The agreement covers all 27 countries of the European Union, the UK, Australia, Canada, and New Zealand. Under terms of the agreement, Alvotech will receive an exclusive license to commercialize AVT23, which will be developed and manufactured by Kashiv. Kashiv will receive an upfront payment and is eligible for subsequent milestone payments and royalties.

“We are very pleased to enter into this exclusive development and commercialization agreement for omalizumab. This demonstrates how Alvotech can leverage its platform and pursue attractive markets either by developing and manufacturing products in-house, or through in-licensing. Here, we can deploy Alvotech’s market access expertise as well as leveraging our global commercial partnerships,” said Robert Wessman, chairman and CEO of Alvotech.

“We are delighted to partner commercial rights to our omalizumab biosimilar program to Alvotech, a global biosimilar company, for multiple major geographies. With this exclusive development and commercialization agreement, Kashiv continues to build upon its strong track record of developing and manufacturing high-quality biosimilars for commercial partners worldwide.  We look forward to continued enrollment of patients in our global Phase III clinical study to expand access to this treatment for patients,” said Dr. Sandeep Gupta, CEO of Kashiv.

Omalizumab is a humanized monoclonal antibody that targets free IgE. Xolair, which contains omalizumab, is indicated for diseases such as severe persistent allergic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP) and chronic spontaneous urticaria [1]. Global sales of Xolair in the last twelve months preceding June 30, 2023, were about $3.7 billion [2].