Amgen's Soliris Biosimilar ABP 959 Shows Promise in Phase 3 Trials, Launch Set for 2025

Amgen's Soliris Biosimilar ABP 959 Shows Promise in Phase 3 Trials

Amgen has recently announced positive outcomes from the phase 3 clinical trials of its biosimilar version of Soliris, known as ABP 959. This biosimilar has shown no significant difference from the original Soliris in terms of efficacy, safety, and immunogenicity, particularly in treating paroxysmal nocturnal hemoglobinuria (PNH).

Key Findings from the Phase 3 Trial

The phase 3 trial focused on patients with PNH, a condition characterized by the destruction of red blood cells. ABP 959 was found to be as effective as Soliris in controlling intravascular haemolysis, a critical aspect of PNH, by maintaining lactate dehydrogenase (LDH) levels within normal ranges. The safety profile and the potential for immune response were also comparable between the two treatments.

Regulatory Filing and Launch Timeline

Amgen is preparing to submit ABP 959 for regulatory approval with the FDA. However, the biosimilar will not be available on the market until March 2025. This delay is in accordance with a 2020 agreement between Amgen and Alexion, which resolved litigation over the patents covering Soliris in the United States.

The Significance of ABP 959

David Reese, Amgen's R&D head, emphasized the importance of ABP 959, stating, "The 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." This development is a crucial step towards offering patients more affordable and accessible treatment options for rare diseases.

The Competitive Landscape

Soliris, a complement C5 inhibitor, is a flagship product for AstraZeneca following its acquisition of Alexion. Despite its success, Soliris is nearing the end of its patent-protected life. Alexion has introduced Ultomiris, a longer-acting C5 inhibitor, to sustain the franchise. Meanwhile, Samsung Bioepis is also developing a biosimilar version of Soliris, indicating a competitive future in the treatment of rare diseases.

This advancement in biosimilar development not only promises to enhance patient access to essential therapies but also underscores the ongoing innovation in the pharmaceutical industry aimed at addressing unmet medical needs.