Aimed at increasing understanding of biosimilar medicines, both on the science and regulation front
The European Medicines Agency (EMA) and the European Commission recently published an information guide for healthcare professionals on biosimilar medicines. The objective of the guide is to provide healthcare professionals with reference information on both the science and regulation underpinning the use of biosimilars.
The EU approved the first biosimilar in 2006 and to date, the Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended 28 biosimilars for use in the EU.
“Today, biosimilars are an integral part of the effective biological therapies available in the EU,” said Professor Guido Rasi, EMA’s Executive Director. “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.
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.
Presenting the guide at the launch, Dr Juan Garcia Burgos, head of EMA’s Public Engagement Department said, “This comprehensive reference material is a joint effort to support information and continuous education of healthcare professionals in the EU, and facilitate dialogue with patients.”
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