Department of Medicine, Division of Rheumatology
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Medical Subject Headings
Animals; Antirheumatic Agents; China; *Drug Approval; Drug Industry; Drugs, Generic; Humans; Rheumatic Diseases; United States
Complex Mixtures | Musculoskeletal Diseases | Pharmacy Administration, Policy and Regulation | Rheumatology | Skin and Connective Tissue Diseases
Biosimilars are protein products that are sufficiently similar to a biopharmaceutical already approved by a regulatory agency. Several biotechnology companies and generic drug manufacturers in Asia and Europe are developing biosimilars of tumor necrosis factor inhibitors and rituximab. A biosimilar etanercept is already being marketed in Colombia and China. In the US, several natural source products and recombinant proteins have been approved as generic drugs under Section 505(b)(2) of the Food, Drug, and Cosmetic Act. However, because the complexity of large biopharmaceuticals makes it difficult to demonstrate that a biosimilar is structurally identical to an already approved biopharmaceutical, this Act does not apply to biosimilars of large biopharmaceuticals. Section 7002 of the Patient Protection and Affordable Care Act of 2010, which is referred to as the Biologics Price Competition and Innovation Act of 2009, amends Section 351 of the Public Health Service Act to create an abbreviated pathway that permits a biosimilar to be evaluated by comparing it with only a single reference biological product. This paper reviews the processes for approval of biosimilars in the US and the European Union and highlights recent changes in federal regulations governing the approval of biosimilars in the US.
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Citation: Arthritis Res Ther. 2011 May 12;13(3):112. doi: 10.1186/ar3310. Link to article on publisher's site
Kay, Jonathan, "Biosimilars: a regulatory perspective from America" (2011). Rheumatology Publications and Presentations. 118.