2021 FDA Science Forum
Using Sandwich ELISA to Measure Free Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) in Human Serum
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Contributing OfficeCenter for Drug Evaluation and Research
Abstract
Biosimilars are drugs that have structural and functional similarities to existing FDA-approved reference products. These biologics have the potential to reduce medication costs, expand patient access to important medications, and have led to treatment of many illnesses. Due to the demonstrated benefits of these drugs, the Food and Drug Administration (FDA) created a licensure pathway to promote biosimilar development. This pathway involves using pharmacological data to determine the biosimilarity between the proposed biosimilar product and the reference product, bypassing the need for expense clinical studies.
In our study, we measured unbound human serum PCSK9 concentrations following the administration of Evolocumab or Alirocumab using a colorimetric assay with a tetramethylbenzidine (TMB) substrate. Ultimately, this free PCSK9 quantification will provide insight into how biomarkers, like PCSK9, can be used to assess the similarity between products like Evolocumab and Alirocumab and minimize the need for extensive clinical trials to provide this assessment.
