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Gary Levin Comments on Ruling that Shortens Notice Time for Biosimilar Applicants

News / July 5, 2017

Partner Gary Levin is extensively quoted in two articles published in the June 2017 issue of Specialty Pharmacy News. The article, “Supreme Court Ruling in Sandoz v. Amgen May Speed Up Biosimilars’ Launch Dates” discusses the recent holding that biosimilar applicants need not wait for FDA approval to notify reference drug manufacturers of their intent to market the drugs. Levin told the publication that the decision is key because it “takes away any potential for an extra 180 days of exclusivity” on top of the 12 years that reference biologic sponsors already have. A related article, “Did Biosimilar Company Give Extra Notice of Commercial Marketing?,” looks at the likelihood that biosimilar applicants will give early notice.

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