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First Biosimilar Drug Now Available; Ongoing Legal Dispute Remains

The first biosimilar is now available in the United States. Sandoz announced the availability of Zarxioâ„¢ (filgrastim-sndz) earlier today, after the Federal Circuit denied Amgen Inc.'s attempt to stall the launch. The launch...more

FDA Denies Amgen's Citizen Petition Regarding Biosimilar Applicant Requirements

Late last week, the U.S. Food and Drug Agency (FDA) dismissed a citizen petition filed by Amgen, Inc. asking the agency to require that biosimilar applicants provide the reference product sponsor with a copy of their...more

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