Alvotech (NASDAQ:ALVO) stock is trading lower on Monday, with a session volume of 2.32 million compared to the average volume of 395.34 thousand as per data from Benzinga Pro.
• ALVO is at important technical levels. See the complete data here.
Alvotech is a biotech company specializing in the development and manufacture of biosimilar medicines.
A biosimilar is a biological drug that is highly similar to an existing, approved biologic drug.
The U.S. Food and Drug Administration (FDA) on Monday issued a complete response letter (CRL) for Alvotech’s Biologics License Application (BLA) for AVT05, in a prefilled syringe and autoinjector presentations, a biosimilar candidate to Johnson & Johnson’s (NYSE:JNJ) Simponi (golimumab), for moderately to severely active rheumatoid arthritis.
The CRL noted certain deficiencies, which were conveyed following the FDA’s pre-license inspection of Alvotech’s Reykjavik manufacturing facility, and concluded in July 2025, must be satisfactorily resolved before this BLA for AVT05 can be approved.
The FDA did not identify any other deficiencies with the application. The facility remains FDA-approved to manufacture and continues supplying the currently commercialized products.
Sales of Simponi in the U.S. in the first half of 2025 were less than $300 million, according to data published by IQVIA. Currently, there are no FDA approvals for a biosimilar to Simponi.
“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,” said Robert Wessman, chairman and CEO of Alvotech.
Following the receipt of the CRL, Alvotech has reevaluated its outlook for 2025.
Total revenues in 2025 are now expected to be $570-$600 million and adjusted EBITDA $130-$150 million, lower than previously provided.
The lowered adjusted EBITDA outlook is primarily driven by the expected continuation of investments related to resolving certain facility issues, which also require a temporary slowdown in production.
ALVO Price Action: ALVO stock is down 33.99% at $5.05 at publication on Monday.
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