Amgen's Wezlana Receives FDA Approval as Interchangeable Biosimilar to J&J's Stelara (Ustekinumab)

The U.S. Food and Drug Administration (FDA) approved Amgen's Wezlana as a biosimilar to Johnson & Johnson's Stelara (ustekinumab) on October 31 local time. It is interchangeable with Stelara for the treatment of various inflammatory diseases, including plaque psoriasis, active psoriatic arthritis, and moderate to severe Crohn's disease. In May this year, Amgen and Janssen reached a settlement in the litigation over the biosimilar of Johnson & Johnson’s biologic Stelara (ustekinumab).