The Food and Drug Administration has approved Amgen's Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases.
Wezlana, like Stelara, is approved to treat the following indications:
Adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; active psoriatic arthritis; moderately to severely active Crohn's disease; and moderately to severely active ulcerative colitis; pediatric patients 6 years of age and older 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, director of the Office of Immunology and Inflammation in the FDA's Center for Drug Evaluation and Research. "Today's approval could have a meaningful impact for patients managing their disease."
"Today's approval exemplifies the FDA's longstanding commitment to support a competitive marketplace for biological products," said Sarah Yim, director of the Office of Therapeutic Biologics and Biosimilars in the FDA's Center for Drug Evaluation and Research. "This approval can empower patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost."