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# After 2 Earlier Denials, Humira Biosimilar OK’d
- URL: https://www.fdaweb.com/after-2-earlier-denials-humira-biosimilar-okd/
- Published: 2024-02-26T12:00:00.000Z
- Updated: 2026-09-14T14:23:50.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5156425

After two complete response letters over inspection concerns, FDA has now granted approval to Alvotech and Teva Pharmaceuticals for Simlandi (adalimumab-ryvk) injection, an interchangeable biosimilar to AbbVie’s Humira. Earlier this year, an FDA reinspection of Alvotech’s Iceland manufacturing facility resulted in a Form FDA-483 with one inspection finding. A 2023 inspection at the facility had cited eight GMP deficiencies leading to a complete response letter ([see story](https://www.fdaweb.com/login.php?sa=v&aid=D5154803&cate=&stid=%241%24Az..J6%2F.%24%2FW0NGQnVsNscxFaMQUb1Z1)) that delayed approval. In 2022, FDA issued Alvotech its first complete response letter ([see story](https://fdaweb.com/login.php?sa=v&aid=D5152671&cate=&stid=%241%24G11.XK5.%246k%2F7mqbIdhsncd0%2FXm3h1%2F&ref=fdaweb.com)) on its biosimilar BLA, this too cited inspection deficiencies at the same facility.

Humira is indicated for treating rheumatoid arthritis, juvenile idiopathic arthritis (four years and older), psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis.

Alvotech has said it is the only company that has both submitted a BLA for a proposed Humira biosimilar and conducted a switching study in support of an FDA designation for interchangeability (pharmacy substitution).