FDA to USP: Biological Product Monographs Could Delay Biosimilar Approvals

USP’s efforts to develop biological product monographs could impede or delay licensure of biosimilars and other biologics, Janet Woodcock, director of FDA’s Center for Drugs Evaluation and Research, and Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, wrote to USP CEO Ronald Piervincenzi in a letter on Wednesday.

Following similar comments from 2014, Woodcock and Marks said USP’s approach to biological product monographs “could complicate the 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.”

They said FDA has 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.’”

In addition, although FDA notes USP’s proposed revisions to its plan for monographs provide some leeway on when a pre-existing monograph associated with a reference product does not apply to a biosimilar, Marks and
Woodcock wrote, “This does not address our concerns that USP’s proposal could delay or impede licensure of a biosimilar that meets the licensure requirements under section 351(k) of the PHS Act, and could create substantial uncertainty for biosimilar applicants. We are particularly concerned that such a process will not be adequate to prevent delays in the licensure of biosimilars.”

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.

USP pointed Focus on Tuesday the revisions, which it said provide “flexibility, making it possible to apply different compendial approaches in situations where products share the same core name but have different suffixes."

USP senior communications manager Anne Bell told Focus via email on Wednesday that USP received FDA's letter, "but will wait until after the comment period closes to allow opportunity to review all perspectives. We look forward to working collaboratively with the FDA on this and other issues in our shared pursuit of ensuring the quality of medicines."

Letter