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Formycon and Celltrion Announce FDA Submission of aBLAs Seeking Approval to Market Aflibercept Biosimilars

On June 29 and 30, 2023, respectively, Formycon AG (“Formycon”) and Celltrion Inc. (“Celltrion”) announced submission to the FDA of aBLAs for their aflibercept biosimilar candidates.  Formycon and Celltrion are the second and third biosimilar developers to announce submissions of aflibercept aBLAs, following Viatris Inc.’s submission in October 2021.  As…

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Regeneron Files Expedited Motion Challenging Mylan’s Designation of Entire aBLA Production as Outside Counsel’s Eyes Only

On Tuesday, December 6, Regeneron filed an expedited motion to compel Mylan’s compliance with the protective order in the parties’ BPCIA litigation concerning Mylan’s proposed aflibercept biosimilar of EYLEA.  Regeneron alleges that Mylan has improperly “designated the entire 1,000,000+ pages of its biosimilar application and regulatory file as ‘Outside Counsel’s…

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Regeneron Files First BPCIA Complaint Regarding Biosimilar Eylea Against Mylan in West Virginia District Court

Regeneron filed a complaint yesterday against Mylan in the U.S. District Court for the Northern District of West Virginia, alleging infringement of twenty-four patents under the BPCIA based on Mylan’s submission of an aBLA for M710, a proposed biosimilar of EYLEA (aflibercept).  Regeneron asserts that use of Mylan’s M710 infringes seven…

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