This article reviews the recent engagement of the Division of Applied Regulatory Science (DARS) in several current initiatives on utilizing pharmacodynamic (PD) biomarkers to demonstrate biosimilarity, potentially streamlining or negate the need for comparative clinical studies.
DARS is a department within the US Food and Drug Administration (FDA) committed to move new science into the FDA regulatory process and addresses emergent regulatory and public health questions.
Capabilities within the Division include laboratory-based research specializing in omics, bioanalysis, microphysiological and cellular systems, immunology, and electrophysiology as well as in silico research performed by informatics and computational modelling groups. In addition, DARS conducts in particular clinical research focused on facilitating new and biosimilar/generic drug development and assessing the safety of marketed drugs .
According to a recent review by Chiu et al., DARS conducts initiatives on the use of PD biomarkers to demonstrate biosimilarity, which may reduce the need for comparative clinical studies. This includes conducting clinical research to fill information gaps, defining best practices for characterizing PD biomarkers and evaluating the use of proteomic and transcriptomic analysis of human plasma to identify novel biomarkers for biosimilar development. DARS is also leading the development of an evidentiary framework to advance the use and acceptance of PD biomarkers to streamline biosimilar development.
The rapid development of biosimilars and generics is influenced by the ability to predict the risk of a stronger immune response in humans to the proposed drug, known as immunogenicity. Currently, this risk is mainly assessed through clinical trials. DARS is exploring non-clinical approaches to predict immunogenicity risk for biosimilars and complex generic drugs, instead of relying solely on clinical trials. This includes evaluating in vitro assays and cell types, in vivo models, and identification of useful controls. The methods can potentially identify products with immunogenicity risk earlier and streamline the development of biosimilars and certain complex generic drugs.
DARS works with stakeholders, including industry, academic institutions, and patient groups, to ensure that biosimilar products meet the standards for quality, safety and efficacy required for FDA approval. The Division also collaborates with international regulatory agencies to ensure that international standards for biosimilar products are consistent with the standards set by FDA.
FDA and the Department of Health and Human Services aim to lower the cost of medicine by boosting the development of biosimilar and generic drugs through the Drug Competition Action Plan (2017) and the Biosimilars Action Plan (2018) which focus on applied research projects .
DARS continues to help make drug development more efficient, as it has done with advancing new methods for biosimilar.
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1. Chiu K, Racz R, Burkhart K, et al. New science, drug regulation, and emergent public health issues: The work of FDA’s division of applied regulatory science. Front Med (Lausanne). 2023;9:1109541. doi:10.3389/fmed.2022.1109541.
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