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  • Posted in:

    • Regulatory

    How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline

    By Aydin Harston October 29, 2018 Comments are off

    European Medicines Agency approves first two pegfilgrastim biosimilars and another adalimumab biosimilar Pfizer launches NivestymTM,...

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    Tagged with: BPCIA, EMA, FDA, Featured, Regulatory

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  • Posted in:

    • News

    Third Time’s a Charm? Amgen Files Another BPCIA Lawsuit Against Apotex

    By Caitlin M. Wilmot August 30, 2018 Comments are off

    Earlier this month, Amgen initiated suit against Apotex in the Middle District of Florida, alleging infringement of U.S. Patent No....

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    Tagged with: Amgen, Apotex, BPCIA, filgrastim, Litigation, Neulasta®, Neupogen®, pegfilgrastim

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  • Posted in:

    • News

    AbbVie Files Suit Against Sandoz Alleging Infringement of Two Humira®-Related Patents

    By Seth Cockrum August 14, 2018 Comments are off

    On August 10, 2018, AbbVie, Inc. and AbbVie Biotechnology Ltd. (collectively “AbbVie”) sued Sandoz Inc., Sandoz GMBH, and Sandoz...

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    Tagged with: AbbVie, BPCIA, Humira®, IPR, News, PTAB, Sandoz

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  • Posted in:

    • Regulatory

    How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline

    By Aydin Harston and Andrew Storaska August 2, 2018 Comments are off

    FDA approves first Neulasta® (pegfilgrastim) and Procrit® (epoetin alfa) biosimilars and second Neupogen® (filgrastim biosimilar)...

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    Tagged with: BPCIA, EMA, FDA, Regulatory

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  • Posted in:

    • News

    Genentech Files Two New Lawsuits Against Celltrion Alleging Infringement of Patents Related to Rituxan® and Herceptin®

    By Seth Cockrum July 12, 2018 Comments are off

    As we previously reported here and here, Celltrion filed suit against Genentech seeking declaratory judgment that a host of patents...

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    Tagged with: BPCIA, Celltrion, Genentech, Herceptin®, News, Patent Dance, Rituxan®, Rituximab, trastuzumab

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  • Posted in:

    • Legal

    New Proposed Legislation: The Hatch-Waxman Integrity Act of 2018

    By Nicole DeAbrantes July 3, 2018 Comments are off

    On June 14, 2018, Senator Orrin Hatch of Utah, the co-author of the Hatch-Waxman Act, filed an amendment to the Hatch-Waxman Act in an...

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    Tagged with: ANDA, BPCIA, FDA, IPR, Legal, PGR

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  • Posted in:

    • Legal

    Litigation Spotlight Update: Epogen® Litigation Status in Face of Retacrit Regulatory Approval

    By Spencer Johnson May 22, 2018 Comments are off

    As we recently covered, May 15, 2018, saw the FDA granting approval to Hospira (now a Pfizer subsidiary) for its Retacrit injection, a...

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    Tagged with: Amgen, BLA, BPCIA, Epogen®, FDA, Featured, Federal Circuit, Hospira, Legal, Pfizer, Retacrit®

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  • Posted in:

    • News

    District Court Grants Genentech’s Motions to Dismiss Celltrion’s Declaratory Judgment Actions in Herceptin® and Rituxan®-Related Suits

    By Seth Cockrum May 11, 2018 Comments are off

    As we previously reported here and here, Celltrion filed suit against Genentech seeking declaratory judgment that a number of patents...

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    Tagged with: BLA, BPCIA, Celltrion, District Court, Genentech, Herceptin®, News, Patent Dance, Rituxan®, Rituximab, trastuzumab

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  • Posted in:

    • Regulatory

    How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline

    By Aydin Harston and Andrew Storaska May 2, 2018 Comments are off

    European Medicines Agency approves second trastuzumab and third insulin glargine biosimilars FDA has not approved any biosimilar...

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    Tagged with: BPCIA, EMA, FDA, Regulatory

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