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Regulatory News

PDA's Regulatory News is a source of pertinent news from all over the globe. This section is set up by distinct parts of the world so you can read what is crucial to you and your company.

EMA Launches Biosimilar Pilot

Jan 30, 2017, 06:46 AM
News Source Link:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/12/news_detail_002668.jsp&mid=WC0b01ac058004d5c1
RegulatoryNewsDate:
Jan 27, 2017, 12:39 PM

EMA will launch a biosimilar-focused pilot project this month. The Agency plans to use this pilot to provide biosimilar developers with recommendations as to what studies they should be conducting based on data from the innovator product. This program is open to all companies looking for scientific advice on developing a biosimilar product.

regulatory-news-regions:
  • Europe