European Commission: Non-EU Reference Product OK for EU Biosimilars

Posted 20 June 2012 | By Louise Zornoza 

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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Commissioner Dalli delivers speech on "Healthy and Active Ageing through improved access to affordable generic medicines"

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