Out-Law / Die wichtigsten Infos des Tages
There is no limit, in principle, on the number of ‘biosimilar’ products that can be safely interchanged with a single reference biologic medicine, the European Medicines Agency (EMA) has said.
The clarification (2-page /107KB PDF) builds on a landmark statement issued by the EMA last year in which it, together with the Heads of Medicines Agencies, said that patients can safely be switched onto ‘biosimilar’ medicines in place of the biologic medicines those biosimilars are based on without that reducing treatment effectiveness.
The original statement was welcomed by biosimilar manufacturers who can obtain a marketing authorisation through an abridged 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.
The EMA said it and national medicines regulators had received “questions for clarification” in response to its original statement, however. It decided to provide further detail on its policy in a question-and-answer format to address the issues raised.
In its new statement, the EMA said that the principle of interchangeability of biosimilars that it endorsed last year is not impacted by either the frequency of switches or number of products involved “if all switches are taking place within the group of products that have the same reference product, or between the reference product and its biosimilars”.
It added: “The comprehensive comparability exercise required for establishing biosimilarity makes negative consequences of switching highly unlikely. Such practice is already taking place in some EU member states without any signs of change in efficacy or safety for the patients.”
The EMA also confirmed that the principle of biosimilars interchangeability applies regardless of the complexity of molecular structure of the biosimilar product.
The EMA said that its statements endorsing the principle of biosimilars interchangeability concern “the active substance and the formulated product” only and that other issues that arise, such as when biosimilars are to be administered differently to their reference biologic, and around physician or patient perception of biosimilars, are to be considered separately. It further emphasised that the principle of biosimilars interchangeability does not mean that biosimilars will automatically be substituted in for reference products across the EU. Decisions on pharmacy-level substitution, for example, sit with each EU member state.
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