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.”
[View source.]
