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Amgen Reports Positive Results for Soliris Biosimilar

August 25, 2022

Amgen reported positive top-line results from its phase 3 study of its experimental therapy ABP 959, a biosimilar of the complement inhibitor Soliris, in adult patients with the rare bone marrow disorder paroxysmal nocturnal hemoglobinuria.

Photo: David Reese, executive vice president of research and development at Amgen

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, life-threatening condition characterized by intravascular hemolytic anemia, bone marrow failure, and thrombo-embolic episodes, and is associated with a significant increase in mortality, development of arterial and venous thrombo-embolic episodes, visceral organ damage, and rapid deterioration in quality of life. The disease is caused by the expansion of a clone of hematopoietic cells lacking glycosylphosphatidylinositol-anchored membrane proteins, which leads to chronic, complement-mediated intravascular hemolysis.

ABP 959 is an experimental biosimilar candidate to Soliris (eculizumab) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and other indications. It is a monoclonal antibody that specifically binds to the complement protein C5 and inhibits the progression of both the classical and alternative complement cascades. ABP 959 has the same amino acid sequence as eculizumab and equivalent non-clinical pharmacologic function, based on comprehensive bioanalytical assays.

The phase 3 DAHLIA study is a randomized, double-blind, active-controlled, two-period crossover study evaluating the efficacy and safety of ABP 959 compared with Soliris in adult patients with PNH.

Amgen said the study met its primary endpoints, demonstrating no clinically meaningful differences between ABP 959 and Soliris based on the control of intravascular hemolysis as measured by lactate dehydrogenase (LDH) at week 27 for the parallel comparison, and the time-adjusted area under the effect curve (AUEC) of LDH from week 13 to week 27, from week 39 to week 53, and from week 65 to week 79 for the crossover comparison.

The safety and immunogenicity profile of ABP 959 was comparable to Soliris. Amgen said detailed results of this study will be presented at a future medical congress and submitted for publication.

“Today’s positive results with ABP 959 demonstrate similar efficacy, safety, and immunogenicity as the reference product, further highlighting Amgen’s commitment to providing patients with access to high-quality, biologic therapies,” said David Reese, executive vice president of research and development at Amgen.

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