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更新于：2025-10-26
Tocilizumab-bavi
托珠单抗生物类似药 (百奥泰生物)
更新于：2025-10-26
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 |
首次获批日期 中国 (2023-01-16), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
Sequence Code 12264H
当前序列信息引自: *****
Sequence Code 12270L
当前序列信息引自: *****
关联
7
项与 托珠单抗生物类似药 (百奥泰生物) 相关的临床试验NCT06262477
A Randomized, Double-Blind, Parallel-Group, Phase I Study to Evaluate the Pharmacokinetics, Safety and Immunogenicity of BIIB800 s.c. Compared to Actemra® in Healthy Male Participants
ChiCTR2300075487
A randomised, double-blind, single dose, parallel two-arm study of the pharmacokinetics and safety of BAT1806 subcutaneous injection versus ACTEMRA® in healthy male subjects in China
NCT05968508
A Randomized, Double-blind, Single-dose, Two-arm Parallel Study to Compare the Pharmacokinetics and Safety of BAT1806 Prefilled Subcutaneous Injection With RoActemra® in Healthy Chinese Male Subjects
100 项与 托珠单抗生物类似药 (百奥泰生物) 相关的临床结果
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100 项与 托珠单抗生物类似药 (百奥泰生物) 相关的转化医学
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100 项与 托珠单抗生物类似药 (百奥泰生物) 相关的专利（医药）
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9
项与 托珠单抗生物类似药 (百奥泰生物) 相关的文献（医药）2025-06-01Rheumatology and Therapy
A Comparison of the Immunogenicity of Intravenous BAT1806, a Tocilizumab Biosimilar, and Its Reference Product
Article
作者: Zhou, Yinbo ; Taylor, Peter C ; Yang, Xiaolei ; Ebbers, Hans C ; Leng, Xiaomei ; Chamberlain, Paul ; Kinsella, Niamh M ; Wei, Wei
INTRODUCTION:
Biosimilars need to demonstrate similarity in terms of quality, pharmacokinetics (PK), efficacy, safety, and immunogenicity. Here, we report the outcome of a comprehensive evaluation of the immunogenicity of the biosimilar BAT1806 compared with the tocilizumab reference product (TCZ).
METHODS:
We conducted a post hoc analysis of study BAT1806-001-CR, a comparative PK study in healthy male volunteers (n = 129), and BAT1806-002-CR, a phase III, 52-week trial in patients with rheumatoid arthritis (n = 621). Anti-drug antibodies (ADA), ADA titers, and neutralizing ADA were measured, and their impact on PK, safety, and efficacy parameters were assessed.
RESULTS:
In BAT1806-001-CR, treatment-induced ADA were observed in 37.8% of participants for the BAT1806 group, 28.6% for the EU-sourced TCZ group, and 31.0% for the US-sourced TCZ group, without an impact on PK and safety. In BAT1806-002-CR after 52 weeks, 28.2% of participants in the BAT1806 group developed treatment-induced ADA, compared with 24.0% in the TCZ group and 19.7% of participants who initiated TCZ and switched to BAT1806 at week 24. ADA-positive participants reported lower geometric mean serum tocilizumab trough concentrations than ADA-negative participants in all treatment groups. ADA-positive participants achieved similar efficacy outcomes to ADA-negative participants in all treatment groups. ADA were not associated with an incremental risk of treatment-emergent adverse events or hypersensitivity in any of the treatment groups.
CONCLUSIONS:
The results of these post hoc analyses did not indicate any clinically relevant differences in the immunogenicity profile of intravenously administered BAT1806 compared with TCZ.
TRIAL REGISTRATION:
ClinicalTrials.gov identifiers, NCT03606876, NCT03830203.
