FDA Issues Complete Response Letter For Alvotech’s Simponi Biosimilar Candidate AVT05

Alvotech, a global biotechnology company dedicated to developing and manufacturing biosimilar medicines, announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for its Biologics License Application (BLA) for AVT05, a biosimilar candidate to Simponi® (golimumab), in both prefilled syringe and autoinjector formats. The CRL cited certain deficiencies identified during the FDA’s pre-license inspection of Alvotech’s Reykjavik manufacturing facility conducted in July 2025, which must be addressed before approval. Importantly, the FDA did not raise any additional concerns regarding the AVT05 application, and the facility remains FDA-approved to produce and supply Alvotech’s currently marketed products.

“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.

According to IQVIA, U.S. sales of Simponi totaled less than $300 million in the first half of 2025, and no biosimilar versions of Simponi are currently approved by the FDA. AVT05 represents Alvotech’s effort to expand its biosimilar portfolio into the immunology space, targeting one of the last remaining TNF inhibitors without a biosimilar counterpart in the U.S. market. The company remains committed to working closely with the FDA to resolve the outstanding issues identified during inspection and to move AVT05 toward approval.

Following the receipt of the CRL, Alvotech adjusted its 2025 financial outlook, now projecting total revenues between $570–$600 million and adjusted EBITDA of $130–$150 million, down from earlier estimates. The revision reflects the company’s continued investments to address the facility observations and a temporary slowdown in production. However, Alvotech emphasized that these investments will strengthen its manufacturing infrastructure and support long-term growth and upcoming biosimilar launches, reinforcing its position as a leading player in the global biosimilar market.