Kashiv BioSciences has reported encouraging topline outcomes from the randomised confirmatory trial of the proposed biosimilar to Novartis’ Xolair (omalizumab), ADL-018.
The multicentre, double-blind study aimed to evaluate the safety and efficacy of the biosimilar in comparison to the reference product Xolair in individuals with chronic idiopathic urticaria (CIU) or chronic spontaneous urticaria (CSU).
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
These subjects remained symptomatic in spite of H1 antihistamine treatments.
The primary and secondary goals were met in the trial, demonstrating equivalence in therapeutic endpoints, as well as comparable safety profiles between the biosimilar and the reference.
Subjects received subcutaneous doses of either 150mg or 300mg every four weeks over 24 weeks.
The company noted that a total of 600 subjects were enrolled in the study. The efficacy and safety were assessed in 400 people receiving a confirmatory dose of 300mg.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataThe change from baseline in the weekly Itch Severity Score (ISS7) at Week 12 was the primary efficacy measure assessed between the biosimilar’s and reference product’s treatment groups.
Kashiv plans to file a biologics licence application (BLA) with the US Food and Drug Administration (FDA) in the fourth quarter of this year.
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has already accepted the marketing authorisation application (MAA) for the biosimilar, and a filing with the European Medicines Agency (EMA) is anticipated in the same timeframe.
A humanised monoclonal antibody, ADL-018, blocks the binding of IgE to FcεR on mast cells and basophils.
Alvotech and Kashiv, along with Amneal Pharmaceuticals, have partnered for the development of this biosimilar, known as AVT23 by Alvotech and ADL-018 by Kashiv BioSciences and Amneal.
Kashiv BioSciences CEO Dr Sandeep Athalye said: “We look forward to collaborating with regulatory authorities to make this treatment available to patients. We remain focused on delivering cost-effective, high-quality therapies to improve patient outcomes globally, working with commercial partners, including Amneal, Alvotech, and Advanz Pharma.”
