6/26/2013

The FDA is reviewing comments on its draft guidances for biosimilars after the feedback period closed last month. As of last week, the agency has conducted 40 out of 56 requested meetings on biosimilar development programs. "FDA is currently reviewing and considering all comments received from the May 11, 2012, public hearing docket and those from the draft guidance dockets as we move forward to finalize the draft guidances and determine plans for developing future policies on biosimilars, including guidance on clinical pharmacology data to support a demonstration of biosimilarity to a reference product," said Lisa Kubaska, a spokeswoman for the agency.

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