FDA News: Issue 2-1 February 2023

Author: [AUTHOR] Published on 2/3/2023 6:00:00 AM

Advancing Innovations in Biosimilar Product Development Highlighted in Recent Publications

Biologic products have revolutionized the treatment options for many diseases and typically carry favorable benefit–risk profiles compared with small molecule drugs. Although these innovative products can enable longer lifespan and improved quality of life, the high cost of these products limits access. In the January 2023 themed issue of Clinical Pharmacology & Therapeutics on Innovations in Biosimilars, the opportunities to leverage innovations in clinical pharmacology and related disciplines to improve the efficiency of biosimilar development and approval are discussed. 

Unlike small molecule drugs, exact copies of biologic products cannot be made, and thus it is not possible to approve “generic” biologics. To address this, legal frameworks and guidelines were established in different countries to enable approval of biosimilars (i.e., a biologic product that is highly similar to, and has no clinically meaningful differences from, an approved reference product) that can rely on existing scientific knowledge about the safety, purity, and potency of the reference product. Although biosimilar development has gained momentum globally since the first approved biosimilar in Europe in 2006, most biologics do not have approved biosimilars, highlighting the need for innovative approaches to enhance development.

In this issue, contributors from the US Food and Drug Administration (FDA) and the global, multi-sector biosimilar development community describe opportunities to apply innovations in clinical pharmacology and related disciplines to improve the efficiency of biosimilar development and approval, including leveraging the use of pharmacodynamic (PD) biomarkers in clinical pharmacology studies in place of comparative clinical studies with efficacy end point(s); how modeling and simulation (or model-informed drug development (MIDD)) can be used to optimize study design and analyses; and characterizing the relationship between product quality characteristics (e.g., structural and functional characterization) and clinical performance to further streamline clinical development. The issue calls for global alignment of regulatory expectations for biosimilar approval to make biosimilar development more efficient and attractive to sponsors and emphasizes the importance of educating clinicians and patients about biosimilars and assessing the cost to patients.

Visit the Clinical Pharmacology and Therapeutics website to access this exciting, themed issue on Advancing Innovations in Biosimilar Development. For additional thoughts from the editors of this issue on the growing importance of biosimilars in Clinical Pharmacology, check out the Building on Biosimilars podcast on the American Society of Clinical Pharmacology and Therapeutics Podcast Channel. To learn more about biosimilars and FDA’s efforts to promote biosimilar development visit the FDA Biosimilars website.

The Office of Clinical Pharmacology (OCP) is pleased to offer the e-mail subscription service Clinical Pharmacology Corner. This is a free service from FDA to provide occasional updates from OCP regarding newly approved therapies, new regulatory and scholarly publications, upcoming events and other items of interest. Subscribe today at https://public.govdelivery.com/accounts/USFDA/subscriber/topics and select Clinical Pharmacology Corner under Drugs.

We always welcome your thoughts regarding the format, content, and utility of this communication. Comments may be sent via email to ocp@fda.hhs.gov.

This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.

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