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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
An FDA perspective on the assessment of proposed biosimilar therapeutic proteins in rheumatology
Nikolay P Nikolov1, Marjorie A Shapiro2
1Division 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, Maryland 20993, USA.
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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