Approval Alert: FDA Approves First Ustekinumab Biosimilar (Amgen)

On 31 October 2023, the FDA approved Amgen’s Wezlana® (ustekinumab-auub), as the first FDA-approved biosimilar to Janssen’s Stelara®.  Wezlana is approved for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis (each in both adults and paediatric patients six years and older), and the treatment of moderately to severely active Crohn’s disease and moderately to severely active ulcerative colitis (in adults).  Wezlana® is a subcutaneous injection in a 45mg/0.5mL pre-filled syringe and a 45mg/0.5mL vial.