Replies to post #144046 on Biotech Values

[jq1234]

European Medicines Agency to accept biosimilar reference medicines sourced outside European Economic Area

[This will make develop biosimilars in both the U.S. AND Europe much easier.]

The European Medicines Agency has updated its guidance for pharmaceutical companies on biosimilar medicines to reflect the European Commission's confirmation that 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 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.

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/09/news_detail_001615.jsp&mid=WC0b01ac058004d5c1