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FDA, USP Clash Over Biologics Monographs

Posted 12 June 2019 | By Michael Mezher 

FDA, USP Clash Over Biologics Monographs

While the US Food and Drug Administration (FDA) and the United States Pharmacopeia (USP) work closely with one another on many issues, the two are at odds over a proposal that would exclude biological products, including biosimilars, from requirements to adhere to USP monographs.
The proposal, which is included in President Donald Trump’s FY2020 budget request and a discussion draft circulated by the Senate Health, Education, Labor and Pensions (HELP) committee last month, is being framed as a means of lowering drug costs and encouraging innovation.
In response to the discussion draft, USP and a group of ten other organizations sent a letter to HELP Committee Chairman Lamar Alexander (R-TN) and Ranking Member Patty Murray (D-WA) calling for the committee to drop the proposal, arguing that there is “no data or rationale” to back up claims that the proposal would lower drug costs or accelerate biologic and biosimilar development.
“In the last Congress, a similar proposal was rejected after robust engagement from numerous stakeholders during consideration of the 21st Century Cures Act. We are alarmed that the proposal is being reexamined and could find its way into legislation to be considered by the HELP or Appropriations Committees this year,” the groups write.

Anthony Lakavage, senior vice president of global affairs at USP told Focus the currnt proposal "puts patient safety at risk, is opposed by prominent patient, healthcare practitioner and industry groups, and will inhibit competition in biologics. The provision would remove requirements that biologic medicines meet transparent public standards, making adherence to public quality standards optional. We strongly believe that when it comes to our families’ health, quality and safety should never be optional."
For its part, FDA has resisted USP’s efforts on monographs for biological products for years. In a letter sent to USP CEO Ronald Piervincenzi last year, Center for Biologics Evaluation and Research Director Peter Marks notes communication with USP dating back to 2014 in which “FDA cited significant concern that monographs for biological products may impede or delay innovative technology and present an additional, unnecessary burden on regulated industry.”
In the latest entry in the ongoing back and forth between FDA and USP, FDA on Wednesday released a Q&A with Steven Kozlowski, director of the Office of Biotechnology Products at the Center for Drug Evaluation and Research (CDER), making FDA’s case against monographs for biologics.
Kozlowski points out that “very few biological products currently have monographs” and that newly introduced monographs could create issues for older biological products.
He also argues that while monographs are appropriate for small molecule drugs, where the standard for generic copies is “sameness,” for biologics and biosimilars, “the approach to demonstrating highly similar may vary from product to product, and still meet all safety and efficacy criteria.”
Kozlowski notes that it’s possible for biologics makers to use the monograph process to block biosimilar competition “by incorporating patented characteristics of their product that are not relevant to safety, purity or potency, further impacting competition.”

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