Possibility of substitution of biosimilars in Europe

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To date, 14 biosimilars within the product classes of human growth hormone (1), granulocyte colony-stimulating factor (8) and erythropoietin (5) have been approved in Europe [1]. EMA Head of Biologicals Dr Peter Richardson and Amgen Director of Value, Access and Policy Mr Thomas Moore speak to BioCentury about substitution of biosimilars in Europe.

Substitution V13F14

In Europe, substitution of biosimilars for their reference products is a decision that is not made by EMA, but is a decision made by each country individually. Currently no country has explicitly authorized the substitution of biologicals from different manufacturers, and a number of EU Member States have gone as far as banning this practice.

In fact, in Norway Amgen went as far as to take legal action after the country’s medicines agency tried to bring about automatic substitution of biosimilars by pharmacists, despite the fact that this practice is against the country’s law.

Dr Richardson explained that in Europe there are strict regulations defining generics and biosimilars, and that biosimilars are not generics. Whereas, a generic should have the same qualitative and quantitative forms as the reference product, a biosimilar will always have some variability in, for example, the isoforms (different forms of proteins).

Biosimilars should, however, be clinically the same, i.e. produce the same effect, and this has been the driving force in reducing the amount of clinical and non-clinical data required for approval in Europe. Whether this could ever be reduced to the level of a generic drug, i.e. a bioequivalence study, is still under debate.

The different legislation in Europe defining generics and biosimilars also affects the prescribing activity in the different Member States and thus means that uptake of biosimilars differ between different European countries. This was made clear in the new report published by the European Commission (EC) [2].

Mr Moore pointed out that despite the fact that biosimilars may not be substituted for their reference biological in Europe, the EC’s report shows annual double-digit growth of biosimilars, showing that the marketplace is evolving even without substitution.

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1.  GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Jun 14]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

2.  European Commission, Enterprise and Industry Directorate-General. Consensus Information Paper 2013. What you need to know about Biosimilar Medicinal Products.

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