Amgen Announces Positive Results for Biosimilar Solaris for Paroxysmal Nocturnal Hemoglobinuria

Amgen announced positive topline results from a Phase 3 study evaluating the safety and efficacy of ABP 959 – a biosimilar candidate to Alexion’s Soliris (eculizumab) – in adult patients with paroxysmal nocturnal hemoglobinuria (PNH).

PNH is a rare, acquired, life-threatening blood disorder characterized by intravascular hemolytic anemia, bone marrow failure and thromboembolic episodes, and is associated with significantly increased mortality, development of arterial and venous thromboembolic episodes , damage to visceral organs and a rapid deterioration in the quality of life.

The most widely used drug to treat PNH is Soliris, the first therapy approved for the treatment of PNH patients to reduce haemolysis, and approved for the treatment of PNH patients in nearly 50 countries around the world, including the United States, the EU and Japan.

The Phase 3 DAHLIA study was a randomized, double-blind, active comparator-controlled, two-period, crossover study in adult patients with PNH previously treated with Soliris for at least six months. The study met its primary endpoints, showing that ABP 959 is as effective as Soliris in key measures of disease activity.

ABP 959 demonstrated no ‘clinically significant’ difference compared to Soliris in the control of intravascular haemolysis, based on its effects on lactate dehydrogenase (LDH) levels. Importantly, the safety and immunogenicity profile of ABP 959 was comparable to that of Soliris.

Commenting on the positive results, David Reese, Executive Vice President of Research and Development at Amgen, said, “Today’s positive results with ABP 959 demonstrate similar efficacy, safety and immunogenicity to of the benchmark product, further underscoring Amgen’s commitment to providing patients with access to high-quality biologic therapies. We look forward to working with regulators to make this potential biosimilar option available to patients. »

According to the US Food and Drug Administration (FDA), biosimilars are biologic products that are “very similar and have no clinically significant differences” from an existing FDA-approved reference product. The drugs show no clinically significant differences in safety or effectiveness compared to the reference product, but they have the potential to reduce healthcare costs.

Consistent with this, ABP 959 has the same amino acid sequence as Soliris and has equivalent non-clinical pharmacological function, based on comprehensive bioanalytical testing.

The company announced its intention to present the detailed results of the study at a future medical congress and to submit the results for publication.

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