, MSB11022, GP2017, and FKB327.

Article

作者: Regueiro, Cristina ; Villaamil, Pablo Vega ; Ruiz Barcia, Maria Jesús ; Baz López, Alina Montserrat ; Bastón-Rey, Iria ; Campos, Amalia Carmona ; Arriero, Gema Molina ; Vázquez Rey, Maria Teresa ; Galego, Monica Ayude

Background:

Biosimilars represent a significant opportunity in the treatment of inflammatory bowel disease (IBD). Our aim is to assess the effectiveness and safety of the five approved adalimumab (ADA) biosimilars in IBD patients naive to biologics.

Methods:

IBD patients naive to biologics from eight Spanish hospitals were enrolled. We included patients who started ADA biosimilars between November 2018 and January 2022. The study endpoints included (1) induction of remission at week 8; (2) drug persistence at the conclusion of the follow-up period; and (3) safety of the five ADA biosimilars.

Results:

In total, 383 patients were included. After induction, 63.8% of patients were in clinical remission. In total, 114 (29.8%) patients discontinued treatment during follow-up. Clinical remission was maintained in 78.4% of patients after a median follow-up of 18 (12-24) months. Dose intensification was performed in 35 (9.1%) patients during follow-up. There was no significant difference in effectiveness for the 5-ADA biosimilars. Additionally, drug persistence was significantly higher in Crohn's disease (CD) patients (P = .012), in the group of patients co-treated with immunomodulators (IMM) (P = .001) and in patients with post-induction (at week 8) ADA levels ≥ 7 μg/mL (P = .002). Adverse events were reported in 30 (7.8%) patients with no significant difference between ADA biosimilars.

Conclusion:

ADA biosimilars are safe and effective in inducing and maintaining remission in a real-life population of bio-naive IBD patients. Furthermore, there is no significant difference between the 5-ADA biosimilars. Drug persistence was significantly higher in patients with CD treated with IMM and with post-induction ADA levels ≥7 μg/mL.

2025-10-03·EXPERT OPINION ON BIOLOGICAL THERAPY

Clinical and out-of-pocket cost outcomes after switching to biosimilar adalimumab-atto in patients with rheumatoid arthritis

Article

作者: Niu, Fang ; Lin, Antony T-H ; Londa, Abbey ; Teshima, Samantha ; Hui, Rita L. ; Delate, Thomas ; Pham, Catherine

BACKGROUND:

Limited real-world studies have evaluated outcomes after switching treatment from a reference product (RP) to a biosimilar product. The objective of this real-world study was to assess the outcomes of switching from RP adalimumab to biosimilar adalimumab-atto in patients with rheumatoid arthritis (RA).

RESEARCH DESIGN AND METHODS:

This was a propensity score matched, non-inferiority study assessing adult patients with RA who switched from RP adalimumab to adalimumab-atto (Switchers) between or received RP adalimumab continuously (Non-Switchers). One-year disease worsening, serious adverse events, and patient out-of-pocket cost outcomes were evaluated. An upper limit of 5% for adalimumab-atto was set as the non-inferiority margin.

RESULTS:

After matching, there were 1,172 patients in each group. 24.8% and 31.0% of patients in the Switcher and Non-Switcher groups, respectively, experienced the disease worsening (non-inferiority p < 0.01). The crude rates per 100 patient-years of the safety outcome and mean monthly changes in out-of-pocket costs were 5.6 (95% CI 4.2-7.5) and 7.2 (95% CI 5.2-9.2) (p = 0.21) and -$51 (±$164) and -$11 (±$152) (p < 0.01) in the Switcher and Non-Switcher groups, respectively.

CONCLUSIONS:

These results provide evidence that switching from RP adalimumab to biosimilar adalimumab-atto did not result in disease worsening or increased adverse events but did deliver modestly lower patient out-of-pocket costs.

2025-09-01·BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

A single‐centre analysis of a biosimilar switching programme for adalimumab in inflammatory bowel disease

Article

作者: Ferguson, John ; Rabbitt, Louise ; Keogh, Áine ; McGuire, Brian E. ; Duane, Linda ; Hobbins, Anna ; Egan, Laurence J. ; Gillespie, Patrick

Aims:

Amgevita is a licensed biosimilar to adalimumab, having demonstrated high pharmacokinetic and clinical similarity to Humira. Switching to a lower‐cost medicine may elicit a nocebo effect, whereby expectations of poorer efficacy impact outcomes despite pharmacological similarity. This prospective cohort study examined clinical and economic outcomes and associated psychosocial variables in a group of patients undergoing a nonmedical switch to biosimilar adalimumab.

