Bio-Thera Solutions Ltd (SHA: 688177), a China-based biopharmaceutical company, announced that its biosimilar version of Roche Holding AG’s (SWX: ROG) Actemra/RoActemra (tocilizumab), known as BAT1806, has passed review by the US FDA. This milestone marks the approval of BAT1806 for use in the US market to treat a range of conditions, including moderate to severe rheumatoid arthritis and various forms of juvenile idiopathic arthritis, under the trade name Tofidence.
Approval and Indications
Roche’s originator drug, Actemra/RoActemra, has been approved in multiple markets for indications such as 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). The drug functions as an inhibitor of the interleukin-6 receptor, suppressing the immune response. It was included in China’s 10th edition of the COVID-19 Infection Diagnosis and Treatment Plan, highlighting its significance in public health.
Global Partnership and Market Expansion
Switzerland-based Biogen Inc. (NASDAQ: BIIB) signed a deal with Bio-Thera in April 2021 to take development and commercialization rights to BAT1806 in markets outside of Greater China. The drug is currently under marketing review in the EU and was approved in China in January this year, indicating its potential for global impact.
Competition in the Biosimilar Space
In addition to Bio-Thera’s BAT1806, Livzon Pharma’s biosimilar version of tocilizumab is also approved in China, indicating a growing competitive landscape for biosimilar drugs targeting rheumatoid arthritis and related conditions.
Conclusion
The US FDA’s approval of BAT1806 is a significant achievement for Bio-Thera Solutions, expanding access to an affordable and effective treatment option for patients in the US. This development underscores the company’s commitment to advancing biosimilar drugs and enhancing global health outcomes.-Fineline Info & Tech
