Tagged as: Biogen

Genentech, Roche, and Biogen Sue Dr. Reddy's and Fresenius for a Proposed Biosimilar of Rituxan in District of New Jersey

Genentech, Roche, and Biogen filed a Complaint on November 17 against Dr. Reddy’s Laboratories (“DRL”) and Fresenius in the U.S. District Court for the District of New Jersey, alleging infringement of 15 patents under the BPCIA based on DRL’s submission of an aBLA for DRL_RI, a proposed biosimilar of RITUXAN (rituximab)…

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BYOOVIZ® (Ranibizumab-Nuna) Granted Interchangeable Status

Recently, Biogen and Samsung Bioepis’s ranibizumab biosimilar (BYOOVIZ) was granted interchangeable status by the U.S. Food and Drug Administration.  BYOOVIZ was deemed interchangeable to Genentech’s LUCENTIS for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization.  BYOOVIZ, the first FDA approved…

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Genentech and Biogen File Joint Stipulation of Dismissal in BPCIA Litigation Regarding Tocilizumab

As we previously reported, in July 2023 Genentech, Inc., Hoffmann-LaRoche, Inc., and Chugai Pharmaceutical Co., Ltd. (collectively, “Genentech”) filed BPCIA litigation against Biogen MA Inc. and Bio-Thera Solutions, Ltd. in the District of Massachusetts, asserting that Biogen sought FDA approval “to commercialize ‘BIIB800,’ a proposed biosimilar to Genentech’s drug Actemra®…

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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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Biogen Announces FDA Approval of TOFIDENCE, a Tocilizumab Biosimilar Referencing ACTEMRA

On September 29, 2023, Biogen announced the FDA approval of TOFIDENCE (tocilizumab-bavi) intravenous formulation which is the first tocilizumab biosimilar approved by the FDA in the United States.  TOFIDENCE is approved for the treatment of moderately to severely active rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (PJIA), and systemic juvenile…

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Genentech Files BPCIA Complaint Against Biogen Regarding Tocilizumab

Yesterday, Genentech, Inc., Hoffmann-LaRoche, Inc., and Chugai Pharmaceutical Co., Ltd. (“Genentech”) filed BPCIA litigation against Biogen MA Inc. and Bio-Thera Solutions, Ltd. in the District of Massachusetts.  In its Complaint, Genentech asserts that Biogen is seeking FDA approval “to commercialize ‘BIIB800,’ a proposed biosimilar to Genentech’s drug Actemra® (tocilizumab).”  Genentech…

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Biogen Seeks Preliminary Injunction in Natilizumab BPCIA Litigation – Hearing Scheduled for May 17

In October 2022, we reported that Biogen was seeking a preliminary injunction in its BPCIA case brought in the District of Delaware against Sandoz relating to Sandoz’s proposed multiple sclerosis biosimilar of TYSABRI (natalizumab). The parties completed their briefing on Biogen’s motion in April, and Judge Williams has scheduled a…

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Purple Book Updates

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.  Pursuant to a law enacted in late 2020, a reference product sponsor must provide patent information to FDA for listing in the Purple Book once…

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Biogen Launches BYOOVIZ (ranibizumab) in Canada

On March 1, 2023, Biogen Canada Inc. announced that BYOOVIZTM (ranibizumab injection), a biosimilar to Genentech’s LUCENTIS, is now available in Canada.  BYOOVIZ is an anti-VEGF (vascular endothelial growth factor) therapy approved for the treatment of various eye disorders, including neovascular age-related macular degeneration (AMD).  According to Biogen, AMD accounts…

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Genentech Files Lawsuits Against Biogen and Millennium for Past Royalties on the Cabilly Patents

This week, Genentech filed separate lawsuits against Biogen and Millennium, alleging breach of a license agreement to the Cabilly patents (U.S. Patent No. 6,331,415 and 7,923,221).  The patents are generally directed to processes for producing an antibody or an antibody fragment by transforming a host cell with a first and…

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