Methods:

Patients with inflammatory bowel disease (IBD) were followed before and after switching from Humira to Amgevita. Objective disease activity was assessed pre‐ and post‐switch using the Harvey–Bradshaw Index (Crohn's disease) or partial Mayo score (ulcerative colitis), faecal calprotectin and C‐reactive protein. Subjective symptom burden was measured using the IBD Control Questionnaire (IBDCQ). Pre‐switch, health anxiety was measured using the Health Anxiety Index (HAI).

Results:

In total, 64 patients aged 18–67 were enrolled. IBDCQ scores marginally improved post‐switch (13.33 vs , 12.49, P = .043), with no significant changes in objective disease activity scores, faecal calprotectin or C‐reactive protein. Sixteen patients reported 17 new adverse events within 4 weeks. Logistic regression revealed a significant relationship between HAI scores and adverse events ( P = .0079); each unit increase in HAI score increased the odds of reporting an adverse event by 21%. Drug cost savings for the 64 patients over 8 weeks totalled €143 958.

Conclusion:

Switching to biosimilar adalimumab did not affect disease control or quality of life. 25% of patients developed new side effects, particularly those with high levels of health anxiety. Significant cost savings were achieved.

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项与阿达木单抗生物类似药（安进生物）相关的新闻（医药）

2026-03-25

·新药进展

复宏汉霖地舒单抗加拿大获批！覆盖原研全部适应症，全球化布局再下一城

当一款中国生物类似药在短短数年内接连登陆美国、欧盟、英国，如今再获加拿大批准，它已不仅是“国产替代”的典范，更是中国生物制药企业全球化能力的集中体现。2026年3月25日，复宏汉霖宣布的这项进展，为其地舒单抗产品的全球版图再添重要拼图。 2026年3月25日，复宏汉霖宣布，加拿大卫生部已批准地舒单抗注射液的上市申请： BILDYOS®（60mg/mL）：PROLIA®的生物类似药 TUZEMTY®（120mg/1.7mL）：XGEVA®的生物类似药两款产品涵盖原研产品在加拿大的所有已批准适应症。这是继美国、欧盟与英国获批之后，复宏汉霖地舒单抗产品在全球化布局中取得的又一重要监管里程碑。01 获批解读：加拿大市场的战略价值加拿大是全球十大医药市场之一，此次地舒单抗两款产品的获批，是复宏汉霖全球化战略的重要一步。市场价值：加拿大医药市场成熟，监管体系严格，对生物类似药需求稳定。地舒单抗在加拿大市场具有可观的销售额，生物类似药的进入有望为患者提供更可及的选择。监管认可：加拿大卫生部的批准，意味着复宏汉霖的生产质量体系和临床数据获得了又一主流监管机构的认可，为其后续产品进入加拿大市场积累了经验。