Primary source: European Medicines Agency (EMA)
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.
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.
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.
Regulatory Intelligence Lead
Review before 2026-10-31.
Revision of definitions and data requirements for similar biological medicinal products; alignment with NPL; potential reduction in the need for comparative efficacy studies (CES) where analytical tools are sufficient; update of preclinical and clinical assessment sections.
The revision will impact the design of Risk Management Plans (RMPs) and post-marketing surveillance for biosimilars. MAHs should anticipate changes in the baseline evidence required for approval and the subsequent intensity of post-approval safety monitoring, especially if clinical comparative data is reduced.
Potential updates required in compliance strategies to align with the new guideline.
Revision of the guideline on similar biological medicinal products reflects new legal definitions.
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.
Published from the Firecrawl policy change extraction pipeline.
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