Advancing Biosimilar Development Using Pharmacodynamic Biomarkers in Clinical Pharmacology Studies.

Abstract

Development and approval of biosimilars is critical for enhancing the availability of affordable, safe, and effective treatment options for patients. Utilization of PD biomarkers can help streamline clinical programs for biosimilar development as the current process can be costly and time consuming. While PD biomarkers have not been prominently used across biosimilar approvals to date, there is ample opportunity to utilize such information alongside or in place of comparative clinical studies with efficacy end point(s) moving forward. PD biomarkers have been successfully utilized as primary end points in PD similarity studies when the PD biomarker was a surrogate end point or a direct measure of clinical outcome. Extending such application beyond surrogate end point PD biomarkers will require some or all the following aspects to be explored: (i) investment in evaluating and synthesizing available information in the literature, (ii) conducting pilot studies, (iii) completing model‐based assessments using available data, and (iv) adopting other novel or emerging technologies, among others. Biosimilar development presents an opportunity for the clinical pharmacology discipline to advance the science around identification and application of PD biomarkers as primary end points in PD similarity studies. The impact on public health is such that the use of PD similarity data in biosimilar programs is a clear means for bringing more affordable, safe, and effective treatments to patients faster.