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 relating to its proposed bevacizumab biosimilar. Genentech asserts that Centus failed to provide sufficient information for Genentech to complete an analysis of potential patent infringements.
17 Nov 20 | The International Generic and Biosimilar Medicines Association (IGBA) launched the first Global Biosimilars Week.
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 infliximab) 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 some operations by the end of 2022, with full operations to commence in 2023.
19 Nov 20 | Alvotech announced the FDA and EMA have accepted 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 to liquidate their joint venture Archigen Biotech. This JV was created for the development of a rituximab biosimilar. The project has been discontinued due to a perceived lack of commercial viability.