Pharma Focus Europe

Alvotech and Kashiv Biosciences Establish Exclusive Licensing Agreement for Development and Commercialization of Proposed Xolair® (Omalizumab) Biosimilar

Wednesday, October 04, 2023

Alvotech (NASDAQ: ALVO) and Kashiv Biosciences LLC have recently announced an exclusive licensing agreement for AVT23 (also known as ADL018), a potential biosimilar to Xolair® (omalizumab), which is currently undergoing clinical development.

This agreement encompasses all 27 European Union countries, the UK, Australia, Canada, and New Zealand. Under the terms of the deal, Alvotech will gain an exclusive license to commercialize AVT23, which will be developed and produced by Kashiv. Kashiv will receive an upfront payment and will also be eligible for milestone payments and royalties.

Robert Wessman, Chairman and CEO of Alvotech, expressed his satisfaction with this development, highlighting how Alvotech's platform allows them to enter attractive markets through in-house development or licensing agreements. He emphasized the use of Alvotech's market access expertise and global commercial partnerships.

Dr. Sandeep Gupta, CEO of Kashiv, shared his enthusiasm for the partnership and their commitment to expanding access to omalizumab biosimilars through global Phase III clinical studies.

Omalizumab is a humanized monoclonal antibody that targets free IgE and is utilized in conditions such as severe persistent allergic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and chronic spontaneous urticaria. Xolair, which contains omalizumab, had global sales of approximately $3.7 billion in the twelve months leading up to June 30, 2023.

AVT23 is a proposed biosimilar to Xolair (omalizumab). It is still in the investigational stage and has not received regulatory approval in any country. Regulatory authorities have not yet confirmed its biosimilarity.

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