适应症覆盖：两款产品涵盖原研产品在加拿大的所有已批准适应症，包括： BILDYOS®：用于骨质疏松症、骨量减少等（对应PROLIA®） TUZEMTY®：用于实体瘤骨转移、骨巨细胞瘤等（对应XGEVA®）全球化布局：此次获批后，复宏汉霖地舒单抗已在美国、欧盟、英国、加拿大等主流市场获批，全球化版图持续扩大。02 产品解读：地舒单抗的生物类似药价值地舒单抗是安进开发的RANK配体抑制剂，通过抑制破骨细胞活化，减少骨吸收。其两款产品PROLIA®和XGEVA®在全球市场销售额巨大，生物类似药的价值不言而喻。 PROLIA®（60mg）：适应症：绝经后女性骨质疏松症、男性骨质疏松症、糖皮质激素诱导的骨质疏松症等。用药频率：每6个月皮下注射一次。市场地位：全球最畅销的骨质疏松症药物。 XGEVA®（120mg）：适应症：实体瘤骨转移相关骨事件、骨巨细胞瘤、恶性肿瘤高钙血症等。用药频率：每月皮下注射一次。市场地位：实体瘤骨转移的标准治疗药物。生物类似药价值：降低医疗成本：生物类似药通常以低于原研药20%-30%的价格进入市场，可显著降低患者和医保负担。增加供给选择：多源供应保障药物可及性，避免单一来源供应中断风险。推动创新迭代：生物类似药的竞争促使原研药企持续创新，推动整个领域发展。03 临床证据：与原研药的高度相似性地舒单抗生物类似药的批准基于与参照药在结构、功能、药代动力学、疗效和免疫原性等方面的全面相似性证明。结构相似性：通过先进的分析技术证明复宏汉霖地舒单抗与原研药在氨基酸序列、高级结构、翻译后修饰等方面高度相似。功能相似性：体外生物学活性研究证实，复宏汉霖地舒单抗与原研药在结合RANKL、抑制破骨细胞分化等方面具有等效性。临床相似性：III期研究在骨质疏松症患者中证实，复宏汉霖地舒单抗与原研药在骨密度改善、骨折发生率等关键终点上具有临床等效性，且安全性、免疫原性相似。外推适应症：基于与原研药的高度相似性，复宏汉霖地舒单抗可外推至原研药已获批的所有适应症。04 全球化布局：复宏汉霖的国际化版图复宏汉霖地舒单抗的加拿大获批，是其全球化战略的重要里程碑。已获批市场：美国：已获批欧盟：已获批英国：已获批加拿大：新获批中国：已上市其他产品：除地舒单抗外，复宏汉霖已有曲妥珠单抗、利妥昔单抗、贝伐珠单抗、阿达木单抗等多个生物类似药在全球市场获批，形成了丰富的生物类似药产品矩阵。国际化能力：连续在多个主流市场获批，证明复宏汉霖具备同时满足不同监管机构要求的质量管理体系、临床开发能力和注册申报能力。创新转型：在生物类似药业务的基础上，复宏汉霖正在加速创新药研发，构建“生物类似药+创新药”双轮驱动的产品布局。05 患者价值：更可及的骨健康选择骨质疏松症和实体瘤骨转移是全球范围内影响广泛的疾病，患者对可及、有效的治疗选择需求迫切。骨质疏松症：全球约2亿女性患有骨质疏松症，绝经后女性是主要人群。地舒单抗每6个月一次皮下注射，是患者依从性最高的骨质疏松症治疗方案之一。生物类似药的进入，有望降低治疗成本，让更多患者获得长期规范的骨健康管理。实体瘤骨转移：乳腺癌、前列腺癌、肺癌等实体瘤常发生骨转移，导致骨痛、骨折、脊髓压迫等骨相关事件。地舒单抗是预防骨相关事件的标准治疗，每月一次皮下注射。生物类似药的可及性提升，将惠及更多肿瘤患者。复宏汉霖的价值：通过提供高质量、可负担的地舒单抗生物类似药，复宏汉霖正在为全球患者贡献“中国方案”。06 未来展望：从生物类似药到创新药复宏汉霖的地舒单抗全球化布局，是其从生物类似药向创新药转型的坚实支撑。现金流支撑：生物类似药的销售收入可为公司提供稳定的现金流，支撑创新药管线的持续投入。国际化经验：多国申报的成功经验，为未来创新药的全球临床开发和注册提供了宝贵借鉴。平台能力：生物类似药的开发锤炼了复宏汉霖的CMC工艺开发能力和临床运营能力，这些能力可复用至创新药研发。创新管线：复宏汉霖正在开发多个创新药，包括PD-1单抗、ADC、双特异性抗体等，未来有望实现“生物类似药+创新药”的双轮驱动。新药君说在创新药的光环之下，生物类似药往往被视为“平凡”的选择。但正是这些“平凡”的产品，构建了中国制药企业走向国际市场的第一块基石。复宏汉霖地舒单抗接连登陆美国、欧盟、英国，如今再获加拿大批准，证明“中国制造”的生物药在质量上完全可以与全球顶尖产品比肩。当越来越多的中国生物类似药走向世界，它们不仅为全球患者带来更可及的治疗选择，也为中国创新药的未来铺就了一条经过验证的国际化道路。从美国到欧盟，从欧盟到英国，从英国到加拿大——复宏汉霖地舒单抗的全球征途，是中国生物制药企业国际化能力的一次完整演练。当这款产品最终走进全球患者的家庭药箱，它所承载的不仅是复宏汉霖的商业价值，更是中国生物药“质优价宜”的全球声誉。（注：以上信息基于复宏汉霖官方新闻稿及公开资料整合。具体用药方案需由医生根据患者病情制定，本文不构成任何医疗建议。）

