Tony Hagen is senior managing editor for The Center for Biosimilars®.
A collaboration with the FDA could lead to new forms of pharmacodymamic measurement that improve speed and efficiency of biosimilar development and approval.
The hunt for biomarkers to add precision to efforts to determine biosimilar equivalence will get an added boost from a collaboration between the FDA and SomaLogic of Boulder, Colorado.
The agreement involves the use of a highly sensitive protein measurement tool to assess changes in circulating proteins in patient blood samples following treatment with reference biologics. These same measurements will be compared with protein levels in samples from patients using biosimilar drug candidates. This type of large-scale analysis of proteins is called proteomics.
“Circulating proteins, when measured at the broadest scale, provide system-wide information on the dynamic effects of drug exposure-response,” Stephen Williams, MD, chief medical officer at SomaLogic, said in a statement. “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.”
The agreement involves collaboration between SomaLogic and the FDA’s Division of Applied regulatory Science.
PD Biomarker Development
The FDA has been working to develop and validate the use of pharmacodynamic (PD) biomarkers for use in determining biosimilarity. Greater reliance on biomarkers for demonstrating biosimilarity is considered an avenue to greater accuracy in comparing biosimilars with reference products and also a means of avoiding costly comparative clinical trials, which use parameters of measurement that are less exact and add to the amount of time and expense needed to assemble evidence for biosimilar approval.
SomaLogic noted that the 28 biosimilars approved so far in the United States for a limited number of reference products has been disappointing and proteomics holds out hope for accelerating this process. “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 biosimilar development,” the company said.
The collaboration will span 5 years and, in addition to identifying circulating PD biomarkers, SomaLogic will seek to develop analytical approaches usable for demonstrating that biosimilar candidates are equivalent to their reference products.
If successful, this proteomic strategy could reduce the need for costly and lengthy comparative clinical studies. This, in turn, should streamline the development of biosimilars and thus accelerate delivery of safe, effective, and affordable biosimilar treatments to patients.
The use of PD biomarkers to establish equivalence has been modest at best, authors of a 2019 clinical article stated. In exploring the rationale for developing and using PD biomarkers in biosimilar development, the authors noted that up until July 2019, PD similarity data had been employed to demonstrate biosimilarity for just 5 approved biosimilars, and these were dose-dependent PD markers: absolute neutrophil count for filgrastim and pegfilgrastim, CD34+ cells for filgrastim, and reticulocyte count and hemoglobin level for epoetin alfa.