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News: FDA Biosimilar drafted guidance receives edits from the EMA

The European Medical Agency (EMA) offered cardinal line-by-line edits and comments on an FDA's recently released draft guidance on biosimilar drugs for comparative analytical assessments. The comments and edits by the EMA, largely, feature the areas of commonality, questions that demanded clarifications, and necessary omitting recommendations for the guidance.

The EMA is vehemently committed to supporting the "preparation for comparative analytical assessment plan" and "accounting for lots/batches to be used for comparison" section of the FDA's draft guidance. The guidance revises the quality consideration from 2015 final guidance on bio similarity demonstrations while it is considered a replacement on the statistical approaches to evaluating bio similarity guidance from 2017, which was removed in 2018 after several quality questions that were raised by various industries.