Kashiv BioSciences, LLC (Kashiv), a US-based vertically integrated biopharmaceutical company, has entered into a licensing and supply agreement with CRISTÁLIA, one of Brazil’s leading pharmaceutical companies, to commercialize ADL-018 / bOmalizumab, a proposed biosimilar to Xolair, in Latin America (LATAM). In 2024, global sales of Xolair were estimated at $5 billion, with the LATAM market contributing around $140 million, according to IQVIA.

Under the agreement, Kashiv will oversee the development of ADL-018 in the defined territories, while CRISTÁLIA will manage licensing, distribution, and commercialization across the LATAM region.

Commenting on the partnership, Dr. Sandeep Athalye, CEO of Kashiv BioSciences, said, “CRISTÁLIA is an ideal partner to commercialize ADL-018 across Latin America, supporting our mission to expand the biosimilar portfolio and increase global access. We look forward to CRISTÁLIA bringing our omalizumab biosimilar to patients in this important region.”

Dr. Ogari Castro Pacheco, chairman of CRISTÁLIA, added, “We are thrilled to partner with Kashiv on licensing omalizumab biosimilars in the LATAM region. This molecule will be a key addition to our biosimilars portfolio and aligns with our strategy to expand patient access to high-quality, affordable treatments.”

ADL-018 is a proposed biosimilar to Xolair (omalizumab), a humanized monoclonal antibody that targets free immunoglobulin E (IgE). Xolair is currently indicated for chronic idiopathic or spontaneous urticaria, severe persistent allergic asthma, chronic rhinosinusitis with nasal polyps, and IgE-mediated food allergies. ADL-018 remains an investigational product and has not yet received regulatory approval in any country.

Kashiv BioSciences is among the few US-based companies to both manufacture and receive marketing authorization for multiple biosimilars, with a portfolio spanning commercial and advanced clinical-stage assets. CRISTÁLIA, with over 50 years in the Brazilian market, is a privately owned biopharmaceutical company recognized for its work in discovery, development, manufacturing, and commercialization of life-saving treatments across Latin America.