1. Pink Sheet

Best Pathway To Interchangeable Insulins Is In The Eye Of The Beholder

 
• By Sue Sutter

Approaches suggested at a US FDA public hearing include allowing follow-on insulins to take a direct route to interchangeability without first having to be approved as biosimilars, and automatically declaring biosimilar insulins interchangeable with one or more reference products.

medicine, diabetes, glycemia, health care and people concept - close up of woman hands making injection with insulin pen or syringe - Image
Stakeholders have different views on how to secure interchangeability designations for biosimilar insulins. • Source: Shutterstock

The US Food and Drug Administration heard a lot of agreement about the need for interchangeable insulins at a 13 May hearing, but different views on how to get there.

Representatives from the biopharma industry and other players in the health care sector, as well as academics and clinicians, suggested various approaches to

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