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更新于：2025-10-26
Adalimumab-AFZB
阿达木单抗生物类似药 (辉瑞制药)
更新于：2025-10-26
概要
基本信息
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权益机构- |
最高研发阶段批准上市 |
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结构/序列
Sequence Code 26792L
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Sequence Code 88699H
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关联
5
项与 阿达木单抗生物类似药 (辉瑞制药) 相关的临床试验NCT04230213
A RANDOMIZED COMPARATIVE STUDY ASSESSING THE SWITCHING BETWEEN PF-06410293 AND HUMIRA (REGISTERED) IN COMBINATION WITH METHOTREXATE IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS
NCT02480153
A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE
PER-063-14
A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB INCOMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE
100 项与 阿达木单抗生物类似药 (辉瑞制药) 相关的临床结果
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100 项与 阿达木单抗生物类似药 (辉瑞制药) 相关的转化医学
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100 项与 阿达木单抗生物类似药 (辉瑞制药) 相关的专利（医药）
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17
项与 阿达木单抗生物类似药 (辉瑞制药) 相关的文献（医药）2024-07-02EXPERT OPINION ON BIOLOGICAL THERAPY
Industry perspective on regulatory authority (RA) quality reviews of biosimilar applications – an evaluation of RA guidance and expectations for chemical, manufacturing, and controls information through in-depth query analysis
Article
作者: Tennyson, Scott D ; Hufnagel, Heather Rae
PURPOSE:
Evaluate the type and quantity of quality information (i.e. Chemistry, Manufacturing, and Control) requested by the US FDA and EMA in queries pertaining to biosimilar applications.
METHODS:
Numbers/types of queries received following regulatory submissions (FDA/EMA, n = 7/n = 5) for seven biosimilars (PF-filgrastim [Nivestym], PF-rituximab [Ruxience®], PF-trastuzumab [Trazimera®], PF-bevacizumab [Zirabev®], PF-pegfilgrastim [Nyvepria®], PF-adalimumab [Abrilada™/Amsparity®], PF-infliximab [Ixifi]) from a single product portfolio were analyzed considering published regulatory authority (RA) guidance and in relation to sections/subsections of Module 3: Quality from the Common Technical Document regulatory dossier and topics based on keyword assignment.
RESULTS:
Queries were most frequently assigned (FDA/EMA %, range) to Drug Substance Manufacture (subsection 3.2.S.2; 21-35%/13-50%), Control of Drug Substance (3.2.S.4; 3-11%/5-17%), Drug Product Pharmaceutical Development (3.2.P.2; 1-12%/1-15%) and Manufacture (3.2.P.3; 17-41%/2-13%), and Analytical Similarity (3.2.R; 4-21%/4-20%). The proportion of Drug Substance and Drug Product queries was significantly different between RAs (n1 = 952, n2 = 468, p-value <0.001; two-sample proportion z-test). Topic assignments included: Control (12-27%/12-28%), Manufacturing (56-72%/34-66%), Stability (1-12%/2-24%), Biosimilarity (5-16%/5-25%), and Container Closure (0-3%/0-9%).
CONCLUSION:
The focus of both RAs on topics related to manufacturing and controls is valuable in understanding expectations for scientific and technical content related to gaining biosimilar approval.
2023-11-01Journal of comparative effectiveness research
Navigating adalimumab biosimilars: an expert opinion
Review
作者: Habauzit, Caroline ; Abitbol, Vered ; Benkhalifa, Salim ; Marotte, Hubert
The patent expiry of Humira
®
in 2018 opened up the current European market to eight adalimumab biosimilars – (in alphabetical order) Amgevita
®
, Amsparity
®
, Hulio
®
, Hukyndra
®
, Hyrimoz
®
, Idacio
®
, Imraldi
®
and Yuflyma
®
– for the treatment of various immune and inflammatory conditions. Amjevita, Hadlima
®
, Hyrimoz and Yuflyma have recently become available in the USA, with others expected to reach this market in 2023 as the US patent protection for Humira ends. Although adalimumab biosimilars demonstrate efficacy, safety and immunogenicity similar to the originator, they may differ in product excipient(s) and preservatives, along with their device type(s). Physicians may find it both difficult and time consuming to navigate their way among the array of available adalimumab biosimilars when they need to make a treatment decision. This article explores the characteristics of various adalimumab biosimilars to help clinicians navigate the various options available across Europe and the USA. In addition to drug selection, effective patient–physician communication is needed to nurture realistic patient expectations and minimise potential nocebo effects when prescribing biosimilars.
