Biosimilar Market Updates: Samsung Biologics, Celltrion, and Alvotech

Samsung Biologics’ third quarter report disclosed that it had suspended its research and development of its SAIT101, a biosimilar of Rituxan.  As we previously reported, the rituximab product was being developed through Archigen Biotech, a joint venture with AstraZeneca.  According to a report in Korea Biomedical Review, a Samsung Biologics representative stated that “Samsung Biologics and AstraZeneca decided to stop commercializing SAIT101 and take steps for the liquidation of Archigen Biotech as we concluded that the product lacks commercial viability after discussing with AstraZeneca.”  There are two other rituximab biosimilars on the market in the US, including Celltrion and Teva’s Truxima (rituximab-abbs) that was approved by the FDA in 2018 and launched in November 2019, and Pfizer’s Ruxience (rituximab-pvvr) that was approved by the FDA in 2019 and launched in January 2020.

During a recent Korea Bio-Industry forum, Celltrion announced its plan to build a third plant in Incheon, Korea.  The plant will allow Celltrion to increase its production capacity from 190,000 liters per year to 250,000 liter per year.  A Celltrion official stated that “[w]ith the construction of the third factory and the research center, we will be able to proactively respond to the rapidly increasing global biopharmaceutical demand, and focus our capabilities on more flexible and efficient biopharmaceutical research in the future.”

Alvotech announced last week that Alvotech hf. and Alvotech & CCHT Biopharmaceutical Co., Ltd. are partnering with Yangtze River Pharmaceutical Group to commercialize eight biosimilars in China.  According to Alvotech’s press release, the “pipeline contains biosimilar candidates for treatment in the fields of autoimmunity, ophthalmology, and oncology, as well for treating severe immune and inflammatory conditions.”  Under the parties’ agreement, Alvotech and Alvotech & CCHT Biopharmaceutical Co., Ltd will conduct development, registration, and supply, while Yangtze River Pharmaceutical will commercialize the biosimilar candidates.