08:46 AM EDT, 06/25/2025 (MT Newswires) -- Amneal Pharmaceuticals ( AMRX ) said Wednesday its clinical trial evaluating a proposed biosimilar to Xolair for patients with chronic idiopathic urticaria, a skin disease, achieved its primary and secondary endpoints.

The confirmatory clinical efficacy and safety trial evaluating ADL-018 achieved the endpoints by establishing equivalence of therapeutic endpoints and comparable safety between ADL-018 and XOLAIR, the company said.

"We are pleased with the positive phase 3 results for ADL-018, which represents an important step towards making a biosimilar to XOLAIR available to US patients," said Sean McGowan, senior vice president, Biosimilars and Branded Oncology at Amneal Pharmaceuticals ( AMRX ).

A biologics license application is expected to be submitted to the US Food and Drug Administration in Q4. Amneal holds exclusive US commercialization rights for the product, pending regulatory approval, the biopharmaceutical said.