Significant biosimilar activities this week include:

  • 15 Nov 20, US: Genentech filed a complaint against Centus Biotherapeutics, Fujifilm Kyowa Kirin Biologics, Fujifilm Corp and Kyowa Kirin in the Eastern District of Texas, relating to 10 Genentech licensed or owned patents to bevacizumab. Genentech also asserts patent dance aberrations.

  • 17 Nov 20: Pulse News reported Celltrion's Q3 2020 earnings have increased 46.4% from the same period last year. This success has been attributed to sales of its HIV drug, and strong demand for biosimilars including Remsima® (biosimilar inflixima) and Truxima® (biosimilar trastuzumab).

  • 18 Nov 20: Samsung Bioepis and Biogen announced the FDA has accepted for review the BLA for SB11 (proposed ranibizumab biosimilar).

  • 18 Nov 20: Samsung Biologics began construction of the world's largest biopharmaceutical manufacturing facility in Incheon, South Korea. The plant is expected to commence operations by the end of 2022, and to be fully operational from 2023.

  • 19 Nov 20: Alvotech announced the FDA and EMA have accepted its regulatory submissions for AVT02 (proposed adalimumab biosimilar). Approval is expected in the US in September 2021 and Q4 2021 in the EU.

  • 19 Nov 20: Korean Biomedical Review reported Samsung Biologics and AstraZeneca will liquidate their joint venture Archigen Biotech and discontinue the development of SAIT101, a rituximab biosimilar. The project was discontinued due to a perceived lack of commercial viability.