Biogen Inc. (BIIB) and China’s Bio-Thera Solutions, Ltd. announced Tuesday results from the Phase 3 study of BAT1806, a proposed biosimilar referencing ACTEMRA/RoACTEMRA (tocilizumab). Biosimilars are products that demonstrate similar efficacy and safety to the originator’s reference product and are cheaper.
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 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.
Biogen and Bio-Thera announced a commercialization and license agreement in April 2021 to develop, manufacture and commercialize BAT1806.
As satisfactory results were met, Biogen will make a payment of $30 million to Bio-Thera Solutions. Should certain commercial milestones be achieved, Bio-Thera Solutions will be eligible to receive potential milestone payments. Biogen will also pay Bio-Thera Solutions tiered royalties.
The BAT1806 clinical trial was a global, randomized, multicenter, double-blind, parallel-group, Phase 3 active-control study designed to evaluate the safety, efficacy, immunogenicity and PK of BAT1806 compared to ACTEMRA/RoACTEMRA in 621 patients with moderate to severe rheumatoid arthritis with inadequate response to methotrexate.
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