After testifying before the FDA on May 11, Inside Health Policy quoted ASBM chairman Dr. Dolinar.
Biologics makers peg biosimilars areas they want clarified:
Alliance for Safe Biologics chairman Richard Dolinar said, “Biologics are complex, large molecule drugs that are grown inside living cells using unique and proprietary processes. For this reason no two biologics made from different cell lines or using different processes can be identical based on today’s science. Biologics are also highly sensitive to the manufacturing process. In fact, altering a single manufacturing parameter can change a compound’s identity and/or the precise effect it has on the human body.”