Pearce IP BioBlast: w/e 05 June 2020

Significant biosimilar activities this week include:

  • May 29: in a filing to the Securities and Exchange Commission, Alexion announced it has settled its eculizumab dispute with Amgen. Under the agreement, Amgen will receive a non-exclusive, royalty-free license to market its product from 01 March 2025.
     

  • May 31: Henlius Biotech announced it has received a positive CHMP opinion, recommending marketing authorisation for HLX02 (proposed trastuzumab biosimilar).
     

  • June 01: Revance Therapeutics and Mylan announced they would move forward with their development of a Botox® biosimilar. Revance and Mylan first signed a collaboration and license agreement for the development of a Botox biosimilar in February 2018.
     

  • June 03: LiveMint reported that Aurobindo Pharma announced it would sell its biosimilars business to its wholly owned subsidiary, CuraTeQ Biologics in 2019/20 Q4 earnings call.
     

  • June 04: Mylan and Lupin announced EMA marketing authorisation for Nepexto® (etanercept) for all indications of the reference product Enbrel®.
     

  • June 04: Bloomberg Law reported on the ongoing US Court of Appeals for the Federal Circuit dispute between Genentech and Amgen regarding bevacizumab. In a hearing on 3 June 2020, Genentech asked the Court to prevent Amgen selling its biosimilar bevacizumab Mvasi® to new patients, despite the trial Court refusing to prevent Amgen's launch, and the US Court of Appeals refusing to injunct Amgen early in the appeal.  Decision reserved.

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Biosimilars Bulletin 

November 9, 2020

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