Introduction of Biosimilar Therapeutics Into Nephrology Practice in the United States: Report of a Scientific Workshop Sponsored by the National Kidney Foundation.
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.
Indiana University Health, Indianapolis, IN. Electronic address: jaywish@earthlink.net.
Jay B
JB
Wish
New York Presbyterian-Queens, Queens, NY.
Chaim
C
Charytan
Stanford University, Stanford, CA.
Glenn M
GM
Chertow
University of California-Irvine, Orange, CA.
Kamyar
K
Kalantar-Zadeh
Yale New Haven Health System, New Haven, CT.
Alan S
AS
Kliger
Georgetown University, Washington, DC.
Robert J
RJ
Rubin
Henry Ford Hospital, Detroit, MI.
Jerry
J
Yee
Hofstra Northwell School of Medicine, Great Neck, NY.
Steven
S
Fishbane
D035843:Biomedical Research; D059451:Biosimilar Pharmaceuticals / Q000627:therapeutic use*; D003226:Congresses as Topic; D004363:Drug Utilization; D006801:Humans; D007674:Kidney Diseases / Q000188:drug therapy; D009398:Nephrology; D017410:Practice Guidelines as Topic; D014481:United States
D059451:Biosimilar Pharmaceuticals
Biosimilar; anemia; biologic; cost; dialysis; drug approval; efficacy; end-stage renal disease (ESRD); erythropoietin analogue; interchangeability; nephrology; pharmacovigilance; reference agent; regulatory; safety; therapeutic equivalency