Phase 3 Study of Amgen Biosimilar to Eculizumab Meets Primary End Points

Amgen on Wednesday announced that its phase 3 study involving ABP 959, a biosimilar candidate to eculizumab (Soliris), had met its primary endpoints in the DAHLIA study. The biosimilar is being developed for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and other indications.

In its statement, Amgen said that “ABP 959 has the same pharmaceutical form, dosage strength, route of administration, and dosing regimen” as the approved eculizumab in both the United States and the European Union.

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

PNH is a rare bone marrow disorder in which expansion of certain hematopoietic cells that lack a key protein cause the destruction of red blood cells, or hemolysis. This life-threatening disease brings about intravascular hemolytic anemia, bone marrow failure, and thromboembolic episodes. Patients experience arterial and venous thromboembolic episodes, visceral organ damage, rapid deterioration in quality of life, and increased mortality. Eculizumab is a monoclonal antibody that works by binding to a complementary protein to halt the mechanism that drive these effects.

DAHLIA was a phase 3, randomized, double-blind, active-controlled, 2-period crossover study in adult patients with PNH treated with eculizumab for at least 6 months. Patients were randomized 1:1 to receive the biosimilar or reference product in 1 of 2 sequences: (1) the biosimilar was given first, every 14 days for 52 weeks, followed by the reference product, every 14 days for 52 weeks; or (2) treatment followed the same schedule, except the reference product was given first. In the second treatment period, the switch occurred after 26 weeks, at week 79.

Results showed there as no clinically meaningful differences between ABP 959 and Soliris, based on control of intravascular hemolysis and measures of effectiveness at predefined time points, including when patients were switched from one product to the other.

“The safety and immunogenicity profile of ABP 959 was comparable to Soliris,” Amgen said in the statement.

"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, MD, 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."