Practical implication
MAHs must prepare for updated risk management plans and post-marketing surveillance processes, reflecting the revised data requirements and definitions for biosimilars as per the NPL.
The concept paper outlines the revision of the overarching guideline on similar biological medicinal products, emphasizing the need to reflect recent scientific advances and regulatory changes. It proposes potential reductions in the necessity for comparative efficacy studies and updates risk management plans and post-marketing surveillance practices.
What changed: The EMA has initiated a public consultation for the revised guideline starting from July 22, 2026, with a comment submission deadline of October 31, 2026.
Why it matters: The revision will significantly impact the baseline evidence required for biosimilar approval and the intensity of post-approval safety monitoring following the potential reduction in comparative clinical data.
Practical implication: MAHs must prepare for updated risk management plans and post-marketing surveillance processes, reflecting the revised data requirements and definitions for biosimilars as per the NPL.
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Published from the Firecrawl policy change extraction pipeline.
