On April 2, 2018, the United States Pharmacopeial Convention (“USP”) issued a statement that it will not develop a new monograph for a biologic unless there is stakeholder consensus supporting its creation, including support from FDA. USP proposed revising 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.” USP’s revision was intended to “align compendial names with FDA’s biologics naming approach and avoid potential issues for manufacturers and other stakeholders.”
In a March 28, 2018 letter to the USP, Janet Woodcock, Director of FDA’s Center for Drug Evaluation and Research, and Peter Marks, Director of FDA’s Center for Biologics Evaluation and Research, raised concerns that “monographs for biological products may impede or delay innovative technology and present additional unnecessary burden on regulated industry.” Specifically, FDA raised concerns that monographs for biological products could complicate licensure of biosimilar products that meet the requirements of PHSA section 351(k), but do not match the standards in the reference product USP monograph.
As an alternative approach, FDA encouraged USP to develop “optional standards ‘that are consistent with the flexible approach FDA uses to properly account for the complex nature of biological products.’”
The comment period for this proposed revision ended on March 30, and USP is currently reviewing stakeholder comments.