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SomaLogic Partners With FDA to Test Proteomic Tech for Evaluating Biosimilars

NEW YORK — SomaLogic said on Thursday that it has partnered with the US Food and Drug Administration to explore the use of large-scale protein analysis in the development of biosimilar drugs.

Under the terms of the five-year deal, SomaLogic and the FDA's Division of Applied Regulatory Science will use the company's SomaScan proteomics platform to compare changes in circulating proteins following treatment with FDA-approved biologics.

These protein measurements will then be evaluated as potential pharmacodynamic biomarkers for use in determining the comparability of candidate biosimilars to approved reference biologics. If successful, the strategy could reduce the need for comparative clinicals studies, streamlining the biosimilar development process, SomaLogic said.

Other terms of the partnership were not disclosed.

"Comparing the 'blood protein fingerprint' of a biosimilar to a reference biologic has the potential to be more efficient and precise than clinical observations for establishing biosimilarity," SomaLogic Chief Medical Officer Stephen Williams said in a statement.

Earlier this month, Boulder, Colorado-based SomaLogic and academic collaborators won a $1 million National Science Foundation grant to explore the use of quantum biosensing technology for proteomic measurement.

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