Biosimilars are products that are highly similar to medicines containing biologic products such as proteins or antibodies.
Biosimilar manufacturers can obtain a marketing authorisation through a streamlined process if they can demonstrate no clinically meaningful differences between their biosimilar and the originator reference medicine in terms of safety, quality and efficacy – i.e. demonstrate ‘biosimilarity’ to regulators.
In a landmark statement, the EMA and the Heads of Medicines Agencies said there was enough evidence gathered on the use of biosimilar medicines in Europe over the past 15 years to consider that “additional systematic switch studies” do not need to be carried out before those biosimilars are prescribed.
The new EU-wide policy does not mean that biosimilars will automatically be substituted in for reference products. Decisions on pharmacy-level substitution, for example, sit with each EU member state. However, the EMA said the statement “aims to address any uncertainty among prescribers of biological medicines and support patient access to biosimilars for treating diseases such as cancer, diabetes and rheumatic diseases”.
“EMA has approved 86 biosimilar medicines since 2006,” said Emer Cooke, the EMA’s executive director. “These medicines have been thoroughly reviewed and monitored over the past 15 years and the experience from clinical practice has shown that in terms of efficacy, safety and immunogenicity they are comparable to their reference products and are therefore interchangeable.”
Amsterdam-based life sciences expert Machteld Hiemstra of Pinsent Masons said: “This is a major breakthrough for all biosimilars aiming at the European market and will likely aid acceptance in daily clinical practice.”