2026-03-24

·一滴发现

制药万亿市值生物制药“教父”：安进（Amgen, AMGN）如何在专利围城中靠“全能管线”重塑增长？

1. 疑问出发点在人类与慢性病长达百年的博弈中，到底哪家公司能同时解决心脏病、骨质疏松、以及日益增长的罕见病需求？更重要的是，当所有人都在追逐“减肥神药”的浪潮时，安进正试图用每月一次的更长效方案，重新定义这个千亿赛道。截至2026年3月，安进市值约为1510亿美金（万亿人名币），2025年营收高达368亿美金。它是全球生物技术的开山鼻祖，拥有14款年销售额超10亿美金的“重磅炸弹”药物，更是生物类似药与罕见病领域的隐形霸主。在同行争抢聚光灯时，安进 quietly 完成了从“传统重症制药”向“慢病、自免与罕见病”三位一体的战略转型。2. 它是干什么的？2.1 发展历史 1980年：在加州千橡市创立，成为全球首批利用重组DNA技术研发药物的先驱。 1989年：首款红细胞生成素Epogen获批，标志着生物药商业化的里程碑。 1990-2010年：陆续推出Neulasta等抗癌支持药物及自免药Enbrel，奠定行业巨头地位。 2019-2023年：通过收购Otezla（约134亿美金）和Horizon Therapeutics（约278亿美金），迅速切入皮肤免疫及罕见病蓝海。 2024-2026年：重点押注MariTide（减肥药）与Repatha（降脂药），成功对冲老款药物的专利到期风险，实现二次增长曲线。2.2 主营业务安进的品牌形象是“全生命周期的生物创新引擎”。它不仅是复杂蛋白药物的制造专家，更是针对全球老龄化背景下“慢病管理”的终极方案提供者。2.2.1 业务板块业务板块核心代表产品 2025年营业额(亿美金) 营业额占比普通医学 (心血管/骨科) Repatha, Prolia, EVENITY 114 31% 炎症与免疫 Enbrel, Otezla, TEZSPIRE 92 25% 罕见疾病 (Horizon遗产) TEPEZZA, KRYSTEXXA 52 14% 肿瘤与血液学 BLINCYTO, LUMAKRAS, Nplate 50 14% 生物类似药及其他 PAVBLU, AMJEVITA 60 16%合计 --368100%2.2.2 客户群体客户名称客户产品描述客户行业地位医药分销三巨头 (如Cencora) 负责安进复杂生物药的全球冷链物流全球药品供应链的“生命线”企业 PBM及私人保险机构 (如UnitedHealth) 决定药物在报销目录中的优先等级美国药品定价与准入的幕后推手全球综合医院及心脏/肿瘤中心处方降脂药Repatha及罕见病药的终端场景医疗技术落地的核心终端政府医保 (Medicare) 负责支付大量老龄化相关的慢病药物费用全球最大的公立医疗买方2.3 行业趋势2.3.1 公司现状目前生物制药行业处于 “重症慢性病化” 的深度转型期——曾经致命的疾病正被转化为需要长期管理的慢性状态。安进已从单纯的“癌症辅助药企”进化为 “慢病+自免+罕见病” 多元驱动的生物药巨头。在行业内，安进以 “极高的制造门槛” 和 “极其稳健的现金流” 著称，是投资者在医药板块波动时的“避风港”。2.3.2 护城河生物制造的“黑科技”：生物药的活性60%取决于生产工艺。安进掌握着全球最精密的细胞培养与提纯技术，使其能将生物类似药作为防御性武器，在对手专利到期时精准狙击。这种制造壁垒，让仿制者望而却步。罕见病领域的溢价权：随着对Horizon Therapeutics的成功整合，安进在甲状腺眼病（TEPEZZA）等细分赛道拥有近乎100%的市场占有率和极强的定价权。这是典型的“小而美”现金牛。 “月度给药”的差异化逻辑：面对礼来、诺和诺德在减重赛道的激烈竞争，安进坚持开发月度甚至季度给药的长效制剂。MariTide的临床数据显示其有望实现每月一次注射，这将极大地提升慢病患者的用药依从性，成为对抗周制剂的核心武器。生物类似药的反向渗透：安进不仅是原研药巨头，更是全球生物类似药的第一梯队玩家。它用自己的仿制药去抢占别人的市场，同时用原研药的品牌护住自己的阵地，这种“攻守兼备”的策略在行业内独树一帜。2.3.3 行业竞争公司名称竞争产品特点行业地位最新市值(亿美金) 礼来 (LLY) 替尔泊肽(双靶点)减重效果领先全球药企市值第一 10200 诺和诺德 (NVO) 司美格鲁肽先发优势巨大 2026年市值重估后的代谢王者 1700 赛诺菲 (SNY) 专注特应性皮炎与自免领域欧洲免疫制药领军者 1280 辉瑞 (PFE) 转型口服减肥药与抗癌药老牌医药全能王 1620 维京治疗 (VKTX) 临床减重数据极其惊艳减肥药赛道最强黑马 952.3.4 产业链安进位于产业链的中游核心研发与精密制造，其产能布局直接左右全球生物药的供给平衡。产业链全貌：上游：生命科学耗材（赛默飞世尔）、基因合成（丹纳赫）、细胞培养基供应商。中游：安进（蛋白质工程、生物类似药平台、全球灌装网络）。下游：分销商（麦卡逊）、专业药房（CVS Specialty）、保险支付方（联合健康）。2.4 管理层姓名职务在职成果工作履历 Robert A. Bradway CEO 主导了罕见病领域的世纪并购（Horizon），带领安进向多元慢病管理转型摩根大通投行部背景，哈佛MBA，深谙资本运作与战略布局 Peter Griffith CFO 维持了行业领先的46%营业利润率，资本配置能力极强前普华永道全球副主席，负责安进复杂的资本运作与分红策略 James Bradner R&D负责人 MariTide临床推进的旗手，被誉为转化医学天才医学博士，曾任诺华研发总裁，诺奖级科学家的“伯乐” Murdo Gordon 首席商务官 Repatha销售突破的主推者，打通PBM准入壁垒拥有30年制药营销经验，擅长复杂的报销谈判 Arleen Paulino 运营高级副总裁构建了韧性极强的全球生物供应链生物工程专家，负责安进分布全球的精密生物反应器集群3. 