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Nephrology Articles

Series

2016

United States

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Introduction Of Biosimilar Therapeutics Into Nephrology Practice In The United States: Report Of A Scientific Workshop Sponsored By The National Kidney Foundation, Jay B. Wish, Chaim Charytan, Glenn M. Chertow, Kamyar Kalantar-Zadeh, Alan S. Kliger, Robert J. Rubin, Jerry Yee, Steven Fishbane Dec 2016

Introduction Of Biosimilar Therapeutics Into Nephrology Practice In The United States: Report Of A Scientific Workshop Sponsored By The National Kidney Foundation, Jay B. Wish, Chaim Charytan, Glenn M. Chertow, Kamyar Kalantar-Zadeh, Alan S. Kliger, Robert J. Rubin, Jerry Yee, Steven Fishbane

Nephrology Articles

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 …


Geriatric Ckd: Value-Based Nephrology, Jerry Yee Jan 2016

Geriatric Ckd: Value-Based Nephrology, Jerry Yee

Nephrology Articles

No abstract provided.