Biogen and Bio-Thera Announce Positive Phase 3 Results On Tocilizumab Biosimilar

Biogen Inc. and Bio-Thera Solutions, Ltd. today announced positive Phase 3 results on BAT1806, a proposed biosimilar to ACTEMRA®/RoACTEMRA (tocilizumab). According to the Biogen press release, the study met its primary endpoints, demonstrating equivalent efficacy and comparable safety to the reference product in patients with moderate to severe rheumatoid arthritis inadequately controlled with methotrexate therapy. Biogen’s global head of biosimilars said that the company believes “BAT1806 demonstrates equivalence in efficacy and pharmacokinetics as well as comparable safety and immunogenicity profile to the reference product.” As we previously reported, in April 2021, Biogen and Bio-Thera announced a commercialization and license agreement to develop, manufacture, and commercialize BAT1806. On the basis of the satisfactory Phase 3 results, Biogen will pay $30 million to Bio-Thera. Bio Thera is eligible for additional milestones in the future and Biogen will pay Bio-Thera tiered royalties.