Teva and Alvotech Expand Biosimilar Partnership for US Market

Teva Pharmaceuticals and Alvotech have expanded their strategic partnership, focusing on the commercialization of biosimilar medicines in the United States. Teva will gain exclusive rights to market two new biosimilar candidates and line extensions of two existing candidates developed and manufactured by Alvotech.

The expanded agreement includes milestone payments, contingent upon product approvals and significant sales targets. Teva and Alvotech will share profits generated from the commercialization of these biosimilars. Teva will also increase its involvement in Alvotech's manufacturing and quality operations, providing on-site support at Alvotech's Iceland facility for upcoming regulatory inspections.

In addition to the commercial partnership, Teva will invest $40 million in subordinated convertible bonds issued by Alvotech. These funds are earmarked to support Alvotech's ongoing development of its biosimilar pipeline. The companies continue to collaborate closely on the US approval processes for AVT02, a biosimilar candidate for Humira, and AVT04, a biosimilar candidate for Stelara.

Alvotech is preparing for anticipated pre-approval inspections by the U.S. Food and Drug Administration (FDA). Alvotech CEO Robert Wessman stated the company's focus on preparation and resolving outstanding issues to bring the biosimilar candidates to patients with Teva. Teva Executive Vice President Sven Dethlefs affirmed Teva's commitment to its leadership in biosimilars and the partnership.