EMA changes biosimilar rules
01.10.2012 - The European Medicines Association has changed its biosimilars guidelines to make it easier to develop biologic follow-on drugs in both the US and Europe.
The London-based agency said it intends to accept batches of reference medicines sourced from outside the European Economic Area (EEA) in the future. This aims to facilitate the global development of biosimilars and avoid the unnecessary repetition of clinical trials.
Under the current European legal framework, companies developing a biosimilar medicine are required to identify a reference medicine that is or has been authorised in the European Economic Area (EEA) and whose batches are sourced from within the EEA. With the new approach, first announced by Commissioner John Dalli in Malta on 15 June 2012, the Agency will begin to accept reference medicine batches sourced from outside the EEA in certain pre-clinical and clinical studies in the comparability exercise.
A draft version of the new guidance is expectedearly next year. Since biosimilars became reality, EMA has become regardedas the most biosimilar-open agency in one of the biggest pharma markets.