Eculizumab is used to treat paroxysmal nocturnal hemoglobinuria (PNH), 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.
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."
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
BioRationality: How Developers Can Expand Their Monoclonal Antibody Biosimilar Portfolio
March 24th 2025Monoclonal antibodies lead biosimilar approvals because of their large market size, well-defined regulatory pathways, and technological feasibility, whereas other biologics encounter development challenges but may see increased adoption as regulatory frameworks advance.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Biosimilar Cases to Watch: Prolia/Xgeva and Denosumab Competitors
March 11th 2025The denosumab biosimilar market is poised for disruption with 3 FDA-approved biosimilars, at least 5 awaiting approval, and launches anticipated to start in May 2025, while ongoing patent litigation continues to shape the competitive landscape.