On 26 September 2025, Amneal Pharmaceuticals announced that it submitted a Biologics License Application (BLA) to the US FDA for ADL-018 (omalizumab), biosimilar to Novartis’ Xolair®.
ADL-018 was developed by Kashiv Biosciences, with Amneal holding exclusive US commercialisation rights for the product under a July 2024 licensing agreement.
Kashiv has also entered into agreements for the commercialisation of ADL-018 in other regions, including with CRISTÁLIA for LATAM markets (August 2025), MS Pharma for MENA markets (August 2025) and Alvotech for the EU, UK, Australia, Canada and New Zealand (AVT23, October 2023). A marketing application for AVT23 was accepted by the UK’s MHRA in March 2025.
Kashiv commenced Phase III trials of ADL-018 in October 2023 (patient enrolment completed in July 2024) in patients with chronic idiopathic/spontaneous urticaria following completion of Phase I trials in June 2023.
On 19 September 2025, Celltrion announced that it will begin the European launch of its biosimilar omalizumab, Omlyclo®, in Norway. Omalizumab biosimilars are also being developed by Aurobindo, Teva and Glenmark.