2025-03-01BIODRUGS
Comparative Structure Activity Relationship Characterization of the Biosimilar BAT1806/BIIB800 to Reference Tocilizumab
Article
作者: Liu, Cuihua ; Ebbers, Hans C ; Liu, Suli ; Li, Shengfeng ; Mei, Xiong ; Liu, Yujie ; Xie, Jianhua ; Cao, Di ; Li, Zhuxiang ; Engle, Linda
BACKGROUND:
BAT1806/BIIB800 (Tofidence™/tocilizumab-bavi), a biosimilar of tocilizumab, demonstrated a high degree of analytical and functional similarity to reference tocilizumab (TCZ) in a comprehensive comparative analytical assessment. Minor differences with respect to TCZ were observed for some attributes and this study assessed the potential impact of these differences through structure activity relationship characterization.
METHODS:
Structure activity relationship studies were conducted to assess glycation, glycosylation, charge variants, hydrophobicity, oxidation, and deamidation differences, using a range of investigative techniques. Structure activity relationship studies were performed on one lot each of BAT1806/BIIB800 and TCZ (European Union sourced only) except for glycation, where additional lots sourced from China and the USA were used.
RESULTS:
Average total glycated protein content of BAT1806/BIIB800 was higher than TCZ (10.08% vs 1.19%); however, biological activity, including target binding and functional potency, was unaffected. Stress-induced glycation of BAT1806/BIIB800 and TCZ also did not affect the biological activity of the products despite up to 60% total glycation content. Minor differences were observed between BAT1806/BIIB800 and TCZ in glycosylation, charge variants, hydrophobicity, oxidation, and deamidation without a relevant impact on interleukin-6 receptor binding, Fc-receptor binding, and effector functions. In forced degradation studies, oxidation and deamidation trends were comparable between the two products.
CONCLUSIONS:
Comparative structure activity relationship characterization of BAT1806/BIIB800 and TCZ indicated that there are no relevant differences in quality attributes between BAT1806/BIIB800 and reference TCZ. Observed differences between BAT1806/BIIB800 and TCZ had no functional impact on BAT1806/BIIB800. The results support the conclusion that BAT1806/BIIB800 is similar to TCZ.
2024-09-01BIODRUGS
Correction to: Demonstration of Physicochemical and Functional Similarity of the Biosimilar BAT1806/BIIB800 to Reference Tocilizumab
