FDA approves interchangeable biosimilar for multiple inflammatory diseases

Nov. 1, 2023
The FDA granted the approval of Wezlana to Amgen, Inc.

The U.S. Food and Drug Administration approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases.

Wezlana, like Stelara, is approved to treat the following indications: 

Adult patients with:

  • moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy;
  • active psoriatic arthritis;
  • moderately to severely active Crohn’s disease; and
  • moderately to severely active ulcerative colitis.

Pediatric patients 6 years of age and older with:

  • moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; and 
  • active psoriatic arthritis.

FDA release