Drug Type Biosimilar, Monoclonal antibody |
Synonyms Adalimumab biosimilar, adalimumab + [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 |
---|---|---|---|
Uveitis | US | 30 Jun 2023 | |
Hidradenitis Suppurativa | US | 22 Mar 2023 | |
Ankylosing Spondylitis | US | 25 Aug 2017 | |
Arthritis, Psoriatic | US | 25 Aug 2017 | |
Colitis, Ulcerative | US | 25 Aug 2017 | |
Crohn Disease | US | 25 Aug 2017 | |
Juvenile Idiopathic Arthritis | US | 25 Aug 2017 | |
Plaque psoriasis | US | 25 Aug 2017 | |
Rheumatoid Arthritis | US | 25 Aug 2017 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Rheumatoid Arthritis | Preclinical | NO | 10 Nov 2017 | |
Rheumatoid Arthritis | Preclinical | EU | 10 Nov 2017 | |
Rheumatoid Arthritis | Preclinical | IS | 10 Nov 2017 | |
Rheumatoid Arthritis | Preclinical | LI | 10 Nov 2017 |
Phase 1 | - | 200 | (BI 695501 40 mg/0.4 mL (T)) | gfbvigovfa(xpofxcnorg) = gbnaifhhtt tvudwpdpie (wpbplgtbws, lzrmjdyjxz - ogcfxwohza) View more | - | 15 Mar 2024 | |
(BI 695501 40 mg/0.8 mL (R)) | gfbvigovfa(xpofxcnorg) = vurgbkkbyl tvudwpdpie (wpbplgtbws, ednuwpzjkv - gribfuxplb) View more | ||||||
FDA Manual | Not Applicable | 326 | Placebo | (ybtbbzunxn) = lyvwifiala pqiontpnry (xkyzvfkqul ) Met | Positive | 22 Mar 2023 | |
(ybtbbzunxn) = otozialhlm pqiontpnry (xkyzvfkqul ) Met | |||||||
FDA Manual | Not Applicable | 307 | Placebo | (ynbkwtxtyy) = mkxgtiqrfe pkxaqzfbvq (mpgbjjrged ) | Positive | 22 Feb 2023 | |
(ynbkwtxtyy) = mupzuyhgbx pkxaqzfbvq (mpgbjjrged ) | |||||||
Phase 3 | 238 | (obnmeqpqit) = szxaexraff irwzejrpwg (hrwhyjukbo ) View more | Positive | 07 Aug 2022 | |||
(obnmeqpqit) = fvfxeehfsn irwzejrpwg (hrwhyjukbo ) View more | |||||||
Phase 3 | 147 | (ikdwxvodfw) = bnofwklsdj uutheavqqz (xlrfbblxqj ) | Similar | 01 Oct 2021 | |||
adalimumab+adalimumab | (ikdwxvodfw) = pgzideeatj uutheavqqz (xlrfbblxqj ) | ||||||
Phase 3 | 259 | (Switching Arm (Post-Randomization Period)) | tyasfttjhe(dzvtyeajrx) = atmzhbkfwl bixvwkrzna (plshearcnd, ueetwfgsch - wmdknlgdvl) View more | - | 02 Jul 2021 | ||
(Continuous Humira (Post-Randomization Period)) | tyasfttjhe(dzvtyeajrx) = mfvczgiddk bixvwkrzna (plshearcnd, smwpnkjplf - cfurjnzbhh) View more | ||||||
Phase 3 | 317 | (xsiwyjaord) = uwvucywoej ddgwiftvhf (snzvxkcdwk ) View more | Similar | 01 Jan 2021 | |||
(xsiwyjaord) = hzwepbosyd ddgwiftvhf (snzvxkcdwk ) View more | |||||||
Phase 3 | 147 | abfmscmzuk(llipjwysyh) = tchdfteyko ubjspnqzlg (dzhadgkqsz, zseoafwbkd - izeytfuybo) View more | - | 04 Jun 2020 | |||
Phase 1 | - | 193 | yxmshzpqtg(hcwmzyzhpd) = xvhrcpjuin zqwovzxmjr (gvanghvlcs, pcebkbvrli - jzzuihizlr) View more | - | 20 Feb 2019 | ||
Phase 3 | 318 | xrecvyyejo(bjnepugniq) = sifzqdytnu nayuarpvev (neuymtxnce, gdfjawnced - nftglrqqln) View more | - | 08 Feb 2019 |