Biosimilars Makers See Gold Mine In EU Clinical Data

Law360, New York (July 18, 2012, 9:35 PM EDT) -- The European Medicines Agency's decision this week to grant outside drug researchers access to reams of clinical trial data could be a big win for biosimilars developers, which experts say could mine the data in a bid to advance their U.S. regulatory reviews.

The EMA is moving closer to throwing open clinical trial data on the drugs it regulates, two years after the European ombudsman found that keeping that information confidential is not in the public interest. The EMA had refused to release such data, arguing...
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