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Investing.com -- Alvotech (NASDAQ:ALVO) stock tumbled 22% after the U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) for the company’s biosimilar candidate to Simponi.
The FDA noted that certain deficiencies identified during a pre-license inspection of Alvotech ’s Reykjavik manufacturing facility in July 2025 must be resolved before the Biologics License Application (BLA) for AVT05 can be approved. The regulator did not identify any other issues with the application, and the facility remains FDA approved to manufacture and supply currently commercialized products.
Alvotech’s AVT05 was being developed as a biosimilar to Simponi (golimumab), which generated less than $300 million in U.S. sales during the first half of 2025, according to IQVIA data. Currently, there are no FDA-approved biosimilars to Simponi in the U.S. market.
"As previously discussed, following the inspection of our facility, Alvotech submitted a comprehensive response to the FDA detailing our Corrective and Preventive Action (CAPA) plan. While we are disappointed in receiving the CRL, we expect to resolve any outstanding issues and will continue to work with the FDA to bring this first-to-market biosimilar to patients in the U.S.," said Robert Wessman, Chairman and CEO of Alvotech.
Following the CRL, Alvotech has reduced its financial outlook for 2025. The company now expects total revenues of $570-$600 million and adjusted EBITDA of $130-$150 million. The company attributed the lowered guidance primarily to continued investments needed to resolve facility issues and a temporary slowdown in production.
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