股市表现3.1 近10年股价与业绩表现年份市值(亿美金) 市值波动利润(亿美金) 利润波动分红率当年核心简评 2016 1100 -5% 77 +5% 2.8% 传统业务承压，平稳过渡 2017 1280 +19% 19.8 -74% 2.5% 税改影响账面，研发投入激增 2018 1290 +1% 73.5 +271% 2.6% 利润恢复正常，管线稳步推进 2019 1430 +25% 78.4 -6% 2.4% 收购Otezla，现金流极度健康 2020 1470 +3% 72.1 -8% 2.9% 疫情下医院用药短期承压 2021 1260 -1% 58.9 -19% 3.1% 疫情持续影响，股价低位徘徊 2022 1320 +5% 65.5 +11% 3.2% 业务逐步恢复，估值修复 2023 1540 +10% 67.2 +3% 3.0% Horizon收购获批，开启罕见病时代 2024 1680 +9% 71.5 +6% 2.8% 减肥药预期推动估值提升 2025 1670 -1% 74.8 +5% 3.1% 平稳过渡，等待MariTide催化 2026* 1510 -10% 78.2* +9% 3.3% 稳健分红对抗板块波动，静待花开注：2026年市值及利润为截至3月数据及市场预期3.2 前10大股东序号股东名称持股比例 1 The Vanguard Group (先锋领航) 9.55% 2 BlackRock, Inc. (贝莱德) 8.24% 3 State Street Corp (道富银行) 5.31% 4 Capital World Investors (资本研究) 4.88% 5 JPMorgan Chase 2.25% 6 Geode Capital Management 2.15% 7 Wellington Management 1.88% 8 Morgan Stanley (摩根士丹利) 1.45% 9 Bank of America 1.32% 10 Northern Trust Corp 1.25%合计 --40.28%3.3 当前优势分析维度分析内容市场地位生物类似药全球第一梯队，能够通过自身降价策略精准挤压竞争对手空间。在罕见病领域拥有多个“垄断级”产品，定价权稳固。财务表现自由现金流极其充沛（2025年约81亿美金），股息连续十余年增长，是标普500中稀缺的“股息增长型”药企。产品组合 “心血管+骨科+罕见病”三大领域均拥有重磅产品，无明显的单一药物依赖风险。Repatha、Prolia等基石产品专利期长，护城河稳固。增长前景 MariTide（减肥）与IMDELLTRA（小细胞肺癌）是未来三年的业绩倍增器。MariTide若能实现月度给药，将在GLP-1红海中开辟差异化蓝海。3.4 当前风险药价谈判冲击：支柱药物Otezla等已被纳入美国IRA法案议价名单，未来几年可能面临直接的利润侵蚀。生物类似药反噬：安进在阻击他人的同时，自己的核心药物（如Enbrel）也正遭遇其他药企更低价的类似药挑战，市场份额面临压力。商业化节点风险：市场对MariTide的乐观预期已部分计入股价，一旦2026年底-2027年初的商业化节奏受阻或临床数据不及预期，可能引发短期估值回调。 Enbrel专利悬崖：作为安进昔日的“现金牛”，Enbrel正面临生物类似药的围攻，销量持续下滑，这块缺口需要新药及时填补。4. 中国类似企业公司名称市值(亿美金) 业务对标维度核心关联逻辑行业地位恒瑞医药 600276.SH 465 创新药大单品同样走“全适应症覆盖+减重药突破”的龙头路径，研发管线深厚。中国创新药绝对领导者。信达生物 01801.HK 65 生物药平台拥有国内领先的单抗/双抗研发能力，是生物药转型的典型代表。中国生物制药创新的尖兵。百济神州 688235.SH / 06160.HK 215 全球化生物药走全球化临床与商业化路线，通过大规模制造对冲专利压力。中国药企国际化程度最高的公司。华东医药 000963.SZ 82 代谢与慢病通过海外并购（医美/自免）快速扩张管线，商业逻辑高度相似。国内减重药及自免领域的先行者。5. 当前总结安进的核心竞争力，在于其极具韧性的产品结构与生物药制造领域的“降维打击”能力。它不追求短期的爆发性增长，而是追求跨越专利周期的持续复利——用生物类似药攻守兼备，用罕见病锁定高壁垒利润，用长效制剂差异化突围红海。在GLP-1赛道，所有人都在盯着“减重效果”，而安进赌的是 “给药频次”。如果MariTide的月度给药最终被证明疗效不输周制剂，它将从根本上改变慢病管理的游戏规则——毕竟，一个月打一针比一周打一针，对患者意味着完全不同的依从性体验。未来空间预测：短期（1年）：股价维持高位横盘，3.3%的股息率将吸引避险资金持续流入。市场等待MariTide的临床读数。中期（3年）：随着MariTide进入上市倒计时，公司将迎来估值与利润的“戴维斯双击”。预计2027-2028年，减肥药管线将成为新的增长引擎。长期（5年以上）：只要老龄化社会对“慢病精准管理”的需求存在，安进作为生物药基石的地位就无可撼动。它可能不会成为增速最快的那个，但一定是最稳的那个。声明：以上数据基于实时市场预测及历史披露信息，仅供参考，不构成投资建议。

