[6-K] Alvotech Current Report (Foreign Issuer)

Rhea-AI Filing Summary

Alvotech filed a Form 6-K noting that the U.S. Food and Drug Administration issued a complete response letter for its AVT05 Biologics License Application, covering prefilled syringe and autoinjector presentations of a proposed biosimilar to Simponi (golimumab). Following the letter, the company has reevaluated its outlook for 2025. The report incorporates the 6-K (excluding the press release) by reference into certain registration statements. The related press release, furnished as Exhibit 99.1, is not deemed filed under the Exchange Act.

Positive

• None.

Negative

• FDA issued a complete response letter for AVT05, prompting a reevaluation of the company’s 2025 outlook.

Insights

Biopharma regulatory analyst

FDA CRL for AVT05 introduces a regulatory setback.

Alvotech disclosed that the FDA issued a complete response letter for AVT05, its proposed biosimilar to Simponi, in prefilled syringe and autoinjector formats. A CRL indicates the application was not approved in its current form.

The company also stated it has reevaluated its 2025 outlook, signaling potential timing or commercialization adjustments tied to AVT05. Specific remediation steps or timelines were not included in the excerpt.

The press release is furnished as Exhibit 99.1, while the rest of the report is incorporated by reference into existing registration statements. Actual impact will depend on the company’s next regulatory interactions.

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

Form 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of November 2025

Commission File Number: 001-41421

Alvotech
(Translation of registrant's name into English)

9, Rue de Bitbourg,
L-1273 Luxembourg,
Grand Duchy of Luxembourg
(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F [ X ]      Form 40-F [   ]

Incorporation by Reference

This Report on Form 6-K (this “Report”) of Alvotech (the “Company”) excluding Exhibit 99.1 attached hereto, shall be deemed to be incorporated by reference into the Company’s registration statements on Forms F-3 (File Nos. 333-266136, 333-273262, 333-275111 and 333-281684), the Company’s registration statement on Form F-3ASR (File No. 333-289006), and the Company’s registration statement on Form S-8 (File No. 333-266881) and to be a part thereof from the date on which this Report is filed, to the extent not superseded by documents or reports subsequently filed or furnished. Exhibit 99.1 to this Report is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act.

Press Releases

On November 2, 2025, Alvotech issued a Press Release announcing that the U.S. Food and Drug Administration (FDA) has 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 Simponi® (golimumab). Following the receipt of the CRL, Alvotech has also reevaluated its outlook for 2025. A copy of the Press Release is furnished herewith as exhibit 99.1.

EXHIBIT INDEX

Exhibit Number		Description
99.1		Press Release dated November 2, 2025

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

		Alvotech
		(Registrant)
Date: November 2, 2025		/s/ Tanya Zharov
		Tanya Zharov
		General Counsel

FAQ

What did ALVO announce in this Form 6-K?

Alvotech reported that the FDA issued a complete response letter for AVT05 and that the company has reevaluated its 2025 outlook.

Which product is affected for ALVO?

AVT05, a proposed biosimilar to Simponi (golimumab), in prefilled syringe and autoinjector presentations.

Did Alvotech provide additional details on next steps?

The excerpt notes the outlook for 2025 was reevaluated; further details are in the press release furnished as Exhibit 99.1.

Is the press release part of the filed record?

The press release (Exhibit 99.1) is furnished, not filed, and is not incorporated by reference under the Exchange Act.

What filings are incorporated by reference?

The 6-K, excluding Exhibit 99.1, is incorporated by reference into Alvotech’s Form F-3s, its Form F-3ASR, and a Form S-8.

When was the press release issued?

November 2, 2025.