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A biosimilar medicines information guide for healthcare professionals has been published by the European Medicines Agency (EMA) and the European Commission.
The 38-page document aims to provide essential reference information covering the science and the regulation of these kinds of products. Biosimilars are biological medicines which are highly similar to a biological medicine that has already been authorised.
Launching the guide, the EMA’s executive director professor Guido Rasi says: “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 document was drawn up by European Union (EU) scientific experts following consultation with healthcare professionals including pharmacists, as well as patients.
The first biosimilar was approved for use across the EU in 2006. To date, the EMA’s Committee for Medicinal Products for Human Use has recommended 28 biosimilars for use in European member states. It is the highest approval record world-wide, according to the guide.
The guide says: “Over the last 10 years, the EU monitoring system for safety concerns has not identified any relevant difference in the nature, severity or frequency of adverse effects between biosimilars and their reference medicines.
“Biosimilar competition can offer advantages to EU healthcare systems, as it is expected to improve patients’ access to safe and effective biological medicines with proven quality.”