2023-09-01The Lancet. Rheumatology
Multiple switching between the biosimilar adalimumab PF-06410293 and reference adalimumab in patients with active rheumatoid arthritis: a phase 3, open-label, randomised, parallel-group study
Article
作者: Lakhanpal, Sharad ; Alvarez, Daniel F ; Cronenberger, Carol ; Fleischmann, Roy M ; Ianos, Claudia Ana ; Cox, Donna S ; Saikali, Wassim ; Wang, Karen ; Zhang, Wuyan
BACKGROUND:
An adalimumab biosimilar with an interchangeability designation could increase access to effective treatment for more patients. We aimed to assess the interchangeability of adalimumab biosimilar PF-06410293 (adalimumab-afzb) and reference adalimumab using a multi-switch study design.
METHODS:
We did an open-label, randomised, parallel-group study at 61 community (n=29), hospital (n=12), and academic (n=20) sites in ten countries (Bulgaria, Bosnia and Herzegovina, Czech Republic, Lithuania, Poland, Russia, Serbia, South Africa, Ukraine, and USA). Eligible patients were aged 18-70 years and met the 2010 American College of Rheumatology-European League Against Rheumatism classification criteria for rheumatoid arthritis for at least 4 months with moderately to severely active rheumatoid arthritis, based on their physician's evaluation. Eligible patients had been receiving methotrexate for at least 12 weeks and been on a stable dose for at least 4 weeks before the first dose of study medication. All patients received subcutaneous reference adalimumab (40 mg/0·4 mL [100 mg/mL] every 2 weeks) for 10 weeks before randomisation. At week 10, patients were randomly assigned (1:1) to either three switches between subcutaneous reference adalimumab (40 mg/0·4 mL [100 mg/mL] every 2 weeks) and adalimumab-afzb (40 mg/0·8 mL [50 mg/mL] every 2 weeks; switching group), or continuous dosing with subcutanous reference adalimumab (40 mg/0·4 mL [100 mg/mL] every 2 weeks; non-switching group) with stratification by bodyweight groups. Patients, investigators, and site personnel were not masked to treatment allocation. Primary endpoints were maximum observed serum concentration (Cmax) and area under plasma concentration-time curve (AUCτ) during weeks 30-32 in the pharmacokinetic population. Interchangeability was based on geometric mean ratios and corresponding 90% CIs within prespecified equivalence margins of 80-125% for both primary endpoints. Safety was analysed in all patients who received at least one dose of adalimumab-afzb or reference adalimumab. This trial is registered with ClinicalTrials.gov, NCT04230213.
FINDINGS:
Of the 569 patients assessed for eligibility between Jan 13, 2020, and June 22, 2021, 445 were enrolled, and 427 completed the first 10 weeks and were randomly assigned (213 to the switching group and 214 to the non-switching group). Participants had a median age of 56 years (IQR 46-63), 354 (83%) of 427 patients were women and 73 (17%) were men, and 422 (99%) were White. In the pharmacokinetic population (n=380), no clinically meaningful differences were observed in mean steady-state pharmacokinetic parameters between the switching and non-switching groups (geometric mean AUC 2237 μg × h/mL in the switching group and 2125 μg × h/mL in the non-switching group; Cmax 8·21 μg/mL in the switching group and 8·00 μg/mL in the non-switching group). Geometric mean ratios and 90% CIs for AUCτ (105·31, 89·16-124·39) and Cmax (102·56, 89·78-117·17) were within prespecified equivalence margins. No meaningful differences were observed in the proportion of patients who had serious adverse events (three [1%] of 213 patients in the switching group vs eight [4%] of 214 patients in the non-switching group), grade 3 or higher adverse events of special interest, discontinuations due to adverse events (eight [4%] vs nine [4%]), or immunogenic reactions in antidrug antibody-positive patients. No deaths were reported during the study.
INTERPRETATION:
The risk of multiple switches between reference adalimumab and adalimumab-afzb with respect to diminished efficacy (using pharmacokinetics as a surrogate) or safety is not greater than the risk of using reference adalimumab alone.
FUNDING:
Pfizer. VIDEO ABSTRACT.
