Tagged as: Eylea

Year in Review: Top Deals in 2023

According to PWC, “2023 was a reasonably strong year for the pharmaceutical and life sciences sector with both deal value and volume of M&A close to pre-pandemic levels.” Below is a recap of the top M&A deals in 2023 that focus on biologics and biosimilars and were covered on the…

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Updates on Patent Challenges by Biosimilar Manufacturers at the PTAB

In the last month, there has been a flurry of activity at the PTAB related to challenges from biosimilar manufacturers related to ustekinumab, aflibercept, and eculizumab patents. 1. STELARA® (ustekinumab) Four months after Janssen Biotech, Inc. settled to terminate Samsung Bioepis Co., Ltd.’s inter partes review (IPR) challenge of U.S….

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Regeneron Sues Formycon AG for Proposed Biosimilar of EYLEA in West Virginia District Court

Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a Complaint on November 29, 2023, against Formycon AG (“Formycon”) in the U.S. District Court for the Northern District of West Virginia, alleging infringement of 39 patents under the BPCIA based on Formycon’s submission of an aBLA for FYB203, a proposed biosimilar of EYLEA (aflibercept). …

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Regeneron Sues Samsung Bioepis for Proposed Biosimilar of EYLEA in West Virginia District Court

Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a Complaint on November 22 against Samsung Bioepis Co., Ltd. (“Bioepis”) in the U.S. District Court for the Northern District of West Virginia, alleging infringement of 37 patents under the BPCIA based on Bioepis’s submission of an aBLA for SB15, a proposed biosimilar of EYLEA…

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European Biologics Regulatory Updates

Bayer’s aflibercept 8 mg recommended for approval in Europe: On November 10, 2023, Bayer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending aflibercept 8 mg for approval for extended treatment intervals in two major retinal…

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Regeneron Sues Celltrion For Proposed Biosimilar of Eylea in West Virginia District Court

Regeneron filed a Complaint on November 8 against Celltrion in the U.S. District Court for the Northern District of West Virginia, alleging infringement of thirty-eight patents under the BPCIA based on Celltrion’s submission of an aBLA for CT-P42, a proposed biosimilar of EYLEA (aflibercept), and Celltrion’s provision of Notice of…

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Update on Ophthalmic Anti-VEGF Therapeutics

Below we provide an update on several ophthalmic anti-VEGF therapeutics currently being studied in clinical trials. EYLEA® HD (Aflibercept, 8 mg) Regeneron announced positive two-year (96 weeks) results from its PULSAR trial investigating Eylea® HD (aflibercept, 8 mg) with 12- and 16-week dosing regimens compared to EYLEA® (aflibercept, 2 mg)…

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Update on Recent International Biosimilar Approvals

Approval of Fresenius Kabi’s Tocilizumab Biosimilar in the EU:  On September 19, 2023, Fresenius Kabi announced that the European Commission (EC) granted marketing authorization for TYENNE (tocilizumab), a biosimilar referencing Roche’s ROACTEMRA.  TYENNE is the first tocilizumab biosimilar approved in the EU.  TYENNE received approval for both subcutaneous (prefilled syringe…

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Formycon Announces FDA Acceptance of the aBLA for Its Aflibercept Biosimilar

On August 29, 2023, Formycon AG and its licensing partner, Klinge Biopharma GmbH, announced that the FDA has accepted the aBLA for FYB203, Formycon’s candidate biosimilar to Regeneron’s EYLEA® (aflibercept).  As we previously reported, when Formycon submitted its aBLA in June 2023, it became the second biosimilar developer to announce…

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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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