title: An FDA perspective on the assessment of proposed biosimilar therapeutic proteins in rheumatology.
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.
authors.affiliation: 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, Maryland 20993, USA.
authors.forename: Nikolay P
authors.initials: NP
authors.lastname: Nikolov
authors.affiliation: 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, Maryland 20993, USA.
authors.forename: Marjorie A
authors.initials: MA
authors.lastname: Shapiro
mesh_terms: D000818:Animals; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D059451:Biosimilar Pharmaceuticals / Q000009:adverse effects / Q000627:therapeutic use*; D004341:Drug Evaluation / Q000379:methods / Q000592:standards; D006801:Humans; D012216:Rheumatic Diseases / Q000188:drug therapy*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D018501:Antirheumatic Agents; D059451:Biosimilar Pharmaceuticals