Alvotech SA Securities Fraud Investigation

Shamis & Gentile, P.A. is investigating claims on behalf of investors of Alvotech SA ("Alvotech" or the "Company") (ALVO). Impacted investors are advised to contact the firm now.

What the Investigation Is About

The law firm is investigating whether Alvotech and certain of its officers and/or directors made false or misleading statements or failed to disclose material information regarding the regulatory status of the Company’s Reykjavik manufacturing facility and the approval prospects for its Biologics License Application (BLA) for AVT05 between January 2025 and October 2025.

On January 27, 2025, Alvotech and Teva announced that the U.S. Food and Drug Administration (FDA) had accepted for review the BLA for AVT05, a proposed biosimilar to Simponi (golimumab). In late June and early July 2025, the FDA conducted a pre-license inspection of Alvotech’s Reykjavik manufacturing facility and identified deficiencies requiring remediation.

On November 2, 2025, Alvotech announced it had received a complete response letter (CRL) from the FDA related to AVT05, citing the previously identified facility deficiencies that must be resolved before approval can be granted. According to the Company’s public statements, the FDA confirmed that no other deficiencies were found with the application itself and that the facility remains authorized to manufacture and supply currently marketed products.

Following the FDA’s decision, Alvotech revised its 2025 financial guidance downward. The Company now expects total revenue between $570 million and $600 million, with adjusted EBITDA between $130 million and $150 million, attributing the revised outlook primarily to “expected continuation of investments related to resolving certain facility issues, which also require a temporary slowdown in production.”

Market Reaction

On this news, Alvotech’s stock fell approximately 34%, declining from $7.65 on October 31, 2025, to $5.03 on November 3, 2025, causing significant losses to investors.

What Investors Can Do

If you purchased or otherwise acquired Alvotech (ALVO) securities between January 2025 and October 2025, you may be eligible to seek compensation for your losses. Contact Shamis & Gentile, P.A. today to discuss your options.

Shamis & Gentile, P.A. stands out as an advocate for investors who are victims of securities fraud. The firm is committed to securing recoveries for investors who have incurred damages due to false and misleading statements or other corporate misconduct by public companies. Shamis & Gentile has recovered over $1 billion for consumers nationwide. Its extensive experience, expertise and resources enable the firm to resolve disputes in a wide range of matters, including class actions, mass torts and mass arbitrations.

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