EMA to Pilot Program for Advice on Biosimilar Development

December 22, 2016

The EMA plans to provide sponsors with advice on the development of biosimilars as part of a pilot program that starts in February.

Specifically, the pilot, which is open to all biosimilar manufacturers, will offer sponsors recommendations on the studies and tests they should conduct, given the currently available quality, analytical and functional data for the candidate.

Applicants seeking advice must submit a briefing package to the EMA that includes: the full development plan for the biosimilar; questions related to the quality, non-clinical and clinical development; analytical and functional data, such as physico-chemical, biological, in vitro tests; and, if applicable, statistical methods or analyses used to compare quality data.

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