Drug Industry Likes FDA’s Revised Biosimilar Analytics Guidance, But Has A Few Criticisms

The FDA’s updated draft guidance on comparative analytical assessments for biosimilars is useful and usable for developers of copycat medicines, drugmakers and trade groups expressed in public comments.

Feedback from big name manufacturers like Pfizer, Genentech, and Novartis, as well as trade groups PhRMA and BIO show that drugmakers see the new draft guidance as an improvement over the previous 2017 guidance, which was withdrawn last year amid industry concerns.

The updated guidance explains the agency’s thinking and approach towards analytical methods to determine similarity to reference products, as well as broader quality-related issues for biosimilars.