Advancing Biosimilar Development Using Pharmacodynamic Biomarkers in Clinical Pharmacology Studies.

To ensure US patients realize the public health benefit of a robust, competitive market for biosimilar products, the US Food and Drug Administration (FDA) is focused on improving the efficiency of biosimilar development and approvals. As noted above and outlined in FDA guidance documents, biosimilars may be approved based on PK and PD biomarker data without a comparative clinical study with efficacy end point(s).[2] Reliance on PK and PD biomarker data allows for shorter and less costly clinical studies than can often be conducted in healthy participants. Under circumstances where an established and sensitive PD biomarker does not exist, there is an opportunity to explore and identify new PD biomarkers to facilitate the use of PD biomarker data in clinical pharmacology studies. [Extracted from the article]