WASHINGTON – On September 27, 2012 the European Medicines Agency (EMA) released a revised version of their 2008 Question and Answer (Q&A) document differentiating the regulatory standards for biosimilar medicines from the standards used to support generic chemical medicines. ASBM Chairman Richard Dolinar, MD, released the following statement in recognition of the importance of that Q & A document:
“We see the changes the EMA made as a clear indication that Europe, and the EMA in particular, continue to distinguish between generics and biosimilars. As a practicing physician, I am pleased that the EMA have taken steps to guide the public to consult with both their physician and their pharmacist before making any changes to their medicines and recognize that biosimilar does not mean identical. We support their efforts to more clearly define the differences between biosimilars and generics.”
About the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines (ASBM) is an 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. Visit us at www.SafeBiologics.org.