Tagged as: biosimilars

Litigation Update: Genentech’s Motion to Dismiss Amgen’s Counterclaims Denied in Avastin Biosimilar Litigation

On February 11, 2020, in the Biogen v. Amgen BPCIA litigation regarding MVASI (bevacizumab-awwb), Amgen’s biosimilar of AVASTIN, Judge Colm Connolly of the Delaware District Court denied most of Genentech’s motion to dismiss Amgen’s affirmative defenses and counterclaims.  Amgen had pled counterclaims seeking declaratory judgments that the asserted patents are…

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Biosimilars Update: Bio-Thera Solutions BAT1706 (bevacizumab) and Pfizer RUXIENCE (rituximab)

Below are a few biosimilar-related updates from the past week. Bio-Thera Solutions announced that in a Phase III clinical trial of BAT1706 (bevacizumab), BAT1706 met its primary endpoint, demonstrating “equivalence in overall response rate (ORR) for the first-line treatment of patients with non-squamous non-small cell lung cancer.”  Bio-Thera indicated that…

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Biosimilar and Biologic Business Developments Update – Collaborations and Licensing Deals

Last week, Almirall signed an agreement with WuXi Biologics to collaborate on multiple bispecific antibodies targeting dermatology conditions, including atopic dermatitis. Almirall’s press release indicated that, “[u]nder the terms of the agreement, Almirall has access to WuXi Biologics’ proprietary antibody platforms including WuXiBody™ to discover multiple novel bispecific antibodies.” This…

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World Health Organization (“WHO”) Prequalifies Biosimilar Trastuzumab – WHO’s First Biosimilar

Today, the World Health Organization (“WHO”) prequalified Samsung Bioepis’s breast cancer biosimilar trastuzumab – WHO’s first biosimilar prequalification.  Prequalification is “a service provided by WHO to assess the quality, safety and efficacy of those products that address global public health priorities.”  The WHO noted that the global average price of…

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Biosimilar Development Updates

Below are some recent highlights of biosimilar news: On August 20th, two companies announced that they had launched competing biosimilars of Eli Lilly’s FORSTEO (teriparatide) in Europe.  First, Gedeon Richter announced that it launched TERROSA in Europe after it received approval from the European Commission.  According to the announcement, the…

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