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Abstract:
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With more recent biosimilar approvals in the pharmaceutical industry, the regulation on the assessment of the analytical similarity is heading towards maturity, especially in the US. The FDA draft guidance on analytical similarity, although still at the draft stage, does set up a common statistical pathway for the industry to follow. However, there are still quite a few challenges left in implementation of the guidance. This presentation will talk about these challenges, possible solutions, and the potential impact of these methodologies on other settings where similarity might be assessed.
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