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US biosimilar guidance: broader population permitted, more immunogenicity requested

This article was originally published in SRA

Executive Summary

Final biosimilars guidance from the US Food and Drug Administration gives sponsors more information about how to bridge data, extrapolate from one condition, choose a study population, and conduct immunogenicity testing. These documents, together with an additional draft guidance, offer pros and cons for sponsors of biosimilar applications and provide substantial additional details on the agency’s regulatory approach to such products.

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