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USP Heeds FDA's Caution on Amendments to Monographs for Biologics


The United States Pharmacopeial Convention (USP) announced that it will not be moving forward with its proposed revisions to drug product monographs for biologic medicines.

The United States Pharmacopeial Convention (USP) recently announced that it will not be moving forward with its proposed revisions to drug product monographs for biologic medicines.

The proposed amendment sought to address the naming of biologic products licensed under the Public Health Service Act. For such products, “the official title shall be the title specified in the relevant monograph plus any suffix designated by the FDA unless otherwise specified in the applicable monograph.”

The revision received pushback from the FDA in the form of a letter, citing concerns that monographs for biologics could inhibit or delay innovative technology, and could be viewed as an additional burden on regulated industry.

“FDA is committed to supporting a robust marketplace of biological products that provide innovative, accessible, therapeutic options to patients. The timely licensure of biosimilar and interchangeable products is essential to achieving greater price competition in this marketplace, which can help bring down the cost of biological products. Thus, any delay in licensure of biosimilar or interchangeable products could cause these potential savings to consumers and the healthcare system to be lost,” the FDA’s letter said.

As of last week, USP stated that it will not move forward in addressing nomenclature issues without further collaboration with the FDA, as well as other stakeholders.

USP also indicated that it will continue its focus on developing “performance standards” applicable to classes of biologics, as well as standards for raw materials. USP is “developing these standards by working closely with industry to identify key challenges in biologics development and establishing benchmarks for quality.”

Separately, USP noted that it intends to move forward with another revision that aims to ensure alignment with the FDA on the use of the term “with sensor” in approved product names for therapies that contain sensor technology. The revised language ensures the continued applicability of the USP monograph for the corresponding drug product. Though the USP has not received comments from the FDA on this amendment thus far, it noted in a statement that it has previously received FDA support for this change.

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