Alvotech: FDA clears second SIMLANDI production suite

Alvotech expects FDA action on other pending applications according to their goal dates, with each application subject to individual review and a regulatory decision.

Rhea-AI Filing Summary

Alvotech said the FDA approved a supplement to the Biologics License Application for AVT02 (adalimumab-ryvk), marketed in the U.S. as SIMLANDI®, allowing drug substance for U.S. commercial supply to be made in either of the 2 production suites at its Reykjavik facility. Alvotech said adding DSM2 effectively doubles the drug-substance manufacturing capacity available to support U.S. supply.

DSM2 supports the full drug-substance process, including cell culture and purification, and was already approved for commercial drug substance for European markets. The approval follows the FDA’s July 2026 closure of its most recent Reykjavik inspection with a Voluntary Action Indicated (VAI) classification and further confirms resolution of inspection-related matters. Alvotech expects FDA action on other pending applications according to their respective goal dates; each remains subject to individual review and a regulatory decision.

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Positive

• Moderate pointU.S. supply capacity effectively doubles with DSM2 approval.

Negative

• None.

Filing Explained

The filing incorporates its 6-K report, excluding Exhibit 99.1, into Alvotech’s identified F-3, F-3ASR and S-8 registration statements as of the filing date. Later filed or furnished documents may supersede the incorporated material.

Key Figures

Production suites for U.S. supply: 2 suites Drug-substance capacity for U.S. supply: Effectively doubles Countries where AVT02 is approved: More than 50 countries +1 more

4 metrics

Production suites for U.S. supply 2 suites DSM1 and DSM2 at the Reykjavik facility

Drug-substance capacity for U.S. supply Effectively doubles Capacity available to support U.S. supply after DSM2 approval

Countries where AVT02 is approved More than 50 countries AVT02 is approved as a biosimilar to Humira

Approved and marketed biosimilars 5 biosimilars Alvotech products marketed in multiple global markets

Key Terms

Biologics License Application (BLA), drug substance, biosimilar, Voluntary Action Indicated (VAI)

4 terms

Biologics License Application (BLA) regulatory

"supplement to the Biologics License Application (BLA)"

A biologics license application (BLA) is a formal request to a government agency seeking approval to sell a biological medicine, such as vaccines or gene therapies, in the market. It is similar to a detailed report that proves the product is safe, effective, and manufactured properly. For investors, a BLA signifies a critical step toward commercial availability, often impacting a company's valuation and market prospects.

drug substance technical

"complete drug substance manufacturing process"

The drug substance is the primary active ingredient in a medicine—the chemical or biological material that produces the intended therapeutic effect. Think of it like the main ingredient in a recipe: its availability, purity, cost to make, and the ability to produce it at scale affect regulatory approvals, manufacturing reliability and profit margins, so investors watch it as a key factor in a drug’s commercial prospects and risk profile.

biosimilar medical

"approved as a biosimilar to Humira"

A biosimilar is a medicine created to be highly similar to an existing complex drug made from living cells, matching its safety and effectiveness while allowing for small, natural variations. For investors, biosimilars matter because they introduce lower-cost competition when patents end, which can cut prices, shift market share, and change revenue forecasts for companies selling the original drugs, much like a generic version does for simpler chemical medicines.

Voluntary Action Indicated (VAI) regulatory

"Voluntary Action Indicated (VAI) classification"

FAQ

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

What did the FDA approve for ALVO’s SIMLANDI supply?

The FDA approved a supplement to the Biologics License Application for AVT02, allowing drug substance for U.S. commercial supply to be manufactured in either of Alvotech’s 2 Reykjavik production suites, DSM1 or DSM2. Alvotech said DSM2 effectively doubles capacity available to support U.S. supply.

Which other Alvotech applications are pending with the FDA?

Other pending applications include BLAs for AVT05, a proposed biosimilar to Simponi and Simponi Aria; AVT06, a proposed biosimilar to Eylea; AVT03, a proposed biosimilar to Prolia and Xgeva; and AVT16/AVT80, proposed biosimilars to Entyvio. Alvotech expects FDA action according to each application’s goal date, subject to individual review and a regulatory decision.

