A More Useful Way of Evaluating New FDA Biosimilar Applications

A Conversation With Gillian Woollett, MA, DPhil, Senior Vice President, Avalere Health In the conclusion of a two-part conversation with one of the real go-to experts in the biosimilar field and US regulatory process, we talk with Dr. Woollett about the need for a new approach by the FDA when evaluating biosimilar applications. Biosimilars Review … Continue reading A More Useful Way of Evaluating New FDA Biosimilar Applications →

FDA’s Gottlieb Wants to Make It Easier to Obtain and Study Biologic Samples

Over the next couple of weeks, I’ll be further analyzing some details of the Food and Drug Administration’s (FDA’s) new Biosimilars Action Plan. Much has been made of the difficulties biosimilar manufacturers have been having in obtaining reference product samples. These are used for the most basic biosimilar development tasks: (1) the reverse engineering … Continue reading FDA’s Gottlieb Wants to Make It Easier to Obtain and Study Biologic Samples →