USP Will Not Develop New Biologic Monographs Without Stakeholder Consensus

Posted 03 April 2018 | By Zachary Brennan 

USP Will Not Develop New Biologic Monographs Without Stakeholder Consensus

USP announced late Monday that it will not develop new product-specific monographs for biologics unless there is stakeholder consensus supporting the creation of a specific monograph, including the support of the US Food and Drug Administration (FDA).
The comment follows a letter sent last week from FDA to USP saying USP’s efforts to develop biological product monographs could impede or delay licensure of biosimilars and other biologics.
The letter follows questions raised by Amgen this week on whether the addition of suffixes to nonproprietary names of biologics and biosimilars could cause the products to be deemed by FDA to be misbranded or adulterated because they do not adhere to the appropriate USP monographs.
The proposed change, according to USP, is intended to align compendial names with FDA’s biologics naming approach and avoid potential issues for manufacturers and other stakeholders “USP is currently reviewing stakeholder comments to our proposed change to USP-NF Section 2.20 Official Articles of the General Notices and Requirements to add the following language at the end of the second paragraph: ‘For a biologic product licensed under the Public Health Service Act, 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.’”
Although the comment period ended 30 March 2018, USP also said that if the changes advance to official status, a summary of the comments will be released to the public and posted in the "Revision and Commentary" section of

Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.