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.

EUCTR2019-003662-40-DE

/ Not yet recruiting临床4期

Prospective, open-label, single-arm, single-center phase IV clinical trial to evaluate efficacy and safety of the adalimumab biosimilar Amgevita in subjects with moderate to severe active chronic inflammatory bowel diesease (Crohn's disease and ulcerative colitis) - Amgevita de novo in CED

开始日期2019-12-18

申办/合作机构

Universitätsklinikum Erlangen

100 项与阿达木单抗生物类似药（安进生物）相关的临床结果

登录后查看更多信息

100 项与阿达木单抗生物类似药（安进生物）相关的转化医学

登录后查看更多信息

100 项与阿达木单抗生物类似药（安进生物）相关的专利（医药）

登录后查看更多信息

项与阿达木单抗生物类似药（安进生物）相关的文献（医药）

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. ; Hobbins, Anna ; Duane, Linda ; 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.

2025-06-01·Rheumatology and Therapy

Real-World Experience with an Adalimumab Biosimilar (ABP 501) in Patients with Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis and Psoriasis in Europe: Results from the Adelphi Disease Specific Programme

Article

作者: Radziszewski, Waldemar ; Piercy, James ; Cohen, Stanley ; Jin, Ran ; Haughton, James M ; Goddard, Emily J ; Meadows, Rachael H ; Courmier, Delphine

INTRODUCTION:

Biosimilars have provided additional treatment options for patients with immune-mediated inflammatory diseases. This study evaluated the real-world use of adalimumab biosimilar ABP 501 in European patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), or psoriasis (PsO).

METHODS:

Data were drawn from the RA, spondyloarthritis, and PsO Adelphi Disease Specific Programmes (DSP)™, cross-sectional surveys conducted in France, Germany, Italy, Spain, and the UK between January 2020 and February 2022. Physicians completed patient record forms which collected data on demographics, treatment history, and clinical outcomes. Patients voluntarily completed questionnaires self-reporting health-related quality of life. Outcome measures were assessed for patients who initiated ABP 501 as the first advanced therapy (AT, "ABP 501 initiators") and patients who switched to ABP 501 from the first-line AT with reference product (RP) ("RP-ABP 501 switchers") in each indication.

RESULTS:

Across disease cohorts, 868 initiators and 428 switchers were analyzed. At time of consultation, physicians reported that 77.1%, 63.2%, 67.8%, and 83.0% of initiators with RA, AS, PsA, and PsO, respectively, presented with mild disease after receiving ABP 501 for a median of 10.4-12.3 months. Among switchers, the most common reasons for switching were related to formulary or financial reasons and insurance restrictions. Most switching patients were assessed by physicians to have mild disease (75.0-87.5% across indications) at time of consultation having received ABP 501 for a median of 11.2-15.3 months. Patients' self-assessment, including EQ-5D and work productivity scores, indicated an overall good state of health while using ABP 501, regardless of indication and prior RP exposure. Overall, more than 89% of physicians and more than 86% patients reported being satisfied with the disease control provided by ABP 501.

CONCLUSION:

Across indications, both physicians and patients reported positive clinical outcomes and high levels of satisfaction with ABP 501 treatment, regardless of prior use of RP.

