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Teva Pharmaceuticals and Alvotech Announce Update on Strategic Biosimilars Partnership

Tuesday, July 25, 2023

Teva Pharmaceuticals and Alvotech have announced the expansion of their existing strategic partnership agreement.

As part of this expansion, the two companies will continue to collaborate closely on matters related to the pending approval in the United States for AVT02. AVT02 is an interchangeable high-concentration biosimilar candidate for Humira® (adalimumab), a widely used medication for various autoimmune conditions.

With the expanded agreement, Teva will gain exclusive commercialisation rights in the United States for two new biosimilar candidates. Additionally, the expansion covers line extensions of two current biosimilar candidates already included in the partnership. These new biosimilar candidates and line extensions will be developed and manufactured by Alvotech.

The existing strategic partnership agreement between Teva and Alvotech already includes four other biosimilar candidates. One of these candidates is AVT04, a proposed biosimilar for Stelara® (ustekinumab), which is currently awaiting approval from the U.S. Food and Drug Administration (FDA).

AVT02 is a monoclonal antibody that has obtained approval as a biosimilar to Humira® (adalimumab) in various countries worldwide, including the 27 member states of the European Union, Norway, Lichtenstein, Iceland, the UK, Switzerland, Canada, Australia, and Saudi Arabia.

AVT04 is an investigational monoclonal antibody and a biosimilar candidate for Stelara® (ustekinumab). Ustekinumab is known to bind to two cytokines, IL-12 and IL-23, which play crucial roles in inflammatory and immune responses. As of now, AVT04 has not received regulatory approval in any country.



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