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更新于：2026-06-28
Golimumab biosimilar (Bio-Thera)
戈利木单抗生物类似药 (百奥泰生物)
更新于：2026-06-28
概要
基本信息
原研机构 |
非在研机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)申请上市 |
特殊审评- |
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结构/序列
Sequence Code 10217CDR2-L
当前序列信息引自: *****
Sequence Code 34550CDR3-L
当前序列信息引自: *****
Sequence Code 208354L
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Sequence Code 1694337H
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Sequence Code 13027041CDR2-H
当前序列信息引自: *****
Sequence Code 535237464CDR3-H
当前序列信息引自: *****
Sequence Code 559603504CDR1-L
当前序列信息引自: *****
Sequence Code 1167865419CDR1-H
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关联
5
项与 戈利木单抗生物类似药 (百奥泰生物) 相关的临床试验NCT05332730
A Randomized, Double-blind, Single-dose, Parallel Three-arm Comparative Study on Pharmacokinetics and Safety of BAT2506 Injection Versus the EU-licensed and US-licensed Simponi® in Healthy Chinese Male Subjects
NCT05046431
A Multicenter, Double-blind, Randomized, Parallel-group Study to Compare the Efficacy and Safety of BAT2506 Versus Simponi® in Participants With Active Psoriatic Arthritis
NCT04152759
A Randomized, Double-blinded, Single-dose, 2-arm Parallel, Comparative Study to Evaluate the Pharmacokinetics and Safety of BAT2506 Injection vs Simponi in Healthy Chinese Male Subjects
100 项与 戈利木单抗生物类似药 (百奥泰生物) 相关的临床结果
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100 项与 戈利木单抗生物类似药 (百奥泰生物) 相关的转化医学
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100 项与 戈利木单抗生物类似药 (百奥泰生物) 相关的专利（医药）
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2
项与 戈利木单抗生物类似药 (百奥泰生物) 相关的文献（医药）2026-05-04EXPERT OPINION ON BIOLOGICAL THERAPY
Comparing the efficacy and safety of biosimilar BAT2506 with reference golimumab in patients with active psoriatic arthritis: 24-week results of a phase 3, multicenter, double-blind, randomized, parallel-group study
Article
作者: Liu, Yi ; Zawadzki, Marek ; Zhou, Yinbo ; Batko, Bogdan ; Yang, Xiaolei ; Tang, Honghu ; Batalov, Anastas ; Dong, Qingfeng ; Dokoupilova, Eva
BACKGROUND:
This study aimed to show equivalent efficacy, pharmacodynamics, pharmacokinetics (PK), safety, and immunogenicity of biosimilar BAT2506 to reference golimumab (Ref-GLM) in patients with active psoriatic arthritis.
RESEARCH DESIGN AND METHODS:
This study comprised a 24-week initial treatment period 1. Patients were randomly assigned (1:2:1) into three groups: Ref-GLM, BAT2506, or start with Ref-GLM and switch to BAT2506 at week 24. The assessment of therapeutic equivalence between BAT2506 and Ref-GLM via percentage of patients achieving an American College of Rheumatology 20 (ACR 20) response at Week 14 was the primary endpoint.
RESULTS:
351 patients were randomized into the BAT2506 group and 353 patients in those groups that started the treatment with Ref-GLM. The 90% confidence interval (CI; -2.91, 7.63) and 95% CI (-3.92, 8.64) for the common risk difference in ACR 20 response between the BAT2506 group and groups that started the treatment with Ref-GLM fully fell within predefined equivalence margins supporting efficacy equivalence between BAT2506 and Ref-GLM at Week 14. Comparable safety, PK, and immunogenicity profiles were observed for BAT2506 and Ref-GLM groups.
CONCLUSIONS:
Data supported equivalence efficacy and comparable pharmacodynamics, PK, safety, and immunogenicity profiles between BAT2506 and Ref-GLM till Week 24.
CLINICAL TRIAL REGISTRATION:
www.clinicaltrials.gov identifier NCT05046431.
