Biogen and Bio-Thera announce positive results from phase III study of BAT 1806, a proposed biosimilar referencing Actemra .

Biogen Inc. and Bio-Thera Solutions, Ltd. announced results from the Phase III study of BAT 1806, a proposed biosimilar referencing Actemra/RoActemra (tocilizumab). The study met its primary endpoints, demonstrating equivalence to the reference medicine in patients with moderate to severe rheumatoid arthritis (RA)inadequately controlled by methotrexate therapy. The primary endpoint in the study was the American College of Rheumatology 20 percent response criteria (ACR20). Actemra/RoActemra’s ( from Genentech/Roche) primary indication is for moderate to severe rheumatoid arthritis in adults as well as juvenile idiopathic polyarthritis, systemic juvenile idiopathic arthritis, giant cell arteritis and cytokine release syndrome. Biosimilars are products that demonstrate similar efficacy and safety to the originator’s reference product, with the advantage that they can be more affordable for patients and healthcare systems. In 2020 global sales of Actemra were 2.8 billion CHF. Biogen has exclusive regulatory, manufacturing and commercial rights to BAT 1806 in all countries excluding China (including Hong Kong, Macau and Taiwan). About BAT 1806 Phase III Trial Design : The BAT 1806 clinical trial was a global, randomized, multicenter, double-blind, parallel-group, Phase III active-control study designed to evaluate the safety, efficacy, immunogenicity and PK of BAT 1806 compared to Actemra/RoActemra in 621 patients with moderate to severe rheumatoid arthritis with inadequate response to methotrexate.