FDA Comments on USP Proposed Revisions to Biologics Monographs

In a letter sent on Wednesday, March 28, 2018, to the CEO of the United States Pharmacopeial Convention, FDA’s Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research, and Dr. Janet Woodcock, Director of the Center for Drugs Evaluation and Research, raised FDA’s concerns that USP’s proposed revisions to drug product monographs for biological products could “impede or delay licensure of biosimilars and other biological products.”  USP has proposed revisions to the monographs for biological products in view of FDA’s naming guidance issued last year.  Under the revision, “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.”  As readers are aware, USP monographs provide quality standards for drugs and drug products with which FDA generally requires compliance.

As explained in the letter, FDA is concerned that the proposed changes by USP to biological product monographs would “deter” a biosimilar sponsor from seeking licensure under the abbreviated pathway created by the BPCIA.  In particular, according to FDA, “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.”  The letter concludes:

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 costs 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.  Because USP’s proposed revisions would aggravate existing concerns that a monograph could impede or delay the licensure of biosimilars and other biological products, FDA strongly encourages USP to withdraw its proposal.

We will continue to monitor and apprise readers of any developments in this discussion.