The FDA is advocating for the removal of the “interchangeability” label for biosimilars to simplify the market and eliminate confusion. The interchangeability status, established in 2009, differentiated biosimilars that could be automatically substituted at pharmacies, but it has since led to misconceptions and is deemed unnecessary by the agency. Sarah Yim, the FDA’s director of Therapeutic Biologics and Biosimilars, stated that this distinction is misleading as both biosimilars and interchangeables meet the same high FDA standards. While the Biden administration previously suggested this legislative change, industry opinions vary, with some like Amgen opposing automatic interchangeability. Despite the pushback, Yim emphasized the importance of moving forward as scientific and clinical reasoning no longer justifies separate classifications. The proposal aims to clarify that all biosimilars possess equivalent levels of quality and safety.
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[Source: Endpoints, April 15th, 2024]
