New biosimilar guidelines launched in the EU

pharmafile | June 1, 2017 | News story | Medical Communications, Research and Development, Sales and Marketing |  EMA, biosimilars 

A joint effort by the EMA and the European Commission has seen the publication of a biosimilar information guide for healthcare professionals, including new guidelines providing both scientific and regulatory information on the biological drugs.

Developed in partnership with EU scientific experts and built on feedback from patient and clinical groups from across the Union, the guide was launched at the EU’s third stakeholder conference on biosimilar medicines this month, a stakeholder discussion forum on the topic attended by figures in regulation, industry, healthcare and more.   

2006 marked the approval of the first biosimilar in the EU, and since then the EC’s Committee for Medicinal Products for Human Use has recommended 28 biosimilars, primarily on the basis that they are just as safe and effective as their originator products.

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

Dr Juan Garcia Burgos, Head of EMA’s Public Engagement Department, added: “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.”

Matt Fellows