Yesterday, SomaLogic, Inc. announced a new five-year agreement and collaboration with the FDA’s Division of Applied Regulatory Science to evaluate the utility of large-scale analysis of proteins for the identification of biomarkers that may be used to help demonstrate whether a proposed biosimilar is biosimilar to a reference product. According to SomaLogic, the project will use data generated on the SomaLogic SomaScan Platform to identify changes in circulating proteins in the blood following treatment with FDA-approved biologics, and then compare that to changes in circulating proteins after treatment with the proposed biosimilar. Through this effort, SomaLogic, along with the FDA, hopes to identify biomarkers and analytical approaches that can be used to demonstrate biosimilarity, which the company says, “could reduce the need for costly and lengthy comparative clinical studies” and “should streamline the development of biosimilars.” In the company’s announcement, Stephen Williams, M.D., chief medical officer at SomaLogic, remarked that “[c]omparing 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.”
