Kashiv BioSciences Announces Positive Topline Results for ADL-018, Biosimilar Candidate to XOLAIR®.

Kashiv BioSciences announced positive topline results from a confirmatory clinical efficacy and safety trial for ADL-018, a proposed biosimilar to XOLAIR (omalizumab). The study achieved its primary and secondary endpoints, establishing equivalence of therapeutic endpoints and comparable safety between ADL-018 and XOLAIR. A total of 600 patients were enrolled, and efficacy and safety were evaluated in 400 patients. The primary efficacy measure was the change from baseline in the weekly Itch Severity Score (ISS7) at Week 12. The results mark a positive advancement for Kashiv's growing biosimilar pipeline and are expected to be filed with the FDA in Q4 2025.

Kashiv BioSciences, LLC has announced positive topline results from a confirmatory clinical efficacy and safety trial for ADL-018, a proposed biosimilar to XOLAIR (omalizumab). The study, which enrolled 600 patients and evaluated 400 patients, achieved its primary and secondary endpoints, establishing equivalence of therapeutic endpoints and comparable safety between ADL-018 and XOLAIR. The primary efficacy measure was the change from baseline in the weekly Itch Severity Score (ISS7) at Week 12.

The positive results represent a significant advancement for Kashiv's growing biosimilar pipeline and are expected to be filed with the FDA in the fourth quarter of 2025. ADL-018, developed by Kashiv in collaboration with Amneal Pharmaceuticals, is poised to be among the first wave of biosimilars in the $3.9 billion U.S. omalizumab market, making it an important growth driver for both companies [1].

Amneal Pharmaceuticals, which holds exclusive U.S. commercialization rights for ADL-018 pending regulatory approval, is expanding its biosimilars portfolio. The company aims to commercialize six biosimilars across eight product presentations by 2027. Sean McGowan, Senior Vice President of Biosimilars and Branded Oncology at Amneal, stated, "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 U.S. patients" [1].

The study, conducted by Kashiv, was a randomized, double-blind, multicenter trial assessing the efficacy, safety, and immunogenicity of ADL-018 compared to XOLAIR in patients with Chronic Idiopathic Urticaria (CIU) or Chronic Spontaneous Urticaria (CSU) who remained symptomatic despite treatment with H1 antihistamines. Participants received subcutaneous doses of either 150 mg or 300 mg every four weeks for a 24-week period.

The UK Medicines and Healthcare Products Regulatory Agency has already accepted the marketing authorization application for ADL-018, indicating progress towards regulatory approval and commercialization in key markets. This milestone strengthens Kashiv's market presence and potential for future collaborations aimed at increasing patient access to important treatments.

References:
[1] https://www.globenewswire.com/news-release/2025/06/25/3105002/0/en/Amneal-Highlights-Positive-Topline-Results-from-Confirmatory-Clinical-Study-of-Biosimilar-Candidate-to-XOLAIR-R-omalizumab-Developed-by-Kashiv-BioSciences.html