USP Backs Down From Biologic Monograph Naming Plan Amid US FDA Objections
Proposed change was aimed at protecting monograph-covered products subject to March 2020 'transition provisions,’ but agency’s objections went to the heart of the monograph system; other stakeholder groups said proposed change would amount to an endorsement of FDA's flawed and unjustified suffix-based naming system for biologics.
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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.
Industry objects to proposal that certain protein product applications pending as of March 23, 2020, will have to be resubmitted as BLAs – and to the idea that transitioned products will lose non-orphan exclusivity.
Certain protein products approved under FD&C Act before March 23, 2020 would lose their remaining non- orphan exclusivity, and would not qualify for 12-year biologic exclusivity.