Amgen shares positive late-stage data for AstraZeneca's Soliris biosimilar
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Disclosing topline data from a Phase 3 trial, Amgen (NASDAQ:AMGN) announced Tuesday that ABP 959, a biosimilar candidate to AstraZeneca's (AZN) Soliris, reached the primary endpoints in adults with rare bone marrow disorder, paroxysmal nocturnal hemoglobinuria (PNH).

The DAHLIA study was designed as a randomized, two-period crossover Phase 3 trial to evaluate the safety and efficacy of ABP 959, a monoclonal antibody that inhibits both the classical and alternative complement pathways.
AMGN said that the trial reached the primary endpoints indicating no clinically meaningful differences between ABP 959 and Soliris. The company added that the safety and immunogenicity profile of ABP 959 was comparable to the reference product.
"We look forward to working with regulators to make this potential biosimilar option available to patients," said David M. Reese, Amgen's (AMGN) Vice President of R&D.
The company expects to share the detailed data at a future medical event and submit the results for publication.

Developed by AstraZeneca (AZN) unit Alexion Pharma (AZN) before its acquisition, Soliris generated ~$1.9B in revenue for the Anglo-Swedish pharma giant in 2021.