Guangzhou-based Bio-Thera Solutions (SHA: 688177) has entered into a new licensing agreement with Russian firm Pharmapark LLC for BAT2306, a biosimilar of Roche’s Cosentyx (secukinumab). Under the terms of the agreement, Pharmapark will hold exclusive commercialization rights for the drug in Russia and the CIS region.
Bio-Thera will oversee the research, development, manufacturing, and commercial supply of BAT2306. This marks the latest collaboration between the two companies, following previous agreements for BAT2506, a biosimilar of Johnson & Johnson’s Simponi (golimumab), and BAT2206, a biosimilar of Janssen Biotech’s Stelara (ustekinumab).
Preparation for marketing filings in China, the U.S., and the European Union is underway for BAT2306, following the successful completion of a global Phase III clinical trial. Pharmapark will handle regulatory submissions in Russia and the CIS markets.
Secukinumab, the reference product, received its initial approval in China in March 2019 for moderate to severe plaque psoriasis and was subsequently approved for ankylosing spondylitis in April 2020. BAT2306, utilizing an IgG1 kappa subtype monoclonal antibody produced in Chinese hamster ovary cells, specifically targets IL-17A and IL-17A/F, effectively inhibiting the autoimmune inflammatory response mediated by IL-17. Notably, no biosimilar of secukinumab has yet been approved in China. – Flcube.com
