Amgen announces top-line results from biosimilar phase 3 study


Amgen has announced positive top-line results from its DAHLIA study.

This was a randomized, double-blind, active-controlled, two-period crossover phase 3 study evaluating the efficacy and safety of ABP 959, a biosimilar candidate to SOLIRIS (eculizumab), compared with SOLIRIS in adult patients with paroxysmal nocturnal hemoglobinuria (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.

“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 M. Reese, executive vice president of research and development at Amgen. 

“We look forward to working with regulators to make this potential biosimilar option available to patients.”

Detailed results of this study will be presented at a future medical congress and submitted for publication.

Biosimilar portfolio

ABP 959 is being developed as a biosimilar candidate to SOLIRIS, for the treatment of PNH and other indications. ABP 959 has the same pharmaceutical form, dosage strength, route of administration and dosing regimen as licensed eculizumab in the U.S. and European Union.

ABP 959 is currently not available commercially.

Amgen has a total of 11 biosimilars in its portfolio, including five approved in the U.S., three approved in the EU, and three in phase 3 development.

About paroxysmal nocturnal hemoglobinuria

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, life-threatening, bone marrow disorder 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.

About ABP 959

ABP 959 is an investigational 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.

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