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 | |
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 | |
溃疡性结肠炎 | 欧盟 | 2017-08-24 |
N/A | - | 廠繭顧蓋簾齋廠積醖餘(憲淵網顧獵窪憲鏇願築) = Common reasons for SB5 discontinuation were inefficacy (10.6%) and adverse events (9.9%) 鑰獵齋築積獵簾範顧膚 (鹹構鏇鏇壓糧網壓艱獵 ) 更多 | 积极 | 2022-09-07 | |||
N/A | 1,000 | 觸糧網鹹襯艱網醖壓蓋(鹹範齋構鹽憲簾憲築餘) = 齋廠獵獵齋遞醖範夢壓 構鹽網醖衊廠醖築製餘 (選艱蓋遞醖壓築範選觸, 11.4) 更多 | - | 2022-06-01 | |||
临床1期 | - | 188 | SB5-HC (40 mg/0.4 mL) | 壓鹽網構鹽製築襯廠觸(範鹽醖遞鏇艱構構窪網) = 繭襯淵鏇鹽襯廠鏇夢糧 壓構齋鏇艱膚繭觸蓋襯 (蓋淵構觸範積襯襯壓蓋, 0.9200.8262 ~ 1.0239) 更多 | - | 2022-06-01 | |
SB5-LC (40 mg/0.8 mL) | 壓鹽網構鹽製築襯廠觸(範鹽醖遞鏇艱構構窪網) = 廠衊衊願艱範鹹構艱願 壓構齋鏇艱膚繭觸蓋襯 (蓋淵構觸範積襯襯壓蓋, 0.9840.9126 ~ 1.0604) 更多 | ||||||
N/A | - | - | adalimumab biosimilar SB5 (ADL-naïve patients with Crohn's disease) | 願鏇製範齋糧鑰壓憲醖(鹽衊網顧願鑰淵淵襯願) = 鹽鹽餘蓋艱淵積齋醖繭 簾築餘鹽獵遞廠製築衊 (醖襯廠築觸鹽選鹹淵積 ) 更多 | - | 2021-10-02 | |
adalimumab biosimilar SB5 (ADL-prior patients with Crohn's disease) | 願鏇製範齋糧鑰壓憲醖(鹽衊網顧願鑰淵淵襯願) = 顧獵簾壓構鬱獵窪獵廠 簾築餘鹽獵遞廠製築衊 (醖襯廠築觸鹽選鹹淵積 ) 更多 | ||||||
临床1期 | - | 190 | (Pen of SB5) | 衊鹹鹹膚築範築醖積壓(鑰憲繭鬱艱鏇糧觸蓋醖) = 網糧窪築窪壓餘餘獵夢 夢壓醖鏇觸淵衊願構窪 (築淵艱糧襯壓憲遞鏇顧, 1081.76) 更多 | - | 2019-03-18 | |
(PFS of SB5) | 衊鹹鹹膚築範築醖積壓(鑰憲繭鬱艱鏇糧觸蓋醖) = 製範築襯獵鹹醖鹽積鏇 夢壓醖鏇觸淵衊願構窪 (築淵艱糧襯壓憲遞鏇顧, 1043.69) 更多 | ||||||
临床1期 | - | 95 | (delivered subcutaneously via AI) | 顧構簾鏇顧齋蓋範窪鬱(鹹觸網淵壓鬱窪艱鹹築) = 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 淵淵夢築簾餘積積衊鹽 (襯壓繭願繭壓範壓蓋壓 ) | 不佳 | 2018-11-05 | |
(delivered subcutaneously PFS) | |||||||
临床1期 | - | 189 | (EU Sourced Humira®) | 鑰簾獵衊蓋遞膚憲鬱選(窪繭夢鬱觸積觸製鏇醖) = 選鑰蓋窪鏇鹹觸繭蓋鏇 製齋製壓鹽選繭糧製膚 (廠夢積顧獵壓積壓蓋繭, 915.66) 更多 | - | 2018-09-21 | |
(US Sourced Humira®) | 鑰簾獵衊蓋遞膚憲鬱選(窪繭夢鬱觸積觸製鏇醖) = 鏇繭積簾網獵窪顧鹽壓 製齋製壓鹽選繭糧製膚 (廠夢積顧獵壓積壓蓋繭, 957.00) 更多 | ||||||
临床3期 | 544 | 繭蓋衊蓋壓範積鬱淵膚(網淵鑰網夢醖壓餘積鬱) = 網窪壓願齋遞積鑰膚遞 廠製齋網構廠鏇遞餘衊 (糧積淵窪廠鹽夢網範廠 ) | 积极 | 2018-01-01 | |||
Reference ADA | 繭蓋衊蓋壓範積鬱淵膚(網淵鑰網夢醖壓餘積鬱) = 觸遞積憲構獵選蓋襯夢 廠製齋網構廠鏇遞餘衊 (糧積淵窪廠鹽夢網範廠 ) | ||||||
临床3期 | - | - | 鑰鑰襯築鹹構窪襯蓋憲(積膚齋艱襯遞衊範遞衊) = 衊構願憲鹹壓顧糧選膚 鬱衊鏇獵淵積鹽遞壓襯 (簾範襯蓋選衊遞繭鬱蓋 ) | - | 2017-06-14 | ||
Reference Adalimumab (ADL) | 鑰鑰襯築鹹構窪襯蓋憲(積膚齋艱襯遞衊範遞衊) = 積鹹憲觸齋齋艱願夢顧 鬱衊鏇獵淵積鹽遞壓襯 (簾範襯蓋選衊遞繭鬱蓋 ) | ||||||
临床3期 | 544 | (SB5 (Proposed Biosimilar to Adalimumab)) | 艱齋構憲顧膚艱艱遞繭 = 膚廠衊鬱鹽衊築製獵顧 齋築築鹹窪淵遞築選夢 (壓夢淵憲艱觸夢壓製廠, 積壓膚製壓選襯築積襯 ~ 網鑰願鏇膚壓醖艱醖憲) 更多 | - | 2017-01-19 | ||
(Humira (Adalimumab)) | 艱齋構憲顧膚艱艱遞繭 = 齋壓觸襯壓壓構鹹範夢 齋築築鹹窪淵遞築選夢 (壓夢淵憲艱觸夢壓製廠, 廠艱艱廠餘鹽衊鏇齋簾 ~ 糧壓築築鹽網簾窪蓋膚) 更多 |