Amgen wins FDA approval for Stelara biosimilar

Nov. 1, 2023

The FDA has approved Amgen’s Wezlana as a biosimilar and interchangeable product to J&J's Stelara, authorizing it for the treatment of various inflammatory diseases.

Stelara was recently included on the initial list of 10 medications designated for Medicare price negotiations in accordance with the Inflation Reduction Act (IRA). The therapy was first approved in 2009 to treat psoriasis and since then has accumulated approvals in ulcerative colitis, arthritis and Crohn’s disease, achieving sales totaling over $6.4 billion in 2022.

Amgen's Wezlana approval mirrors the indications of Stelara, providing therapeutic options for both adult and pediatric patients. Adult patients with conditions such as moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn's disease, and moderately to severely active ulcerative colitis could be treated with Wezlana.

Even though the drug has secured regulatory approval, it will be awhile before patients have the biosimilar available to them. J&J recently struck a deal with Amgen, delaying the launch of a proposed biosimilar until 2025.