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Alvotech (NASDAQ: ALVO) bets on U.S. biosimilars with Lotus

Filing Impact
(Neutral)
Filing Sentiment
(Neutral)
Form Type
6-K

Rhea-AI Filing Summary

Alvotech (ALVO) announced a strategic licensing and commercialization agreement with Lotus Pharmaceutical for two biosimilar candidates, AVT34 (proposed biosimilar to Imfinzi, durvalumab) and AVT87 (proposed biosimilar to Hemlibra, emicizumab) in the United States and selected Asian markets.

Under a semi-exclusive U.S. arrangement, Alvotech will co-commercialize both products alongside Lotus, which will use its U.S. subsidiary Alvogen as commercial platform. Alvotech will handle development, U.S. marketing authorizations, and act as exclusive supplier globally. In eight Asian markets, Lotus receives exclusive commercialization rights and will manage local regulatory submissions.

The agreement has a potential value to Alvotech of up to approximately $150 million in upfront and milestone payments, plus ongoing product-supply revenues. The reference products Imfinzi and Hemlibra generated 2025 global sales of about $6.1 billion and CHF4.8 billion, respectively, highlighting the scale of the target markets.

Positive

  • Licensing deal could provide Alvotech up to approximately $150 million in upfront and milestone payments, plus ongoing supply revenues.
  • Agreement gives Alvotech, for the first time, a role in direct U.S. commercialization of its biosimilars, allowing it to retain a greater share of product value.
  • Lotus receives exclusive rights in eight Asian markets, potentially broadening uptake of AVT34 and AVT87 across key oncology and rare-disease markets.

Negative

  • None.

Filing Explained

The August 21 Form 6-K incorporates the report—but not its attached press release—into six specified registration statements; the release is furnished only and is not incorporated into any filing.

Potential agreement value approximately $150 million Upfront and milestone payments potentially payable to Alvotech under the Lotus agreement
Imfinzi global sales approximately $6.1 billion Global sales in 2025 for oncology biologic Imfinzi, reference for AVT34
Hemlibra global sales CHF4.8 billion (approximately $5.8 billion) Global sales in 2025 for Hemlibra, reference for AVT87
Asian markets with exclusive rights for Lotus 8 markets South Korea, Taiwan, Thailand, Vietnam, the Philippines, Singapore, Hong Kong and Malaysia
Number of approved biosimilars 5 biosimilars Biosimilars already approved and marketed by Alvotech in multiple global markets
biosimilar medical
"specializing in the development and manufacture of biosimilar medicines"
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.
semi-exclusive agreement financial
"Under a semi-exclusive agreement in the United States, Alvotech retains"
A semi-exclusive agreement is a contract that gives one party special, but limited, rights to sell, distribute, or use a product or service while the other party retains the ability to work with others under specified limits. The exclusivity is narrowed by factors like geography, customer type, sales channels, products, or time period. For investors, it signals partial protection of revenue and market access—more predictability than a nonexclusive deal but less control than full exclusivity.
upfront and milestone payments financial
"potential value to Alvotech of up to approximately $150 million in upfront and milestone payments"
marketing authorizations regulatory
"obtaining and maintaining marketing authorizations in the United States"
A marketing authorization is an official government approval that allows a company to sell a drug, medical device, or health product in a particular country or region. It matters to investors because it is the legal key to generate revenue and reach customers—like a driver’s license for a product—so obtaining, losing, or delaying authorization directly affects a company’s potential sales, regulatory risk and valuation.
routine prophylaxis medical
"a biologic for routine prophylaxis to prevent or reduce the frequency"

FAQ

What did Alvotech (ALVO) announce in this Form 6-K?
Alvotech announced a strategic licensing and commercialization agreement with Lotus Pharmaceutical for AVT34 and AVT87, proposed biosimilars to Imfinzi and Hemlibra, covering the United States and eight selected Asian markets.

How much is the Lotus agreement potentially worth to Alvotech (ALVO)?
The agreement has a potential value to Alvotech of up to approximately $150 million in upfront and milestone payments, in addition to ongoing revenues from supplying commercial product.

What are AVT34 and AVT87 in Alvotech’s (ALVO) pipeline?
AVT34 is a proposed biosimilar to Imfinzi (durvalumab), an oncology biologic, and AVT87 is a proposed biosimilar to Hemlibra (emicizumab), used for routine prophylaxis in hemophilia A.

What commercialization rights does Lotus receive under the Alvotech (ALVO) deal?
In the United States, Lotus can commercialize AVT34 and AVT87 via Alvogen under a semi-exclusive arrangement with Alvotech. In Asia, Lotus receives exclusive commercialization rights in South Korea, Taiwan, Thailand, Vietnam, the Philippines, Singapore, Hong Kong and Malaysia.

