On 25 July 2024, Kashiv BioSciences announced completion of patient enrolment in a Phase III trial of ADL018, its biosimilar to Genentech’s and Novartis’ Xolair® (omalizumab). The study aims to compare ADL018 and Xolair® in terms of efficacy, safety, tolerability, and immunogenicity in patients with chronic idiopathic/spontaneous urticaria (CSU) who remain symptomatic following H1 antagonist treatment.
Kashiv completed a Ph I clinical trial for ADL018 on 30 June 2023. On 1 July 2024, Kashiv and Amneal Pharmaceuticals announced they had entered into an exclusive licence agreement for the US in relation to ADL018. In October 2023, Alvotech announced that it had entered an exclusive licensing agreement with Kashiv for ADL018 (AVT23) in the EU, UK, Australia, Canada, and New Zealand.