Alvotech Licenses Biosimilar Development and Commercialization Rights for Xolair Candidate

Biotechnology company Alvotech has entered into an exclusive licensing agreement with U.S.-based Kashiv BioSciences for the development and commercialization of AVT23, a proposed biosimilar to Xolair® (omalizumab). The deal covers significant global markets.

The agreement grants Alvotech exclusive rights to commercialize AVT23 across all 27 European Union countries, the UK, Australia, Canada, and New Zealand. Kashiv BioSciences will be responsible for the development and manufacturing of the drug candidate. Alvotech's Chairman and CEO, Robert Wessman, stated the agreement highlights the company's strategy of leveraging its platform and pursuing attractive markets through in-licensing.

Omalizumab is a monoclonal antibody used to treat conditions including severe allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic spontaneous urticaria. The original drug, Xolair, generated approximately $3.7 billion in global sales in the twelve months preceding June 30, 2023.

Kashiv BioSciences CEO, Dr. Sandeep Gupta, expressed enthusiasm for the partnership and noted the ongoing Phase III clinical study aims to expand patient access to the treatment.

AVT23 is an investigational compound and has not yet received regulatory approval in any country. Financial terms of the deal were not disclosed but include an upfront payment to Kashiv, with potential for subsequent milestone payments and royalties.