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

Rhea-AI Filing Summary

Alvotech filed a Form 6-K to share regulatory news about one of its biosimilar products. The company announced that AVT05, a biosimilar to Simponi (golimumab), has been approved for marketing in the European Economic Area. This approval means Alvotech can commercialize AVT05 in European markets covered by the EEA, potentially expanding its biosimilar portfolio reach. The filing also notes that the accompanying press release is furnished as an exhibit but is not incorporated by reference into the company’s securities registration statements.

Positive

• AVT05 EEA approval: AVT05, a biosimilar to Simponi (golimumab), received marketing approval in the European Economic Area, potentially adding a new commercial product to Alvotech’s portfolio.

Negative

• None.

Insights

Biopharma and regulatory affairs analyst

EEA marketing approval for AVT05 expands Alvotech’s biosimilar lineup.

Alvotech reports that AVT05, its biosimilar to Simponi (golimumab), has been approved for marketing in the European Economic Area. EEA approval typically allows commercial sales across multiple European countries under a single regulatory decision, so this can add a new revenue-contributing product to Alvotech’s portfolio once launched.

The product targets the same reference medicine as Simponi, a TNF-alpha inhibitor used in autoimmune diseases, which is a well-established therapeutic class. Actual commercial impact will depend on pricing, market access, and how quickly Alvotech and its partners can roll out AVT05 in EEA markets. Future disclosures from the company can provide more detail on launch timing, partnering structures, and early sales performance for this biosimilar.

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 20, 2025, Alvotech issued a Press Release announcing that AVT05, a biosimilar to Simponi (golimumab), 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 20, 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 20, 2025		/s/ Tanya Zharov
		Tanya Zharov
		General Counsel

FAQ

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

Alvotech reported that AVT05, its biosimilar to Simponi (golimumab), has been approved for marketing in the European Economic Area (EEA), as disclosed in a press release furnished as an exhibit.

What is AVT05 in the context of Alvotech (ALVO)?

AVT05 is an Alvotech biosimilar to the reference medicine Simponi (golimumab). The Form 6-K states that AVT05 has received marketing approval in the EEA.

Which region granted marketing approval for Alvotech’s AVT05 biosimilar?

The filing states that AVT05, a biosimilar to Simponi (golimumab), has been approved for marketing in the European Economic Area.

Is the AVT05 press release incorporated into Alvotech’s registration statements?

The Form 6-K explains that the Report, excluding Exhibit 99.1, is incorporated by reference into certain Alvotech registration statements, while Exhibit 99.1 itself is only furnished and is not deemed filed or incorporated by reference under the Securities Act or Exchange Act.

What is included as Exhibit 99.1 in Alvotech’s November 2025 Form 6-K?

Exhibit 99.1 is a press release dated November 20, 2025, in which Alvotech announces that AVT05, a biosimilar to Simponi (golimumab), has been approved for marketing in the EEA.

Which SEC reporting format does Alvotech (ALVO) use for its annual reports?

The Form 6-K indicates that Alvotech files its annual reports under cover of Form 20-F, not Form 40-F.