223

项与阿达木单抗生物类似药（安进生物）相关的新闻（医药）

2025-12-06

·Biotech前瞻

四家已获批，多家在路上丨地舒单抗，处在集采前夜

点击蓝字关注我们本期看点十年前，谁都觉得地舒单抗是“最不需要担心前途”的品种：刚需慢病 + 长期用药 + 医患高度黏性。如今，故事明显变了。一边是安进原研全球年销已逼近 75 亿美元的超级单品体量；另一边，是国内 4 家生物类似药已获批、多家处于Ⅱ/Ⅲ期、复宏汉霖HLX14刚刚获NMPA受理的“集团军”压境。本期内容 01 地舒单抗的市场潜力 02 市场竞争格局生变 03 生物类似药的竞争十分激烈 04 总结与展望【01 地舒单抗的市场潜力放在全球视角，地舒单抗仍是骨代谢领域的绝对王牌。 Prolia®/Xgeva® 安加维地舒单抗 Amgen 原研产品安加维®是由安进公司研发的一种人免疫球蛋白G2（IgG2）单克隆抗体，对RANKL具有高特异性和亲和性。骨巨细胞瘤由表达RANKL的基质细胞和表达RANK受体的破骨细胞样巨细胞组成，其发病机理是RANKL的过度表达引起肿瘤生长和骨质破坏。RANKL是破骨细胞形成、发挥功能和生存所必需的跨膜或可溶性蛋白；破骨细胞负责骨吸收，从而调节骨钙释放。RANK 受体信号传导促进了骨质溶解和肿瘤生长。安加维®通过与RANKL结合，阻止其激活破骨细胞、破骨细胞前体和破骨细胞样巨细胞表面的RANK，从而达到抑制肿瘤生长和减少骨破坏的目的。安进通过 Prolia（60mg）和 Xgeva（120mg）占据骨质疏松和肿瘤骨病双赛道，产品 2022 年销售额达 56.4 亿美元，2024 年全球销售规模已逼近 75 亿美元级别，属于典型的“高确定性现金奶牛”。 02 市场竞争格局生变但在中国市场，地舒单抗已经面临多家国内企业生物类似药的冲击。目前已获 NMPA 批准上市的地舒单抗生物类似药包括：绿叶制药控股子公司博安生物的博优倍®（BA6101），2022 年 11 月获批，是全球首个获批的 Prolia 生物类似药；迈威生物子公司泰康生物的迈利舒®，2023 年 3 月获批，是全球第二个地舒单抗生物类似药；齐鲁制药的鲁可欣®，2023 年 10 月获批；菲洋生物 / 康宁杰瑞吉林的恒盖®，2024 年 9 月获批。复宏汉霖的 HLX14 则已在美国、欧盟、英国获批，以 BILDYOS®/BILPREVDA® 之名上市，并于 2025 年 12 月 2 日在中国递交 NDA 获 NMPA 受理。集采的必要条件已经具备，处于集采前夜的大单品，未来市场究竟谁主沉浮尚不可知。