The US FDA to Waive Interchangeability Standard for Insulin Biosimilars

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  • Two doctors called for interchangeability requirements for biologics to be waived for insulin products under the Biologics Price Competition and Innovation Act (BPCIA) of 2009
  • The FDA guidance is a reminder that the rules of BPCIA should be carefully reinterpreted in order to maximize benefit, affordability, and access to insulin for all patients with diabetes in the US. The FDA streamlined the approval process for biosimilar insulins by removing the interchangeability requirement
  • Switching insulins to the biologic pathway means that biosimilar insulin manufacturers will have to conduct extra clinical trials to prove interchangeability with existing insulin products. The policy plays a major role in robust generic competition and ensuring access to high quality and affordable insulin

Click here to read full press release/ article | Ref: The US FDA | Image: Behance