On November 2, 2025, the FDA issued a complete response letter for Alvotech’s biologics license application for the Simponi biosimilar AVT05, citing deficiencies identified during a pre‑license inspection of the company’s Reykjavik manufacturing facility that concluded in July 2025.
The letter means the AVT05 BLA is not yet approved, delaying the product’s launch in the United States. Alvotech must implement corrective and preventive actions, which will temporarily slow production and increase operating costs, postponing AVT05 availability and potentially affecting revenue recognition.
In response, Alvotech revised its 2025 financial outlook. Total revenue guidance was lowered to $570‑$600 million, and adjusted EBITDA guidance was cut to $130‑$150 million, down from the earlier $600‑$700 million revenue and $200‑$280 million EBITDA guidance issued in May 2025.
The company attributes the downward revision to the capital outlay required to resolve the facility issues and the resulting production slowdown. Alvotech’s Reykjavik plant remains FDA‑approved to produce and supply its currently commercialized products, and the company has previously faced CRLs for its Humira and Stelara biosimilars.
Prior to the CRL, Alvotech had reported strong quarterly results, with Q1 2025 revenue of $132.8 million and adjusted EBITDA of $20.5 million, and had raised its full‑year guidance earlier in the year.
Alvotech’s AVT05, marketed as Gobivaz in Europe, received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use in September 2025, indicating progress in other major markets despite the U.S. setback.
The CRL delays the expected Q4 2025 approval timeline and underscores ongoing challenges with the company’s manufacturing compliance.
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