【03 生物类似药的竞争十分激烈】回顾之前的阿达木单抗、贝伐珠单抗、曲妥珠单抗、阿柏西普等案例，生物药纳入集采，基本有三条“硬指标线”：获批企业 ≥3 家，具备稳定供应和竞价基础；已纳入医保，且使用量足够大，对医保支出构成实质性压力；适应症清晰、可比性强，便于制定统一采购规则。地舒单抗这三条，基本都已满足：四家生物类似药齐备，且规格/适应症高度重叠，形成完全可替代体系；安进原研及国产类似药已通过国家医保谈判进入目录，属于长期、持续、刚性支付品类；适应症集中于骨折高风险的骨质疏松人群（绝经后女性、男性、糖皮质激素相关等），临床使用场景标准化程度高。更值得一提的是，复宏汉霖的 HLX14 在欧美完成注册、拿到 FDA/EMA/MHRA 三地批准之后，HLX14 未来的国际定价、海外医保谈判结果，都将对其在中国的预期定价形成锚定。一旦海外价格走低，而国内又进入集采谈判周期，企业在中国“守价”的空间将被进一步压缩。换句话说，从监管与支付视角，地舒单抗已经不具备“回避集采”的客观条件。对于所有玩家而言，现在讨论的只剩下：——是主动预判、提前通过区域/省级谈判试探价格底线，还是被动等国家集采“一刀切”？ 04 总结与展望综合来看，地舒单抗集采将是板上钉钉的事情。但相较于其他产品，地舒单抗在集采后不会立马受到冲击，而是会进入一个低价、长周期、高周转、强现金流考验的新运行阶段。价格必然下行，需求大概率被激活，但企业的盈利结构、现金流模型和组织效率，都将被迫重构。综合当前政策环境与产业格局判断，地舒单抗已经进入国家生物药集采的明确观察窗口期。国内四家生物类似药获批上市，复宏汉霖 HLX14 提交上市申请并具备国际化注册背书，医保覆盖稳定、临床可替代性充分，这些因素决定了该品种继续维持高价体系的空间已非常有限。未来 1–2 年内，地舒单抗进入国家或跨省联盟集采的概率持续上升。从市场结构看，集采后地舒单抗将由“高单价、有限覆盖”的用药模式，转向“低单价、广覆盖”的慢病管理型生物药。价格下行预计将显著提升基层和普通患者的可及性，带动处方量与使用人群扩容，但同时也将快速压缩单支产品的利润空间。企业的竞争重点将从单纯的产品质量和学术推广，转向生产成本控制、供应稳定性、渠道覆盖和账期管理能力。从企业层面分析，不同主体在该品种上的经营风险敞口存在明显差异。具备多产品矩阵、强渠道和规模化制造能力的平台型企业，具备较强的抗压能力；而更多依赖单一生物类似药放量、尚处于现金流爬坡阶段的企业，将面临更为严格的盈利能力和资金周转考验。同时，具有海外定价体系和国际商业化布局的产品，还需额外应对国内低价对全球价格体系的传导风险。总体来看，地舒单抗后续竞争的核心不再是“谁先放量”，而是谁能够在集采和价格下行常态化背景下，建立可持续的成本结构和现金流模型。其发展路径将在未来两年内逐步清晰，并对中国生物类似药产业的成熟度与商业化能力形成重要参考。 ★

