Treats moderately to severely active Crohn’s disease. BLA 761154, held by Mylan Pharms Inc. Adalimumab-Fkjp.
As of Nov 13, 2026, BLA 761154 (Hulio), held by Mylan Pharms Inc, was first approved by FDA on Jul 6, 2020, with 5 approved supplements and 0 published complete response letters.
Adalimumab-fkjp is a tumor necrosis factor (TNF) blocker indicated for: Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. J uvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 14, 2022 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Jul 6, 2020 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hulio20MG;0.4ML · injectable;injection | Adalimumab-Fkjp | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 5, 2025 | Supplement 9Biosimilar · Standard review | Approved | |
| Dec 15, 2023 | Supplement 8Labeling · Standard review | Approved | |
| Aug 25, 2023 | Supplement 5Bioequivalence | Approved | |
| Mar 3, 2023 | Supplement 3 | Approved | |
| Jul 14, 2022 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Jul 6, 2020 | Original application | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