2026-03-17

·Firstwordpharma

Biopharma bites: A trio of drugs join TrumpRx, BioMarin stops several studies, plus paediatric proof for Lilly's Ebglyss

Drugs from Amgen, GSK join TrumpRxBioMarin stops certain skeletal studies after safety signalLilly's Ebglyss passes paediatric testDrugs from Amgen, GSK join TrumpRxTrumpRx, a direct-to-consumer (DTC) platform run by the US government, welcomed three new products to its site on Monday, according to a post on X from the White House. Amgen is offering its migraine medicine Aimovig (erenumab), as well as Amjevita (adalimumab-atto) — its biosimilar of AbbVie's Humira (adalimumab) — for a monthly cash-pay price of $299 each. GSK's Incruse Ellipta (umeclidinium), an inhaled treatment for chronic obstructive pulmonary disease (COPD), is available for $159.20 per month on TrumpRx for self-pay patients. The three additions to TrumpRx come after the website officially launched in February with price cuts for about 43 medications.Both pharmas, along with seven other drugmakers, agreed in December to sell some of their products on DTC sites as part of a most favoured nation drug pricing agreement with the Trump administration. -Elizabeth EatonBioMarin stops certain skeletal studies after safety signalBioMarin disclosed in a securities filing Monday that, following a safety signal in a pair of investigator-sponsored trials, it has halted its own Phase II studies evaluating Voxzogo (vosoritide) in patients with certain skeletal conditions. The drugmaker said that "several" cases of slipped capital femoral epiphysis (SCFE) occurred in the investigator-sponsored trials. As a result, it will discontinue dosing and enrollment in its studies involving patients with Turner syndrome, SHOX-deficiency and ACAN-deficiency. BioMarin emphasised that SCFE events have not been observed in its trials of these indications, nor in any of its achondroplasia or hypochondroplasia studies. The Phase II CANOPY trial evaluating Voxzogo in children with Noonan syndrome, as well as those living with idiopathic short stature (ISS) without ACAN-deficiency, will continue unaffected. The FDA approved Voxzogo for achondroplasia in 2021; since then, the company has made expanding the modified C-type natriuretic peptide's label into additional skeletal conditions central to its growth strategy. Before Monday's setback, BioMarin had been targeting five new indications for Voxzogo by 2031, including hypochondroplasia, ISS, Noonan syndrome, Turner syndrome and SHOX deficiency. -Elizabeth EatonLilly's Ebglyss passes paediatric testEli Lilly's Ebglyss (lebrikizumab-lbkz) met the primary and key secondary endpoints of the Phase III ADorable-1 trial in paediatric patients with moderate-to-severe atopic dermatitis. The company plans to submit the data to the FDA and other regulators for a potential update to the IL-13 inhibitor's label.Top-line results showed that 63% of patients on Ebglyss achieved meaningful skin improvement at week 16, as measured by a 75% improvement in the Eczema Area and Severity Index (EASI) from baseline, and 44% achieved clear or almost clear skin on the Investigator's Global Assessment (IGA). For patients taking placebo, 22% achieved EASI-75 and 15% had clear or almost clear skin based on IGA."Ebglyss has already changed what's possible for adults and adolescents," said Adrienne Brown, president of Lilly Immunology. "Now, these data show Ebglyss also provided disease control in paediatric patients."The company has rights to Ebglyss in all markets, except Europe, where Almirall has licensed rights for all dermatology indications, including atopic dermatitis.-Matthew Dennis

