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 June 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Form S-8 (File No. 333-266881) and to be a part thereof from the date on which this Report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
Exhibits 99.1 and 99.2 to this Report are 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.
Company Announcements
On June 3, 2026, Alvotech issued a press release to announce that the meeting minutes and voting results of Alvotech’s 2026 Annual General Meeting will be published on the Company’s special web portal for the 2026 Annual General Meeting at https://investors.alvotech.com. A copy of the Press Release is furnished herewith as exhibit 99.1.
On June 4, 2026, Alvotech issued a press release to announce the resubmission to the U.S. Food and Drug Administration (FDA) of U.S. Biologics License Applications (BLAs) for AVT05, a proposed biosimilar to Simponi® and Simponi Aria® (golimumab), and AVT06, a proposed biosimilar to Eylea® (aflibercept) 2 mg. A copy of the Press Release is furnished herewith as exhibit 99.2.
EXHIBIT INDEX
| Exhibit Number | | Description |
| | | |
| 99.1 | | Press Release dated June 3, 2026 | | |
| 99.2 | | Press Release dated June 4, 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: June 4, 2026 | | /s/ Tanya Zharov |
| | | Tanya Zharov |
| | | General Counsel |
| | | |
EXHIBIT 99.1
Main Results of 2026 Annual and Extraordinary General Meeting
The 2026 Annual and Extraordinary General Meeting of Alvotech (the "2026 AGM") was held on June 3, 2026, at Arendt House, 41A Avenue John F. Kennedy, L-2082 Luxembourg.
All of the draft resolutions on the 2026 AGM agenda were approved. Notarized meeting minutes and voting results will be published on the Company’s special web portal for the 2026 Annual General Meeting at https://investors.alvotech.com/events/event-details/annual-general-meeting-2026.
Alvotech Investor Relations
Benedikt Stefansson
alvotech.ir@alvotech.com
EXHIBIT 99.2
Alvotech announces resubmission of U.S. Biologics License Applications for AVT05, a proposed biosimilar to Simponi® and Simponi Aria®, and AVT06, a proposed biosimilar to Eylea®
REYKJAVIK, Iceland, June 4, 2026 - Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the resubmission to the U.S. Food and Drug Administration (FDA) of Biologics License Applications (BLAs) for AVT05, a proposed biosimilar to Simponi® and Simponi Aria® (golimumab), and AVT06, a proposed biosimilar to Eylea® (aflibercept) 2 mg.
Under a partnership with Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), Alvotech is responsible for the development and manufacturing of AVT05 and AVT06, while Teva is responsible for commercialization.
The resubmissions follow the submission of Alvotech’s response to the FDA’s Post-Application Action Letter (PAAL) related to the company’s Reykjavik manufacturing facility. In addition, the company has submitted responses to observations from a routine cGMP surveillance FDA inspection at the facility, completed in May 2026, and has continued to strengthen its quality systems and manufacturing operations as part of its ongoing enhancement program.
The company expects the FDA to conduct a six-month review of the resubmitted applications, consistent with the applicable regulatory timelines.
AVT03, Alvotech’s proposed biosimilar to Prolia® and Xgeva® (denosumab), is partnered with Dr. Reddy’s Laboratories Ltd. which, as applicant, is responsible for the U.S. regulatory submission.
“These resubmissions represent an important milestone following extensive work across our manufacturing and quality organization,” said Lisa Graver, Chief Executive Officer of Alvotech. “We have worked closely with the FDA throughout this process, including responding to the agency’s Post-Application Action Letter and supporting a routine inspection of our Reykjavik facility in May. As previously disclosed, we believe the outcome of the recent inspection demonstrated the strong cGMP fundamentals of the site and the robustness of the improvements implemented since last year. We remain focused on execution, operational discipline and bringing high-quality biosimilars to patients worldwide.”
AVT05 is a proposed biosimilar to Simponi® and Simponi Aria® (golimumab), biologic medicines used to treat a variety of chronic inflammatory conditions. AVT06 is a proposed biosimilar to Eylea® (aflibercept) 2 mg, a biologic medicine used to treat several serious retinal disorders, including conditions that may lead to vision loss or blindness.
About AVT05
AVT05 is a biosimilar to Simponi® (golimumab) that has been approved in multiple markets globally including in the European Economic Area (EEA), the United Kingdom, and Japan. In the United States, AVT05 is being developed as a biosimilar candidate to Simponi® as a subcutaneous formulation and Simponi Aria® as an intravenous formulation.
About AVT06
AVT06 is a biosimilar to Eylea® (aflibercept) 2 mg that has been approved in multiple markets globally, including in the European Economic Area (EEA), the United Kingdom, Japan and Canada.
About AVT03
AVT03 is a biosimilar to Prolia® and Xgeva® (denosumab) that has been approved in multiple markets globally, including the EEA, the UK and Japan.
About Simponi® and Simponi Aria®
Simponi® (golimumab) is a subcutaneous tumor necrosis factor (TNF) blocker and Simponi Aria® (golimumab) is the intravenous formulation. Simponi and Simponi Aria are approved for a range of chronic inflammatory diseases including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis and polyarticular juvenile idiopathic arthritis.
About Eylea®
Eylea® (aflibercept) is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of several retinal diseases including neovascular (wet) age-related macular degeneration, diabetic macular edema and retinal vein occlusion.
About Prolia® and Xgeva®
Prolia® / Xgeva® (denosumab) is a monoclonal antibody used to treat osteoporosis and to prevent skeletal-related events in patients with certain cancers involving bone.
Use of trademarks
Simponi® and Simponi Aria® are trademarks of Johnson & Johnson. Eylea® is a trademark of Regeneron Pharmaceuticals Inc. Prolia® and Xgeva® are trademarks of Amgen. Reference to these trademarks does not imply any affiliation between Alvotech, Teva or Dr. Reddy’s and the trademark owners.
For further information, contact:
Media
Benedikt Stefansson
Sarah MacLeod
alvotech.media@alvotech.com
Investors
Dr. Balaji V Prasad
Benedikt Stefansson
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 biosimilars 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 nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, 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 investor portal, and our website or follow us on social media on LinkedIn, Facebook, Instagram and YouTube.
Alvotech 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 the regulatory progress and expected timing of BLA resubmission for AVT05 and AVT06, the adequacy of the improvements on cGMP since last year, competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, 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.
