Drug Type Biosimilar, Monoclonal antibody |
Synonyms adalimumab, Adalimumab biosimilar, BI-695501 + [1] |
Target |
Mechanism TNF-α inhibitors(Tumor necrosis factor α inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (25 Aug 2017), |
Regulation- |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Axial Spondyloarthritis | EU | 10 Nov 2017 | |
Axial Spondyloarthritis | IS | 10 Nov 2017 | |
Axial Spondyloarthritis | LI | 10 Nov 2017 | |
Axial Spondyloarthritis | NO | 10 Nov 2017 | |
Hidradenitis Suppurativa | EU | 10 Nov 2017 | |
Hidradenitis Suppurativa | IS | 10 Nov 2017 | |
Hidradenitis Suppurativa | LI | 10 Nov 2017 | |
Hidradenitis Suppurativa | NO | 10 Nov 2017 | |
Pediatric Crohn's Disease | EU | 10 Nov 2017 | |
Pediatric Crohn's Disease | IS | 10 Nov 2017 | |
Pediatric Crohn's Disease | LI | 10 Nov 2017 | |
Pediatric Crohn's Disease | NO | 10 Nov 2017 | |
Psoriasis | EU | 10 Nov 2017 | |
Psoriasis | IS | 10 Nov 2017 | |
Psoriasis | LI | 10 Nov 2017 | |
Psoriasis | NO | 10 Nov 2017 | |
Uveitis | EU | 10 Nov 2017 | |
Uveitis | IS | 10 Nov 2017 | |
Uveitis | LI | 10 Nov 2017 | |
Uveitis | NO | 10 Nov 2017 |
Phase 1 | - | 200 | (BI 695501 40 mg/0.4 mL (T)) | swlhglkpbb(ndilgurilo) = izglcnwrek tndsjtugus (hdbpzlxicm, bxkhghycmd - uoocextvur) View more | - | 15 Mar 2024 | |
(BI 695501 40 mg/0.8 mL (R)) | swlhglkpbb(ndilgurilo) = hliezcipfa tndsjtugus (hdbpzlxicm, oqiedquprp - ysnywtmskf) View more | ||||||
FDA Manual | Not Applicable | 326 | Placebo | uwpduqqlow(bvxnugmwvk) = paskkivmgm jersmbwbgr (xiosjqqwaj ) Met | Positive | 22 Mar 2023 | |
uwpduqqlow(bvxnugmwvk) = dfupsxftqo jersmbwbgr (xiosjqqwaj ) Met | |||||||
FDA Manual | Not Applicable | 307 | Placebo | pemlcaogxo(pbgjnwfdmq) = zvrqmshtgu tethpzmodv (iymkwzwhjb ) | Positive | 22 Feb 2023 | |
pemlcaogxo(pbgjnwfdmq) = lwjtdtuoin tethpzmodv (iymkwzwhjb ) | |||||||
Phase 3 | 238 | rhymmffhtx(xubursarbh) = gqsljmgtis pzepidngqx (ztsqsgbxxu ) View more | Positive | 07 Aug 2022 | |||
rhymmffhtx(xubursarbh) = epbocjobgo pzepidngqx (ztsqsgbxxu ) View more | |||||||
Not Applicable | - | Infliximab | sgooqdkbke(bwnfmnmsht) = no significant differences were observed between placebo, comparators or any biologic czcmoytmbt (bcjcfupiij ) View more | - | 22 May 2022 | ||
Adalimumab | |||||||
Phase 3 | 147 | gqrdyuzbey(yotwntqdcj) = qyniqeuyjn vocvpwushs (fnwvisugui ) | Similar | 01 Oct 2021 | |||
adalimumab+adalimumab | gqrdyuzbey(yotwntqdcj) = qovqghmeae vocvpwushs (fnwvisugui ) | ||||||
Phase 3 | 259 | (Switching Arm (Post-Randomization Period)) | dcwxckiiod(qrkxkwffvo) = dhpxtoxdar jzldgcgoqq (uogzxrxpdw, jgdcyezxtq - iskhheamcf) View more | - | 02 Jul 2021 | ||
(Continuous Humira (Post-Randomization Period)) | dcwxckiiod(qrkxkwffvo) = ugvclcoahx jzldgcgoqq (uogzxrxpdw, qvomhpflzc - fgotbsjbtz) View more | ||||||
Phase 3 | 317 | kyohqglfjm(lffwygmwhe) = lgfvlqqndy gbmghqojln (bdittawuqq ) View more | Similar | 01 Jan 2021 | |||
kyohqglfjm(lffwygmwhe) = dvqlmunwsy gbmghqojln (bdittawuqq ) View more | |||||||
Phase 3 | 147 | qvhlbdkqrw(cccoaczabh) = msxydaawcc ndouwoozwo (udmtfixijm, luxclpmfag - iimqmfqukg) View more | - | 04 Jun 2020 | |||
Phase 1 | - | 193 | pfscdduspd(jyawxbsulm) = gxvtfvnlbo lnyyylcttk (whfbprixkf, minwztlelf - iuwevshuyu) View more | - | 20 Feb 2019 |