生物类似药上市批准临床1期

2025-11-26

·GlobeNewswire-Health Care

Alvotech Announces Approval of AVT03, a Biosimilar to Prolia® and Xgeva® (denosumab) in the European Economic Area

November 25, 2025 — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the European Commission (EC) has approved AVT03 as a biosimilar to Prolia® and Xgeva® (denosumab). The European denosumab market is currently valued at approximately US$1.2 billion across all indications, based on originator sales in the last 12 months including the second quarter of 2025[1]. Denosumab is widely used to manage osteoporosis and to prevent skeletal related events in patients with certain cancers. A biosimilar option can help broaden access to these established treatments in Europe. AVT03 is approved in two presentations: as a biosimilar to Prolia® 60 mg/mL single use pre-filled syringe for the treatment of osteoporosis and bone loss; and as a biosimilar to Xgeva® 70 mg/mL single use vial for the prevention of skeletal related events in adults with advanced malignancies involving bone. “We welcome the European Commission’s approval of AVT03, which demonstrates the continued strength of our end-to-end platform and our ability to deliver high quality biosimilars at scale. This milestone reflects not only the dedication and expertise of our teams, but also the strong partnerships we have built to bring affordable medicines to patients across Europe. Working together, we can help broaden access to essential osteoporosis and oncology supportive care treatments and strengthen the resilience of supply in key markets,” said Robert Wessman, Chairman and Chief Executive Officer of Alvotech. The EC decision represents continued progress across Alvotech’s biosimilar portfolio and underscores the company’s role as a longer term partner to health systems across Europe. In Europe, disabilities due to osteoporosis are greater than those caused by common cancers (with the exception of lung cancer) and comparable to those caused by chronic noncommunicable diseases, such as rheumatoid arthritis, asthma and high blood pressure. Fragility fractures represent a significant economic burden, with incident and prior fragility fractures estimated at €57 billion in 2019[2]. Biosimilars play an important role in supporting sustainable healthcare budgets across Europe by offering cost-effective treatment options. In Europe, AVT03 will be commercialised in partnerships with STADA and Dr. Reddy’s, where each partner holds semi-exclusive rights in the EEA, Switzerland and the UK. STADA will market AVT03 as Kefdensis®, biosimilar to Prolia® and as Zvogra®, biosimilar to Xgeva®. Dr. Reddy’s will market AVT03 as Acvybra®, biosimilar to Prolia® and as Xbonzy®, biosimilar to Xgeva®. The European Commission’s approval of AVT03 as a biosimilar to Prolia and Xgeva was based on a totality of evidence that included comparative analytical, pharmacokinetic and pharmacodynamic data, and data from a confirmatory clinical study. The clinical data package included the PK similarity study AVT03-GL-P01[3] in healthy adult males (ClinicalTrials.gov identifier NCT05126784) and the comparative efficacy study AVT03-GL-C01[4] in post menopausal women with osteoporosis (ClinicalTrials.gov identifier NCT05395091) with Prolia used as the reference product in both clinical studies. The results of the clinical studies demonstrate equivalent pharmacokinetics and efficacy, and comparable safety and immunogenicity to the reference product and were reported in peer reviewed publications[3,4] . Analytical similarity studies also compared AVT03 with both Prolia and Xgeva. AVT03 is a human monoclonal antibody and a biosimilar to Prolia® (denosumab 60 mg/mL single use pre-filed syringe) and Xgeva® (denosumab 70 mg/mL single use vial), that has been approved for marketing in the EEA and Japan. Denosumab targets and binds with high affinity and specificity to the RANK ligand membrane protein, preventing the RANK ligand/RANK interaction from occurring, resulting in reduced osteoclast numbers and function, thereby decreasing bone resorption and cancer-induced bone destruction[5]. Prolia® and Xgeva® are registered trademarks of Amgen Inc. Kefdensis® and Zvogra® are registered trademarks of STADA Arzneimittel. Acvybra® and Xbonzy® are registered trademarks of Dr. Reddy’s Laboratories SA. References [1] IQVIA [2] Osteoporosis in Europe: a compendium of country-specific reports | Archives of Osteoporosis [3] Expert Opinion on Investigational Drugs Vol. 34, 2025 – Issue 6 [4] Expert Opinion on Biological Therapy, Vol. 25, 2025 – Issue 8 [5] Prolia product information, EMA Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Two biosimilars, to Humira® (adalimumab) and Stelara® (ustekinumab), are already approved and marketed in multiple global markets. The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has established a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Dr. Reddy’s (EEA, UK and US), Biogaran (FR), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release. The content above comes from the network. if any infringement, please contact us to modify.

