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    • News

    Global Approvals for Insulin Glargine Promise a More Affordable, Long-Acting Treatment for Diabetes

    By Caitlin M. Wilmot April 3, 2018 Comments are off

    Last week, Mylan N.V. and Biocon Ltd. announced that their jointly-developed insulin glargine biosimilar, Semglee™, received marketing...

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    Tagged with: Abasaglar™, Biocon, Eli Lilly, FDA, Insulin glargine, Lantus®, Lusduna™, Merck, Mylan, Sanofi, Semglee™, trastuzumab

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    • Legal

    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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    Samsung Bioepis and Merck Launch Renflexis® in the U.S.

    By C. Nichole Gifford August 9, 2017 Comments are off

    On July 24, 2017, Samsung Bioepis and Merck & Co., Inc. announced the launch of Renflexis® (infliximab-abda) in the United States. ...

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    Tagged with: Infliximab, Janssen, Merck, News, Remicade®, Renflexis®, Samsung Bioepsis

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    • News

    FDA Grants Tentative Approval for Merck’s Insulin Glargine

    By C. Nichole Gifford July 25, 2017 Comments are off

    Merck & Co., Inc. (“Merck”) announced last week that the FDA has granted tentative approval for its insulin glargine injection...

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    Tagged with: Diabetes, Follow-on biologic, Insulin glargine, Lantus®, Legal, LUSDUNA™ Nexvue™, Merck, News, Sanofi

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Featured Posts

  • Litigation Spotlight Update: The Infliximab (Remicade®) Litigation

    February 5, 2018

  • Litigation Spotlight Update: The Epoetin alfa (Epogen®) Litigation

    August 2, 2017

  • Litigation Spotlight Update: The Saga Continues: The Infliximab (Remicade®) Litigation

    June 12, 2017

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