On May 5th, 2017, the European Medicines Agency (EMA) and the European Commission have published the first information guide for healthcare professionals on biosimilar medicines. This drug category refers to biological medicines highly similar in terms of safety, quality and efficacy to a biological medicine (the “reference medicine”) that has already been authorized. Biological medicines contain active substances from a biological source, such as living cells or organisms and they are often produced by cutting-edge biotechnology in order to offer treatment options for patients with chronic and often disabling conditions such as diabetes, autoimmune diseases and cancers.
The EU has pioneered the regulation of biosimilar medicines by establishing a solid framework for their approval and globally development and guaranteeing, through the EMA support, the evaluation of the majority of the applications to market them.
Given the importance of a proper information and regulation of this drug category, this new guide on biosimilar medicine was developed by EMA and European Commission, in collaboration with EU scientific experts and in response to request from healthcare professionals. The aim of the document is to provide healthcare professionals with reference information on both the science and regulation underpinning the use of biosimilars.
The guide was launched 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.
Dr Juan Garcia Burgos, head of EMA’s public Engagement Department presented the guide at the launch and explained that “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.”
“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.”