Tagged as: Eylea

FDA Approves Regeneron’s 8 mg injection of EYLEA (aflibercept) and VEOPOZ (pozelimab)

Bottle of Pills and a FDA APPROVED rubber stamp

On August 18, 2023, Regeneron Pharmaceuticals, Inc. (“Regeneron”) announced that the FDA approved EYLEA HD®, an 8 mg injection of EYLEA® (aflibercept).  EYLEA HD®, jointly developed with Bayer A.G., is approved for the treatment of wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR).  EYLEA® was…

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Samsung Bioepis Files IPR Petition Challenging Regeneron Aflibercept Patent

On August 18, Samsung Bioepis Co., Ltd. (“Samsung Bioepis”), filed a petition for Inter Partes Review, IPR2023-01312, challenging the validity of claims 1-18 of U.S. Patent No. 10,464,992, assigned to Regeneron Pharmaceuticals, Inc. (“Regeneron”).  According to the petition, the ’992 patent claims “encompass a formulation comprising the VEGF inhibitor protein,…

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Update: Post-Trial Briefing in Regeneron v. Mylan Aflibercept BPCIA Case Now Complete

We previously reported on the opening post-trial briefs in Regeneron’s BPCIA case against Mylan and Biocon (who was added as a defendant after the original defendant, Mylan, transferred its rights to the aflibercept biosimilar to Biocon). Now, post-trial briefing is complete. The parties submitted their responsive briefs on July 24,…

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Regeneron Received FDA Complete Response Letter For Its Higher Dose Aflibercept Injection BLA

Last week, Regeneron published a press release stating that the FDA had issued a Complete Response Letter (“CRL”) for its aflibercept 8 mg BLA for the treatment of patients with wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy, “due to an ongoing review of inspection findings at a…

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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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Amgen Intervenes in Regeneron v. Mylan BPCIA Aflibercept Litigation to Seek Public Access to Sealed Documents

As we have previously reported, Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding in the U.S. District Court for the Northern District of West Virginia, with a two-week trial scheduled to begin on June 12, 2023.  On May 23, 2023, Amgen filed a motion to intervene in…

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New Patents Listed in the Purple Book for Regeneron’s EYLEA

FDA’s Purple Book provides a searchable database of licensed biological products and includes the patent information provided to biosimilar applicants during the BPCIA patent dance.  As we previously reported, a patent list for Regeneron’s EYLEA (aflibercept) was added to the Purple Book in April 2022.  That original list contained 29 patents, including…

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Regeneron v. Mylan BPCIA Aflibercept Litigation Update: Claim Construction Order and Stipulation to Narrow the Case for June 2023 Trial

As we have previously reported, Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding on an expedited schedule, with a two-week trial scheduled to begin on June 12, 2023. On April 19, the Court issued a claim construction order construing seven terms from the claims of the four…

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Regeneron v. Mylan - Update on Aflibercept BPCIA Litigation

As we previously reported, Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding on an expedited schedule, with a two-week trial scheduled to begin on June 12, 2023, less than a year from Regeneron’s filing of its complaint in August 2022.  The Court’s scheduling order, issued in October…

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