Draft Guidance on Biosimilars and Interchangeables Tries to Smooth Path for Post-Approval Changes By John W.M. Claud —

https://www.thefdalawblog.com/2024/07/draft-guidance-on-biosimilars-and-interchangeables-tries-to-smooth-path-for-post-approval-changes/?utm_source=rss&utm_medium=rss&utm_campaign=draft-guidance-on-biosimilars-and-interchangeables-tries-to-smooth-path-for-post-approval-changes There is a growing consensus among legal experts that after Loper Bright, FDA may rely on non-binding guidance to instruct industry with hopes of charting regulatory pathways that avoid litigation. In areas like biologics, biosimilars, and interchangeable biosimilars, where emerging technologies meet regulatory complexities, this is perhaps a wise strategy. The top line from FDA for any cGMP-governed industry like these is always going to be that quality matters. But in the biologics and biosimilar industries, maintaining quality can be a very nuanced—if not difficult—process.