EMA tells EU pharma companies to plan for non-European data in market authorisations
This means the EU, plus Norway, Iceland and Liechtenstein
The European Medicines Agency (EMA) has told pharmaceutical companies to prepare for European Union (EU) marketing authorisation applications using data from proposals made outside the European Economic Area (EEA). This means the EU, plus Norway, Iceland and Liechtenstein. It comes in revised EMA guidance on market authorisations for so-called ‘biosimilar’ medicines that have similar active ingredients to pharmaceuticals approved elsewhere.
Until now, EMA has only allowed pharmaceutical companies to use previously collected data culled from tests for approved medicines carried out in the EEA, but the European Commission will in future allow the use of non-EEA assessments.
Data would have to be accompanied, said EMA, by ‘extensive analytical comparison [and] comparative pharmacokinetic and pharmacodynamic data to ascertain the suitability of batches of the reference medicines’.
The agency indicated that it should formally approve the practice in 2013.
EMA said this aims to facilitate the global development of biosimilars and avoid the unnecessary repetition of clinical trials.