Kashiv Biosciences and Alvotech Enter Exclusive Licensing Agreement for Biosimilar ADL018

Kashiv Biosciences LLC and Alvotech have recently announced an exclusive licensing agreement for ADL018, a proposed biosimilar to Xolair® (omalizumab). This agreement covers several major geographies, including the European Union, the UK, Australia, Canada, and New Zealand.

Under the terms of the agreement, Alvotech will receive an exclusive license to commercialize ADL018, while Kashiv will be responsible for its development and manufacturing. As part of the deal, Kashiv will receive an upfront payment and may be eligible for milestone payments and royalties in the future.

Dr. Sandeep Gupta, CEO of Kashiv Biosciences, expressed his excitement about the partnership, highlighting Kashiv’s commitment to developing high-quality biosimilars for global commercial partners. He also mentioned that Kashiv is actively seeking commercial partners for other major geographies to maximize the potential of ADL018.

Robert Wessman, chairman and CEO of Alvotech, emphasized the company’s ability to leverage its platform and pursue attractive markets through in-licensing and internal development. He mentioned that this agreement allows Alvotech to utilize its market access expertise and global commercial partnerships effectively.

Xolair, the reference product for ADL018, is a humanized monoclonal antibody used to treat severe persistent allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic spontaneous urticaria. With global sales of approximately $3.7 billion in the last twelve months, Xolair has proven to be a significant therapeutic option for patients.

ADL018 is currently in clinical development and has not received regulatory approval in any country. The biosimilarity of ADL018 to Xolair has not been established by regulatory authorities.

Kashiv Biosciences is a fully integrated biopharmaceutical company with expertise in developing biosimilars and other complex products. They have a robust pipeline of biosimilars and other products in development, with manufacturing facilities in the United States and India.

Alvotech, founded by Robert Wessman, is dedicated to the development and manufacture of biosimilar medicines. They aim to be a global leader in the biosimilar space, delivering high-quality and cost-effective products through their integrated approach and strategic commercial partnerships.

The exclusive licensing agreement between Kashiv Biosciences and Alvotech for ADL018 represents a significant step towards expanding access to biosimilar therapies for patients in multiple countries. Both companies are committed to advancing the development and commercialization of ADL018, providing a potential alternative treatment option for patients in need.