Rockville, MD, June 24, 2020 – In March 2020, USP published a Compendial Notice to solicit stakeholder feedback on an important USP proposal regarding biologics nomenclature. The proposal is a revision to the General Notices of the United States Pharmacopeia–National Formulary and is intended to clarify the continued application of USP standards to biological products, including originator, biosimilar, and transition biological products licensed under the Public Health Service Act (PHS).
USP is seeking stakeholder feedback on this proposal; comments are due to Pharmacopeial Forum (PF) on July 31st. In addition to the comment submission process, USP also held a Biologics Nomenclature Virtual Roundtable on June 23, 2020. This virtual event was intended to capture comprehensive feedback on this proposal from a diverse community of stakeholders.
To submit comment to PF, go to: www.uspnf.com/pharmacopeial-forum. Note that a one-time registration is required to access PF.
To access a recording of the virtual roundtable, visit: https://youtu.be/TWCnfMz7C4o
USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. Through our standards, advocacy and education, USP helps increase the availability of quality medicines, supplements and food for billions of people worldwide. For more information about USP, visit www.usp.org.