Alvotech SA Securities Lawsuit Investigation

Shamis & Gentile P.A., a law firm that advocates for investors who are victims of securities fraud, is investigating potential claims against Alvotech SA (ALVO).

If you purchased or acquired Alvotech SA securities and suffered losses, you may be eligible to join this securities investigation and seek compensation.

About Alvotech SA

Alvotech SA is a global biopharmaceutical company headquartered in Reykjavik, Iceland. It develops and manufactures biosimilar medicines as alternatives to branded biologic drugs.

The company also operates a U.S. subsidiary, Alvotech USA Inc., located in Arlington, Virginia, which serves as its agent for service of process in the United States.

Potential Concerns Under Investigation

Lawyers are investigating potential concerns related to Alvotech SA’s disclosures and actions surrounding its Biologics License Application (BLA) for AVT05 and subsequent regulatory developments.

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). The FDA’s acceptance represented a significant milestone in Alvotech’s biosimilar pipeline. 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, due to the facility deficiencies identified in July, which must be resolved before approval can be granted.

According to Alvotech'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. Alvotech attributed the revised outlook primarily to "expected continuation of investments related to resolving certain facility issues, which also require a temporary slowdown in production."

On this news, Alvotech’s stock fell approximately 34% from closing at $7.65 on October 31, 2025, to $5.03 on November 3, 2025, the next trading day.

Attorneys are reviewing whether Alvotech adequately disclosed the risks associated with the facility inspection, potential impacts on the approval timeline, and the financial implications of remediation efforts before issuing revised guidance. The investigation will also assess whether previous company statements accurately reflected the risks to investors and the expected timing of AVT05’s approval.

Your Rights and Next Steps

This is an ongoing investigation and not a filed lawsuit. Investors who purchased or held Alvotech SA securities and suffered losses may have legal rights. If evidence shows that investors were misled, the case could lead to a class action lawsuit to recover damages for affected shareholders.

Lawyers are available to help investors review their options and determine whether they qualify to participate. There is no cost or obligation to join the investigation, and participation is confidential.

You May Be Entitled to Compensation

Securities investigations are time-sensitive, and acting promptly can help protect your rights. If you purchased or otherwise acquired Alvotech securities between January 2025 and October 31, 2025, you may be eligible to join this investigation and seek compensation for your losses.

To learn more about your options and to participate in the investigation, complete the form below.