EMA Releases New Guide on Biosimilar Medicine
The European Medicines Agency (EMA) and the European Commission have published a new guide on biosimilars for health professionals.
Biosimilars are biological medicines (high-molecule-weight) that are highly similar in all essential aspects to a biological medicine that has already been authorised. They are officially approved versions of original products, and can be manufactured when the original product's patent expires
The use of the first biosimilar was approved in the European Union (EU) in 2006. Since then, an additional 27 biosimilars have been approved. Evidence to date shows that EMA-approved biosimilars can be safely and effectively used for all of their approved endpoints, along with other biologic drugs.
The new guide has been developed jointly with EU organizations, including organizations representing doctors.This guide discusses the safety aspects of biosimilars and explains how health professionals can help improve the pharmacovigilance of these drugs. The document also deals with interchangeability, the switch from one drug to another, and the principle of substitution. It also provides advice on where to find information for patients on biosimilars.
“Today, biosimilars are an integral part of the effective biological therapies available in the EU,” said Professor Guido Rasi, EMA’s Executive Director, at the launch of the new guide. "Given the role of healthcare professionals on the front line of patient care, it is vital that they have access to reliable information on these medicines: what they are and how they are developed, approved and monitored."
- Reference: New guide on biosimilar medicines for healthcare professionals, ema.europa.eu