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

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6-K
Rhea-AI Filing Summary

Alvotech has announced positive topline results from a confirmatory efficacy study comparing AVT23, their proposed biosimilar to Xolair® (omalizumab), with the reference biologic. The announcement was made via press release on June 25, 2025.

This Form 6-K filing includes important administrative updates:

  • The report will be incorporated into multiple Alvotech registration statements, including Forms F-3 (File Nos. 333-266136, 333-273262, 333-275111, and 333-281684) and Form S-8 (File No. 333-266881)
  • Exhibit 99.1 (Press Release) is being furnished and not "filed" under Section 18 of the Securities Exchange Act
  • The document was signed by Tanya Zharov, General Counsel of Alvotech

This development represents a significant milestone in Alvotech's biosimilar development program, potentially expanding their portfolio of biological alternatives in the pharmaceutical market.

Alvotech ha annunciato risultati positivi preliminari da uno studio di efficacia confermativo che confronta AVT23, il loro biosimilare proposto a Xolair® (omalizumab), con il biologico di riferimento. L'annuncio è stato diffuso tramite comunicato stampa il 25 giugno 2025.

Questo deposito del Modulo 6-K include importanti aggiornamenti amministrativi:

  • Il rapporto sarà incorporato in diverse dichiarazioni di registrazione di Alvotech, inclusi i Moduli F-3 (Numeri di File 333-266136, 333-273262, 333-275111 e 333-281684) e il Modulo S-8 (Numero di File 333-266881)
  • L'Esibizione 99.1 (Comunicato Stampa) viene fornita e non "depositata" ai sensi della Sezione 18 del Securities Exchange Act
  • Il documento è stato firmato da Tanya Zharov, Consigliere Generale di Alvotech

Questo sviluppo rappresenta una tappa importante nel programma di sviluppo di biosimilari di Alvotech, potenzialmente ampliando il loro portafoglio di alternative biologiche nel mercato farmaceutico.

Alvotech ha anunciado resultados positivos preliminares de un estudio confirmatorio de eficacia que compara AVT23, su biosimilar propuesto a Xolair® (omalizumab), con el biológico de referencia. El anuncio se realizó mediante un comunicado de prensa el 25 de junio de 2025.

Esta presentación del Formulario 6-K incluye importantes actualizaciones administrativas:

  • El informe será incorporado en múltiples declaraciones de registro de Alvotech, incluyendo los Formularios F-3 (Números de Archivo 333-266136, 333-273262, 333-275111 y 333-281684) y el Formulario S-8 (Número de Archivo 333-266881)
  • El Anexo 99.1 (Comunicado de Prensa) se proporciona y no se "presenta" bajo la Sección 18 de la Ley de Intercambio de Valores
  • El documento fue firmado por Tanya Zharov, Asesora General de Alvotech

Este avance representa un hito significativo en el programa de desarrollo de biosimilares de Alvotech, potencialmente ampliando su portafolio de alternativas biológicas en el mercado farmacéutico.

Alvotech는 AVT23이라는 자사의 바이오시밀러와 기준 생물학적 제제인 Xolair® (오말리주맙)을 비교한 확인 효능 연구에서 긍정적인 초기 결과를 발표했습니다. 이 발표는 2025년 6월 25일 보도 자료를 통해 이루어졌습니다.

이번 Form 6-K 제출에는 중요한 행정 업데이트가 포함되어 있습니다:

  • 보고서는 Alvotech의 여러 등록 서류에 포함될 예정이며, 여기에는 Form F-3(파일 번호 333-266136, 333-273262, 333-275111, 333-281684)과 Form S-8(파일 번호 333-266881)이 포함됩니다.
  • Exhibit 99.1(보도 자료)은 증권거래법 섹션 18에 따라 '제출'이 아닌 '제공' 형식입니다.
  • 문서는 Alvotech의 법률 고문인 Tanya Zharov가 서명했습니다.

이번 성과는 Alvotech의 바이오시밀러 개발 프로그램에서 중요한 이정표를 의미하며, 제약 시장에서 생물학적 대체제 포트폴리오를 확장할 가능성을 열어줍니다.

