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SEC · EDGAR 财务披露·· 8 小时前AI 评分58

Alvotech:FDA批准雷克雅未克工厂新增SIMLANDI美国市场生产产能

6-K - Alvotech (0001898416) (Filer)

AI 导读

Alvotech表示,美国食品药品监督管理局(FDA)已批准其雷克雅未克工厂新增生产能力,用于生产面向美国市场的SIMLANDI®。SIMLANDI®是Alvotech的Humira®生物类似药;公司于10月5日发布相关新闻稿并以6-K提交披露。

正文

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Form S-8 (File No. 333-266881) and to be a part thereof from the date on which this Report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.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
     

来源:SEC EDGAR · 本站存档