FDA Fears USP's Monograph Changes Could Discourage Biosimilars

Samantha DiGrande

One of the more serious concerns the FDA has discussed is the possibility that a developer of a proposed biosimilar could be deterred from seeking approval of its product, because United States Pharmacopeial Convention's (USP) proposed changes could complicate the licensure of a proposed biosimilar that meets the approval requirements of the FDA but does not match the USP’s standards of a monograph.

Yesterday, Peter Marks, MD, and Janet Woodcock, MD, directors of the Center for Biologics Evaluation and Research at the FDA, sent a letter to the United States Pharmacopeial Convention (USP) in response to its request for comments regarding its recently proposed revisions to drug product monographs for biologic medicines.

The letter, addressed to Ronald Piervincenzi, PhD, CEO of USP, thanked USP for the opportunity comment, but addressed serious concerns the FDA has about the potential consequences of the proposed revisions.

Under the Social Security Act, the Medicare program provides reimbursement for medical and other health services including drugs and biologics. In 1980, the USP Convention determined that the USP should attempt to include monographs for all drug entities and products marketed in the United States, which led to all drugs approved by the FDA being eligible for inclusion.

In September 2017, USP issued a Notice of Intent to Revise, which proposed the following change to its Official Articles of the General Notices and Requirements:

“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 the FDA unless otherwise specified in the applicable monograph.”

In a previous letter to USP in 2014, the FDA noted concerns that monographs for biologics could inhibit or delay innovative technology and could be seen as an additional burden on regulated industry. In this letter, the FDA suggested that USP develop optional standards that are “consistent with the flexible approach FDA uses to properly account for the complex nature of biological products.”

“We understand that USP’s proposed revisions are intended to harmonize its approach to biological product monographs with the policy described in FDA’s guidance for industry, ‘Nonproprietary Naming of Biological products,’” read the letter.

The FDA’s naming guidance states that the nonproprietary name for each originator biologic, related biologic, and biosimilar product will be a combination of the core name followed by a 4-letter suffix devoid of meaning.

One of the more serious concerns the FDA has discussed is the possibility that a developer of a proposed biosimilar could be deterred from seeking approval of its product, because USP’s proposed changes could complicate the licensure of a proposed biosimilar that meets the approval requirements of the FDA but does not match the USP’s standards of a monograph.

“FDA is committed to supporting a robust marketplace of biological products that provide innovative, accessible, therapeutic options to patients,” said the letter. “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.”

Though the FDA ultimately encouraged USP to withdraw its proposed revisions, Marks and Woodcock said that that they welcome future interaction and discussions with USP on these issues.