The Alliance for Safe Biologic Medicines (“ASBM“), a self-described “organization composed of diverse healthcare groups and individuals from patients to physicians, innovative medical biotechnology companies, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion,” urges FDA in a new paper to adopt unique non-proprietary names for all biological products licensed under the Public Health Service Act (“PHS Act”), and in particular biosimilar versions of reference products (even those that are interchangeable).
Read full article at FDA Law Blog