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An FDA perspective on the assessment of proposed biosimilar therapeutic proteins in rheumatology

Nature Reviews Rheumatology volume 13, pages 123–128 (2017)Cite this article

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Abstract

Biologic products have revolutionized the management of many rheumatic diseases, but access to these products might be limited by their relatively high costs. The US Biologics Price Competition and Innovation Act of 2009, which is contained within the Patient Protection and Affordable Care Act, established an abbreviated pathway for licensure by the FDA of biologic products that are demonstrated to be biosimilar to or interchangeable with FDA-licensed biologic products, termed reference products. This law allows for the approval of biosimilar biologic products, which are expected to increase access to treatment for patients, and ensuring the implementation of this Act is a high priority for the FDA. In this Perspectives article we describe the considerations for approval of proposed biosimilar products, including those to treat rheumatological conditions, by describing the FDA's rigorous approach to assessment of biosimilarity.

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Figure 1: Overview of biosimilar product development.
Figure 2: Features of antibody structure important for biosimilar cytotoxic effects.

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Acknowledgements

The authors thank S. Yim, B. Chowdhury, S. Kozlowski, K. Clouse, S. Lim, J. Weiner, L. Zhang, D. Abernethy and L. Christl for critical review of the manuscript. This article reflects the views of the authors and should not be construed to represent FDA's views or policies.

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Authors and Affiliations

  1. Division of Pulmonary, Allergy, and Rheumatology Products, Office of New Drugs, HFD-570, Center for Drug Evaluation and Research, FDA, 10903 New Hampshire Avenue, Silver Spring, 20993, Maryland, USA

    Nikolay P. Nikolov

  2. Division of Biotechnology Review and Research 1, Office of Biotechnology Products, HFD-123, Center for Drug Evaluation and Research, FDA, 10903 New Hampshire Avenue, Silver Spring, 20993, Maryland, USA

    Marjorie A. Shapiro

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Both authors researched data for article and made substantial contributions to discussions of the content, writing and review/editing of manuscript before submission.

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Correspondence to Nikolay P. Nikolov.

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Nikolov, N., Shapiro, M. An FDA perspective on the assessment of proposed biosimilar therapeutic proteins in rheumatology. Nat Rev Rheumatol 13, 123–128 (2017). https://doi.org/10.1038/nrrheum.2016.204

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