FDA denies Stelara biosimilar application from Alvotech
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Key takeaways:
- The FDA issued a complete response letter to Alvotech’s application for AVT04, citing issues at the company’s Reykjavik facility.
- Alvotech plans to resubmit the biologics license application.
The FDA has denied a biologics license application from Alvotech for its biosimilar to ustekinumab, citing “certain deficiencies” at the company’s facility in Reykjavik, Iceland, according to the manufacturer.
The announcement follows a complete response letter to Alvotech from the FDA regarding AVT04, the company’s biosimilar candidate to ustekinumab (Stelara, Janssen). According to a statement from Alvotech, the letter noted “certain deficiencies” uncovered following the FDA’s inspection of the company’s Reykjavik facility that concluded in March. These deficiencies “must be satisfactorily resolved” prior to approval, the company said.
“AVT04 has recently been approved in Japan, and other marketing applications for AVT04 are currently awaiting approval in other major markets,” Robert Wessman, chairman and CEO of Alvotech, said in the company release. “Based on our latest interactions with the FDA, we are currently expecting that the agency will reinspect our facility in the beginning of next year. We look forward to being able to bring AVT04 to U.S. patients, pending a satisfactory inspection and [biologics license application (BLA)] approval, no later than in February 2025, in accordance with our license entry date agreement.”
According to the statement, Alvotech plans to resubmit its BLA for AVT04, which could trigger a 6-month review period.
A settlement agreement announced in June between Alvotech, Teva Pharmaceuticals — Alvotech’s commercialization partner for AVT04 — and Janssen’s parent company Johnson & Johnson had allowed the ustekinumab biosimilar to enter the U.S. market no later than Feb. 21, 2025, pending FDA approval.
This is not the first FDA denial stemming from issues at Alvotech’s Reykjavik manufacturing facility.
The FDA in April denied a similar application for Alvotech’s AVT02, a high-concentration adalimumab (Humira, Abbvie) biosimilar candidate. That rejection was based on “deficiencies associated with Alvotech’s manufacturing facility that must be satisfactorily resolved,” read a press release from Teva at the time.
In September 2022, Healio reported that the approval process for AVT02 was paused so the company could address deficiencies uncovered during an inspection at the Reykjavik manufacturing facility.
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