SomaLogic And FDA Will Streamline Biosimilar Development

Agreement Aims To Identify Pharmacodynamic Biomarkers For Reference Biologics

03 Nov 2020

Further to the US Food and Drug Administration’s own plans to develop a framework to further the use of pharmacodynamic biomarkers and potentially streamline biosimilar development, the FDA has joined forces with US-based specialist SomaLogic, gaining access to its proprietary technology platform.

Washington, D.C., USA- January 13, 2020: FDA Sign outside their headquarters in Washington DC. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA. — SomaLogic's proteomic strategy, if successful, could reduce the need for comparative clinical studies • Source: Shutterstock

SomaLogic is joining forces with the US Food and Drug Administration’s Division of Applied Regulatory Science to potentially streamline biosimilar development, using the US-based clinical diagnostic firm’s proprietary protein measurement platform technology to identify circulating pharmacodynamic biomarkers for reference biologics.

The five-year agreement will see data generated on the SomaLogic SomaScan Platform – which makes 5,000 protein measurements simultaneously in...