Voices: Kuehn

Getting to Know Biosimilars

Although generic style competition is unlikely, biosimilars cost-savings potential remains

By Steven E. Kuehn, Editor in Chief
Nov 5, 2015

In March 2015 the U.S. FDA approved Zarxio (filgrastim-sndz), the United States’ first biosimilar product to earn the distinction. According to the FDA, Sandoz Inc.’s Zarxio is biosimilar to Amgen Inc.’s Neupogen (filgrastim), originally licensed in 1991. At the time FDA Commissioner Margaret A. Hamburg, M.D., explained “Biosimilars will provide access to important therapies for patients who need them. Patients and the health care community can be confident that biosimilar products approved by the FDA meet the agency’s rigorous safety, efficacy and quality standards.”

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