FDA Guidance Concerning Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-Derived Products

摘要

This document addresses the concept of product comparability and describes current FDA practice concerning product comparability of human biological products regulated by the Center for Biologics Evaluation and Research (CBER), including therapeutic biotechnology-derived products, regulated by CBER, and therapeutic biotechnology-derived products regulated by the Center for Drug Evaluation and Research (CDER). It describes those steps that manufacturers may perform and which FDA may evaluate to allow manufacturers to make manufacturing changes without performing additional clinical studies to demonstrate safety and efficacy.