A Critical Analysis of the FDA Omics Perspective on Pharma-codynamic Biomarkers to Support Biosimilarity, and its Surrogates.
Sarfaraz Niazi
Abstract:Demonstrating biosimilarity entails comprehensive analytical evaluations, clinical pharmacolo-gy profiling, and efficacy testing for at least one medical indication in patients. These require-ments are stipulated by the U.S. Biologics Price Competition and Innovation Act (BPCIA). The costliest element—efficacy testing—can be waived if other compliance benchmarks are satisfied, including comparing functional pharmacodynamic (PD) biomarkers, even when they do not di-rectly correlate with clinical outcomes. Most … Show more
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