China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced that a Biologic License Application (BLA) for its BAT1806, a biosimilar version of Roche Holding AG’s (SWX: ROG) Actemra/RoActemra (tocilizumab), has been accepted for review by the European Medicine Agency (EMA). This marks a significant step forward in the global development and potential commercialization of the biosimilar.
Roche’s Tocilizumab and Market Indications
Roche’s originator version of tocilizumab, marketed under the brand name RoActemra/Actemra, has been approved in multiple markets for various indications. These include pediatric juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, giant cell arteritis, and CAR-T cell-induced cytokine release syndrome, in addition to rheumatoid arthritis. The drug is an inhibitor of the interleukin-6 (IL-6) receptor and acts to suppress the immune response.
Global Development and Commercialization Rights
In April 2021, Biogen signed an agreement with Bio-Thera to take over the development and commercialization rights to BAT1806 in markets outside of Greater China. This deal granted Biogen exclusive rights to the drug worldwide, except for the Greater China region, which includes mainland China, Hong Kong, Macau, and Taiwan.
Future Outlook
The acceptance of the BLA for BAT1806 by the EMA underscores Bio-Thera Solutions’ commitment to advancing biosimilar therapies and expanding its global footprint. If approved, BAT1806 could offer a more accessible treatment option for patients with various inflammatory and autoimmune conditions.-Fineline Info & Tech