临床结果临床3期临床2期上市批准

100 项与阿达木单抗生物类似药（安进生物）相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	阿达木单抗生物类似药（安进生物）	L04AB04	DB00051

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
非放射性轴性脊柱关节炎	日本	Daiichi Sankyo Co., Ltd.	2025-03-19
全葡萄膜炎	日本	Daiichi Sankyo Co., Ltd.	2022-02-16
中间葡萄膜炎	日本	Daiichi Sankyo Co., Ltd.	2022-02-16
后葡萄膜炎	日本	Daiichi Sankyo Co., Ltd.	2022-02-16
活动性中度克罗恩病	日本	Daiichi Sankyo Co., Ltd.	2021-08-25
活动性重度克罗恩病	日本	Daiichi Sankyo Co., Ltd.	2021-08-25
白塞氏葡萄膜炎	日本	Daiichi Sankyo Co., Ltd.	2021-01-22
脓疱型银屑病	日本	Daiichi Sankyo Co., Ltd.	2021-01-22
活动性中度溃疡性结肠炎	日本	Daiichi Sankyo Co., Ltd.	2021-01-22
活动性重度溃疡性结肠炎	日本	Daiichi Sankyo Co., Ltd.	2021-01-22
中轴性脊柱关节炎	欧盟	Amgen Europe BV	2017-03-21
中轴性脊柱关节炎	冰岛	Amgen Europe BV	2017-03-21
中轴性脊柱关节炎	列支敦士登	Amgen Europe BV	2017-03-21
中轴性脊柱关节炎	挪威	Amgen Europe BV	2017-03-21
附着点炎相关关节炎	欧盟	Amgen Europe BV	2017-03-21
附着点炎相关关节炎	冰岛	Amgen Europe BV	2017-03-21
附着点炎相关关节炎	列支敦士登	Amgen Europe BV	2017-03-21
附着点炎相关关节炎	挪威	Amgen Europe BV	2017-03-21
化脓性汗腺炎	欧盟	Amgen Europe BV	2017-03-21
化脓性汗腺炎	冰岛	Amgen Europe BV	2017-03-21

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
炎症	临床3期	美国	Amgen, Inc.	2022-01-30

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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


