Biosimilars Council Urges Global Comparators And Dropping ‘Unnecessary’ Studies
US Industry Association Calls For ‘Streamlining’ Of FDA Approval Process For Biosimilars
In a position paper published by the AAM’s Biosimilars Council, the industry association has called for a streamlining of the FDA’s approval process for biosimilars that includes eliminating “unnecessary” clinical efficacy studies and establishing global regulatory comparators.
