FDA Approval of Alvotech/Teva Ustekinumab Biosimilar

On April 16, Alvotech and Teva announced the FDA approval of SELARSDI™ (ustekinumab-aekn), biosimilar to Johnson and Johnson’s STELERA® (ustekinumab).  The product was approved as a subcutaneous injection for the treatment of adult and pediatric patients 6 years and older with moderate to severe plaque psoriasis and for active psoriatic arthritis.  SELARSDI™ was developed by Alvotech and will be commercialized by Teva in the United States.  As we previously reported, Alvotech and Tech settled with Johnson & Johnson in June 2023, with an agreement that their ustekinumab biosimilar can be marketed in the United States no later than February 21, 2025.

SELARSDI is now the second ustekinumab biosimilar to be approved by the FDA, following FDA approval of Amgen’s WEZLANA (ustekinumab-auub) in October 2023.