Alvotech Reports Positive Results for Xolair Biosimilar Drug Trial

Alvotech has announced positive topline results from a confirmatory efficacy study comparing AVT23, their proposed biosimilar to Xolair® (omalizumab), with the reference biologic.

Rhea-AI Filing Summary

Alvotech has announced positive topline results from a confirmatory efficacy study comparing AVT23, their proposed biosimilar to Xolair® (omalizumab), with the reference biologic. The announcement was made via press release on June 25, 2025.

This Form 6-K filing includes important administrative updates:

• The report will be incorporated into multiple Alvotech registration statements, including Forms F-3 (File Nos. 333-266136, 333-273262, 333-275111, and 333-281684) and Form S-8 (File No. 333-266881)
• Exhibit 99.1 (Press Release) is being furnished and not "filed" under Section 18 of the Securities Exchange Act
• The document was signed by Tanya Zharov, General Counsel of Alvotech

This development represents a significant milestone in Alvotech's biosimilar development program, potentially expanding their portfolio of biological alternatives in the pharmaceutical market.

Positive

• Positive topline results announced from confirmatory efficacy study comparing AVT23 (proposed biosimilar) to Xolair® (omalizumab)

Negative

• None.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Alvotech (ALVO) announce in their June 25, 2025 Form 6-K filing?

Alvotech (ALVO) announced positive topline results from a confirmatory efficacy study comparing AVT23, their proposed biosimilar to Xolair® (omalizumab), with the reference biologic.

What registration statements will ALVO's June 2025 6-K be incorporated into?

The Form 6-K will be incorporated into Alvotech's registration statements on Forms F-3 (File Nos. 333-266136, 333-273262, 333-275111 and 333-281684) and Form S-8 (File No. 333-266881), except for Exhibit 99.1.

Who signed ALVO's June 2025 Form 6-K filing?

The Form 6-K was signed by Tanya Zharov, General Counsel of Alvotech, on June 25, 2025.

Is ALVO's June 2025 press release (Exhibit 99.1) considered 'filed' under the Exchange Act?

No, Exhibit 99.1 (the press release) is being furnished and is explicitly stated as not being 'filed' for purposes of Section 18 of the Securities Exchange Act of 1934, nor will it be incorporated by reference in any Securities Act or Exchange Act filings.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 06/25/2025 - 06:00 AM EDT Learn about SEC filing dates

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 June 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, and 333-275111 and 333-281684) 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 Release

On June 25, 2025, Alvotech issued a press release announcing the positive topline results from a confirmatory efficacy study comparing AVT23 a proposed biosimilar to Xolair® (omalizumab), with the reference biologic. A copy of the Press Release is furnished herewith as exhibit 99.1.

EXHIBIT INDEX

Exhibit Number		Description
99.1		Press Release dated June 25, 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: June 25, 2025		/s/ Tanya Zharov
		Tanya Zharov
		General Counsel