Shares of Alvotech (ALVO), a biotech company that manufactures biosimilar medicines, were trading 22.88% lower at $5.90 in pre-market trading on Monday, following disappointing regulatory news.
The FDA has issued a complete response letter or CRL for the company's Biologics License Application or BLA for AVT05, a biosimilar candidate to Johnson & Johnson's (JNJ) Simponi.
Simponi or golimumab is prescribed for Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis, Ulcerative Colitis, and Spondyloarthritis. It belongs to TNF alpha inhibitors, a group of medicines that suppress the body's natural response to tumour necrosis factor, a protein produced by white blood cells involved in early inflammatory events.
The U.S. regulatory agency declined to approve the BLA for AVT05, citing deficiencies in Alvotech's Reykjavik manufacturing facility. However, the firm reported that the FDA did not identify any other deficiencies with the application.
According to data published by IQVIA, sales of Simponi in the U.S. in the first half of 2025 were less than $300 million. Currently, there are no FDA-approved biosimilars to Simponi.
Commenting on the development, Robert Wessman, Chairman and CEO of Alvotech, said, " 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."
In addition, following the receipt of the CRL, Alvotech has lowered its outlook for 2025. Total revenues in 2025 are now expected to be $570 to $600 million and adjusted EBITDA to be $130 to $150 million, both lower than the previously provided ranges.
ALVO closed Friday's trading at $7.65, down 2.42%.
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