29 August 2019 - Although regulators rarely offer public comments on another regulator’s guidance, the European Medicines Agency (EMA) late last month offered line-by-line comments and edits on a recently released draft guidance from the US Food and Drug Administration (FDA) on comparative analytical assessments for biosimilars.

While noting the close collaboration between EMA and FDA on the statistical aspects of comparative analytical assessments, the EMA comments feature questions for clarification, recommendations to omit and areas of commonality. EMA pledges its support for the sections of the guidance related to the preparation of a “(prospective) comparative analytical assessment plan” and “accounting for lots/batches to be used for comparison.”

Read Regulatory Affairs Professional Society article