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.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Amneal Pharmaceuticals Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9483201-en) on June 25, 2025, and is solely responsible for the information contained therein.