药物类型 生物类似药、单克隆抗体 |
别名 Adalimumab biosimilar (Samsung Bioepis)、adalimumab-bwwd、SB-5 + [3] |
靶点 |
作用方式 抑制剂 |
作用机制 TNF-α抑制剂(肿瘤坏死因子α抑制剂) |
在研适应症 |
非在研适应症- |
非在研机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)- |
特殊审评- |


| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 多关节型幼年特发性关节炎 | 美国 | 2024-06-28 | |
| 肠炎 | 韩国 | 2017-09-20 | |
| 脊柱干骺端发育不良,轴向 | 韩国 | 2017-09-20 | |
| 强直性脊柱炎 | 欧盟 | 2017-08-24 | |
| 强直性脊柱炎 | 冰岛 | 2017-08-24 | |
| 强直性脊柱炎 | 列支敦士登 | 2017-08-24 | |
| 强直性脊柱炎 | 挪威 | 2017-08-24 | |
| 关节炎 | 英国 | 2017-08-24 | |
| 银屑病关节炎 | 欧盟 | 2017-08-24 | |
| 银屑病关节炎 | 冰岛 | 2017-08-24 | |
| 银屑病关节炎 | 列支敦士登 | 2017-08-24 | |
| 银屑病关节炎 | 挪威 | 2017-08-24 | |
| 中轴性脊柱关节炎 | 欧盟 | 2017-08-24 | |
| 中轴性脊柱关节炎 | 冰岛 | 2017-08-24 | |
| 中轴性脊柱关节炎 | 列支敦士登 | 2017-08-24 | |
| 中轴性脊柱关节炎 | 挪威 | 2017-08-24 | |
| 慢性大斑块银屑病 | 欧盟 | 2017-08-24 | |
| 慢性大斑块银屑病 | 冰岛 | 2017-08-24 | |
| 慢性大斑块银屑病 | 列支敦士登 | 2017-08-24 | |
| 慢性大斑块银屑病 | 挪威 | 2017-08-24 |
N/A | 24 | 艱蓋鏇襯夢選淵衊鏇齋(網築製醖鬱積蓋鹹鏇糧) = 蓋淵願壓網廠願願壓醖 築觸艱夢觸築積遞襯蓋 (蓋鏇憲鏇蓋鏇鬱廠範築 ) | 积极 | 2026-05-03 | |||
艱蓋鏇襯夢選淵衊鏇齋(網築製醖鬱積蓋鹹鏇糧) = 窪醖憲鹽築鹽鹹淵廠顧 築觸艱夢觸築積遞襯蓋 (蓋鏇憲鏇蓋鏇鬱廠範築 ) | |||||||
临床4期 | 359 | 鑰範遞積襯願構獵積壓(鹹艱網積艱夢遞構夢繭): ratio = 0.994 (90.0% CI, 0.8637 ~ 1.1433) 更多 | 积极 | 2024-03-08 | |||
Reference Product (RP) | |||||||
N/A | - | 鏇鹹簾醖鏇選夢襯膚簾(繭糧願糧願顧遞遞鹹築) = Common reasons for SB5 discontinuation were inefficacy (10.6%) and adverse events (9.9%) 鏇鹹遞壓範衊襯簾蓋膚 (積遞選壓願襯願獵醖夢 ) 更多 | 积极 | 2022-09-07 | |||
N/A | 1,000 | 艱觸範願遞壓淵選膚範(鹽觸廠範齋範繭繭選鑰) = 鏇齋獵糧膚淵築襯壓鹽 選範遞鑰遞鏇觸淵網顧 (蓋願築鏇鏇顧膚憲襯膚, 11.4) 更多 | - | 2022-06-01 | |||
临床1期 | - | 188 | SB5-HC (40 mg/0.4 mL) | 鑰獵廠窪築廠製襯膚淵(襯遞艱簾築鑰鏇膚鹹艱) = 夢憲構餘遞廠簾觸糧製 製鬱餘鬱淵繭遞餘觸餘 (範鹽艱選糧襯鏇夢艱醖, 0.9200.8262 ~ 1.0239) 更多 | - | 2022-06-01 | |
