FDA Approves First Interchangeable Stelara Biosimilar

The FDA has approved a biosimilar that is interchangeable with Johnson & Johnson’s Stelara (ustekinumab). Amgen’s Wezlana (ustekinumab-auub) is approved to treat patients with multiple inflammatory diseases, including plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. Wezlana is expected to launch no later than Jan. 1, 2025, after an agreement with J&J.

Both products are monoclonal antibodies that binds to two cytokines, IL-12 and IL-23, that are involved in inflammatory and immune responses.

“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, M.D., director of the Office of Immunology and Inflammation in the FDA’s Center for Drug Evaluation and Research, said in a press release. “Today’s approval could have a meaningful impact for patients managing their disease.”

According to the FDA, the approval of Wezlana is based on a review of scientific evidence demonstrating that there are no clinically meaningful differences between the two products in terms of safety, purity and potency. This evidence included comparisons of the products on an analytical level using chemical and biological tests and biological assays that confirmed similarity in the structural and functional features.

Other expected Stelara biosimilars include:

• Alvotech and Teva’s AVT04, which is expected to launch no later Feb. 21, 2025. Last month, the FDA issued a complete response letter for AVT04 because of deficiencies in Alvotech’s Iceland, facility. The company plans to resubmit its application once these are addressed.
• Fesenius Kabi and Formycon plan to launch their biosimilar to Stelara, FYB202, no later than April 15, 2025.