USA – FDA published a Draft Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers

This guidance provides answers to commonly asked questions from applicants and other interested parties (collectively referred to as applicants throughout this guidance) regarding postapproval manufacturing changes (referred to as manufacturing changes throughout this guidance) made to licensed biosimilars and licensed interchangeable biosimilars. This question-and-answer (Q&A) guidance is intended to inform prospective and current applicants of the nature and type of information that applic...