Following two BLA rejections for its Humira biosimilar, Alvotech is expanding its partnership with Teva Pharmaceuticals, which will enable the latter to have greater involvement with quality and control.
Pictured: Teva U.S. headquarters in New Jersey/iStock, JHVEPhoto
Teva Pharmaceuticals has broadened its existing collaboration with biosimilar-focused Alvotech along with a $40 million purchase of the latter’s subordinated convertible bonds, the companies announced Monday.
Though exact details of the expanded agreement remain sparse, Teva will have “increased involvement” regarding manufacturing and quality and control at Alvotech’s Iceland facility, which the partners are currently preparing for another round of FDA inspections, according to the press release.
Alvotech is developing AVT02, a biosimilar to AbbVie’s Humira (adalimumab) for the treatment of rheumatoid arthritis, Crohn’s disease and other inflammatory conditions. In April 2023, however, the FDA denied Alvotech’s Biologics License Application (BLA) for AVT02, pointing to “certain deficiencies” at its Reykjavik manufacturing plant that “must be satisfactorily resolved before the application can be approved.”
An FDA warning letter following an inspection in March 2022 revealed several issues at Alvotech’s Iceland facility, including “an unacceptably high number of mold recoveries” in rooms designated for drug manufacturing. Bacterial contamination has also exceeded acceptable levels and the company’s corrective and preventive actions for these “were inadequate to avoid future occurrences,” according to the regulator. A follow-up inspection a year later did not flag these issues, suggesting that Alvotech had resolved them.
A second BLA for AVT02, which sought the FDA’s interchangeability designation, was also rejected in June 2023. In its Complete Response Letter, the FDA again cited quality deficiencies at the Reykjavik site.
These rejections pushed Teva to take a more hands-on approach to Alvotech’s manufacturing plant, a Teva spokesperson told Endpoints News. AVT02 is part of the companies’ initial partnership, which was signed in August 2020, and covers four other biosimilar candidates—including AVT04, an investigational biosimilar to J&J’s Stelara (ustekinumab), also for inflammatory conditions.
Under the terms of Monday’s expanded agreement, Teva will also gain exclusive U.S. commercialization rights to two new biosimilar candidates. The partners have also agreed to line extensions for two current candidates in the original deal. Alvotech will take charge of development and manufacturing, as well as be eligible for milestones such as product approvals.
Teva and Alvotech will also share the profits from these biosimilars, though the specific financial details of the expanded deal remain confidential.
In other Teva news, the company has settled its patent dispute over Exelixis’ cancer drug Cabometyx (cabozantinib). The California-based biotech filed the lawsuit in 2022, challenging Teva’s abbreviated New Drug Application for its generic candidate. Under the settlement, Exelixis will allow Teva to market its generic version of Cabometyx, pending FDA approval, starting on January 1, 2031.
Tristan Manalac is an independent science writer based in metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
Correction (July 26): This story has been updated to clarify that the FDA’s warning letter for mold and bacterial recoveries at Alvotech’s Iceland plant was filed in March 2022, instead of March 2023. The most recent Form 483, which no longer cites these issues, has also been included in the story.
