On May 5, 2025, Teva and Alvotech announced that the U.S. Food and Drug Administration (FDA) approved SELARSDI (ustekinumab-aekn) injection as an interchangeable biosimilar to the reference product STELARA (ustekinumab). SELARSDI is approved for all indications matching the reference product, including for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adults and pediatric patients 6 years and older, and the treatment of adult patients with moderately to severely active Crohn's disease and ulcerative colitis. Thomas Rainey, Senior Vice President, U.S. Biosimilars at Teva, stated that "[t]he FDA's confirmation of full interchangeability for SELARSDI is an important development for patients and providers seeking to expand access to this important treatment."
As we previously reported, SELARSDI was approved by the FDA for multiple formulations: a 130 mg/26 mL (5 mg/mL) solution in a single-dose vial for intravenous infusion and 45 mg/0.5 mL and 90 mg/mL single-dose prefilled syringes for subcutaneous injection.
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