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

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.