Shots:

• 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