NCT05073315 (CTgov)	临床3期	斑块状银屑病	425	adalimumab (Period 2 (Switching Group))	顧醖繭壓憲糧膚範夢憲(鏇艱願膚遞築廠構襯窪) = 齋壓遞壓築餘簾艱廠醖製醖壓窪範積鹹觸蓋蓋 (鏇夢遞糧鑰製鹽鹽鏇製, 156.6) 更多	-	2024-02-09
				adalimumab (Period 2 (Continued-use Group))	顧醖繭壓憲糧膚範夢憲(鏇艱願膚遞築廠構襯窪) = 鹽憲簾夢範齋鬱淵鬱願製醖壓窪範積鹹觸蓋蓋 (鏇夢遞糧鑰製鹽鹽鏇製, 174.9) 更多
AAD2023	N/A	银屑病	271	Adalimumab Biosimilar (ABP 501)	構夢顧鑰憲壓遞膚窪遞(範築廠願鬱鬱築築蓋廠) = 鏇網夢餘夢獵簾襯簾鏇觸糧襯淵醖獵構齋醖鹽 (鹽窪範廠夢衊範夢鹽夢 ) 更多	-	2023-03-17
				Adalimumab Biosimilar (ABP 501)	構夢顧鑰憲壓遞膚窪遞(範築廠願鬱鬱築築蓋廠) = 鏇鬱憲衊蓋窪襯網範餘觸糧襯淵醖獵構齋醖鹽 (鹽窪範廠夢衊範夢鹽夢 ) 更多
AAD2023	N/A	银屑病	-	ABP501	鏇醖廠網廠齋簾鹽積夢(鏇製夢憲艱簾製簾選鹽) = 窪醖獵網鹽鏇膚夢鹹鹹構廠鏇壓餘構窪簾繭膚 (廠觸鏇襯範憲網憲鹹選, 8.1 ~ 13.0)	-	2023-03-17
				Reference product (RP) or other ADA biosimilars	鏇醖廠網廠齋簾鹽積夢(鏇製夢憲艱簾製簾選鹽) = 構淵選選壓淵積鏇壓構構廠鏇壓餘構窪簾繭膚 (廠觸鏇襯範憲網憲鹹選, 7.0 ~ 9.8)
SPOSAB ABP 501 (UEGW2020)	N/A	炎症性肠病	559	ADALIMUMAB BIOSIMIADA ABP 501 (Group A: naive to ADA and naive to anti-TNFs)	構鏇鏇鑰顧築構選鬱憲(膚膚簾網築膚餘願憲鏇) = 願齋夢觸鹹艱艱餘範顧選願壓遞鹽淵範淵齋鬱 (製夢艱鏇憲鬱鹹衊遞遞 ) 更多	积极	2020-10-01
				ADALIMUMAB BIOSIMILAR ABP 501 (Group B: naive to ADA and previously exposed to anti-TNFs)	憲艱齋願簾餘蓋窪鏇繭(衊簾蓋膚餘鑰網構壓築) = 淵網遞範顧蓋顧襯鏇鹽廠廠膚夢壓繭醖窪鹹網 (淵範膚簾簾顧鹹淵淵憲 )
NCT01970475 (EULAR2019)	临床3期	类风湿关节炎 adalimumab \| anti-adalimumab antibodies	30	ABP 501	鑰鹹淵糧醖艱繭齋糧夢(衊鑰壓廠簾範醖廠獵構) = 製遞顧遞夢繭願鏇壓選選齋鬱構範獵廠醖築餘 (鑰蓋顧膚餘鏇齋憲顧觸 )	-	2019-06-12
NCT02114931 (Pubmed \| J Rheumatol \| Arthritis Res Ther) 人工标引	临床3期	类风湿关节炎	466	ABP 501	-	积极	2019-03-29
				ABP 501+adalimumab
UEGW2018	临床3期	银屑病	347	ABP 501	艱範膚壓艱鏇衊襯繭淵(壓願顧顧簾積簾觸顧製) = 窪製顧願簾願衊選鏇艱構夢淵積膚餘觸憲築艱 (願簾選鬱窪鬱窪鹽憲齋 ) 更多	积极	2018-10-01
				Adalimumab RP	艱範膚壓艱鏇衊襯繭淵(壓願顧顧簾積簾觸顧製) = 願淵積齋繭艱襯鬱顧簾構夢淵積膚餘觸憲築艱 (願簾選鬱窪鬱窪鹽憲齋 ) 更多
UEGW2018	临床3期	斑块状银屑病	-	ABP 501	糧鹹鏇遞構蓋憲蓋築膚(鑰積網夢遞醖窪壓積簾) = 選獵蓋壓鹽艱築醖醖繭膚齋遞蓋鑰簾壓鑰顧蓋 (醖獵窪製糧製膚顧憲夢 ) 更多	积极	2018-10-01
				Adalimumab RP	糧鹹鏇遞構蓋憲蓋築膚(鑰積網夢遞醖窪壓積簾) = 簾網淵簾蓋窪構夢壓夢膚齋遞蓋鑰簾壓鑰顧蓋 (醖獵窪製糧製膚顧憲夢 ) 更多
UEGW2018	临床3期	-	-	ABP 501	鬱鹹製廠鹹夢網遞願餘(鬱範蓋壓蓋鏇築簾繭壓) = 艱衊鏇網糧餘廠積構襯範廠蓋簾淵餘壓淵糧鹹 (廠簾鹹淵繭衊築網願選 ) 更多	积极	2018-10-01
				Adalimumab (RP)	鬱鹹製廠鹹夢網遞願餘(鬱範蓋壓蓋鏇築簾繭壓) = 繭憲鑰糧膚簾衊鑰顧糧範廠蓋簾淵餘壓淵糧鹹 (廠簾鹹淵繭衊築網願選 ) 更多
NCT01561313 \| NCT01970488 \| NCT01970475 \| NCT01502423 (EULAR2018)	临床3期	斑块状银屑病 \| 类风湿关节炎	-	ABP 501 formulation	壓艱糧膚糧簾網構憲襯(淵齋蓋淵獵觸鏇鏇積鑰) = 餘願簾鑰簾蓋繭衊衊顧築鹹鹹願齋築襯繭餘廠 (齋衊艱鑰築製積鏇蓋遞 )	积极	2018-06-13