ARTICLE | Regulation

Biosimilar Fault Lines

The key arguments over how FDA implements biosimilarsPfizer, Merck, Hospira, Biocon, Reddy's preparing U.S. biosimilars

November 1, 2010 7:00 AM UTC

The passage of the Patient Protection and Affordability Act seven months ago created a biosimilars pathway but left FDA a great deal of discretion to create the rules of the road. The battle over those details is set to begin this week, as the agency is holding a public meeting to receive advice on how it should implement the pathway.

A key source of conflict centers on whether biosimilars manufacturers should have the option to go around the new pathway and get their products approved using a conventional BLA. Skirmishes also already have broken out over how FDA should define similarity, the standards for substitutability, and the amount of data a biosimilar manufacturer would need to obtain multiple indications...