Teva and Alvotech FDA Approval of Interchangeability for SELARSDI with Stelara

The FDA has approved SELARSDI™ (ustekinumab-aekn) as interchangeable with Stelara® (ustekinumab) for Teva Pharmaceuticals (TEVA) and Alvotech (ALVO). The approval, effective April 30, 2025, covers all presentations matching the reference product. SELARSDI is indicated for treating moderate to severe plaque psoriasis, active psoriatic arthritis in patients 6+ years, and moderately to severely active Crohn's disease and ulcerative colitis in adults. The drug is available in multiple presentations: 45 mg/0.5 mL and 90 mg/mL prefilled syringes, 45 mg/0.5 mL single-dose vial, and 130 mg/26 mL IV infusion vial. This marks Teva's second FDA-approved interchangeable biosimilar following SIMLANDI®, with three additional biosimilar candidates under FDA review with BsUFA goal dates in Q4 2025.

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