Teva Pharmaceuticals, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and Alvotech, a global biotech company specializing in the development and manufacture of biosimilars, expanded their existing strategic partnership agreement. Teva will also acquire subordinated convertible bonds to be issued by Alvotech.

The companies will continue working closely on matters concerning pending approval in the U.S. for AVT02, an interchangeable high-concentration biosimilar candidate for Humira (adalimumab). The existing strategic partnership agreement also includes four other biosimilar candidates, one of which is AVT04, a proposed biosimilar for Stelara (ustekinumab), which is currently pending U.S. FDA approval.

Under the expanded partnership agreement, Teva gains exclusive commercialization in the U.S. of two new biosimilar candidates and line extensions of two current biosimilar candidates, to be developed, and manufactured by Alvotech. The agreement includes milestone payments, the majority paid following product approvals and upon achieving significant sales milestones. Teva and Alvotech will share profit from the commercialization of the biosimilars. 

The agreement also includes Teva’s increased involvement regarding manufacturing and quality at Alvotech’s manufacturing facility. Teva is actively supporting Alvotech on-site in Iceland to be fully ready for an FDA inspection.

Teva has agreed to acquire subordinated convertible bonds to be issued by Alvotech pursuant to a convertible bond instrument, dated December 20, 2022, for $40 million. Teva’s investment will be used by Alvotech as part of the funding for continued development of its biosimilars pipeline over the near-term.

“We welcome Teva’s continued partnership and this expansion of our partnership agreement,” said Robert Wessman, Chairman and CEO of Alvotech. “We remain focused on preparing for a successful pre-approval inspection and resolving any outstanding issues identified by the FDA to be able to bring our biosimilar candidates to patients in the U.S. with Teva as soon as possible.”