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- W3093633730 abstract "Biologic agents are large-molecule drugs developed from living sources. Biologic agents include vaccines, monoclonal antibodies, blood components and a variety of other therapies. Widely used for a variety of disease states, biologic agents are generally more expensive than small-molecule drugs, accounting for 69% of Medicare Part B drug expenditures in 2014.1 Spending on biologic agents in the United States rose at least 10% per year from 2011 to 2016. In 2016, 5 of the top 10 drugs in terms of US market spend were biologic agents.2 The Biologic Price Competition and Innovation Act (BPCIA) defined biosimilars as drugs that are highly similar to an existing biologic agent (often call the reference biologic) and have no clinically meaningful differences in efficacy or safety.3 In 2010, the BPCIA created an expedited pathway for approval of biosimilars. Several of the requirements for biosimilar approval established in the BPCIA are similar to those established for the approval of generic small-molecule drugs under the Hatch-Waxman Act. However, there are substantial differences that have resulted in decreased market permeation of biosimilars relative to small-molecule generic drugs.3 The biosimilar market environment that resulted has changed the impact on health-system pharmacy from that initially predicted.4,5" @default.
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- W3093633730 date "2020-10-22" @default.
- W3093633730 modified "2023-09-30" @default.
- W3093633730 title "Barriers to biosimilar utilization in the United States" @default.
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- W3093633730 doi "https://doi.org/10.1093/ajhp/zxaa297" @default.
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