USP States That It Will Not Revise Biologics Monographs Without Stakeholder Consensus

USP stated last week that it will not develop new product-specific monographs for biologics without stakeholder consensus in supporting their creation, including the support of FDA.  USP had proposed revisions for these monographs in which “the official title shall be the title specified in the relevant monograph plus any suffix designated by FDA unless otherwise specified in the applicable monograph.”  USP’s revision was intended to “align compendial names with FDA’s biologics naming approach and avoid potential issues for manufacturers and other stakeholders.”  The comment period for this proposed revision ended on March 30, and USP is currently reviewing the comments it received.

USP’s statement follows a letter sent by FDA to USP in late March, stating that USP’s proposed revisions to such monographs could “impede or delay licensure of biosimilars and other biological products.” Specifically, FDA had raised concerns that “USP’s approach could complicate licensure of a biosimilar that meets the approval requirements under section 351(k) of the Public Health Service Act, but that does not match the standards in the USP monograph associated with the reference product.”

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