EMA published an information guide on biosimilars

| By | Drug Quality Control, EMA

The European Medicines Agency (EMA) and the European Commission have published an information guide for healthcare professionals on biosimilar medicines. Biosimilars are biological medicines that are highly similar in all essential aspects to a biological medicine that has already been authorised.

The objective of the guide is to provide healthcare professionals with reference information on both the science and regulation underpinning the use of biosimilars.

“Today, biosimilars are an integral part of the effective biological therapies available in the EU,” said Professor Guido Rasi, EMA’s Executive Director.

The guide is a joint initiative of EMA and the European Commission. It was developed in collaboration with EU scientific experts, in response to requests from healthcare professionals. Organisations from across the EU representing doctors, nurses, pharmacists and patients have also shared useful views, to ensure that the guide adequately addresses questions relevant to healthcare professionals.

The guide was launched today at the European Commission’s third stakeholder event on biosimilar medicines, a discussion forum that provides a platform for stakeholders interested in biosimilars, including healthcare professionals, patients, payers, regulators and industry.