In preparation for anticipated 2026 launches in the US for an omalizumab biosimilar, we are monitoring the developments of some of the leading candidates. Top-line, preliminary phase 3 results were released June 25 by partners Amneal Pharmaceuticals and Kashiv Biosciences for ADL-018, their progressing omalizumab biosimilar.
In their double-blinded, randomized clinical efficacy and safety trial of ADL-018, clinical outcomes did not differ significantly with those of the reference product Xolair.
Six hundred patients with chronic idiopathic urticaria or chronic spontaneous urticaria who remained symptomatic despite treatment with antihistamines took part in this phase 3 investigation, and 400 patients were evaluated for the safety and efficacy endpoints at the 300-mg dose. The primary efficacy endpoint was change (from baseline) in the weekly itch severity score by week 12.
According to their press release, Kashiv expects to submit its 351(k) application to the FDA in the fourth quarter of 2025. Celltrion’s Omyldo was the first omalizumab biosimilar to obtain FDA approval (in March 2025), and at least two other manufacturers have active clinical development programs. Celltrion hopes to launch in the third quarter of 2026.
Sean McGowan, Senior Vice President, Biosimilars and Branded Oncology at Amneal Pharmaceuticals, said, “Pending FDA approval, we believe this will be a key addition to our biosimilars portfolio and part of our broader strategy to commercialize six biosimilars across eight product presentations by 2027.”
