351(k) pathway

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Sanofi Files Suit Against Merck Sharp & Dohme Over Second NDA for Insulin Glargine Biologic: A Look at the Differences in Biosimilar Approval Pathways
By Nicole DeAbrantes October 19, 2017 Comments are off
On August 8, 2017, Sanofi-Aventis (“Sanofi”) filed a patent infringement suit in the United States District Court for the District of...

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Tagged with: 351(k) pathway, 505(b)(2), BLA, District Court, Guidance, Merck, NDA, Patent Dance, Sanofi

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