上市批准生物类似药引进/卖出

2025-11-20

·一座城堡

关于manufacturing process patents的论战

当你的公司准备海外上市biosimilar时，作为CMC或IP的一员，你有没有被原研厂家数量巨大的manufacturing process patents吓到？特别是CMC的小伙伴可能会问，这不是用了十几年的工艺吗，现在还能申请专利？这个专利工艺几乎cover了所有的单克隆抗体生产过程，专利保护范围能这么广？有这类困惑的，不只是CMC从业人员和IP小伙伴，这不，美国几所顶尖法学院的学者合作写了一篇文章来抨击这个事情，并给出了合理的政策建议。然后工业界们坐不住了，强烈抵触学术界呼吁的立法改革，我们一起看看吧。 Round 1 第一篇文章于2025年3月在线发表于Nature biotechnology，主要内容概括如下：作者通过调研发现，在原研公司告biosimilar厂家专利侵权的patents里，最多的是manufacturing process patents；而在这些manufacturing process patents中，有75%以上是在原研药获批上市一年后才开始陆续提交申请的。关键这些manufacturing process patents，大部分都是平台专利（platform patents），也就是说，他们不局限于某个产品，而是不同的biosimilar可能都会被同一件manufacturing process patents cover。这就导致了，BPCIA虽然实施了十几年，但biosimilar的竞争并未如预期般活跃，大量manufacturing platforms patents严重推迟了部分biosimilars的上市时间。基于以上问题，作者开展了一项研究，研究的专利包括patents containing at least one claim to (i) the preparation and production of the master cell line containing the gene for the desired protein; (ii) large-scale growing of cells that produce the protein, along with any tool designed for that purpose; (iii) isolation, purification, analysis and post-production modification of the protein to make it ready for therapeutic use; and (iv)methods for producing engineered proteins and formulations. 选取的公司来自2022年IQVIA十大生物制剂制造商中的八家：AbbVie, Amgen, BMS, Genentech, Janssen, Merck, Novartis and Sanofi。由于胰岛素和GLP-1产品市场的高比重，Top10里的Eli Lilly和Novo Nordisk被排除在外，不在本次调研范围内。由于Regeneron近年来在biosimilars相关诉讼中比较活跃，虽然不在2022 US sales top10之列，仍被纳入本次研究中。所以作者选取的研究对象为以下9家公司：AbbVie, Amgen, BMS, Genentech, Janssen, Merck, Novartis, Sanofi and Regeneron. 检索范围：实际申请日在2004-2022之间，专利申请地区美国，专利类型为授权专利或再颁专利。作者最终的检索结果包含653 platform patents and 336 biologic-specific patents. 以AbbVie为例， AbbVie的平台专利申请比较集中的那几年，其实是没有重组生物制品获批的。但这些平台专利却被部分用来起诉Humira biosimilar厂家，而Humira其实在2002年就获批上市了。以Genentech为例，它于2004年获批Avastin (bevacizumab)，然后在此之后陆续获得了73件平台专利，而这些专利不仅用于部分后续产品（如Actemra, approved in 2010）的生物类似药诉讼中，甚至被用于非常早期的产品（如Rituxan(rituximab), approved 1997 and Herceptin(trastuzumab), approved 1998)生物类似药的相关诉讼中。如下表所列举的这3个专利，不仅用于起诉Actemra (tocilizumab) biosimilars，还被用来起诉RHA (Rituxan, Herceptin and Avastin) biosimilars，而这些专利要么因为在先商业化公开使用本不应该被授权（无效的），要么压根就不在这些产品上使用过（毕竟是在产品上市获批后多年才申请的）。