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Amneal and Kashiv Partner on Omalizumab Biosimilar in US

Jul 1, 2024

On 1 July 2024, Amneal Pharmaceuticals and Kashiv Biosciences announced that they have entered into an exclusive licence agreement for the US in relation to ADL018, biosimilar to Genentech’s and Novartis’ Xolair® (omalizumab).   
ADL018 was developed by Kashiv and is currently in a Phase III clinical trial, commenced in October 2023, in patients with chronic idiopathic/spontaneous urticariaKashiv completed a Phase I clinical trial for ADL018 on 30 June 2023. 
Amneal and Kashiv have previously partnered including in relation to Fylnetra™ (biosimilar pegfilgrastim), which was approved by the FDA on 27 May 2022. 
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.