EMA’s Biotech CMC Focal Points Include Biosimilar Guideline Revisions and Joint Reviews with FDA

EMA is nearing release of revised drafts of its biosimilars guidelines to reflect experience gained and stakeholder input and is refining its cooperative application review process with FDA – two of the European agency’s focal points in the biotech CMC arena.

EMA biotech initiatives were addressed at a CASSS Europe CMC Strategy Forum in late April in Berlin, Germany, in a presentation by EMA Biological Section Head Peter Richardson and were explored further in a panel session following his presentation, which included FDA Office of Biotech Products Deputy Director Jeffrey Baker.

Richardson provided updates specifically on the various European biosimilar guidelines under development, including an overarching guideline and its guides addressing quality and clinical/non-clinical aspects of biosimilars.  He also addressed EMA’s efforts with FDA to share information and facilitate mutual understanding regarding biosimilars.

The biologics official’s discussion encompassed a recently-released final guidance on the require­ments for quality documentation for biologi­cal investigational medicinal products in clinical trials (IPQ “The News in Depth” May 31, 2012).  Also explored was an initiative the EU Commission is undertaking regarding EMA’s variations regulations.

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