作者认为，USPTO在审查这些专利时，应当确认它们是否有在先的商业生产使用，是否有新颖性/非显而易见性问题。但，作者在调研中没有找到一个专利，审查员曾经在审查历史档案中询问过申请人真正的manufacturing process是什么。作者质疑，如果审查员在审查这些专利时都没有考虑过这方面的现有技术，那么我们有什么理由相信类似于Genentech这样的专利是稳定有效的呢？ 2024年7月，美国参议院通过Cornyn–Blumenthal Affordable Prescriptions for Patients Act，规定原研药企针对某一参考药物的biosimilar提出诉讼时，secondary patents最多不能超过20个，以便加快biosimilar的市场准入。该法案同时规定，原研公司在FDA批准其参考药物后的4年内，如果想要主张secondary patents，必须提供相关专利信息（如专利有效期、专利适用范围等）。基于以上要求，作者又分析了FDA批准4年后的platform patents，像Amgen, Genentech, Regeneron这几家公司，数量依然惊人，如下图：虽然法院有权决定是否执行20项的上限，但作者认为，如果能有效执行Cornyn–Blumenthal Affordable Prescriptions for Patients Act规定的相关限制，也能部分降低对biosimilars上市的阻碍。因此，作者提出了三条政策建议： 1.事前预防 (Pre-issuance)：加强机构间信息共享，提升专利质量落实并优化2023年IPCIA中的规定，建立FDA与USPTO之间的直接信息共享机制，允许USPTO专利审查员在保密前提下，获取药企提交给FDA的、被视为商业秘密的制造工艺信息。这样审查员就能够基于完整的现有技术（包括申请人自己的商业用途）来评估专利的新颖性和非显而易见性，从源头杜绝无效专利的授权。文中特别指出，现行IPCIA草案中要求机构在共享信息前需与产品赞助商协商的条款，会给本已时间紧张的官员带来沉重负担，应当删除。 2.事后限制 (Post-issuance)：立法限制无效或未使用专利的诉讼权利支持Corryn–Blumenthal Affordable Prescriptions for Patients Act中的相关条款，对原研公司可用于起诉生物类似药的次级专利数量设置上限。此上限主要针对两类专利： 1）“迟交”的专利：实际申请日期在生物药获批4年之后的专利。 2）“未使用”的专利：所涵盖的制造工艺并非原研公司生产该参照产品时所实际使用的专利。同时建议取消法院的自由裁量权，并建立一种机制，让生物类似药公司能够确定某专利是否被原研公司实际使用，以加强该条款的约束力。这样能大幅减少原研公司利用大量未使用或后期申请的专利进行“专利丛林”战术的能力，降低生物类似药的诉讼成本和上市障碍。 3.激励机制 (Incentive Alignment)：将透明度要求与平台技术认定政策挂钩针对FDA新设立的“platform technology designation”(平台技术认定)程序，附加专利透明度义务。获得该认定好处的公司应被要求： 1)公开披露哪些已上市产品使用了该平台技术。 2)列出覆盖该平台技术的关键专利。虽然此披露要求仍不及小分子药“橙皮书”的严格程度，但能为生物类似药竞争者提供关键的路标，减轻其检索和识别相关平台专利的负担。 Round 2 在这篇文章发表后的5个月（2025年8月），Amgen作出了回应。首先Amgen声明，自己既是原研生物药厂家，同时又是biosimilar厂家，应该是比较合适来做这个回应人的。我们来逐条看看Amgen的回应： 1.反驳“生物类似药市场发展缓慢”论自2015年以来，FDA已批准了近70个生物类似药，涉及19种原研药，仅2024年就创纪录地批准了18个。延迟的主要原因是生物类似药本身需要8-10年的开发周期，以及许多原研药仍处于Regulatory Exclusivity（监管独占期）。以安进自身的阿达木单抗生物类似药为例，其上市等待主要是为了应对艾伯维的制剂专利（而非manufacturing patents），这些专利最终于2022年到期。 2.反驳“专利无效”论 Jefferson等人没有提供任何证据证明有制造专利因“先前商业使用”而被认定为无效。安进作为原研药和生物类似药公司，参与了几乎所有相关专利诉讼，从未见过制造专利因这一理由被判定无效。制造工艺在药品获批后会持续改进和创新，这些改进（如提高产量、质量、降低成本）理应获得专利保护。FDA也有专门的指南来管理获批后的工艺变更。 3.反驳“平台专利被滥用以阻碍竞争”论考虑到生物药制造的极端复杂性（涉及数十个步骤）和过去18年技术的快速进步，现有的专利数量并不令人惊讶。尽管诉讼开始时可能涉及大量专利，但最终进入审判程序的专利数量很少。安进与山德士的诉讼也很快和解，山德士的产品在化合物专利到期后不久即上市。