Monday November 2, 2020 0 comments
BOULDER -- SomaLogic, Inc. announced an agreement with the U.S. Food and Drug Administration’s Division of Applied Regulatory Science to evaluate the utility of large-scale analysis of proteins (proteomics) for the identification of biomarkers that may be useful in demonstrating biosimilarity of a proposed biosimilar to a reference biologic.
The collaborative project will use data generated on the SomaLogic SomaScan® Platform, which makes 5,000 protein measurements simultaneously in small samples of blood, to compare changes in circulating proteins following treatment with FDA-approved biologics.
The protein measurements from an FDA-approved reference biologic could then be compared to those generated by a candidate biosimilar drug.
“Circulating proteins, when measured at the broadest scale, provide system-wide information on the dynamic effects of drug exposure-response,” said Stephen Williams, chief medical officer at SomaLogic.
“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.”
Despite potential cost savings in the billions, the use of biosimilars in the U.S. has been less widespread than originally hoped. At present, there are only 28 biosimilars approved by the FDA for only a small number of biologic drugs.
Regulatory approval of a proposed biosimilar requires demonstration that it is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product, a process that can take several years.
The research at the center of this agreement aims to advance the use of novel tools and approaches that could streamline biosmiliar development.
Under the terms of the new five-year agreement, SomaLogic will collaborate with the FDA to identify circulating pharmacodynamic biomarkers and analytical approaches that could be used to demonstrate biosimilarity of a candidate biosimilar drug to a reference FDA-approved biologic drug.
If successful, this proteomic strategy could reduce the need for costly and lengthy comparative clinical studies, the company said. This, in turn, should streamline the development of biosimilars and thus accelerate delivery of safe, effective, and affordable biosimilar treatments to patients.
Specific details of the agreement were not disclosed.