Treats moderately to severely active Crohn’s disease. BLA 761299, held by Alvotech USA Inc. Adalimumab-Ryvk.
As of Nov 14, 2026, BLA 761299 (Simlandi), held by Alvotech USA Inc, was first approved by FDA on Feb 23, 2024, with 9 approved supplements and 2 published complete response letters.
SIMLANDI is a tumor necrosis factor (TNF) blocker indicated for: 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 rheumatoid arthritis. Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. Reducing signs and symptoms in adult patients with active ankylosing spondylitis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 23, 2024 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Simlandi40MG/0.4ML · injectable;injection | Adalimumab-Ryvk | Rx |
| Nov 6, 2025 | Supplement 24Labeling · Standard review | Approved | |
| Oct 16, 2025 | Supplement 25Biosimilar | Approved | |
| Apr 7, 2025 | Supplement 13Manufacturing · Standard review | Approved | |
| Apr 7, 2025 | Supplement 20Manufacturing | Approved | |
| Feb 14, 2025 | Supplement 16Manufacturing | Approved | |
| Aug 26, 2024 | Supplement 3Labeling · Standard review | Approved | |
| Aug 26, 2024 | Supplement 6Labeling · Standard review | Approved | |
| Jun 26, 2024 | Supplement 7Manufacturing | Approved | |
| May 31, 2024 | Supplement 1Labeling · Standard review | Approved | |
| Feb 23, 2024 | 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
