Biogen Inc. and Bio-Thera Solutions, Ltd. announced results from the Phase 3 study of BAT1806, a proposed biosimilar referencing ACTEMRA®/RoACTEMRA®. The study reached its primary endpoints, indicating equivalence to the reference medicine in patients with moderate to severe rheumatoid arthritis inadequately controlled by methotrexate therapy. The primary endpoint in the study was the American College of Rheumatology 20% response criteria.
The primary indication of ACTEMRA/RoACTEMRA 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 show similar efficacy and safety to the originator’s reference product, with the advantage that they can be more affordable for patients and healthcare systems.
Biogen Inc and Bio-Thera announced a commercialization and license agreement in April 2021 to develop, manufacture and commercialize BAT1806. Biogen Inc will make a payment of $30 million to Bio-Thera Solutions. Bio-Thera Solutions will be eligible to receive potential milestone payments. Biogen will also pay Bio-Thera Solutions tiered royalties.
Shengfeng Li, PhD, chief executive officer at Bio-Thera Solutions said that the results were pleasing on our third proposed biosimilar with positive Phase 3 study results. These results demonstrate the potential of our proposed tocilizumab biosimilar to be a safe and effective treatment. Bio-Thera is committed to increasing patient access to innovative medicines through the development of high-quality biosimilars.