Biogen, Bio-Thera: Positive Results From Phase 3 Study

 The comparative study met its primary endpoints and showed equivalent efficacy and comparable safety profile in patients with moderate-to-severe rheumatoid arthritis

 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).

https://finance.yahoo.com/news/biogen-bio-thera-announce-positive-113000165.html