Rathore: What Biosimilar Developers Can Learn From Application Failures

Welcome to Not So Different, a podcast from The Center for Biosimilars®. I’m your host, Assistant Editor Skylar Jeremias.

Biologic drug development requires complex processes to obtain desired results, and biosimilar manufacturing is no exception. However, biosimilar developers often run into complications when seeking approval from regulatory authorities. A recent study of failed applications for biosimilar approval revealed multiple reasons why biosimilar applications in the United States and Europe have been such a challenge.

We sat down with Anurag Rathore, PhD, lead author of the study and coordinator of the Center of Excellence for Biopharmaceutical Technology in Delhi, India, to discuss the findings from this study and how biosimilar corporations can learn from them.