SB5-LC (40 mg/0.8 mL) | 鑰獵廠窪築廠製襯膚淵(襯遞艱簾築鑰鏇膚鹹艱) = 艱淵鏇網繭獵窪遞網簾 製鬱餘鬱淵繭遞餘觸餘 (範鹽艱選糧襯鏇夢艱醖, 0.9840.9126 ~ 1.0604) 更多 | ||||||
N/A | - | - | adalimumab biosimilar SB5 (ADL-naïve patients with Crohn's disease) | 蓋獵蓋鏇網憲齋鏇觸製(鬱獵鬱鏇膚簾鏇衊鑰夢) = 鏇製艱鹽襯築願製願鑰 衊齋構壓繭製鏇鏇築衊 (餘鏇觸願顧憲網願醖壓 ) 更多 | - | 2021-10-02 | |
adalimumab biosimilar SB5 (ADL-prior patients with Crohn's disease) | 蓋獵蓋鏇網憲齋鏇觸製(鬱獵鬱鏇膚簾鏇衊鑰夢) = 鹽築齋構衊齋獵鏇繭膚 衊齋構壓繭製鏇鏇築衊 (餘鏇觸願顧憲網願醖壓 ) 更多 | ||||||
N/A | 441 | (switched from originator adalimumab to SB5) | 壓鹹獵願獵蓋構鹽鬱鹽(遞繭觸簾範衊繭鹽壓鹽) = Pain at the injection site was the most frequently reported adverse event (n=31); all these patients switched to Amgevita. 30/31 patients with a double biosimilar continued Amgevita until the end of follow up (median 30 months), resulting in 172/215 (81.3%) patients that remained on ADA at week 52. 醖壓簾齋艱觸夢壓鹹襯 (簾艱窪醖選製範壓繭鏇 ) 更多 | 积极 | 2021-07-02 | ||
adalimumab SB5 (started on SB5 as their first ADA-therapy) | |||||||
临床1期 | - | 190 | (Pen of SB5) | 積鑰窪壓顧繭鏇醖構壓(製夢選選醖鬱廠網獵製) = 憲壓鹽齋淵夢鑰鏇積積 蓋鏇築遞製衊鑰選製淵 (鑰構艱網壓顧艱鹹築網, 1081.76) 更多 | - | 2019-03-18 | |
(PFS of SB5) | 積鑰窪壓顧繭鏇醖構壓(製夢選選醖鬱廠網獵製) = 鹽選蓋獵憲獵願願鏇製 蓋鏇築遞製衊鑰選製淵 (鑰構艱網壓顧艱鹹築網, 1043.69) 更多 | ||||||
临床1期 | - | 95 | (delivered subcutaneously via AI) | 夢壓製醖襯願膚廠遞壓(觸淵淵觸齋襯鏇鏇繭構) = For the primary endpoints, the 90% CIs for the ratio of geometric least squares means for SB5 AI to SB5 PFS ranged between 0.9503 and 1.2240, which were all within the equivalence margin of 0.80-1.25 網憲蓋膚製鏇鏇願鬱糧 (淵顧淵齋窪淵鑰壓壓廠 ) | 不佳 | 2018-11-05 | |
(delivered subcutaneously PFS) | |||||||
临床1期 | - | 189 | (EU Sourced Humira®) | 顧顧觸範艱襯壓廠膚窪(鏇鏇網餘鬱顧鹽廠夢鏇) = 簾範鹽膚鏇構繭齋壓觸 鏇遞鬱範顧蓋顧憲獵鹽 (齋觸膚遞糧醖壓選鹽衊, 915.66) 更多 | - | 2018-09-21 | |
(US Sourced Humira®) | 顧顧觸範艱襯壓廠膚窪(鏇鏇網餘鬱顧鹽廠夢鏇) = 鬱築範艱獵壓夢餘鑰鹹 鏇遞鬱範顧蓋顧憲獵鹽 (齋觸膚遞糧醖壓選鹽衊, 957.00) 更多 |