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

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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 2026

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 Release

On October 5, 2026, Alvotech issued a Press Release announcing that the U.S. Food and Drug Administration (FDA) approved additional manufacturing capacity in the company's Reykjavik facility for the production of SIMLANDI®, Alvotech’s biosimilar to Humira®, for the U.S. market. A copy of the Press Release is furnished herewith as exhibit 99.1.

EXHIBIT INDEX

Exhibit Number		Description
99.1		Press Release dated October 5, 2026

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 5, 2026		/s/ Lisa Graver
		Lisa Graver
		CEO

EXHIBIT 99.1

FDA approves additional U.S. manufacturing capacity for SIMLANDI®, Alvotech’s biosimilar to Humira®

Approval enables AVT02 drug substance for U.S. commercial supply to be manufactured in either of Alvotech’s two Reykjavik drug substance suites

Further confirms resolution of FDA inspection-related matters at the Reykjavik site

REYKJAVIK, Iceland, Oct. 05, 2026 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the U.S. Food and Drug Administration (FDA) has approved a supplement to the Biologics License Application (BLA) for AVT02 (adalimumab-ryvk), marketed in the U.S. as SIMLANDI®, enabling drug substance for the product to be manufactured in a second production suite at the company’s Reykjavik facility. This approval further confirms resolution of inspection-related matters at the Reykjavik site.

“This approval is important both operationally and as a further regulatory milestone for our Reykjavik facility,” said Lisa Graver, Chief Executive Officer of Alvotech. “The addition of DSM2 effectively doubles the drug substance manufacturing capacity available to support U.S. supply and provides greater flexibility for commercial supply of AVT02 to the U.S. market. It also reflects the significant progress our teams have made in strengthening quality systems and manufacturing operations at the site.”

The second suite, DSM2, supports the complete drug substance manufacturing process, including cell culture and purification, and doubles Alvotech’s manufacturing capacity available to support U.S. supply. DSM2 is already approved for the manufacture of commercial drug substance for European markets, including for AVT02, AVT03, and AVT05. Following the FDA approval, Alvotech can now manufacture AVT02 drug substance for U.S. commercial supply in either DSM1 or DSM2, providing additional capacity and greater flexibility across its manufacturing operations.

The approval follows the FDA’s July 2026 closure of its most recent inspection of the Reykjavik facility with a Voluntary Action Indicated (VAI) classification. Alvotech therefore expects the FDA to be able to take action on other pending applications associated with the facility according to their respective goal dates. These include BLAs for AVT05, Alvotech’s proposed biosimilar to Simponi® and Simponi Aria® (golimumab), AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept), AVT03, Alvotech’s proposed biosimilar to Prolia® and Xgeva® (denosumab) and AVT16/AVT80, Alvotech’s proposed biosimilars to Entyvio® (vedolizumab). Each application remains subject to the FDA’s individual review and regulatory decision.

About AVT02 / SIMLANDI® (adalimumab-ryvk)

AVT02 is a monoclonal antibody approved as a biosimilar to Humira® (adalimumab) in more than 50 countries globally, including the United States, Europe, Canada and Australia. It is currently marketed in the U.S. as SIMLANDI® and under private label, in Europe as HUKYNDRA®, in Canada as SIMLANDI® and in Australia as ADALACIP®. Teva Pharmaceuticals is Alvotech’s strategic partner for the exclusive commercialization of SIMLANDI® in the United States, while Alvotech is responsible for development and manufacturing. 

For further information, contact:

Media
Benedikt Stefansson
Sarah MacLeod
alvotech.media@alvotech.com

Investors
Dr. Balaji V Prasad
Benedikt Stefansson
Mikaela Vilchez
alvotech.ir@alvotech.com

About Alvotech 

Alvotech is a biotechnology company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high-quality, cost-effective products and services, enabled by a fully integrated approach and broad in-house capabilities. Five biosimilars are already approved and marketed in multiple global markets, including biosimilars to Humira® (adalimumab), Stelara® (ustekinumab), Simponi® (golimumab), Eylea® (aflibercept) and Prolia®/Xgeva® (denosumab). The current development pipeline includes disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. For more information, please visit https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.

For more information, please visit our  website or follow us on social media on LinkedIn, Facebook, Instagram, and YouTube.

Use of trademarks

Third party trademarks are the property of their respective owners.

Forward Looking Statements

Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed.

Filing Exhibits & Attachments

1 document

Press Releases

• EX-99.1 EXHIBIT 99.1 8.2 KB