Who is responsible for development and regulatory approvals in the Alvotech (ALVO)–Lotus agreement?
Alvotech will develop the products, obtain and maintain marketing authorizations in the United States, and act as the exclusive supplier for all covered markets. Lotus will handle local regulatory submissions and commercialization in its eight Asian territories.

How large are the markets targeted by Alvotech’s AVT34 and AVT87 biosimilars?
In 2025, Imfinzi generated approximately $6.1 billion in global sales and Hemlibra generated CHF4.8 billion (approximately $5.8 billion), indicating sizable reference markets for the proposed biosimilars AVT34 and AVT87.

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

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Form 6-K: How Foreign Companies Report to the SEC →
 

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 August 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 August 21, 2026, Alvotech issued a Press Release announcing that the company had formed an agreement with Lotus Pharmaceutical for proposed biosimilars to durvalumab and emicizumab in the U.S. and Selected Asian Markets. A copy of the Press Release is furnished herewith as exhibit 99.1.

EXHIBIT INDEX

 

Exhibit Number Description
   
99.1 Press Release dated August 21, 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: August 21, 2026     /s/ Lisa Graver    
  Lisa Graver
  CEO
  

EXHIBIT 99.1

Alvotech Announces Licensing and Commercialization Agreement with Lotus Pharmaceutical for proposed biosimilars to durvalumab and emicizumab in the U.S. and Selected Asian Markets

REYKJAVIK, Iceland, Aug. 21, 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 a strategic licensing and commercialization agreement with Lotus Pharmaceutical (TWSE Stock Code: 1795) covering two of Alvotech’s candidates in the United States and selected Asian markets: AVT34, a proposed biosimilar to Imfinzi® (durvalumab), and AVT87, a proposed biosimilar to Hemlibra® (emicizumab).

Imfinzi® is an oncology biologic used in the treatment of multiple cancers, which generated global sales of approximately $6.1 billion in 2025ˆ. Hemlibra® is a biologic for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A that generated global sales of approximately CHF4.8 billion (approximately $5.8 billion) in 2025².

Under a semi-exclusive agreement in the United States, Alvotech retains the right to commercialize both products directly alongside Lotus, while Lotus will commercialize the products through Alvogen, its U.S.-based wholly owned subsidiary. Alvotech will retain responsibility for product development, and for obtaining and maintaining marketing authorizations in the United States, and will serve as the exclusive supplier of the products for all markets.

In Asia, Lotus will have exclusive commercialization rights in eight selected markets: South Korea, Taiwan, Thailand, Vietnam, the Philippines, Singapore, Hong Kong and Malaysia. Lotus will be responsible for local regulatory submissions and commercialization in these markets.

The agreement has a potential value to Alvotech of up to approximately $150 million in upfront and milestone payments, in addition to ongoing revenues from the supply of commercial product.

“This agreement represents an important evolution of Alvotech’s commercial strategy,” said Lisa Graver, Chief Executive Officer of Alvotech. “For the first time, we will have the opportunity to participate directly in the future commercialization of our products in the United States, allowing us to retain a greater share of the value we create through our development and manufacturing platform. At the same time, our partnership with Lotus extends the potential reach of these two important pipeline assets across key Asian markets. We look forward to working together to bring these medicines to patients and broaden access to high-quality biologics.”

“We are pleased to partner with Alvotech on two important biosimilar candidates that meaningfully advance Lotus’ global growth strategy,” said Petar Vazharov, Chief Executive Officer of Lotus. “By combining Alvotech’s integrated biosimilar development and manufacturing capabilities with Alvogen’s established U.S. commercial platform and Lotus’s deep market presence across Asia, we are building a strong foundation for the future commercialization of AVT34 and AVT87 across key global markets. These candidates expand the scale and reach of our biosimilar portfolio in oncology and rare diseases, and reinforces our commitment to broadening access to high-quality medicines.”

Imfinzi® and Hemlibra® are registered trademarks and the property of their respective owners.

1) AstraZeneca PLC. (2026). Annual report on Form 20-F for the fiscal year ended December 31, 2025. U.S. Securities and Exchange Commission.
https://www.sec.gov/Archives/edgar/data/901832/000110465926019130/azn-20251231x20f.htm
2) Roche, Finance Report 2025, F. Hoffmann-La Roche Ltd,
https://assets.roche.com/f/176343/x/fca190f63e/fb25e.pdf
  


Contacts

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

Investor Relations contacts – alvotech.ir@alvotech.com
Dr. Balaji V Prasad
Benedikt Stefansson

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.

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.

Source: View Original Filing on SEC EDGAR

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