Division of Novartis AG
Latest From Sandoz Inc.
A look at the evolution of litigation, from Amgen's 'bold' at-risk launch of Herceptin and Avastin biosimilars to the jump in settlements, new battles over manufacturing information and an expected petition to the Supreme Court.
Court rejects Sandoz's arguments that patents covering Enbrel's active ingredient and method of manufacture are invalid; decision comes three years after FDA approved Sandoz's biosimilar.
Companies generally support decision not to require statistical equivalence testing but challenge agency’s skepticism about combining data from US and foreign reference products to set analytical similarity acceptance criteria.
Generic applicants can request monograph changes while FDA assessment is ongoing.
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Greg Nulty, VP, Head, Finance & CFO
Patrick Genestin, VP, Bus. Dev. & Licensing
Carlos Sattler, MD, VP, Clin. Dev. & Medical Affairs
Scott Smith, VP, Commercial Operations, US
Anthony Maffia, III, VP, Regulatory Affairs
Carol Lynch, Pres.
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Phone: (609) 627-8500
100 College Rd. West
Princeton, NJ 08540
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