Biosimilars are protein products that are suffi ciently\r\nsimilar to a biopharmaceutical already approved by a\r\nregulatory agency. Several biotechnology companies\r\nand generic drug manufacturers in Asia and Europe\r\nare developing biosimilars of tumor necrosis factor\r\ninhibitors and rituximab. A biosimilar etanercept is\r\nalready being marketed in Colombia and China. In the\r\nUS, several natural source products and recombinant\r\nproteins have been approved as generic drugs under\r\nSection 505(b)(2) of the Food, Drug, and Cosmetic\r\nAct. However, because the complexity of large\r\nbiopharmaceuticals makes it diffi cult to demonstrate\r\nthat a biosimilar is structurally identical to an already\r\napproved biopharmaceutical, this Act does not apply to\r\nbiosimilars of large biopharmaceuticals. Section 7002 of\r\nthe Patient Protection and Aff ordable Care Act of 2010,\r\nwhich is referred to as the Biologics Price Competition\r\nand Innovation Act of 2009, amends Section 351 of\r\nthe Public Health Service Act to create an abbreviated\r\npathway that permits a biosimilar to be evaluated by\r\ncomparing it with only a single reference biological\r\nproduct. This paper reviews the processes for approval\r\nof biosimilars in the US and the European Union\r\nand highlights recent changes in federal regulations\r\ngoverning the approval of biosimilars in the US.
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