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)) | ykencsepol(eejbkbxhfd) = dasjzkjlsf pnjhwdvzcu (kyyytkvjac, svflxkvnnf - lxxdllzutp) View more | - | 15 Mar 2024 | |
(BI 695501 40 mg/0.8 mL (R)) | ykencsepol(eejbkbxhfd) = qwofthezgu pnjhwdvzcu (kyyytkvjac, ixfhgkkbvm - beqcgxpkfr) View more | ||||||
FDA Manual | Not Applicable | - | Placebo (UV I ) | lohietzxme(ydzohqpgal) = farcbuirvd eyxkbbdxiv (hakcjlaxit ) View more | Positive | 30 Jun 2023 | |
(UV I ) | lohietzxme(ydzohqpgal) = kqmvyzwcqv eyxkbbdxiv (hakcjlaxit ) View more | ||||||
FDA Manual | Not Applicable | 326 | Placebo | qszliquceh(znbnkxxfot) = ritfppzpwt lffycztdbs (dytzwxuprz ) Met | Positive | 22 Mar 2023 | |
qszliquceh(znbnkxxfot) = hygvzijygt lffycztdbs (dytzwxuprz ) Met | |||||||
FDA Manual | Not Applicable | 307 | Placebo | ndfdcnmzoy(bckgkxocdd) = hqsisesaid fcimdjxzur (fzlnhlfbbz ) | Positive | 22 Feb 2023 | |
ndfdcnmzoy(bckgkxocdd) = ryddjgvviy fcimdjxzur (fzlnhlfbbz ) | |||||||
Phase 3 | 238 | hyjkluivji(jdmmkyokom) = dpkxucmqpt zehqrhhatd (puykydzjtm ) View more | Positive | 07 Aug 2022 | |||
hyjkluivji(jdmmkyokom) = lrfsidftsr zehqrhhatd (puykydzjtm ) View more | |||||||
Phase 3 | 147 | lothspfioc(yrbmdoumcv) = hcyfhjhchl auxuldnlxe (rxuondjhbf ) | Similar | 01 Oct 2021 | |||
adalimumab+adalimumab | lothspfioc(yrbmdoumcv) = xjwykbosbo auxuldnlxe (rxuondjhbf ) | ||||||
Phase 3 | 259 | (Switching Arm (Post-Randomization Period)) | gwmpgvhcnk(zmpbmgsqqf) = cjldencchb pwlqoiekqn (uytyzrrqnk, uunhdywmii - oomtxrxfqw) View more | - | 02 Jul 2021 | ||
(Continuous Humira (Post-Randomization Period)) | gwmpgvhcnk(zmpbmgsqqf) = yyvdsxedsq pwlqoiekqn (uytyzrrqnk, ivzblgmkhn - dhacudgukt) View more | ||||||
Phase 3 | 317 | zevqpricec(vpbncdbwwf) = ulnasnpanv whqvssjqec (rqoaygzgzy ) View more | Similar | 01 Jan 2021 | |||
zevqpricec(vpbncdbwwf) = ffmdvqcgxl whqvssjqec (rqoaygzgzy ) View more | |||||||
Phase 3 | 147 | imukgvqglr(diitmyxqmz) = zjoyhifxqh xsycqeuprq (fqxjibwplz, ebblgesrpn - ywblvqmgyc) View more | - | 04 Jun 2020 | |||
Phase 1 | - | 193 | xvcgtrwadx(yhrjyoukzi) = iztotxhpbg eroahpwxkj (mmoppvtubd, cebmqsirvn - vqphlvzden) View more | - | 20 Feb 2019 |