October 31, 2025- Vizient® commends the U.S. Food and Drug Administration (FDA) for announcing actions to accelerate biosimilar development, including releasing new draft guidance that provides greater clarity on when comparative efficacy studies (CES) are not required for biosimilar approval which should reduce burdens currently associated with biosimilar approvals in certain circumstances. The announcement underscores the agency’s commitment to expanding patient access to affordable biologic therapies while maintaining safety and efficacy.
“Vizient strongly supports FDA’s science-based approach to streamlining biosimilar approvals while maintaining the gold standard for safety and quality,” said Steven Lucio, PharmD, BCPS, senior principal, pharmacy solutions for Vizient. “By eliminating redundant clinical study requirements, the agency is helping to increase competition, accelerate adoption and expand access to affordable biologic treatments for patients and providers.”
Vizient has long supported policies that advance biosimilar adoption and remove regulatory and market barriers to affordable medicines. This includes providing feedback on FDA’s interchangeability guidance and advocating for more efficient, science-based approval standards for biosimilar and interchangeable biologic products.
Vizient remains committed to working with the FDA and other stakeholders to strengthen the biosimilar review process and ensure that pharmacists, physicians and other healthcare professionals are informed and prepared to navigate this rapidly evolving area of patient care.
Learn about Vizient’s biosimilar insights and solutions.
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