On April 16, Alvotech and Teva announced the FDA approval of SELARSDI (ustekinumab-aekn), a biosimilar to Johnson and Johnson’s STELERA® (ustekinumab). This approval marks a significant milestone in the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in both adult and pediatric patients aged 6 years and older. SELARSDI is administered as a subcutaneous injection.
Developed by Alvotech, SELARSDI will be commercialized by Teva in the United States. This development follows a settlement agreement between Alvotech, Teva, and Johnson & Johnson in June 2023, which allows the marketing of their ustekinumab biosimilar in the United States no later than February 21, 2025.
SELARSDI is the second ustekinumab biosimilar to receive FDA approval, following the approval of Amgen’s WEZLANA (ustekinumab-auub) in October 2023.