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# Teva/Alvotech’s Interchangeable Stelara Biosimilar OK’d
- URL: https://www.fdaweb.com/teva-alvotechs-interchangeable-stelara-biosimilar-okd/
- Published: 2025-05-07T12:00:00.000Z
- Updated: 2026-09-14T15:11:10.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5159139

FDA has approved Teva Pharmaceuticals and Alvotech’s Selarsdi (ustekinumab-aekn) injection as an interchangeable biosimilar to Janssen’s reference biologic Stelara (ustekinumab) for treating psoriatic arthritis and plaque psoriasis, as well as Crohn’s disease, and ulcerative colitis.

Ustekinumab is a human monoclonal antibody that selectively targets the p40 protein, a component common to both interleukin (IL)-12 and IL-23 cytokines, which play crucial roles in treating immune-mediated diseases like psoriasis and psoriatic arthritis, and inflammatory diseases like Crohn’s disease and ulcerative colitis, the companies say. “Alvotech developed and produces Selarsdi using Sp2/0 cells and a continuous perfusion process, which are the same type of host cell line and process used in the production of Stelara,” they say.