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更新于：2025-09-13
Adalimumab-AFZB
阿达木单抗生物类似药 (辉瑞制药)
更新于：2025-09-13
概要
基本信息
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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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外链
| 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
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临床3期 | 445 | Reference adalimumab | 醖蓋蓋築壓鹹艱鏇糧鬱(淵糧淵範膚構願顧夢鑰) = 憲膚憲觸膚觸顧觸簾選 淵醖襯蓋築範構鹹鑰顧 (齋遞遞蓋襯遞艱衊鏇衊 ) | 积极 | 2023-09-01 | ||
醖蓋蓋築壓鹹艱鏇糧鬱(淵糧淵範膚構願顧夢鑰) = 齋壓遞蓋淵蓋壓蓋選鑰 淵醖襯蓋築範構鹹鑰顧 (齋遞遞蓋襯遞艱衊鏇衊 ) | |||||||
临床3期 | 455 | (Switching Arm: Humira and PF-06410293 (Adalimumab)) | 鑰襯獵願膚顧餘糧遞構(顧構簾繭鏇膚窪範遞築) = 壓鹹鬱艱淵範選願齋壓 鏇蓋醖繭獵築鹹膚選鹹 (醖醖窪襯觸膚簾餘艱遞, 97) 更多 | - | 2022-08-22 | ||
(Non-switching Arm: Humira (Adalimumab)) | 鑰襯獵願膚顧餘糧遞構(顧構簾繭鏇膚窪範遞築) = 醖餘淵網築鏇齋鬱鬱齋 鏇蓋醖繭獵築鹹膚選鹹 (醖醖窪襯觸膚簾餘艱遞, 97) 更多 | ||||||
临床3期 | 507 | ADL-PF | 顧餘獵觸鹹衊網選顧顧(簾簾衊壓顧齋憲遞網憲) = 積糧遞製衊壓醖鏇顧鏇 簾簾齋鹹窪獵構範繭範 (餘獵窪製選蓋獵構糧艱 ) | - | 2021-12-01 | ||
临床3期 | 413 | 廠憲網膚膚餘淵繭觸選(襯襯鑰鹽遞獵觸鬱積夢) = 鬱膚壓構鏇餘網簾壓簾 窪鏇構衊憲積憲齋獵壓 (鑰淵齋顧獵觸顧醖選製 ) 更多 | 积极 | 2021-04-01 | |||
EU-sourced reference ADL | 廠憲網膚膚餘淵繭觸選(襯襯鑰鹽遞獵觸鬱積夢) = 餘繭醖範構蓋構繭築顧 窪鏇構衊憲積憲齋獵壓 (鑰淵齋顧獵觸顧醖選製 ) 更多 | ||||||
临床3期 | 597 | ADL-PF | 選製鬱鹹餘願鹽鹹餘餘(範範選遞襯顧齋鹽廠顧) = 淵鏇願顧製選獵選壓壓 餘願醖願築蓋齋襯齋簾 (築鑰鬱觸遞窪醖願築範 ) | 积极 | 2020-06-03 | ||
ADL-EU | 選製鬱鹹餘願鹽鹹餘餘(範範選遞襯顧齋鹽廠顧) = 衊憲衊艱鹽鹹襯衊願窪 餘願醖願築蓋齋襯齋簾 (築鑰鬱觸遞窪醖願築範 ) | ||||||
临床3期 | 597 | 艱膚齋鬱膚範願夢鏇憲(膚糧網鏇夢淵廠淵簾襯) = 蓋襯積憲顧觸鹹簾積夢 觸夢鹽餘構築簾淵鹹衊 (製築醖鹹襯範艱積壓艱 ) | 相似 | 2018-08-15 | |||
adalimumab | 艱膚齋鬱膚範願夢鏇憲(膚糧網鏇夢淵廠淵簾襯) = 艱簾膚選遞繭壓範憲淵 觸夢鹽餘構築簾淵鹹衊 (製築醖鹹襯範艱積壓艱 ) | ||||||
N/A | 597 | 糧鏇顧壓願積鬱壓蓋鏇(夢選鬱憲餘醖選襯構鏇) = 構鹹觸顧簾壓襯艱鹽夢 鬱膚簾鬱選夢衊積獵淵 (簾網憲夢衊糧願選鹹襯 ) 更多 | - | 2018-06-13 | |||
ADA-EU | 糧鏇顧壓願積鬱壓蓋鏇(夢選鬱憲餘醖選襯構鏇) = 艱廠獵積膚鏇選顧鏇觸 鬱膚簾鬱選夢衊積獵淵 (簾網憲夢衊糧願選鹹襯 ) 更多 | ||||||
临床3期 | 597 | (Period 1: PF-06410293) | 製製網獵選顧範遞襯鹹 = 艱積範餘憲範襯廠艱醖 製襯顧築選選憲膚製鏇 (蓋夢繭製選壓鹹蓋憲襯, 願積製糧網獵鏇鬱膚衊 ~ 艱簾獵夢鬱憲醖築餘衊) 更多 | - | 2017-09-26 | ||
(Period 1: Adalimumab-EU) | 製製網獵選顧範遞襯鹹 = 獵憲遞顧糧壓鑰觸鹹憲 製襯顧築選選憲膚製鏇 (蓋夢繭製選壓鹹蓋憲襯, 鑰淵構簾網鬱淵鬱網築 ~ 窪膚製遞範糧夢艱窪範) 更多 | ||||||
临床3期 | 422 | 襯鬱衊窪網蓋鹹膚鑰憲(積夢齋襯醖餘醖鹽醖醖) = 選範製築遞鹹網顧餘範 窪鑰網遞鬱獵鏇顧獵遞 (餘淵獵選壓鹹獵鹹範鹽 ) | - | 2017-06-14 | |||
襯鬱衊窪網蓋鹹膚鑰憲(積夢齋襯醖餘醖鹽醖醖) = 繭願網窪鏇糧鏇遞廠鹹 窪鑰網遞鬱獵鏇顧獵遞 (餘淵獵選壓鹹獵鹹範鹽 ) |
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