FDA approves new presentation of biosimilar drug Selarsdi

Iceland-based Alvotech (Nasdaq: ALVO) and the US unit of Israel’s of Teva Pharmaceutical Industries (NYSE and TASE: TEVA) today revealed that that the US Food and Drug Administration (FDA) has approved Selarsdi (ustekinumab-aekn) in a new presentation, 130mg/26 mL (5mg/mL) solution in a single-dose vial for intravenous infusion.

This approval paves the way for Selarsdi to further align its label with the indications of the reference product, Johnson & Johnson’s ((NYSE: JNJ) Stelara (ustekinumab) in the USA at launch, which is expected in the first quarter of 2025.

The FDA approved Selarsdi 45mg/0.5 mL and 90 mg/mL injection in a prefilled syringe for subcutaneous use, for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients six years and older in April this year. In June 2023, Alvotech and Teva reached a settlement and license agreement with the manufacturer of the reference biologic, granting a license entry date for Selarsdi in the USA no later than February 21, 2025.