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The Food and Drug Administration (FDA) regulates innovator biologics and biosimilar products through Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). To obtain licensure for a new biologic, the sponsor (generally the manufacturer of the product) submits to the agency a biologics license application (BLA) with data demonstrating that the biologic, and the facility in which it is manufactured, processed, packed, or held, meet standards to assure that the product is safe, pure, and potent. The Biologics Price Competition and Innovation Act (BPCIA), enacted as Title VII of the Patient Protection and Affordable Care Act (ACA, P.L. 111–148), established an abbreviated licensure pathway for biosimilar biological products or biosimilars. To obtain licensure for a biosimilar, the sponsor submits to FDA a BLA that provides information demonstrating, among other things, biosimilarity based on data from analytical studies (structural and functional tests), animal studies (toxicity tests), and/or a clinical study or studies (tests in human patients).³

Since enactment of the BPCIA in 2009, as of 29 May 2019, 19 biosimilars, for nine reference products, have been licensed in the United States. However, many of these licensed biosimilars are not yet available to patients, primarily due to ongoing litigation, although various other factors may impact the uptake of biosimilars.⁴