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

Rhea-AI Filing Summary

Alvotech announced that the European Medicines Agency has accepted a Marketing Authorization Application for AVT23, a proposed biosimilar to Xolair®. The company developed AVT23 with Kashiv BioSciences LLC and has licensed commercialization rights to Advanz Pharma Holdco Limited across the European Economic Area, the UK, Switzerland, Canada, Australia and New Zealand.

This filing notifies investors that regulatory review will proceed for a late‑stage biosimilar candidate and clarifies the commercialization partner and covered territories, which could affect future revenue timing and market access if authorization is granted.

Positive

• EMA accepted the MAA for AVT23, initiating formal regulatory review
• Commercialization rights licensed to Advanz across multiple major markets (EEA, UK, Switzerland, Canada, Australia, New Zealand)
• Development collaboration with Kashiv BioSciences secures R&D partnership continuity

Negative

• None.

Insights

Regulatory Affairs Specialist

EMA acceptance starts formal review for AVT23's marketing approval.

The acceptance of a Marketing Authorization Application by the European Medicines Agency initiates the agency's formal evaluation of AVT23, a biosimilar to Xolair®. This moves the program from submission preparation into active regulatory review.

Primary dependencies include the EMA's assessment timeline and any outstanding data requests; the outcome will determine whether AVT23 can be authorized for the listed territories and when commercial launch could follow if approved.

Business Development Analyst

Licensing to Advanz secures commercialization routes across multiple global markets.

The licensing arrangement with Advanz Pharma Holdco Limited for the EEA, UK, Switzerland, Canada, Australia and New Zealand clarifies go‑to‑market responsibilities and potential revenue share if AVT23 is authorized. The collaboration with Kashiv BioSciences LLC indicates upstream R&D partnership continuity.

Key items to watch are the EMA decision timeline and any parallel regulatory filings or approvals in the licensed territories that would enable synchronized launches and revenue realization.

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 October 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 October 6, 2025, Alvotech issued a Press Release announcing that the European Medicines Agency has accepted a Marketing Authorization Application for AVT23, a proposed biosimilar to Xolair®. Alvotech developed AVT23 in collaboration with Kashiv BioSciences LLC, and has licensed commercialization rights to its partner Advanz Pharma Holdco Limited, for the European Economic Area (European Union, Norway, Iceland and Lichtenstein), UK, Switzerland, Canada, Australia and New Zealand. A copy of the Press Release is furnished herewith as exhibit 99.1.

EXHIBIT INDEX

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

FAQ

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

The company announced the EMA has accepted a Marketing Authorization Application for AVT23, a proposed biosimilar to Xolair®.

Who developed AVT23 with Alvotech (ALVO)?

Kashiv BioSciences LLC collaborated with Alvotech on the development of AVT23.

Which company holds commercialization rights for AVT23 in key markets?

Advanz Pharma Holdco Limited holds commercialization rights for the EEA, UK, Switzerland, Canada, Australia and New Zealand.

Does EMA acceptance mean AVT23 is approved?

No. Acceptance of an MAA starts EMA's formal review; approval will depend on the agency's evaluation and any outstanding data requests.

Which territories are covered by the commercialization license mentioned by Alvotech (ALVO)?

The license covers the European Economic Area, the UK, Switzerland, Canada, Australia and New Zealand.