安进开发并申请专利是为了保护具有商业价值的技术。任何生物类似药公司如果未经许可使用了这些专利技术，就应当承担侵权后果，无论安进自身是否在使用该特定专利技术。 4.反驳“通知透明度不足”论 BPCIA中的 “专利舞蹈” 机制就是为了让原研药公司提前告知生物类似药公司相关专利。此外，FDA的 “紫皮书” 也会列出被主张的专利（包括manufacturing patents）。生物类似药开发商是资本雄厚、经验丰富的企业（biosimilar的开发成本超1亿美元），完全有能力进行专利检索，并根据其自身的工艺设计规避方案。生物药制造技术足够成熟和多样，不存在一个能封锁所有制造路径的“平台专利”。 5.强烈反对立法提案（如IPCIA）现有的 “诚信义务” 规则以及在诉讼中被指控“不当行为” 的风险，已足够激励申请人在向FDA和USPTO提交材料时保持诚实。IPCIA 将迫使本已超负荷的专利审查员去审阅数千页与可专利性无关的FDA文件，这将加剧专利积压、降低专利质量。最大的风险在于企业的机密制造信息可能被泄露给外国竞争对手，从而损害美国企业的竞争优势。 Amgen的论证策略是用市场事实反驳学术假设，用自身实践经验反驳理论推演。其核心信息是：现状是健康的，专利代表真创新，立法改革是危险的。Amgen 将 Jefferson 等人的研究描绘成一个脱离实际、基于臆测的“学术谜题”，并呼吁进行“基于事实的讨论”。 Round 3 然后，Jefferson 等人对Amgen的回应也在Nature biotechnology上在线发表了。在这篇最终答复中，作者没有提出新的建议，而是致力于巩固其原始论点的基石，并逐一瓦解Amgen的反驳。 1.关于“生物类似药上市延迟” 回复引用多项研究，证明专利诉讼和解是获批后延迟上市的主因。例如，首批贝伐珠单抗和曲妥珠单抗的生物类似药分别延迟了22和27个月上市。指出安进自家的阿达木单抗生物类似药在获批75个月后才上市，这是专利问题导致延迟的有力证据。 2.关于“缺乏无效专利证据” 他们无法提供直接证据，正是因为原研公司以“商业秘密”为由，拒绝公开关键的制造档案。他们以安进自身产品NPlate的审评报告为例，显示有156页制造信息被完全隐匿。在 AbbVie v. Amgen 诉讼中，安进自己曾强烈控诉AbbVie拒绝提供关键制造信息，阻碍其判断专利有效性。作者质问：如果系统如此有效，为何Amgen自己需要为此苦苦斗争？ 3.关于“通知透明度不是问题” 以自身为例，一个由三名博士科学家组成的团队花费超过一年时间才整理出平台专利数据集写出这篇文章，这本身就是政策失败的证明。并引用业内人士的话，将生物类似药开发比作“一个不断出现新墙、出口不断移动的迷宫”。同时指出安进在开发过程中也曾被新出现的平台专利“突袭”（如强生收购Momenta后获得的新专利），这恰恰证明了通知系统存在严重缺陷。 4.关于“制造工艺持续改进” 作者澄清他们从未否认工艺可以改进。他们的核心论点是：专利审查员应有足够信息来判断这些“改进”是否真的值得专利保护。而他们的研究证实，审查员从未在审查中询问过新工艺与现有商业工艺的差异。作者进一步为他在第一篇文章里提出的政策改革辩护： 1.支持IPCIA（机构信息共享）：他们认为，与其依赖资本雄厚的公司通过昂贵的诉讼来挖掘真相，不如让专业的专利审查员在保密前提下提前获取信息，从而更一致、高效、公正地评估专利有效性。 2.支持对未使用/迟交专利的限制：他们再次强调，如果制造工艺专利是有效的（即不同于获批时使用的工艺），那么它就不应被用来阻止生物类似药使用“旧的”工艺。因此，立法限制这类专利的诉讼权是合理的。 Jefferson等人的回复文将辩论焦点从“学术假设”转向了 “系统性的现实失败”。他们将Amgen描绘成一个现行系统的既得利益者，这个系统虽然对安进这样的大公司而言可以驾驭，但却以牺牲公共利益、竞争和真正的专利质量为代价。往期精彩： GLP-1赛道的BIC之争 KRAS竞争格局整理如何证明1+1>2？如何查找已披露BD Deal的合同原文？国内可以考美国专利代理人证书并执业吗？在已知CDR上改一个氨基酸，可以申请专利吗？用已知单抗拼双抗，可以申请专利吗？联合用药专利，何去何从？专利申请可以挑数据吗？没做过的实施例可以写入专利吗？美国专利实践中的Double Patenting 如何计算美国专利到期日？临床试验方案公开对专利申请的影响（欧洲篇）临床试验方案公开对专利申请的影响（美国篇）临床试验方案公开对专利申请的影响（中国篇）临床试验是否构成“使用公开”？（美国篇）聊聊专利保密审查 PTE法规要求和计算公式（中国篇） PTE法规要求和计算公式（美国篇） SPC法规要求和计算公式（欧洲篇） PTE案例解析（中国篇） PTE案例解析（美国篇）如何准确认定专利发明人？药品集采中的专利问题补充实验数据的接受标准和案例分析（中国篇）补充实验数据的接受标准和案例分析（欧洲篇）补充实验数据的接受标准和案例分析（美国篇）化合物结构的非显而易见性判例学习 Skinny Label的运用及挑战开放式和封闭式权利要求