2021-01-02Expert opinion on investigational drugs2区 · 医学
A Phase I, Randomized, Double-Blind, Single-Dose, Parallel-Group Study to compare Pharmacokinetic Similarity, Safety, and Immunogenicity Between BAT2506 and Golimumab in Healthy Chinese Male Subjects
2区 · 医学
Article
作者: Zhang, Hong ; Wang, Zhaohe ; Wei, Jin ; Xu, Jia ; Ding, Yanhua ; Sun, Jixuan ; Yu, Jinchen ; Li, Shengfeng ; Wu, Dandan ; Wu, Min
Background: To compare the pharmacokinetic (PK) profile, safety, and immunogenicity between golimumab and the biosimilar BAT2506 in healthy Chinese male subjects. Research design and methods: A total of 180 healthy male subjects were recruited for this randomized, double-blinded, single-dose, parallel study. They received 50 mg BAT2506 or golimumab (1:1 ratio) by single subcutaneous injection. The evaluation index included maximum plasma concentration (Cmax), area under the plasma concentration-time curve (AUC0-t, AUC0-∞), safety, and immunogenicity. Results: The results showed that the 90% confidence interval (CI) of the geometric mean ratio (GMR) of BAT2506 to reference drug (golimumab) for Cmax, AUC0-∞ and AUC0-t were 99.26% (90.59-108.76%), 102.06% (93.31%-111.64%), and 102.05% (93.51-111.38%), respectively. All 90% CIs were within the range of 80-125% range, which is the limitation of the equivalence margin. Furthermore, similarity of treatment-emergent adverse events was also found between the two drugs. A total of 14 subjects (7.8%) developed anti-drug antibody after administration. Conclusions: Our study confirmed the PK similarity between BAT2506 and golimumab, and showed good tolerance of BAT2506 in healthy subjects. There were no differences in safety and immunogenicity between the two drugs. Therefore, BAT2506 meets the criteria for biosimilarity to golimumab. Trial registration: The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT04152759).
100 项与 戈利木单抗生物类似药 (百奥泰生物) 相关的药物交易
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研发状态
批准上市
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 强直性脊柱炎 | 欧盟 | 2026-02-10 | |
| 强直性脊柱炎 | 冰岛 | 2026-02-10 | |
| 强直性脊柱炎 | 列支敦士登 | 2026-02-10 | |
| 强直性脊柱炎 | 挪威 | 2026-02-10 | |
| 银屑病关节炎 | 欧盟 | 2026-02-10 | |
| 银屑病关节炎 | 冰岛 | 2026-02-10 | |
| 银屑病关节炎 | 列支敦士登 | 2026-02-10 | |
| 银屑病关节炎 | 挪威 | 2026-02-10 | |
| 中轴性脊柱关节炎 | 欧盟 | 2026-02-10 | |
| 中轴性脊柱关节炎 | 冰岛 | 2026-02-10 | |
| 中轴性脊柱关节炎 | 列支敦士登 | 2026-02-10 | |
| 中轴性脊柱关节炎 | 挪威 | 2026-02-10 | |
| 溃疡性结肠炎 | 欧盟 | 2026-02-10 | |
| 溃疡性结肠炎 | 冰岛 | 2026-02-10 | |
| 溃疡性结肠炎 | 列支敦士登 | 2026-02-10 | |
| 溃疡性结肠炎 | 挪威 | 2026-02-10 | |
| 非放射性轴性脊柱关节炎 | 欧盟 | 2026-02-10 | |
| 非放射性轴性脊柱关节炎 | 冰岛 | 2026-02-10 | |
| 非放射性轴性脊柱关节炎 | 列支敦士登 | 2026-02-10 | |
| 非放射性轴性脊柱关节炎 | 挪威 | 2026-02-10 |
未上市
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 活动性中度溃疡性结肠炎 | 申请上市 | 美国 | 2025-07-16 | |
| 活动性重度溃疡性结肠炎 | 申请上市 | 美国 | 2025-07-16 |
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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 | 704 | 獵鹽鏇簾積襯鏇窪蓋網(選觸願築艱選衊鬱願窪) = 憲簾夢網獵願鏇觸餘鹽 觸遞鹹醖糧膚淵選顧鬱 (餘網壓鏇廠壓鹽鏇夢築 ) 更多 | 积极 | 2026-06-11 | |||
临床1期 | - | 180 | 廠選鏇餘網窪艱廠遞積(蓋壓夢蓋鹽齋膚襯廠廠) = 顧鏇願窪窪醖艱繭衊願 願淵獵鬱構簾鏇憲顧齋 (蓋廠壓構製齋憲遞觸積, 93.51 ~ 111.38) 更多 | - | 2021-01-01 |
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