FDA Approves Interchangeable Ustekinumab Biosimilar for Inflammatory Diseases

The FDA has approved ustekinumab-auub (Wezlana; Amgen) as an interchangeable biosimilar to ustekinumab (Stelara; Janssen) for the treatment of multiple inflammatory diseases.

The FDA granted the biosimilar with interchangeable designation after clinical trials found no clinically significant differences in safety and efficacy for the indicated conditions, including adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; active psoriatic arthritis; moderately to severely active Crohn disease; and moderately to severely active ulcerative colitis. In pediatric patients, the biosimilar is approved for use in patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; and active psoriatic arthritis.

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

Biosimilars are medications with a strong similarity to biologic drugs, but are not clinically different from the currently approved biological products. Interchangeable designation allows healthcare providers to substitute a biosimilar for a reference product without requiring a prescription. An interchangeable biosimilar that meets state and other legal requirements can be made available at pharmacies able to make a pharmacy-level substitution of the biosimilar in place of the brand-name drug.

Before the FDA approved the product, the interchangeable biosimilar underwent a series of chemical tests, biological tests, and assays to confirm it shares structural and functional features with the reference product. Investigators collected comparative human pharmacokinetic data, clinical immunogenicity data, and safety and efficacy data, which show that both products have clinically meaningful similarity in safety, purity, and potency.

The most common adverse events (AEs) associated with ustekinumab include nasopharyngitis, upper respiratory tract infection, headache, fatigue, nausea, vomiting, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, sinusitis, abdominal pain, influenza, fever, and diarrhea. The biosmilar contains labeling that discusses the risks and other AEs, and an associated Medication Guide that addresses these risks.

“Today’s approval exemplifies the FDA’s longstanding commitment to support a competitive marketplace for biological products,” said Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, in a press release. “This approval can empower patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost.”

Reference

FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases. FDA. News Release. October 31, 2023. Accessed on November 1, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-interchangeable-biosimilar-multiple-inflammatory-diseases