• Naomi Pearce, Emily Bristow

Pearce IP BioBlast: w/e 27 November 2020

Significant biosimilar activities this week include:

  • 22 Nov 20: Innovent released results of Ph III trials of Tyvyt® (sintilimab) with Byvasda® (biosimilar bevacizumab) as first-line treatment in patients with Advanced Hepatocellular Carcinoma (HCC).

  • 24 Nov 20, EU: the EMA approved Pfizer's Nyvepria® (biosimilar pegfilgrastim).

  • 24 Nov 20, CA: BGP Pharma received a NOC from Health Canada for Hulio® (biosimilar adalimumab).

  • 24 Nov 20, CN: Alvotech and Alvotech & CCHT Biopharmaceutical announced they have partnered with Yangtze River Pharmaceutical Group to form an exclusive strategic partnership for the commercialisation of eight biosimilar medicines in China. Alvotech and Alvotech & CCHT will be jointly responsible for the development, registration, and supply of biosimilars in China, while Yangtze River Pharmaceutical will exclusively commercialise them. The products will be manufactured in a new biopharmaceutical facility currently being built in Changchun, China through the Alvotech & CCHT partnership.

  • 25 Nov 20, EU: Bio-Thera Solutions announced it has submitted a marketing authorisation application for BAT1706 (proposed bevacizumab biosimilar) in EU.

  • 26 Nov 20: the Centre for Biosimilars reported on Alvotech's global biosimilar strategy. Dr Joseph McClellan, Alvotech's Chief Scientific Officer commented on Alvotech's long-term expansion plans for global biosimilars markets, suggesting that Alvotech will obtain regulatory approvals for multiple products almost simultaneously in multiple countries before launching.

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