On October 22, 2024, Alvotech and Teva announced that SELARSDI" (ustekinumab-aekn) received FDA approval for a new presentation, 130 mg/26 mL (5 mg/mL) solution in a single-dose vial for intravenous infusion. We previously reported that SELARSDI" was approved by the FDA for 45 mg/0.5 mL and 90 mg/mL in a single-dose prefilled syringe for subcutaneous injection. This new presentation allows for SELARSDI" to expand its label to align with the indications of the reference product STELARA® (ustekinumab). Thomas Rainey, Senior Vice President, U.S. Biosimilars, stated "This development allows us to serve patients battling gastrointestinal diseases as the U.S. launch of SELARSDI approaches in early 2025."
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
