On 11 September 2025, Kashiv BioSciences announced that it has entered into a licensing and supply agreement with Brazilian pharmaceutical company, CRISTÁLIA, to bring ADL-018, biosimilar to Novartis’ Xolair® (omalizumab), to the Latin American market.
Under the agreement, Kashiv will handle product development, while CRISTÁLIA is responsible for licensing, distribution, and commercialisation across Latin America. According to IQVIA records, omalizumab generated around $5 billion in global sales in 2024, with approximately $140 million from Latin America, highlighting the region’s growing role in the biologics market.
Kashiv has previously entered into agreements for commercialisation of ADL-018 in other regions, including with 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.
Omalizumab biosimilars are also under development by Celltrion, Aurobindo, Teva and Glenmark. On 10 September 2025, Celltrion confirmed that Omlyclo®/CT-P39 (omalizumab) is set to be launched in Europe later in 2025, securing ‘first mover advantage’. Omlyclo® is approved in the EU (May 2024), Korea (June 2024), Australia (November 2024), Canada (December 2024), the US (March 2025) and New Zealand (April 2025). It has been the subject patent infringement actions in at least the UK and Europe.