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Findings from USP study will help scale use of MAM by manufacturers
Rockville, Md., September 29, 2022 – As part of the U.S. Government’s Biosimilar User Fee Act (BsUFA), the Food and Drug Administration (FDA) awarded U.S. Pharmacopeia (USP) a grant to study ways to enhance biosimilar and interchangeable biosimilar product development and regulatory science, specifically through use of the Multi-Attribute Method (MAM). The objective of this work is to assess challenges associated with implementation of MAM and to create a knowledge base that can lower the barrier to adoption and enable wider use of MAM by biosimilar manufacturers.
“The results of this study will help support the transition from conventional techniques to MAM,” said Ronald T. Piervincenzi, PhD, CEO, USP. “I'm proud that USP’s commitment to facilitating timely access to safe and effective biosimilar medicines for patients has been recognized by the FDA with this award."
USP’s study, led by its Global Biologics group, will assess the performance of the mass spectrometry-based MAM versus conventional QC methods to identify changes in product quality attributes upon forced degradation and to correlate changes in those attributes with bioactivity, binding affinity and structure. This work builds on activities USP has been leading to promote the quality and consistency of biotherapeutics and performance standards.
About USP
USP is an independent, international, and scientific nonprofit organization focused on building trust in the supply of safe, quality medicines. We are working to strengthen the global supply chain so the medicines people rely on for health are available when needed and work as expected. USP has 16 offices across 13 countries and implements global health programs in 40+ countries worldwide.