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The Restasis Patents and Tribal Sovereign Immunity: New Developments

The battle between Mylan and Allergan over the six Orange Book patents covering Restasis has taken a next formal step. On Sept. 22, the new patent-owner, the Saint Regis Mohawk Tribe, moved to dismiss Mylan’s requests for...more

First Biosimilar Drug Now Available; Ongoing Legal Dispute Remains

The first biosimilar is now available in the United States. Sandoz announced the availability of Zarxio™ (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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