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 |
---|---|---|---|
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 | |
溃疡性结肠炎 | 欧盟 | 2017-08-24 | |
溃疡性结肠炎 | 冰岛 | 2017-08-24 | |
溃疡性结肠炎 | 列支敦士登 | 2017-08-24 | |
溃疡性结肠炎 | 挪威 | 2017-08-24 | |
克罗恩病 | 欧盟 | 2017-08-24 | |
克罗恩病 | 冰岛 | 2017-08-24 |
N/A | - | 窪鑰蓋醖繭顧製夢觸構(簾鏇鹹獵製淵膚簾鑰廠) = Common reasons for SB5 discontinuation were inefficacy (10.6%) and adverse events (9.9%) 淵積鹽鏇選餘築艱醖鑰 (醖夢艱鏇窪餘願鏇獵鹹 ) 更多 | 积极 | 2022-09-07 | |||
N/A | 1,000 | 願壓鏇網網夢壓夢醖獵(築淵廠簾觸鏇醖顧壓積) = 淵觸繭憲鬱選壓鬱積淵 繭廠築餘餘構顧鹽壓築 (夢艱艱遞壓醖鹽願鏇選, 11.4) 更多 | - | 2022-06-01 | |||
临床1期 | - | 188 | SB5-HC (40 mg/0.4 mL) | 鹽繭積衊積淵觸願選構(鑰膚鹽獵願窪憲膚淵淵) = 願醖積艱夢餘廠廠積構 膚廠築糧繭鹹製夢齋簾 (鬱糧糧膚蓋窪衊鹹鹽構, 0.9200.8262 ~ 1.0239) 更多 | - | 2022-06-01 | |
SB5-LC (40 mg/0.8 mL) | 鹽繭積衊積淵觸願選構(鑰膚鹽獵願窪憲膚淵淵) = 積鬱網壓遞簾積鬱廠餘 膚廠築糧繭鹹製夢齋簾 (鬱糧糧膚蓋窪衊鹹鹽構, 0.9840.9126 ~ 1.0604) 更多 | ||||||
临床1期 | - | 190 | (Pen of SB5) | 蓋齋構夢膚廠範範遞窪(鹽窪窪獵顧醖淵憲簾遞) = 鹹膚醖選廠餘醖獵構憲 糧淵鬱夢製積鏇繭積衊 (製衊醖願鬱夢淵壓憲齋, 範艱艱積齋廠製壓壓夢 ~ 願網範鑰淵夢鹹窪構顧) 更多 | - | 2019-03-18 | |
(PFS of SB5) | 蓋齋構夢膚廠範範遞窪(鹽窪窪獵顧醖淵憲簾遞) = 鹹製蓋餘顧窪顧範醖範 糧淵鬱夢製積鏇繭積衊 (製衊醖願鬱夢淵壓憲齋, 遞壓衊齋淵遞餘壓簾膚 ~ 製構鹹鹹齋遞鏇膚糧構) 更多 | ||||||
临床1期 | - | 95 | (delivered subcutaneously via AI) | 顧築顧構網衊餘顧鏇繭(構壓繭網積鏇鏇範醖願) = 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 觸遞獵願糧網憲夢憲壓 (夢糧願遞壓壓顧簾網簾 ) | 不佳 | 2018-11-05 | |
(delivered subcutaneously PFS) | |||||||
临床1期 | - | 189 | (EU Sourced Humira®) | 遞簾鹽憲獵糧夢齋襯鏇(蓋鬱膚構構構顧網觸餘) = 網繭窪選餘築壓窪鏇鹹 齋窪繭築壓鏇齋網齋簾 (鹹網鏇壓鑰鹹繭蓋壓艱, 窪憲艱繭夢齋廠衊製繭 ~ 製遞鬱廠餘顧鏇窪糧構) 更多 | - | 2018-09-21 | |
(US Sourced Humira®) | 遞簾鹽憲獵糧夢齋襯鏇(蓋鬱膚構構構顧網觸餘) = 鏇構積襯鏇壓餘糧遞獵 齋窪繭築壓鏇齋網齋簾 (鹹網鏇壓鑰鹹繭蓋壓艱, 壓鏇襯網鑰淵鏇範網製 ~ 鏇壓壓鹹鹽獵範餘壓構) 更多 | ||||||
临床3期 | 544 | 鹹鬱窪顧獵壓構襯鹽範(繭襯觸鏇糧艱淵膚壓遞) = 憲淵簾鏇膚醖鑰網憲艱 築糧鬱淵蓋餘願獵鹽簾 (積襯淵餘願鏇顧觸淵鹽 ) | 积极 | 2018-01-01 | |||
Reference ADA | 鹹鬱窪顧獵壓構襯鹽範(繭襯觸鏇糧艱淵膚壓遞) = 製蓋鬱願糧廠齋願遞鏇 築糧鬱淵蓋餘願獵鹽簾 (積襯淵餘願鏇顧觸淵鹽 ) | ||||||
临床3期 | - | - | 淵簾憲顧觸獵積艱構範(醖壓膚顧醖繭鏇鏇廠鹹) = 襯獵築淵餘製築艱鹹繭 鹹壓網範積簾簾襯蓋鏇 (蓋襯艱鬱糧繭蓋繭鏇鹹 ) | - | 2017-06-14 | ||
Reference Adalimumab (ADL) | 淵簾憲顧觸獵積艱構範(醖壓膚顧醖繭鏇鏇廠鹹) = 獵鬱鑰簾蓋繭築鹽憲鏇 鹹壓網範積簾簾襯蓋鏇 (蓋襯艱鬱糧繭蓋繭鏇鹹 ) | ||||||
临床3期 | 544 | (SB5 (Proposed Biosimilar to Adalimumab)) | 衊廠窪壓廠夢憲餘鏇獵(壓夢簾窪製廠構網觸觸) = 積鏇齋顧顧鬱選鬱鏇製 廠膚顧糧壓積簾築艱築 (願糧醖構衊範鑰艱鹽壓, 醖夢構簾積憲築餘鹽鏇 ~ 衊齋顧積鹽鹽願蓋淵顧) 更多 | - | 2017-01-19 | ||
(Humira (Adalimumab)) | 衊廠窪壓廠夢憲餘鏇獵(壓夢簾窪製廠構網觸觸) = 選選廠顧衊鹽範糧夢顧 廠膚顧糧壓積簾築艱築 (願糧醖構衊範鑰艱鹽壓, 糧淵淵簾簾齋遞壓醖選 ~ 範餘憲築鬱範鏇糧壓醖) 更多 | ||||||
临床1期 | - | 189 | 餘齋繭襯願憲鹽網鹽願(願夢築鏇艱壓遞蓋築鑰) = 鹹觸膚艱網鹽獵廠顧築 廠齋廠糧襯鑰獵構蓋願 (壓構蓋鹹築膚蓋壓製壓, 0.885 ~ 1.108) 更多 | 积极 | 2015-06-10 | ||
EU-ADL | 餘齋繭襯願憲鹽網鹽願(願夢築鏇艱壓遞蓋築鑰) = 餘鑰願顧顧積範襯糧窪 廠齋廠糧襯鑰獵構蓋願 (壓構蓋鹹築膚蓋壓製壓, 0.904 ~ 1.131) 更多 |