The American journal of managed care
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There are now 10 approved biosimilars in the United States, including 3 oncology drugs, and at least 16 others in late-stage development. The introduction of competition into the biologic space launches a new era in the treatment of cancer, possibly increasing access to the extremely costly biologics. The most important and influential stakeholders for biosimilar acceptance and usage are healthcare providers, such as pharmacists and physicians, as well as patients. ⋯ Patients require education on the basic definition of biosimilars versus generic drugs, how biosimilars are tested and approved, costs, and availability of clinical trials. Meanwhile, payers may need to find ways to incentivize physicians to prescribe biosimilars over biologics, as well as to provide information on cost and quality directly to patients in order to drive uptake. Finally, legal challenges to approved and pending biosimilars have limited the market access of these agents.
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Created via the Biologics Price Competition and Innovation Act, the biosimilar class of drugs was conceived as an opportunity to introduce competition for commonly used biologics following loss of patent protection and market exclusivity, similar to the generic paradigm that has helped sustain access and innovation for more than 3 decades. The FDA approves a biosimilar after a manufacturer establishes that the product is highly similar to a previously approved originator biologic reference product without any clinically meaningful differences in safety, purity, and potency. ⋯ Understanding those various aspects can improve clinician acceptance and advance the science of biologics and biosimilars. In this report, various factors are addressed to improve the knowledge of biosimilars, including clinical, manufacturing, and cost considerations.