Biogen, Bio-Thera's Biosimilar Referencing Tocilizumab Meets Primary Endpoints In Late-Stage Study

  • Biogen Inc BIIB and China's Bio-Thera Solutions Ltd have announced results from the Phase 3 study of BAT1806, a proposed biosimilar referencing Roche Holding's RHHBY 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.
  • ACTEMRA/RoACTEMRA's primary indication is for moderate to severe rheumatoid arthritis in adults and juvenile idiopathic polyarthritis, systemic juvenile idiopathic arthritis, giant cell arteritis, and cytokine release syndrome.
  • As satisfactory results were met, Biogen will make a payment of $30 million to Bio-Thera Solutions.
  • The BAT1806 clinical trial was designed to evaluate the safety, efficacy, immunogenicity, and PK of BAT1806 compared to ACTEMRA/RoACTEMRA in 621 patients.
  • Price Action: BIIB shares are down 0.80% at $265.34 during the market session on the last check Tuesday.
Market News and Data brought to you by Benzinga APIs
Posted In: BiotechNewsHealth CareContractsGeneralBriefsPhase 3 Trial
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!