China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the market approval filing of BAT1806, a biosimilar version of Roche Holding AG’s (SWX: ROG) Actemra/RoActemra (tocilizumab). The CHMP’s recommendation paves the way for the drug’s approval to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19 in the European Union.
Roche’s Actemra/RoActemra, the originator drug, has been approved in multiple markets for various indications, including pediatric juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, giant cell arteritis, and CAR-T cell-induced cytokine release syndrome, in addition to rheumatoid arthritis (RA). It functions as an interleukin-6 receptor inhibitor, modulating the immune response. The drug was included in China’s 10th edition of the COVID-19 Infection Diagnosis and Treatment Plan for its potential use in treating severe COVID-19 cases.
In April 2021, Switzerland-based Biogen Inc. (NASDAQ: BIIB) entered into an agreement with Bio-Thera to secure development and commercialization rights for BAT1806 in markets outside of Greater China. The biosimilar has received regulatory approvals in China and the US in January and October 2023, respectively.- Flcube.com
