Stelara is an approved human interleukin-12 and interleukin-23 antagonist, which was developed by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson
Amgen secures FDA approval for Wezlana as an interchangeable biosimilar to Janssen Pharmaceuticals’ Stelara. (Credit: Amgen Inc.)
The US Food and Drug Administration (FDA) has approved Amgen’s Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for the treatment of various inflammatory diseases.
Stelara is an approved human interleukin-12 and interleukin-23 antagonist, which was developed by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson.
Similar to Stelara, Wezlana has been indicated for the treatment of adults with conditions such as moderate to severe plaque psoriasis in those suitable for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn’s disease, and moderately to severely active ulcerative colitis.
Additionally, the Amgen biosimilar is approved for use in pediatric patients aged six years and older who have moderate to severe plaque psoriasis and are candidates for phototherapy or systemic therapy, as well as in cases of active psoriatic arthritis.
FDA Center for Drug Evaluation and Research Office of Immunology and Inflammation director Nikolay Nikolov said: “Biosimilar medications offer additional safe and effective treatment options that have the potential to increase access for people requiring treatment for inflammatory diseases.
“Today’s approval could have a meaningful impact for patients managing their disease.”
The FDA said that its approval of Wezlana was based on a thorough assessment of scientific evidence, which established its high similarity to Stelara with no clinically significant disparities in terms of safety and efficacy.
The evidence encompassed comparisons through chemical and biological tests and biological assays, which confirmed Wezlana’s structural and functional likeness to Stelara. These include factors influencing safety and effectiveness.
Additionally, comparative human pharmacokinetic data, clinical immunogenicity data, and other clinical safety and effectiveness data were considered. The evidence also affirmed that Wezlana met all legal criteria for being interchangeable with Stelara at the pharmacy level, said the FDA.
FDA Center for Drug Evaluation and Research Office of Therapeutic Biologics and Biosimilars director Sarah Yim said: “Today’s approval exemplifies the FDA’s longstanding commitment to support a competitive marketplace for biological products.
“This approval can empower patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost.”