Pearce IP BioBlast: w/e 02 October 2020

Significant biosimilar activities this week include:

  • 28 Sep 20: Innovent announced its ph III trial of Byvasda® (proposed bevacizumab biosimilar) in combination with Tyvyt® (sintilimab) met its primary endpoints of progression-free survival and overall survival.  Innovent reported that the safety profile of both products was consistent with previously reported studies, and no new safety signals were identified. 
     

  • 28 Sep 20, US: the Alliance of Community Health Plans (ACHP) released a new report 'Health Care 2030: ACHP's Roadmap to Reform' which calls for nonpartisan and practical changes to the American healthcare system.  Among these proposed changes, ACHP has called for reforms to IP laws which are used to block the launch of biosimilar drugs, the promotion of FDA approval and clinical adoption of more biosimilars.
     

  • 29 Sep 20, EU: Centus Biotherapeutics announced it has received EC marketing authorisation for Equidacent® (biosimilar bevacizumab).  Equidacent® has been exclusively licensed to Fujifilm Kyowa Kirin Biologics on a worldwide basis.
     

  • 30 Sep 20, US: California's Governor Gavin Newsom signed legislation to lower the cost of prescription drugs.  The legislation, SB852, allows the California Health and Human Services Agency (CHHS) to develop manufacturing partnerships to produce or distribute generic prescription drugs.  
     

  • 30 Sep 20: the University of Oxford announced it has commenced ph II trials of adalimumab as a treatment for patients with COVID-19.  The trial will enrol up to 750 patients from community care settings throughout the UK and is funded by the COVID-19 Therapeutics Accelerator, an initiative set up by Wellcome and Mastercard.  The trial will assess Hyrimoz® (biosimilar adalimumab), developed by Sandoz.
     

  • 01 Oct 20, AU: Lupin received approval for biosimilar etanercept in Australia under the trade names Etera® and Rymti® in PFS presentations.  

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Biosimilars Bulletin 

October 4, 2020

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