Article

A Critical Analysis of the FDA Omics Perspective on Pharma-codynamic Biomarkers to Support Biosimilarity, and its Surrogates.

2023-09-06

Abstract excerpt

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 pharma...

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Literature Corpus work: 3d8f653e-a349-58e8-a8ba-768ce2cdedde
DOI: 10.20944/preprints202309.0353.v1

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