AUTHOR OF THIS BLOG

DR ANTHONY MELVIN CRASTO, WORLDDRUGTRACKER
Aug 262014
 

BIO, PhRMA and Genentech all take particular issue with the FDA’s four possible outcomes for the analytical comparison of a proposed biosimilar product with its reference product

Industry slams FDA draft guidance on biosimilarity

By Zachary Brennan+, 15-Aug-2014

Industry groups BIO and PhRMA, as well as biotech company Genentech, are taking issue with US FDA draft guidance  that is designed to help companies design and use clinical pharmacology studies to help prove that a developing biosimilar is similar to its reference product.

READ AT

http://www.biopharma-reporter.com/Markets-Regulations/Industry-slams-FDA-draft-guidance-on-biosimilarity

http://www.biopharma-reporter.com/Markets-Regulations/Industry-slams-FDA-draft-guidance-on-biosimilarity?nocount

 

 

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