生物类似药专利侵权

100 项与阿达木单抗生物类似药（安进生物）相关的药物交易

登录后查看更多信息

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,

后查看更多信息

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,

后查看更多信息

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

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

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))	獵膚蓋廠願鏇願壓遞鏇(壓鹽獵選憲糧夢憲範鏇) = 壓夢衊選膚廠顧築獵蓋廠鏇糧淵鹹簾蓋積範壓 (簾積顧繭窪觸醖壓願夢, 156.6) 更多	-	2024-02-09
				adalimumab (Period 2 (Continued-use Group))	獵膚蓋廠願鏇願壓遞鏇(壓鹽獵選憲糧夢憲範鏇) = 鏇鬱鑰繭壓餘顧淵襯夢廠鏇糧淵鹹簾蓋積範壓 (簾積顧繭窪觸醖壓願夢, 174.9) 更多
AAD2023	N/A	银屑病	271	Adalimumab Biosimilar (ABP 501)	鹹遞壓獵蓋鬱繭選鬱憲(蓋膚憲鹹襯窪獵鏇膚壓) = 憲齋繭範壓襯顧憲獵齋餘構遞願遞鏇願製鑰壓 (鑰顧襯窪蓋簾簾築顧繭 ) 更多	-	2023-03-17
				Adalimumab Biosimilar (ABP 501)	鹹遞壓獵蓋鬱繭選鬱憲(蓋膚憲鹹襯窪獵鏇膚壓) = 鏇繭鑰夢觸構鬱築構製餘構遞願遞鏇願製鑰壓 (鑰顧襯窪蓋簾簾築顧繭 ) 更多
AAD2023	N/A	银屑病	-	ABP501	範衊鏇餘淵醖蓋製窪襯(膚淵顧築夢壓願積範繭) = 構醖顧鏇膚餘構糧壓夢餘餘醖鹽獵壓襯範憲觸 (鹹夢艱築夢鹽淵鹹夢膚, 8.1 ~ 13.0)	-	2023-03-17
				Reference product (RP) or other ADA biosimilars	範衊鏇餘淵醖蓋製窪襯(膚淵顧築夢壓願積範繭) = 積齋願鑰醖顧製鏇齋壓餘餘醖鹽獵壓襯範憲觸 (鹹夢艱築夢鹽淵鹹夢膚, 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)	糧鑰鑰淵構範鑰構鬱蓋(蓋窪觸觸鹹築醖簾觸築) = 顧憲築醖糧範衊鏇糧膚蓋製製醖觸壓夢鹹構糧 (遞鏇窪願夢範襯鹽願觸 ) 更多	积极	2020-10-01
				ADALIMUMAB BIOSIMILAR ABP 501 (Group B: naive to ADA and previously exposed to anti-TNFs)	願蓋壓獵淵鑰簾鬱觸積(顧壓鏇艱遞構窪糧製網) = 簾積鹹獵夢積網範醖廠構範願獵鏇鏇遞鏇壓醖 (獵膚鹹獵衊餘選鏇網餘 )
NCT01970475 (EULAR2019)	临床3期	类风湿关节炎 adalimumab \| anti-adalimumab antibodies	30	ABP 501	構網窪觸繭鹹糧鹽簾構(壓鹹廠糧淵憲製構顧壓) = 積壓簾襯襯鏇製齋簾鏇鬱衊築製網鏇醖構窪鹹 (願選鬱廠鹽鏇艱網膚鏇 )	-	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	廠夢蓋範衊鬱蓋餘製窪(鹽憲遞獵壓餘鹽築廠鑰) = 膚夢蓋鬱醖鏇蓋艱窪淵鑰淵艱壓壓選選鑰壓鑰 (鑰醖簾遞壓鹹獵觸醖繭 ) 更多	积极	2018-10-01
				Adalimumab RP	廠夢蓋範衊鬱蓋餘製窪(鹽憲遞獵壓餘鹽築廠鑰) = 鑰襯憲膚積遞餘蓋艱鏇鑰淵艱壓壓選選鑰壓鑰 (鑰醖簾遞壓鹹獵觸醖繭 ) 更多
UEGW2018	临床3期	斑块状银屑病	-	ABP 501	顧蓋齋鏇夢憲憲獵選鹽(蓋蓋構築鏇製夢淵壓繭) = 網蓋艱窪衊夢醖選網遞獵糧衊壓構窪憲鹽遞鬱 (衊淵鬱廠醖選壓選壓範 ) 更多	积极	2018-10-01
				Adalimumab RP	顧蓋齋鏇夢憲憲獵選鹽(蓋蓋構築鏇製夢淵壓繭) = 觸繭遞範鏇範餘範構艱獵糧衊壓構窪憲鹽遞鬱 (衊淵鬱廠醖選壓選壓範 ) 更多
UEGW2018	临床3期	-	-	ABP 501	築遞鏇製觸遞遞鏇蓋製(製蓋鑰鑰廠壓鹽鑰鹹窪) = 顧簾鏇淵繭壓鑰鹽顧鑰淵壓願遞遞願糧範齋網 (製願蓋醖窪網夢蓋願膚 ) 更多	积极	2018-10-01
				Adalimumab (RP)	築遞鏇製觸遞遞鏇蓋製(製蓋鑰鑰廠壓鹽鑰鹹窪) = 範網鹹餘構憲獵鏇製夢淵壓願遞遞願糧範齋網 (製願蓋醖窪網夢蓋願膚 ) 更多
EULAR2018	N/A	类风湿关节炎	-	ABP 501	積範鹹鑰鹹衊壓淵鬱選(範鏇淵鬱遞鑰齋蓋蓋鑰) = 糧糧廠壓繭繭簾襯廠壓齋衊憲選夢選膚範顧繭 (構壓蓋鏇簾鹹鹽網鬱築 ) 更多	-	2018-06-13
				Adalimumab reference product	積範鹹鑰鹹衊壓淵鬱選(範鏇淵鬱遞鑰齋蓋蓋鑰) = 衊積繭淵夢鏇醖顧齋構齋衊憲選夢選膚範顧繭 (構壓蓋鏇簾鹹鹽網鬱築 ) 更多