FDA approves Stelara biosimilar for treatment of psoriasis, multiple inflammatory diseases

Key takeaways:

• Wezlana was approved as a Stelara biosimilar for plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.
• Due to a legal settlement, Wezlana will be launched in January 2025.

The FDA has approved Wezlana as a Stelara biosimilar for the treatment of plaque psoriasis, psoriatic arthritis and other inflammatory diseases, according to an FDA press release.

Wezlana (ustekinumab-auub, Amgen) is now approved as an interchangeable biosimilar to Stelara (ustekinumab, Janssen) for the treatment of moderate to severe plaque psoriasis in patients aged 6 years and older who are candidates for phototherapy or systemic therapy, as well as active psoriatic arthritis in patients aged 6 years and older.

In addition to dermatologic indications, Wezlana has also been approved to treat moderately to severely active Crohn’s disease and ulcerative colitis in adults.

“Biosimilar medications offer additional safe and effective treatment options that have the potential to increase access for people requiring treatment for inflammatory diseases,” Nikolay Nikolov, MD, director of the office of immunology and inflammation in the FDA’s Center for Drug Evaluation and Research, said in the release. “[This] approval could have a meaningful impact for patients managing their disease.”

The approval was based on “a comprehensive review of scientific evidence” which demonstrated the clinical similarities between Wezlana and Stelara in terms of “safety, purity and potency,” according to the release. Biosimilars must meet the same rigorous approval standards as other biological products before receiving approval status.

Earlier this year, Healio reported that Janssen’s parent company, Johnson & Johnson, settled a patent lawsuit with Amgen regarding Wezlana, indicating a January 2025 launch for the biosimilar.