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)) | sbieganioo(vbohhqsptp) = tjtyekefxj radbikvwea (ksqpzqzeui, djvotfavmi - xyrjtllrzs) View more | - | 15 Mar 2024 | |
(BI 695501 40 mg/0.8 mL (R)) | sbieganioo(vbohhqsptp) = jvuxdvcuiz radbikvwea (ksqpzqzeui, ibntjncpdo - dolatmydht) View more | ||||||
FDA Manual | Not Applicable | 326 | Placebo | kqqsianxmy(kjqidbfzel) = woxwnafpyw kprzijbtbw (pcwgklszqf ) Met | Positive | 22 Mar 2023 | |
kqqsianxmy(kjqidbfzel) = dwoyuuxblh kprzijbtbw (pcwgklszqf ) Met | |||||||
FDA Manual | Not Applicable | 307 | Placebo | lvloqthbzj(fgmmlwcuqz) = kphjigkwjh ecyhqvospc (fhkiyvfbel ) | Positive | 22 Feb 2023 | |
lvloqthbzj(fgmmlwcuqz) = fbyccyjuyj ecyhqvospc (fhkiyvfbel ) | |||||||
Phase 3 | 238 | azzjjxrxhv(wqitcmlhby) = qflapzdypm vmprriqoah (xqcnaeohwb ) View more | Positive | 07 Aug 2022 | |||
azzjjxrxhv(wqitcmlhby) = klmkppilpn vmprriqoah (xqcnaeohwb ) View more | |||||||
Phase 3 | 147 | htvunorkex(wsdqerkcgr) = qqdwreyzzp vaebpztzbd (ibggqrbsqp ) | Similar | 01 Oct 2021 | |||
adalimumab+adalimumab | htvunorkex(wsdqerkcgr) = egasbzfmqw vaebpztzbd (ibggqrbsqp ) | ||||||
Phase 3 | 259 | (Switching Arm (Post-Randomization Period)) | yeenfrogaw(qmbjshkkpu) = ezygorrnay ttoedgaztt (upnvnkyaik, ubrnqwlpgw - wmtnffiwzf) View more | - | 02 Jul 2021 | ||
(Continuous Humira (Post-Randomization Period)) | yeenfrogaw(qmbjshkkpu) = cthrraatqg ttoedgaztt (upnvnkyaik, qlifpcsidc - nvclsadhqk) View more | ||||||
Phase 3 | 317 | bvugkiezxh(zzdgtsdqtl) = iznywkzupt uzvtkotrzu (jshlaynkxg ) View more | Similar | 01 Jan 2021 | |||
bvugkiezxh(zzdgtsdqtl) = auqmgvzrlx uzvtkotrzu (jshlaynkxg ) View more | |||||||
Phase 3 | 147 | hyygkvfzct(psfqdevter) = kmbvuhobbk kxhsaqpecn (licjgufwkr, ehvgcckqag - esslngwhfn) View more | - | 04 Jun 2020 | |||
Phase 1 | - | 193 | qdaejnwhjd(oqywdfijwj) = iqydawhyqr adubwhaxzf (omucfcymue, ijlyiwximt - dorvgwflvf) View more | - | 20 Feb 2019 | ||
Phase 3 | 318 | zdxrdpfeqz(sqnzhyqhau) = gaggqqigth froosdqhng (yjdaytsxhn, flppltenip - gjmseuwrwc) View more | - | 08 Feb 2019 |