Amneal Pharmaceuticals Inc. has announced positive topline results from a confirmatory clinical study evaluating ADL-018, a proposed biosimilar to XOLAIR® (omalizumab). The study, conducted by Kashiv BioSciences, assessed the efficacy, safety, and immunogenicity of ADL-018 compared to XOLAIR® in patients with Chronic Idiopathic Urticaria or Chronic Spontaneous Urticaria who remained symptomatic despite treatment with H1 antihistamines. Amneal holds exclusive U.S. commercialization rights for the biosimilar, pending FDA approval. A Biologics License Application is expected to be submitted in the fourth quarter of 2025. The results indicate a significant step towards making a biosimilar to XOLAIR® available to U.S. patients.
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