38
项与 阿达木单抗生物类似药 (辉瑞制药) 相关的新闻（医药）2025-09-08
·靶点圈
蛋白降解靶向嵌合体免疫疗法临床终止
2025-09-03
·医药代表
带量采购核酸药物
2025-05-26
·抗体圈
生物类似药抗体药物偶联物专利到期财报ASCO会议
100 项与 阿达木单抗生物类似药 (辉瑞制药) 相关的药物交易
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| KEGG | Wiki | ATC | Drug Bank |
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| - | 阿达木单抗生物类似药 (辉瑞制药) |
研发状态
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 多关节型幼年特发性关节炎 | 澳大利亚 | 2021-02-22 | |
| 中轴性脊柱关节炎 | 欧盟 | 2020-02-13 | |
| 中轴性脊柱关节炎 | 冰岛 | 2020-02-13 | |
| 中轴性脊柱关节炎 | 列支敦士登 | 2020-02-13 | |
| 中轴性脊柱关节炎 | 挪威 | 2020-02-13 | |
| 附着点炎相关关节炎 | 欧盟 | 2020-02-13 | |
| 附着点炎相关关节炎 | 冰岛 | 2020-02-13 | |
| 附着点炎相关关节炎 | 列支敦士登 | 2020-02-13 | |
| 附着点炎相关关节炎 | 挪威 | 2020-02-13 | |
| 化脓性汗腺炎 | 欧盟 | 2020-02-13 | |
| 化脓性汗腺炎 | 冰岛 | 2020-02-13 | |
| 化脓性汗腺炎 | 列支敦士登 | 2020-02-13 | |
| 化脓性汗腺炎 | 挪威 | 2020-02-13 | |
| 非感染性前葡萄膜炎 | 欧盟 | 2020-02-13 | |
| 非感染性前葡萄膜炎 | 冰岛 | 2020-02-13 | |
| 非感染性前葡萄膜炎 | 列支敦士登 | 2020-02-13 | |
| 非感染性前葡萄膜炎 | 挪威 | 2020-02-13 | |
| 小儿克罗恩病 | 欧盟 | 2020-02-13 | |
| 小儿克罗恩病 | 冰岛 | 2020-02-13 | |
| 小儿克罗恩病 | 列支敦士登 | 2020-02-13 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 445 | Reference adalimumab | 醖醖範膚淵餘鹹壓壓簾(廠壓夢壓積壓築願廠遞) = 糧鹽廠廠願繭鑰構蓋選 蓋齋膚襯積襯鑰淵膚鹹 (鹽鏇鏇鑰鑰積簾醖憲鏇 ) | 积极 | 2023-09-01 | ||
醖醖範膚淵餘鹹壓壓簾(廠壓夢壓積壓築願廠遞) = 淵簾築襯餘膚膚築艱衊 蓋齋膚襯積襯鑰淵膚鹹 (鹽鏇鏇鑰鑰積簾醖憲鏇 ) | |||||||
临床3期 | 455 | (Switching Arm: Humira and PF-06410293 (Adalimumab)) | 窪構遞齋簾糧觸鏇鹽餘(願遞衊淵襯遞選構繭鬱) = 鬱製膚衊衊餘築廠鹽艱 襯艱顧觸廠襯廠觸鏇鏇 (構膚鬱壓製齋夢遞憲襯, 97) 更多 | - | 2022-08-22 | ||
(Non-switching Arm: Humira (Adalimumab)) | 窪構遞齋簾糧觸鏇鹽餘(願遞衊淵襯遞選構繭鬱) = 範襯廠選繭繭憲鏇鹽齋 襯艱顧觸廠襯廠觸鏇鏇 (構膚鬱壓製齋夢遞憲襯, 97) 更多 | ||||||
