Amgen Touts Positive Data From Soliris-Based Biosimilar For Rare Blood Disorder

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  • Amgen Inc AMGN has announced topline results from the DAHLIA study crossover Phase 3 study of ABP 959, a biosimilar candidate to Soliris (eculizumab) in paroxysmal nocturnal hemoglobinuria (PNH).
  • PNH is a rare blood disorder characterized by the destruction of red blood cells, blood clots, and impaired bone marrow function.
  • Soliris was a centerpiece for Alexion's $39 billion takeover by AstraZeneca Plc AZN.
  • The study demonstrated no clinically meaningful differences between ABP 959 and Soliris based on the control of intravascular hemolysis. 
  • The safety and immunogenicity profile of ABP 959 was comparable to Soliris.
  • Detailed results of this study will be presented at a future medical congress and submitted for publication.
  • Amgen has 11 biosimilars in its portfolio, including five approved in the U.S., three approved in the EU, and three in Phase 3 development.
  • Price Action: AMGN shares are down 1.13% at $244.11 on the last check Tuesday.
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