Tagged as: Biogen

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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FDA Accepts Biogen’s aBLA for Tocilizumab

On December 9, 2022, Biogen announced that the FDA has accepted for review an aBLA for BIIB800, Biogen’s tocilizumab biosimilar candidate.  BIIB800 references Genetech’s ACTEMRA product, which is an anti-interleukin-6 receptor monoclonal antibody indicated for moderate to severe rheumatoid arthritis in adults as well as juvenile idiopathic polyarthritis and systemic…

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Biogen Seeks a Preliminary Injunction in Natalizumab BPCIA Case Against Sandoz

Biogen seeks a preliminary injunction in its BPCIA case against Sandoz related to Sandoz’s proposed biosimilar of TYSABRI (natalizumab).  On October 20, 2022, the Court issued a sealed order on the parties’ joint stipulation and proposed schedule for a preliminary injunction motion.  A redacted version of the parties’ proposed schedule…

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Biogen Announces EMA Acceptance of Tocilizumab Biosimilar Application

Biogen Inc. (“Biogen”) recently announced that the European Medicines Agency (EMA) has accepted the marketing authorization application for BIIB800 (BAT1806), a biosimilar candidate referencing Roche’s ACTEMRA (tocilizumab).  ACTEMRA, an anti-interleukin-6 receptor monoclonal antibody, is approved in Europe as an intravenous formulation for severe, active and progressive rheumatoid arthritis, juvenile idiopathic polyarthritis, active…

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Biogen Files Sealed Complaint Against Sandoz and Polpharma Biologics Regarding Natalizumab

On September 9, 2022, Biogen filed a complaint in the District of Delaware against Sandoz and Polpharma Biologics.  Biogen’s complaint is filed under seal.  Based on the list of 28 asserted patents, the case appears to be a BPCIA litigation related to Sandoz and Polpharma’s proposed natalizumab biosimilar.  The asserted…

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Supreme Court Cert Petitions on Skinny Label Inducement and Written Description Issues

On July 11, 2022, Teva filed a cert petition with the Supreme Court, seeking review of the Federal Circuit’s split per curiam opinion holding that Teva’s label for its generic drug Coreg induced doctors to infringe a GSK method-of-use patent, despite having a “skinny” label carving out the sole patented…

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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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Q1 2022 Earnings Roundup: Biologics and Biosimilars Update

Below are some highlights from first quarter 2022 earnings reports recently released by biologics and biosimilars companies: Biogen:  Last week, Biogen reported total quarterly revenues of $2,532 million, and biosimilar revenue of $194 million decreased 5% versus the prior year.  As reflected by the assumption in the Company’s Full Year…

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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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