Rockville, MD, March 2, 2020 – Today, in its online publication Pharmacopeial Forum (PF), USP has proposed a revision to the General Notices section of the United States Pharmacopeia–National Formulary clarifying the continued application of USP public quality standards to biologics products, including originator, biosimilar, interchangeable, and transition biological products licensed under the Public Health Service Act.
USP welcomes and encourages comments and feedback about the impact of this revision and will hold a roundtable during the PF comment period. Invited stakeholders will include the US Food & Drug Administration along with organizations representing the pharmaceutical industry; patients and consumers; and healthcare practitioners including physicians, pharmacists and nurses.
To view the proposal in PF, click here (a free login through Access Point will be required).
About USP
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.