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FDA Official ‘Not A Fan Of,’ But Sees Logic For, Biologics Naming Plan

May 08, 2019
The head of FDA’s biologics staff said she is not a fan of the agency’s biologics and biosimilars naming convention but that she understands the rationale behind it -- chiefly, a need to bolster active pharmacovigilance and to help distinguish between small molecule drugs and biologics. Contrary to what some believe, the official added, the naming convention may help squelch misconceptions that a biosimilar is different from its originator biologic. Sarah Yim, acting director of the agency’s biologics and biosimilars...


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