Shares of Alvotech (NASDAQ: ALVO) fell 22% on Monday after the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the company’s proposed biosimilar to Simponi.
The FDA stated that deficiencies identified during a pre-license inspection of Alvotech’s Reykjavik, Iceland, manufacturing facility in July 2025 must be addressed before the Biologics License Application (BLA) for AVT05 can receive approval. However, the agency clarified that no additional concerns were found with the application itself, and the facility remains authorized to produce and supply Alvotech’s currently marketed products.
AVT05 is Alvotech’s biosimilar candidate referencing Simponi (golimumab), a drug that generated less than $300 million in U.S. sales in the first half of 2025, according to IQVIA data. To date, the FDA has not approved any biosimilars to Simponi in the U.S.
“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.
In light of the FDA’s decision, Alvotech revised its 2025 financial guidance downward, now expecting total revenue between $570 million and $600 million and adjusted EBITDA in the range of $130 million to $150 million.
The company attributed the lower outlook primarily to ongoing remediation investments needed to address the facility’s inspection findings, along with a temporary slowdown in production as corrective measures are implemented.