Alliance for Safe Biologic Medicines Welcomes FDA Biosimilars Draft Guidance, Urges Cautious Approach to Ensure Patient Safety
April 16, 2012
Comments to FDA Stress Need for Clinical Trials, Restraint for Interchangeability Designations, and Unique Names for Biosimilar Products Washington, D.C. — In response to the U.S. Food and Drug Administration’s (FDA) draft guidance on the approval of biosimilar medicines, the Alliance for Safe Biologic Medicines (ASBM) submitted comments to the FDA that outlined recommended steps […]