Amgen Announces Positive Data for ABP959, Biosimilar Candidate to Soliris

Study evaluates efficacy, immunogenicity, safety of the product to eculizumab in patients with paroxysmal nocturnal hemoglobinuria.

Amgen announced positive topline results from the DAHLIA (NCT03818607) study, evaluating the efficacy, immunogenicity, and safety of ABP 959, a biosimilar candidate to eculizumab (Soliris; Alexion, AstraZeneca) compared with eculizumab in adults with paroxysmal nocturnal hemoglobinuria (PNH).1

“We look forward to working with regulators to make this potential biosimilar option available to patients,” David Reese, MD, executive vice president of Research and Development at Amgen, said in a statement.1

The active-controlled, double-blind, randomized, 2-period phase 3 study met its primary endpoint, demonstrating no clinically meaningful differences between ABP 959 and eculizumab.1

This was based on the control of intravascular hemolysis as measured by lactate dehydrogenase (LDH) at week 27 for parallel comparison and the time-adjusted area under the effect curve 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.1

Investigators also noted that the immunogenicity and safety profile of both drugs was comparable.1

The study included individuals with PNH who were previously treated with eculizumab for at least 6 months. Investigators randomized individuals 1 to 1 to receive each investigational product in 1 of 2 sequences: either treatment T followed by treatment R or treatment R followed by treatment T.1

The treatment was administered over 2 periods: period 1 was 52 weeks long, and period 2 started at week 53 with a crossover in treatment and was 26 weeks in duration.1

Treatment T consisted of treatment with ABP 959 at a dose of 900 mg intravenously approximately every 14 days, while treatment R consisted of eculizumab at a dose of 900 mg given intravenously approximately every 14 days.1

Detailed results of the study will be presented at a future medical congress and will be submitted for publication.1

ABP 959 is being developed as a biosimilar candidate for eculizumab not only as a treatment of PNH but also for other indications. It has the same dosage strength, dosing regimen, pharmaceutical form, and route of administration as licensed eculizumab in the European Union and the United States.1

ABP 959 is not commercially available.1

Amgen has a total of 11 biosimilars in its portfolio, including 5 that are approved in the United States, 3 that are approved in the European Union, and 3 that are in phase 3 development.1

PNH is a disorder that can lead to premature death and impair the production of blood cells, according to the National Center for Advancing Translational Sciences.2

The disorder is typically diagnosed in young adulthood and has symptoms that include abnormally pale skin, fatigue, increased heart rate, shortness of breath, and weakness.2

Reference

1. Study evaluated the efficacy, safety and immunogenicity of ABP 959 compared to eculizumab in patients with paroxysmal nocturnal hemoglobinuria. News release. Amgen. August 23, 2022. Accessed August 24, 2022. https://wwwext.amgen.com/newsroom/press-releases/2022/08/amgen-announces-positive-topline-results-from-phase-3-study-of-abp-959-biosimilar-candidate-to-soliris-eculizumab

2. Paroxysmal nocturnal hemoglobinuria. National Center for Advancing Translational Sciences. Updated November 8, 2021. Accessed August 24, 2022. https://rarediseases.info.nih.gov/diseases/7337/paroxysmal-nocturnal-hemoglobinuria