EMA backs switch to biosimilars
Evidence shows medicines approved as biosimilars in the EU may be prescribed interchangeably | Additional ‘switch’ studies no longer not need to be carried out.
In a move set to be welcomed by generic drug makers, the European Medicines Agency (EMA) has confirmed that patients can safely switch to ‘biosimilar’ medicines as a substitute for the treatments they are based on.
In a statement released this week, the agency explained the rationale behind the decision.
“Considering all the available scientific evidence and the successful experience with biosimilars in clinical practice over the years, the CHMP and all working parties with expertise in biological medicines and biosimilars support that medicines approved as biosimilars in the EU may be prescribed interchangeably.“
This statement has been endorsed by the Committee for Medicinal Products for Human Use and the Biologics Working Party.
Emer Cooke, the EMA’s executive director said that the EMA has approved 86 biosimilar medicines since 2006.
“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.”
Commenting on the development, Amsterdam-based life sciences partners 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.”
According to the EMA, this move will allow more patients to have access to biological medicines necessary for treating diseases such as cancer, diabetes and rheumatic diseases.
The agency said that evidence gathered on the use of biosimilar medicines in Europe over the past 15 years led it to the conclusion that “additional systematic switch studies” do not need to be carried out before those biosimilars are prescribed.
Decisions on pharmacy-level substitution will still sit with each EU member state.
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”.
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