Teva expands Alvotech collab with 2 more biosims, increased manufacturing oversight and a $40M investment

After Teva’s Alvotech-partnered Humira biosimilar suffered its second FDA rejection, the generics giant is stepping up its role in their long-term collaboration with increased manufacturing involvement and $40 million in funding for its partner.

In an expanded partnership, revealed Monday, the companies said they will add two more biosimilar candidates to their collaboration, bringing the total to seven. The branded drugs they're targeting pull down tens of billions in U.S. sales each year.

Teva will handle U.S. commercialization for all of the meds, while Alvotech is on the hook for development and supply. In addition, Teva will boost its presence at Alvotech’s Icelandic production site and is “actively supporting” the company on-site to prepare for an FDA inspection, the companies said in a recent release.

The Israel-based drugmaker will also acquire subordinated convertible bonds issued by Alvotech for $40 million, an investment Alvotech will use “as part of the funding” for continued development of their biosimilar pipeline.

“We welcome Teva’s continued partnership and this expansion of our partnership agreement,” Alvotech CEO Robert Wessman said in the statement. “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.”

In April, the partners' Humira biosimilar received an FDA complete response letter after the agency flagged deficiencies at Alvotech’s Reykjavik, Iceland, manufacturing plant. That setback came after a 2022 inspection found bacteria and mold at the facility, among other deviations, which prompted the first rejection.

However, the mold issues weren’t found on the second inspection, suggesting that problem had been resolved. Instead, the agency cited quality issues, subpar written records and problems with incoming stoppers and computer controls, among other shortfalls.

With the recent rejection in late June, the partners' hopes for a July 1 launch were dashed. Alvotech said in a statement at the time that it will resubmit its application after an expected reinspection. Thanks to the delay, the company pledged to “explore options” to raise more capital in order to continue working on its pipeline.

For its part, Teva is operating under its “Pivot to Growth” strategy under new CEO Richard Frances, which hinges on its generics, biosimilars, “focused capital allocation” and its pipeline.