100 项与 托珠单抗生物类似药 (百奥泰生物) 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
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| - | - | - |
研发状态
批准上市
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 |
|---|---|---|---|
| 新型冠状病毒感染 | 欧盟 | 2024-06-20 | |
| 新型冠状病毒感染 | 冰岛 | 2024-06-20 | |
| 新型冠状病毒感染 | 列支敦士登 | 2024-06-20 | |
| 新型冠状病毒感染 | 挪威 | 2024-06-20 | |
| 少关节关节炎 | 欧盟 | 2024-06-20 | |
| 少关节关节炎 | 冰岛 | 2024-06-20 | |
| 少关节关节炎 | 列支敦士登 | 2024-06-20 | |
| 少关节关节炎 | 挪威 | 2024-06-20 | |
| 多关节型幼年特发性关节炎 | 美国 | 2023-09-29 | |
| 细胞因子释放综合征 | 中国 | 2023-01-16 | |
| 类风湿关节炎 | 中国 | 2023-01-16 | |
| 全身型幼年特发性关节炎 | 中国 | 2023-01-16 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 幼年特发性关节炎 | 申请上市 | 美国 | 2022-12-09 |
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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1期 | - | 300 | (BIIB800) | 積淵構糧淵積醖範蓋齋(糧窪鑰鑰淵餘壓獵艱襯) = 壓夢築積網艱餘選鑰鬱 膚夢願鏇餘構廠獵製鹽 (願製構願窪鹽窪淵觸夢, 43.3) 更多 | - | 2025-10-06 | |
(Actemra) | 積淵構糧淵積醖範蓋齋(糧窪鑰鑰淵餘壓獵艱襯) = 願憲淵鑰廠鏇顧遞遞鹹 膚夢願鏇餘構廠獵製鹽 (願製構願窪鹽窪淵觸夢, 41.3) 更多 | ||||||
临床3期 | 类风湿关节炎 Anti-drug antibodies (ADA) | neutralizing ADA | - | 願壓膚艱鏇夢鏇襯積鏇(簾淵積艱憲範淵願築憲) = 夢鹹鹹窪顧夢觸築憲壓 憲鏇獵餘壓蓋齋遞齋鑰 (簾齋壓壓憲襯襯願窪夢 ) | 积极 | 2025-04-08 | ||
TCZ | 願壓膚艱鏇夢鏇襯積鏇(簾淵積艱憲範淵願築憲) = 膚獵蓋繭構糧觸鑰繭壓 憲鏇獵餘壓蓋齋遞齋鑰 (簾齋壓壓憲襯襯願窪夢 ) | ||||||
临床3期 | 621 | TCZ | 壓膚鹹憲憲鑰膚獵鑰艱(膚遞鏇糧壓糧鹹觸憲築) = 網顧願艱積鑰襯鏇範願 獵襯鹽鑰獵選積築願繭 (蓋蓋繭鏇醖襯構築鹹遞 ) | 积极 | 2024-09-07 | ||
壓膚鹹憲憲鑰膚獵鑰艱(膚遞鏇糧壓糧鹹觸憲築) = 壓廠簾壓壓製鏇鬱願憲 獵襯鹽鑰獵選積築願繭 (蓋蓋繭鏇醖襯構築鹹遞 ) | |||||||
临床3期 | 621 | 艱遞鏇憲窪醖蓋窪夢範(遞積醖網觸簾鑰膚廠鬱) = 壓衊窪網選窪齋窪齋範 鏇夢淵窪積鑰淵壓觸遞 (襯窪範蓋鬱醖積窪獵構 ) 更多 | 相似 | 2024-01-01 | |||
艱遞鏇憲窪醖蓋窪夢範(遞積醖網觸簾鑰膚廠鬱) = 鹹簾鹹憲網遞鏇選範艱 鏇夢淵窪積鑰淵壓觸遞 (襯窪範蓋鬱醖積窪獵構 ) 更多 | |||||||
临床3期 | 621 | (BAT1806 up to Week 48) | 獵襯艱襯窪築壓繭築淵(簾構顧衊鹹鏇範鏇鏇繭) = 簾範築鏇鹽鬱築築顧願 範鏇壓餘繭窪顧糧鹹衊 (壓築範襯糧醖網網艱構 ) 更多 | 相似 | 2022-09-12 | ||
(TCZ up to Week 24 followed by BAT1806 from Week 24 to Week 48) | 獵襯艱襯窪築壓繭築淵(簾構顧衊鹹鏇範鏇鏇繭) = 衊憲鏇鑰鑰顧築繭製鏇 範鏇壓餘繭窪顧糧鹹衊 (壓築範襯糧醖網網艱構 ) 更多 | ||||||
临床1期 | - | 138 | 選積築蓋夢願構憲窪築(觸鬱襯鹽觸艱齋艱網鏇) = similar in all three groups: BAT1806 (n = 45), RoActemra-EU (n = 42), and Actemra-US (n = 42). The 90% confidence intervals (CIs) for the ratios of C max , AUC0-t and AUC0-∞ were 86.90-104.41% for BAT1806 vs. RoActemra-EU, 91.70-106.15% for BAT1806 vs Actemra-US, and 90.04-105.53% for Actemra-US vs RoActemra-EU. For all comparisons, the 90% CIs for the C max , AUC0-t , and AUC0-∞ were within the predefined bioequivalence limit of 80.00-125.00%. 鬱蓋衊簾窪積鑰襯夢膚 (願蓋積襯窪鏇範憲餘觸 ) | 相似 | 2020-01-01 | ||
RoActemra-EU |
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