FDA denies Alvotech’s application for Humira biosimilar candidate
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Key takeaways:
- The complete response letter cites facility issues in denying the biosimilar.
- The approval process had been on hold while Alvotech addressed the facility problems.
The FDA has denied a biologics license application to Alvotech for AVT02, a high-concentration adalimumab biosimilar candidate, according to a press release from Teva Pharmaceutical Industries.
“While this outcome is disappointing, Teva remains fully committed to its leadership in biosimilars and the partnership with Alvotech,” Teva said in the press release. “The company remains optimistic about additional compounds in the pipeline and further progress with AVT02.”
According to the press release, the denial is based on “deficiencies associated with Alvotech’s manufacturing facility that must be satisfactorily resolved.” The FDA issued a complete response letter for the denial.
In September 2022, Healio reported that the approval process for the adalimumab (Humira, Abbvie) biosimilar was paused so the company could address “certain deficiencies” uncovered during an inspection at its manufacturing facility in Reykjavik, Iceland. The FDA at the time stated in a complete response letter to Alvotech that a satisfactory resolution to these deficiencies would be required before the administration may approve the application for AVT02.
According to the press release, Alvotech is conducting a review of the FDA’s comments so that the next steps may be chosen.
Alvotech had been one of nine companies that have settled with Humira manufacturer AbbVie to allow the eventual release of adalimumab biosimilars in the United States come 2023 — the end result of years of legal wrangling and delays over copyright. According to the court settlement — and had the FDA approved its application — Alvotech’s AVT02 could have legally been released in the United States on July 1, 2023.
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