FDA Issues Final Guidance on Biosimilar Interchangeability
Late last week, FDA issued the final guidance on biosimilar interchangeability titled, “Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry.” Below, FENIX provides thoughts on the FDA interchangeability guidance in the context of the insulin market.
About The Author
Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.
If you receive our email blasts, you already have an account. Log in now
You can read the article’s full content online after purchase.