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

Rhea-AI Filing Summary

Alvotech filed a Form 6-K reporting that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved its biosimilar to Simponi (golimumab), marketed as Gobivaz. The company furnished a press release announcing the approval as Exhibit 99.1.

The report states that this Form 6-K, excluding Exhibit 99.1, is incorporated by reference into Alvotech’s registration statements on Forms F-3 (File Nos. 333-266136, 333-273262, 333-275111 and 333-281684), its Form F-3ASR (File No. 333-289006), and its Form S-8 (File No. 333-266881). Exhibit 99.1 is furnished, not filed, under the Exchange Act.

Positive

• MHRA approval of Gobivaz (biosimilar to Simponi) expands Alvotech’s approved portfolio in the UK.

Negative

• None.

Insights

Biopharma regulatory analyst

MHRA approved Alvotech’s Simponi biosimilar Gobivaz; press release furnished.

Alvotech disclosed that the UK MHRA approved its biosimilar to Simponi (golimumab), sold as Gobivaz. Regulatory approval is a key step that permits commercial availability in the UK subject to standard launch logistics and market access processes.

The 6-K clarifies mechanics: the main body is incorporated by reference into multiple shelf and employee plan registrations, while Exhibit 99.1 (the press release) is furnished, not filed. This preserves disclosure while avoiding Section 18 liabilities for the exhibit.

The approval was announced on November 6, 2025. Any revenue impact would depend on pricing, tenders, and adoption relative to the reference product; those details are not included in this report.

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 6, 2025, Alvotech issued a Press Release announcing that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Alvotech’s biosimilar to Simponi (golimumab) under the tradename Gobivaz. A copy of the Press Release is furnished herewith as exhibit 99.1.  

EXHIBIT INDEX

Exhibit Number		Description
99.1		Press Release dated November 6, 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 6, 2025		/s/ Tanya Zharov
		Tanya Zharov
		General Counsel