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Biosimilars in Dermatology

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Biologic and Systemic Agents in Dermatology

Abstract

Biosimilars are imitations of original biologics that are structurally similar and have the same pharmacologic mechanism of action. The US Food and Drug Administration defines a biosimilar as a biological product that is highly similar to the reference product notwithstanding minor differences in clinically inactive components, and with no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency. With patent expiration dates of multiple important biologic drugs on the horizon, including those widely used in dermatology, interest in biosimilars is intensifying. Introduction of these agents into the health care marketplace has elicited some concern from health care professionals since biosimilars are not identical copies of their originator drugs. This review aims to provide a comprehensive summary of biosimilars focusing on key concerns, the current and future marketplace, protein structure and manufacturing, regulatory guidelines, and relevance to dermatology.

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Authors and Affiliations

  1. David Geffen School of Medicine at UCLA, Dermatology Institute and Skin Care Center, 2001 Santa Monica Blvd Suite 1160W, Santa Monica, CA, 90404, USA

    Paul S. Yamauchi MD, PhD

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  1. Paul S. Yamauchi MD, PhD
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Correspondence to Paul S. Yamauchi MD, PhD .

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  1. Division of Dermatology, David Geffen School of Medicine a UCLA, Los Angeles, California, USA

    Paul S. Yamauchi

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Yamauchi, P.S. (2018). Biosimilars in Dermatology. In: Yamauchi, P. (eds) Biologic and Systemic Agents in Dermatology. Springer, Cham. https://doi.org/10.1007/978-3-319-66884-0_26

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  • DOI: https://doi.org/10.1007/978-3-319-66884-0_26

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