Biotech company Alvotech S.A. (NASDAQ:ALVO) and Teva Pharmaceuticals, a US affiliate of Israel-based pharmaceutical company Teva Pharmaceutical Industries Ltd (NYSE:TEVA) (TASE:TEVA), on Monday announced US Food and Drug Administration (FDA) approval of SELARSDI (ustekinumab-aekn) as interchangeable with Stelara (ustekinumab), effective 30 April 2025.

SELARSDI is now approved for all indications of the reference product, including moderate to severe plaque psoriasis, active psoriatic arthritis, Crohn's disease and ulcerative colitis in both adults and paediatric patients aged six and older.

The biosimilar is available in subcutaneous and intravenous formats matching Stelara, including single-dose prefilled syringes and vials.

SELARSDI was developed by Alvotech using the same host cell line and continuous perfusion process as Stelara.

Teva and Alvotech have an exclusive US commercialisation partnership that began in 2020 and expanded in 2023 to cover seven biosimilar products.

This marks the second FDA-approved interchangeable biosimilar from the collaboration, following SIMLANDI (adalimumab-ryvk), approved in February 2024.

Three additional biosimilars from the Alvotech-Teva pipeline are currently under FDA review.