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

Rhea-AI Filing Summary

Alvotech reported that its product AVT03, a biosimilar to Prolia and Xgeva (both denosumab), has been approved for marketing in the European Economic Area.

This approval means Alvotech can market AVT03 across the EEA, potentially opening a new revenue stream in the osteoporosis and oncology-related bone disease markets targeted by the reference medicines. The news was communicated through a press release dated November 24, 2025, which is furnished as an exhibit to this report.

Insights

Biotech and regulatory analyst

EU approval of AVT03 opens a key commercial pathway in denosumab biosimilars.

Alvotech announced that AVT03, a biosimilar to Prolia and Xgeva (denosumab), has been approved for marketing in the European Economic Area. Prolia and Xgeva are widely used in osteoporosis and cancer-related bone disease, so an approved biosimilar can address a large, established treatment category.

Regulatory approval in the EEA is a major gate for commercial launches in those member countries. While pricing, market uptake, and payer decisions are not described here, approval itself removes a significant development and regulatory hurdle for AVT03.

This development may influence Alvotech’s product mix and geographic revenue exposure once AVT03 is launched in EEA markets. Further company disclosures and future filings can provide detail on launch timing, partnering, and any early sales trends following the November 24, 2025 announcement.

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 24, 2025, Alvotech issued a Press Release announcing that AVT03, a biosimilar to Prolia (denosumab) and Xgeva (denosumab) has been approved for marketing in the European Economic Area. A copy of the Press Release is furnished herewith as exhibit 99.1.

EXHIBIT INDEX

Exhibit Number		Description
99.1		Press Release dated November 24, 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 24, 2025		/s/ Tanya Zharov
		Tanya Zharov
		General Counsel

FAQ

What did Alvotech (ALVO) announce in this Form 6-K?

Alvotech reported that AVT03, its biosimilar to Prolia and Xgeva (denosumab), has been approved for marketing in the European Economic Area, as disclosed in a November 24, 2025 press release.

What is AVT03 in Alvotech’s (ALVO) pipeline?

AVT03 is described as a biosimilar to Prolia and Xgeva, both denosumab-based medicines used in osteoporosis and oncology-related bone disease, and it has now been approved for marketing in the European Economic Area.

Which region approved Alvotech’s AVT03 biosimilar to Prolia and Xgeva?

The filing states that AVT03 has been approved for marketing in the European Economic Area, allowing Alvotech to offer the product across that region subject to local market access conditions.

When did Alvotech (ALVO) announce the approval of AVT03?

Alvotech announced the approval of AVT03 in a press release dated November 24, 2025, which is furnished as Exhibit 99.1 to this report.

Is the AVT03 press release incorporated by reference into Alvotech’s registration statements?

The report itself, excluding Exhibit 99.1, is incorporated by reference into certain Alvotech registration statements, while the Exhibit 99.1 press release is furnished and is not deemed filed or incorporated by reference under the Securities Act or Exchange Act.

What type of document did Alvotech file for the AVT03 approval news?

Alvotech filed a Form 6-K, a report of a foreign private issuer, to furnish information including the press release about the European Economic Area marketing approval of AVT03.