FDA approves interchangeable Ustekinumab biosimilar for inflammatory disease

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 interchangeable designation because clinical trials found no clinically significant differences in safety and efficacy in specified conditions, including adults with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Patients with; active psoriatic arthritis; moderately to severely active Crohn’s disease; and moderately to severely active ulcerative colitis. In pediatric patients, the biosimilar is approved for patients with moderate to severe plaque psoriasis who are eligible for phototherapy or systemic therapy; and active psoriatic arthritis.

“Biosimilars provide additional safe and effective treatment options with the potential to increase access for patients in need of 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. middle. “Today’s approval could have a meaningful impact on disease management for patients.”

Biosimilars are drugs that are very similar to biologic drugs but are clinically indistinguishable from currently approved biologics. The interchangeable designation allows healthcare providers to substitute a biosimilar for a reference product without a prescription. Interchangeable biosimilars that meet state and other legal requirements may be offered by pharmacies that are able to substitute a pharmacy-grade version of the biosimilar for a brand-name drug.

Before FDA approves the product, the interchangeable biosimilar undergoes a series of chemical tests, biological tests and assays to confirm that it has the same structural and functional characteristics as the reference product. Researchers collected comparative human pharmacokinetic data, clinical immunogenicity data, and safety and efficacy data demonstrating clinically meaningful similarities in safety, purity, and potency between the two products.

The most common adverse events (AEs) associated with ustekinumab include nasopharyngitis, upper respiratory tract infection, headache, fatigue, nausea, vomiting, injection site erythema, vulvovaginal candidiasis/fungal infection, bronchitis, pruritus, urinary road infections, sinusitis, abdominal pain, flu, fever and diarrhea. Biosimilars contain labeling that discusses risks and other adverse events, as well as associated Medication Guidelines that address these risks.

“Today’s approval demonstrates the FDA’s long-term commitment to supporting competitive markets for biologics,” Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, said in a press release. “This approval empowers patients by helping them obtain safe, effective and high-quality medicines at lower costs.”

refer to

The FDA approves interchangeable biosimilars for the treatment of a variety of inflammatory diseases. U.S. Food and Drug Administration. Press Releases. October 31, 2023. Accessed 1 November 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-interchangeable-biosimilar-multiple-lingual-diseases