// March 02, 2020

USP Proposes Revision to Clarify Applicability of Standards to Transition Biologics

This morning, USP published a proposal in the Pharmacopeial Forum (PF) on Biological Products Nomenclature. The proposal is intended to help ensure patients can continue to trust the quality of their medicines, including products like insulins, that are transitioning from being regulated under the Federal Food, Drug, and Cosmetic Act (FDCA) to the Public Health Service Act under the Biologics Price Competition and Innovation Act (BPCIA). While their regulatory approval pathway is changing, it is critical that patients can continue to trust the quality of products like insulins and that patients and practitioners are confident that insulins have the correct active ingredient and dosage, are free of contaminants, and are packaged, labeled, and stored in a manner that ensures the medication will work as intended. To put this simply, patients expect these products to be the same despite a change in their regulatory pathway. Many of these products, including widely used medicines such as insulins, benefit from USP public standards which, for decades, have helped ensure consistency and quality for patients and practitioners as these medicines evolved. While these transitioning biological products will not have their names changed, newly approved biosimilars to those products are expected to be assigned suffixes by FDA. Under the proposal published today, transition biological products and any biosimilar or interchangeable products to those transition products will continue to be subject to the public quality standards in the USP–NF regardless of the addition of a suffix to their names.  

USP applauds the implementation of the regulatory paradigm authorized by Congress in the BPCIA, and we hope it will lead to broader patient access to biologic medicines for America’s patients. Studies indicate that public standards also help foster a more competitive marketplace for medicines after a medicine's patent life expires because the standards provide transparency on the quality expectation for a medicine, which helps new manufacturers come to market. USP has published 20 quality standards for insulin. These transparent standards provide drug makers with important guidance and quality parameters as they develop biosimilar versions of insulin.

USP public quality standards help ensure quality across the insulin supply and distribution chain, lead to broader patient access to quality medicines, and are essential to patient and practitioner trust. These are goals shared by many stakeholders, and today’s announcement is not intended to be the end of this discussion. USP is convening a roundtable and inviting key stakeholders, including the U.S. FDA and organizations representing patients and consumers, the biopharmaceutical industry, healthcare providers, and healthcare practitioner groups representing physicians, pharmacists, and nurses to hear perspectives about this proposal. We look forward to hearing from our stakeholders over the 90-day public comment period for this proposal.