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

Rhea-AI Filing Summary

Alvotech reported regulatory progress for multiple biosimilars in September 2025. Fuji Pharma received Japanese marketing authorization for three Alvotech-developed products: AVT03 (referencing Xgeva/denosumab), AVT05 (referencing Simponi/golimumab) and AVT06 (referencing Eylea/aflibercept). Separately, the European Medicines Agency's CHMP adopted positive opinions recommending approval in the European Economic Area for AVT03 (referencing Prolia/Xgeva) and AVT05 (referencing Simponi); final European Commission decisions are pending. The company furnished press releases as Exhibits 99.1–99.3, which are provided for incorporation by reference but are not being "filed" for certain Exchange Act liabilities.

Positive

• Japanese marketing authorization granted for AVT03, AVT05 and AVT06 via Fuji Pharma
• CHMP positive opinions recommending approval for AVT03 and AVT05 in the European Economic Area
• Multiple regulatory jurisdictions advanced in a short timeframe (Japan and Europe)

Negative

• European approvals are not final: final decisions by the European Commission are pending for AVT03 and AVT05
• Press releases furnished but not filed: exhibits 99.1–99.3 are furnished and not deemed filed for certain Exchange Act liabilities

Insights

Regulatory Affairs Specialist

TL;DR: Multiple regulatory milestones achieved: three approvals in Japan and CHMP positive opinions for two candidates in Europe, moving products toward market access.

The receipt of Japanese marketing authorization for AVT03, AVT05 and AVT06 demonstrates successful submissions and regulatory acceptance in a key market, enabling commercialization via Alvotech's local partner, Fuji Pharma. CHMP positive opinions for AVT03 and AVT05 are critical EU procedural steps that, pending European Commission decisions, could allow access to the European Economic Area. These developments materially advance regulatory pathways but require final EC approvals and local launch preparations before commercial revenue is realized.

Commercialization / Partnering Analyst

TL;DR: Partner-led commercialization enabled immediate regulatory milestones in Japan and strengthens prospects in Europe pending final approvals.

Approvals in Japan are tied to Alvotech's commercialization partner, indicating partner execution is progressing and allowing market entry for three biosimilars. CHMP positive opinions suggest regulatory alignment in Europe for AVT03 and AVT05; the announcements note that final European Commission decisions remain pending, so commercialization timelines and market launches will depend on those outcomes and subsequent local marketing activities by partners.

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 September 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, 99.2 and 99.3 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, 99.2 and 99.3 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 September 19, 2025, Alvotech issued a Press Release announcing that Alvotech’s commercialization partner in Japan, Fuji Pharma Co., Ltd. has received marketing authorization in Japan from the Japanese Ministry of Health, Labor and Welfare for three new biosimilars developed and manufactured by Alvotech. The biosimilars approved for sale in the Japanese market are AVT03, referencing Xgeva (denosumab), AVT05, referencing Simponi (golimumab) and AVT06, referencing Eylea (aflibercept). A copy of the Press Release is furnished herewith as exhibit 99.1.

On September 22, 2025, Alvotech issued a Press Release announcing that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human use (CHMP) has adopted a positive opinion recommending approval of a marketing authorization in the European Economic Area for AVT03, Alvotech’s biosimilar candidate referencing Prolia (denosumab) and Xgeva (denosumab). A final decision by the European Commission to grant the marketing authorization is now pending. A copy of the Press Release is furnished herewith as exhibit 99.2.

On September 22, 2025, Alvotech and its commercialization partner Advanz Pharma Holdco Limited issued a Alvotech issued a Press Release announcing that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human use (CHMP) has adopted a positive opinion recommending approval of a marketing authorization in the European Economic Area for AVT05, Alvotech’s biosimilar candidate referencing Simponi (golimumab). A final decision by the European Commission to grant the marketing authorization is now pending. A copy of the Press Release is furnished herewith as exhibit 99.3.

EXHIBIT INDEX

Exhibit Number		Description
99.1		Press Release dated September 19, 2025
99.2		Press Release dated September 22, 2025
99.3		Press Release dated September 22, 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: September 22, 2025		/s/ Tanya Zharov
		Tanya Zharov
		General Counsel

FAQ

What approvals did Alvotech (ALVOW) announce in Japan?

A copy of the press release states that Fuji Pharma received Japanese marketing authorization for AVT03, AVT05 and AVT06, referencing denosumab (Xgeva), golimumab (Simponi) and aflibercept (Eylea), respectively.

Which Alvotech biosimilars received CHMP positive opinions in Europe?

The CHMP adopted positive opinions recommending approval in the European Economic Area for AVT03 (referencing Prolia/Xgeva) and AVT05 (referencing Simponi); final European Commission decisions are pending.

Are the European approvals for Alvotech final?

No; the press releases state that a final decision by the European Commission is pending for AVT03 and AVT05.

Were the press releases included in the 6-K filed or furnished?

Exhibits 99.1–99.3 (the press releases) are furnished with the report and are not deemed "filed" for purposes of Section 18 of the Exchange Act or incorporated by reference in certain filings.

Who is Alvotech's commercialization partner in Japan?

The filing identifies Fuji Pharma Co., Ltd. as Alvotech's commercialization partner in Japan.