European Commission: Non-EU Reference Product OK for EU Biosimilars
The European Commission plans to allow the use of a reference product not authorized in the EU in support of a biosimilar application, according to a speech delivered by Health and Consumer Policy Commissioner Dalli at the 18thEuropean Generic Medicines Association Annual Conference.
Dalli announced "that after careful analysis of the scientific and regulatory elements, the European Commission will revise its interpretation" of existing EU law. The details of the revised policy are still under review, and the focus is on the conditions that would ensure that "different reference products in the EU and outside are comparable."
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