The U.S. Food and Drug Administration (FDA) has approved Wezlana, the first biosimilar of Stelara (ustekinumab), a drug used to treat psoriasis, Crohn's disease, and other inflammatory conditions. This approval follows a series of clinical trials by Amgen and a settlement with Johnson & Johnson (J&J), the manufacturer of Stelara, regarding patent infringement claims. Wezlana's approval could provide a more affordable alternative to Stelara, potentially increasing access to treatment for a wide range of patients.
Interchangeability Designation
Wezlana has been granted an interchangeability designation by the FDA. This allows pharmacists to substitute Wezlana for Stelara without needing to consult the prescribing physician, a practice known as pharmacy-level substitution. According to Health and Human Services Secretary Xavier Becerra, this approval is a "welcome step forward" for a drug taken by tens of thousands of Americans.
Background on Biosimilars
Biosimilars are drugs that are similar to reference biologics but not identical. Unlike generic drugs, which are chemical copies of small-molecule drugs, biosimilars are complex biological products derived from living cells. Dr. Marcus Snow, a rheumatologist with the University of Nebraska Medical Center, notes that biosimilars undergo a "very stringent review process" by the FDA to ensure they work the same way and achieve the same patient outcomes as the original biologic.
Market Impact and Cost Savings
Stelara has been a top-performing drug for J&J, with nearly $10 billion in sales in 2019. The introduction of Wezlana is expected to capture a significant portion of Stelara's market share, potentially leading to billions of dollars in cost savings for the healthcare system. An Amgen spokesperson stated that biosimilars are important for providing greater flexibility of choice and potential cost savings.
Legal Disputes and Settlement
The FDA's approval of Wezlana followed a legal dispute between J&J and Amgen, where J&J alleged patent infringement. Despite the legal challenges, the two companies reached a settlement earlier this year. Amgen agreed to delay the release of Wezlana until no later than January 1, 2025. Other terms of the settlement remain confidential.
Clinical Significance
Dr. Nikolay Nikolov, Director of the Office of Immunology and Inflammation in the FDA’s Center for Drug Evaluation and Research, stated that this approval could have a meaningful impact for patients managing their disease. He added that biosimilar medications offer additional safe and effective treatment options that have the potential to increase access for people requiring treatment for inflammatory diseases. Amgen emphasized its commitment to providing patients and physicians with additional treatment options to address unmet needs in inflammatory diseases.