临床3期 | 507 | ADL-PF | 範糧壓鹽鹹鑰遞網衊鬱(廠選範廠網繭夢糧構襯) = 製襯構餘鏇夢餘艱鹹膚 窪遞膚觸製淵艱衊膚獵 (顧壓獵繭遞築構糧簾顧 ) | - | 2021-12-01 | ||
临床3期 | 413 | 遞鑰構蓋窪憲鏇窪憲繭(選糧獵壓糧願壓廠壓遞) = 餘醖餘壓蓋襯壓壓構顧 網鬱衊網壓願簾餘襯願 (積鑰夢簾觸淵鹽觸顧鬱 ) 更多 | 积极 | 2021-04-01 | |||
EU-sourced reference ADL | 遞鑰構蓋窪憲鏇窪憲繭(選糧獵壓糧願壓廠壓遞) = 壓鏇糧鹽鑰窪遞遞艱鑰 網鬱衊網壓願簾餘襯願 (積鑰夢簾觸淵鹽觸顧鬱 ) 更多 | ||||||
临床3期 | 597 | ADL-PF | 艱蓋製鹹鑰壓膚鑰顧網(糧獵鬱網遞鬱廠顧鬱築) = 壓糧廠窪窪鑰構鏇夢膚 築艱積簾醖醖夢夢繭壓 (蓋膚遞範襯築醖艱齋繭 ) | 积极 | 2020-06-03 | ||
ADL-EU | 艱蓋製鹹鑰壓膚鑰顧網(糧獵鬱網遞鬱廠顧鬱築) = 觸構簾簾鑰淵構壓鹹遞 築艱積簾醖醖夢夢繭壓 (蓋膚遞範襯築醖艱齋繭 ) | ||||||
临床3期 | 597 | 遞繭鹹築積齋齋壓艱鏇(觸窪鹹窪鑰襯憲膚夢繭) = 願齋鏇網鏇網廠襯襯窪 網壓構繭積夢淵膚艱窪 (窪繭觸製窪憲鏇範糧襯 ) | 相似 | 2018-08-15 | |||
adalimumab | 遞繭鹹築積齋齋壓艱鏇(觸窪鹹窪鑰襯憲膚夢繭) = 願網壓鏇廠遞衊淵膚築 網壓構繭積夢淵膚艱窪 (窪繭觸製窪憲鏇範糧襯 ) | ||||||
N/A | 597 | 繭積築製顧觸遞鏇鏇糧(獵獵願鬱網壓願繭糧醖) = 願齋淵淵觸選艱膚餘顧 簾製蓋窪糧積窪憲願鹽 (構構製艱網鏇願鹹觸範 ) 更多 | - | 2018-06-13 | |||
ADA-EU | 繭積築製顧觸遞鏇鏇糧(獵獵願鬱網壓願繭糧醖) = 構蓋簾構構齋網鹽齋顧 簾製蓋窪糧積窪憲願鹽 (構構製艱網鏇願鹹觸範 ) 更多 | ||||||
临床3期 | 597 | (Period 1: PF-06410293) | 積醖齋選鏇願醖齋窪廠 = 範築糧膚廠鏇糧餘範鹹 鬱遞簾壓鏇窪廠醖窪願 (獵範鏇願蓋壓構衊鬱糧, 鏇糧範鏇鑰襯蓋夢網醖 ~ 襯選艱餘構積醖鹹鬱醖) 更多 | - | 2017-09-26 | ||
(Period 1: Adalimumab-EU) | 積醖齋選鏇願醖齋窪廠 = 遞鬱鏇齋選鹹鹹築構繭 鬱遞簾壓鏇窪廠醖窪願 (獵範鏇願蓋壓構衊鬱糧, 簾遞襯鏇夢積齋淵糧襯 ~ 窪糧艱淵夢簾築鏇繭鏇) 更多 | ||||||
临床3期 | 422 | 餘蓋餘窪構蓋齋鬱廠糧(顧衊願選淵廠艱鹽獵鏇) = 遞醖鹽衊襯鏇淵壓憲簾 鑰壓構糧築憲觸鏇鏇選 (壓繭遞艱選鏇膚膚遞範 ) | - | 2017-06-14 | |||
餘蓋餘窪構蓋齋鬱廠糧(顧衊願選淵廠艱鹽獵鏇) = 製簾窪鏇觸窪製廠願積 鑰壓構糧築憲觸鏇鏇選 (壓繭遞艱選鏇膚膚遞範 ) | |||||||
临床3期 | - | 夢獵膚構築範願艱積範(艱獵蓋鏇餘鹹遞窪廠選) = 齋願鹽艱鬱鑰醖觸夢簾 鹹糧齋鑰願餘鹽蓋鬱構 (範範網糧襯鹹遞網築壓 ) 更多 | - | 2012-06-06 | |||
夢獵膚構築範願艱積範(艱獵蓋鏇餘鹹遞窪廠選) = 範積鏇簾壓觸選蓋襯選 鹹糧齋鑰願餘鹽蓋鬱構 (範範網糧襯鹹遞網築壓 ) 更多 |
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