Tagged as: Eylea

PTAB Issues Final Written Decisions Finding Claims of Regeneron’s Aflibercept Patents Invalid

On November 9, 2022, the PTAB issued final written decisions in IPR2021-00880 and IPR2021-00881, filed by Mylan on two Regeneron patents related to aflibercept—U.S. Patent Nos. 9,254,338 and 9,669,069.  The PTAB ruled in Mylan’s favor in both IPRs, holding all challenged claims of both patents invalid as anticipated by the same…

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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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Formycon Q1 2022 Financial Results - Big Molecule Watch

First Quarter Earnings Graphic

Formycon recently announced its sales and earnings figures for the first quarter of 2022.  Earnings before interest, taxes, depreciation and amortization (EBITDA) amounted to EUR -4.0 million (Q1/previous year: EUR -1.7 million), which was in line with expectations.  According to the press release, the reported revenues were mainly a result…

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BYOOVIZ Launch - Big Molecule Watch

On June 2, 2022, Biogen Inc. and Samsung Bioepis Co., Ltd. announced  that BYOOVIZ™ (ranibizumab-nuna), a biosimilar referencing Genentech’s LUCENTIS®, will be available in the United States on July 1, 2022.  BYOOVIZ™ is the first FDA approved ophthalmology biosimilar.  The FDA approved BYOOVIZ™ in September 2021 for the treatment of neovascular…

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Samsung Biologics Completes Full Acquisition of Samsung Bioepis

In January 2022, Biogen Inc. announced it had reached an agreement to sell its equity stake in the Samsung Bioepis joint venture to partner Samsung Biologics.  On April 20, 2022, Samsung Biologics and Biogen announced that Samsung Biologics has now fully acquired Samsung Bioepis for a total consideration of USD…

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Regeneron’s Disclaimer of Aflibercept Formulation Patent Causes PTAB Denial of Institution of Celltrion PGR

On March 15, 2022, the Patent Trial and Appeal Board (PTAB) denied institution of post-grant review (PGR) proceedings initiated by Celltrion Inc. concerning Regeneron Pharmaceutical’s U.S. Patent No. 10,857,231 (the ’231 Patent) after Regeneron disclaimed the patent.  The ’231 patent has claims directed to formulations of aflibercept, the active ingredient…

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Phase 1 Clinical Trial of Aflibercept (Eylea®) Biosimilar Completed by Alteogen

Alteogen recently announced that it has successfully completed a Phase 1 clinical trial for its Eylea® biosimilar, ALT-L9.  Alteogen conducted the clinical trials in South Korea, where its headquarters are located.  In the clinical trials, ALT-L9 and Eylea® were randomly assigned to 28 patients with neovascular (wet) age-related macular degeneration (wet…

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EYLEA (Aflibercept) Biosimilar Development Updates (Part 2)

Regeneron’s EYLEA (aflibercept) was approved by the U.S. FDA on November 18, 2011 and is indicated for the treatment of patients with Neovascular (Wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR). As previously reported, Momenta in collaboration with Mylan began…

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