The European Medicines Agency (EMA) and the European Commission (EC) have released a guide on biosimilar medicines. The guide aims to provide healthcare professionals with information on both the science and regulation supporting the use of biosimilars.
Biosimilars are biological medicines that are highly similar in all essential aspects to a biological medicine that has already been authorised. Since approval of the first biosimilar in the EU just over 10 years ago, the evidence gained from clinical experience shows that biosimilars approved in the EU are as safe and effective in all their approved indications as other biological medicines. To date, the Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended 28 biosimilars for approval in the EU.
Professor Guido Rasi, EMA’s Executive Director said “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 was created in collaboration with EU scientific experts, in response to requests from healthcare professionals. Groups from across the EU representing doctors, nurses, pharmacists and patients also shared useful views to ensure that the guide adequately addresses questions relevant to healthcare professionals.
Presenting the guide, Dr Juan Garcia Burgos, head of EMA’s Public Engagement Department emphasised 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.”
The EU has led the way in the regulation of biosimilar medicines by instituting a solid framework for their approval and by shaping biosimilar development globally.
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