Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries, and Alvotech, a global biotech company specialising in biosimilar medicines, have decided to expand their existing strategic partnership agreement.

The collaboration will now include the exclusive commercialisation in the US by Teva of two new biosimilar candidates and line extensions of two current biosimilar candidates developed and manufactured by Alvotech.

The partnership initially focused on AVT02, an interchangeable high-concentration biosimilar candidate for Humira (adalimumab), and AVT04, a proposed biosimilar for Stelara (ustekinumab). Both these are undergoing the approval process by the US Food and Drug Administration (FDA).

The expansion of the agreement will involve milestone payments, with the majority to be paid after product approvals and upon achieving significant sales milestones. Teva and Alvotech will share the profits from the commercialisation of the biosimilars. However, the specific financial terms and product details of the agreement remain confidential.

In addition to the commercial aspects, Teva will also increase its involvement in manufacturing and quality at Alvotech’s manufacturing facility. Teva is actively supporting Alvotech’s facility in Iceland to prepare for an FDA inspection.

As part of the partnership expansion, Teva will acquire $40m worth of subordinated convertible bonds to be issued by Alvotech. The investment from Teva will be utilized by Alvotech to fund the continued development of its biosimilars pipeline in the near term.

Overall, this expanded strategic partnership between Teva and Alvotech signifies their joint commitment to advancing biosimilar medicines and providing patients with more accessible and affordable treatment options.

Alvotech chairman and CEO Robert Wessman said: “We welcome Teva’s continued partnership and this expansion of our partnership agreement.

“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.”

About AVT02

AVT02, a monoclonal antibody developed by Alvotech, has achieved approval as a biosimilar to Humira (adalimumab) in numerous countries worldwide. These approvals include the 27 member states of the European Union, Norway, Lichtenstein, Iceland, the UK, Switzerland, Canada, Australia, and Saudi Arabia. As a result, AVT02 is currently available in the market in multiple European countries and Canada.

About AVT04 (ustekinumab)

AVT04 is a monoclonal antibody and a biosimilar candidate to Stelara (ustekinumab). Ustekinumab targets IL-12 and IL-23 cytokines, which play crucial roles in inflammatory and immune responses.