The comparative study met its primary endpoints and showed equivalent efficacy and comparable safety profile in patients with moderate-to-severe rheumatoid arthritis
CAMBRIDGE, Mass. and GUANGZHOU, China -- Biogen Inc. (Nasdaq: BIIB) and Bio-Thera Solutions, Ltd. (688177.SH) today announced results from the Phase 3 study of BAT1806, 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 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 BAT1806 in all countries excluding China (including Hong Kong, Macau and Taiwan).
“We are excited about these results and believe BAT1806 demonstrates equivalence in efficacy and pharmacokinetics as well as a comparable safety and immunogenicity profile to the reference product,” said Ian Henshaw, head of global biosimilars at Biogen. “Biosimilars have the potential to generate cost savings, healthcare sustainability and, if approved, BAT1806 would enable us to bring an additional therapeutic option to patients.”
“We are pleased to report 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,” said Shengfeng Li, Ph.D., chief executive officer at Bio-Thera Solutions. “Bio-Thera is committed to increasing patient access to innovative medicines through the development of high-quality biosimilars.”
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.
About Biosimilars
Biosimilars are biologic products that have been demonstrated to be similar in efficacy, safety and immunogenicity to the originator’s approved reference product, with the advantage that they offer cost savings to healthcare systems. Biosimilars may lower healthcare system costs broadly, creating headroom for innovation and could enable governments to potentially redirect savings to priorities such as increasing access to transformative therapies.
About BAT1806 Phase 3 Trial Design
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. More information regarding the BAT1806 Phase 3 clinical trial, including inclusion and exclusion criteria and primary and secondary outcome measures, can be found here: https://clinicaltrials.gov/ct2/show/study/NCT03830203
Results of the study will be presented at a future medical meeting or summarized in publication.
