Biosimilars Forum Statement Regarding Newly Released EMA Information Guide on Biosimilars For Healthcare Professionals
WASHINGTON, DC, May 11, 2017 – The Biosimilars Forum—the nonprofit organization solely dedicated to expanding patient access to biosimilars in the United States—today issued the following statement regarding the newly released EMA information guide on biosimilars for healthcare professionals:
The Biosimilars Forum is pleased to share information that was released by the European Medicines Agency (EMA) and the European Commission. The EMA published an information guide for healthcare professionals on biosimilar medicines. Biosimilars have been approved in the EU since 2006 and the information collected from experience in the general population supports the regulatory determination that biosimilars can be used as safely and effectively in all their approved indications as their reference medicines. To date, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for 18 biosimilars (marketed as 29 different branded products).
According to Professor Guido Rasi, EMA’s Executive Director, “Over the last 10 years, the EU monitoring system for safety concerns has not identified any relevant difference in the nature, severity or frequency of adverse effects between biosimilars and their reference medicines.”
'Stacie Phan, President of the Biosimilars Forum stated, “This report is important in that it reflects on 10 years of real-world experience and evidence about the safety and efficacy of biosimilars. The EU has some of the best surveillance systems in the world and the fact that they have not detected any relevant difference in adverse effects between biosimilars and reference biologics should provide added confidence to physicians and patients.”
About the Biosimilars Forum
The Biosimilars Forum is a nonprofit organization whose mission is to advance biosimilars in the United States with the intent of expanding access and availability of biological medicines, and improving health care. The founding members of the Biosimilars Forum represent the majority of companies with the most significant U.S. biosimilars development portfolios.
Aimee Steel Lubin