Introduction of Biosimilar Therapeutics Into Nephrology Practice in the United States: Report of a Scientific Workshop Sponsored by the National Kidney Foundation
详细信息 查看全文
- 作者：Jay B. Wish ; MD<sup>1sup><sup> ; sup><sup>jaywish@earthlink.net" class="auth_mail" title="E-mail the corresponding authorsup> ; Chaim Charytan ; MD<sup>2sup> ; Glenn M. Chertow ; MD<sup>3sup> ; Kamyar Kalantar-Zadeh ; MD<sup>4sup> ; Alan S. Kliger ; MD<sup>5sup> ; Robert J. Rubin ; MD<sup>6sup> ; Jerry Yee ; MD<sup>7sup> ; Steven Fishbane ; MD<sup>8sup>
- 关键词：Biosimilar ; biologic ; erythropoietin analogue ; dialysis ; regulatory ; therapeutic equivalency ; reference agent ; drug approval ; safety ; efficacy ; cost ; anemia ; nephrology ; end-stage renal disease (ESRD) ; pharmacovigilance ; interchangeability
- 刊名：American Journal of Kidney Diseases
- 出版年：2016
- 出版时间：December 2016
- 年：2016
- 卷：68
- 期：6
- 页码：843-852
- 全文大小：256 K
文摘
Biosimilars are biologic medicines highly similar to the reference product with no meaningful clinical differences in terms of safety, purity, and potency. All biologic medicines are produced by living cells, resulting in an inherent heterogeneity in their higher order structures and post-translational modifications. In 2010, the US Congress enacted legislation to streamline the approval process for biosimilars of products losing patent protection, with the goal of decreasing costs and improving patient access to therapeutically important but expensive biologic agents. In 2015, the US Food and Drug Administration approved the first biosimilar agent through this pathway. Approval of additional biosimilar agents in the United States, including those used by nephrologists, is anticipated. Given the relative lack of knowledge regarding biosimilars and their approval process and a lack of trust by the nephrology community regarding their safety and efficacy, the National Kidney Foundation conducted a symposium, Introduction of Biosimilar Therapeutics Into Nephrology Practice in the U.S., September 17 to 18, 2015. Issues related to manufacturing, the regulatory approval process, interchangeability, substitution/switching, nomenclature, and clinician and patient awareness and acceptance were examined. This report summarizes the main discussions at the symposium, highlights several controversies, and makes recommendations related to public policy, professional and patient education, and research needs.