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

·1 min read
  • Biogen Inc (NASDAQ: 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 (OTC: 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.

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