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US FDA Vs. USP: Regulator Sees Biologic Product Monographs As Barrier To Biosimilars

Executive Summary

USP's proposed change aimed at harmonizing with FDA's suffix-based naming system for biologics would 'aggravate existing concerns' that biologic product-specific monographs are too inflexible and may impede development of biosimilars, agency says in a letter publicized through a tweet by the commissioner.

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