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SomaLogic And FDA Will Streamline Biosimilar Development

Agreement Aims To Identify Pharmacodynamic Biomarkers For Reference Biologics

 
• By Dean Rudge

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...

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