Kashiv BioSciences has entered a partnership with Brazilian biopharmaceutical firm CRISTÁLIA to facilitate the marketing of ADL-018/Omalizumab, a proposed biosimilar to Genentech and Novartis’ Xolair, across Latin America (LATAM).

Kashiv will oversee the development of ADL-018 within the specified territories, while CRISTÁLIA will manage licensing, distribution and commercialisation efforts in the region.

CRISTÁLIA chairman Dr Ogari Castro Pacheco stated: “We are thrilled to have entered a partnership with Kashiv for the licensing of Omalizumab biosimilars in the LATAM region.

“CRISTÁLIA is confident that this molecule will be a key asset to our biosimilars portfolio and as part of our company strategy to expand patient access to high-quality, affordable treatments in the future.”

The humanised monoclonal antibody Omalizumab is aimed at free immunoglobulin E (IgE).

The original medication, Xolair, is used to treat conditions such as chronic idiopathic urticaria, severe persistent allergic asthma, immunoglobulin E-mediated food allergies and chronic rhinosinusitis with nasal polyps.

ADL-018 is still under investigation and has not been approved by any regulatory body.

Its biosimilarity to Xolair has not been officially established.

Kashiv BioSciences CEO Dr Sandeep Athalye stated: “CRISTÁLIA is an ideal partner to commercialise ADL-018 across Latin America, supporting Kashiv’s mission to expand its biosimilar portfolio and increase global access. We look forward to CRISTÁLIA bringing our omalizumab biosimilar to patients in this important region.”

In August 2025, Kashiv announced a similar agreement with MS Pharma for the Middle East and North Africa region.

In 2024, Xolair secured approval from the US Food and Drug Administration to treat multiple food allergy reactions.