Alvotech a annoncé des résultats préliminaires positifs issus d'une étude d'efficacité confirmatoire comparant AVT23, leur biosimilaire proposé à Xolair® (omalizumab), au biologique de référence. L'annonce a été faite via un communiqué de presse le 25 juin 2025.

Ce dépôt du formulaire 6-K comprend des mises à jour administratives importantes :

  • Le rapport sera intégré dans plusieurs déclarations d'enregistrement d'Alvotech, y compris les formulaires F-3 (numéros de dossier 333-266136, 333-273262, 333-275111 et 333-281684) et le formulaire S-8 (numéro de dossier 333-266881)
  • L'exhibit 99.1 (communiqué de presse) est fourni mais non "déposé" conformément à la section 18 du Securities Exchange Act
  • Le document a été signé par Tanya Zharov, conseillère juridique générale d'Alvotech

Cette avancée représente une étape majeure dans le programme de développement de biosimilaires d'Alvotech, pouvant potentiellement élargir leur portefeuille d'alternatives biologiques sur le marché pharmaceutique.

Alvotech hat positive Zwischenergebnisse aus einer bestätigenden Wirksamkeitsstudie bekannt gegeben, in der AVT23, ihr vorgeschlagenes Biosimilar zu Xolair® (Omalizumab), mit dem Referenzbiologikum verglichen wurde. Die Bekanntgabe erfolgte per Pressemitteilung am 25. Juni 2025.

Diese Einreichung des Formulars 6-K enthält wichtige administrative Aktualisierungen:

  • Der Bericht wird in mehrere Registrierungserklärungen von Alvotech aufgenommen, einschließlich der Formulare F-3 (Aktenzeichen 333-266136, 333-273262, 333-275111 und 333-281684) und Formular S-8 (Aktenzeichen 333-266881)
  • Anlage 99.1 (Pressemitteilung) wird bereitgestellt und nicht gemäß Abschnitt 18 des Securities Exchange Act "eingereicht"
  • Das Dokument wurde von Tanya Zharov, General Counsel von Alvotech, unterzeichnet

Diese Entwicklung stellt einen bedeutenden Meilenstein im Biosimilar-Entwicklungsprogramm von Alvotech dar und könnte deren Portfolio biologischer Alternativen auf dem Pharmamarkt erweitern.

Positive
  • Positive topline results announced from confirmatory efficacy study comparing AVT23 (proposed biosimilar) to Xolair® (omalizumab)
Negative
  • None.

Alvotech ha annunciato risultati positivi preliminari da uno studio di efficacia confermativo che confronta AVT23, il loro biosimilare proposto a Xolair® (omalizumab), con il biologico di riferimento. L'annuncio è stato diffuso tramite comunicato stampa il 25 giugno 2025.

Questo deposito del Modulo 6-K include importanti aggiornamenti amministrativi:

  • Il rapporto sarà incorporato in diverse dichiarazioni di registrazione di Alvotech, inclusi i Moduli F-3 (Numeri di File 333-266136, 333-273262, 333-275111 e 333-281684) e il Modulo S-8 (Numero di File 333-266881)
  • L'Esibizione 99.1 (Comunicato Stampa) viene fornita e non "depositata" ai sensi della Sezione 18 del Securities Exchange Act
  • Il documento è stato firmato da Tanya Zharov, Consigliere Generale di Alvotech

Questo sviluppo rappresenta una tappa importante nel programma di sviluppo di biosimilari di Alvotech, potenzialmente ampliando il loro portafoglio di alternative biologiche nel mercato farmaceutico.

Alvotech ha anunciado resultados positivos preliminares de un estudio confirmatorio de eficacia que compara AVT23, su biosimilar propuesto a Xolair® (omalizumab), con el biológico de referencia. El anuncio se realizó mediante un comunicado de prensa el 25 de junio de 2025.

Esta presentación del Formulario 6-K incluye importantes actualizaciones administrativas:

  • El informe será incorporado en múltiples declaraciones de registro de Alvotech, incluyendo los Formularios F-3 (Números de Archivo 333-266136, 333-273262, 333-275111 y 333-281684) y el Formulario S-8 (Número de Archivo 333-266881)
  • El Anexo 99.1 (Comunicado de Prensa) se proporciona y no se "presenta" bajo la Sección 18 de la Ley de Intercambio de Valores
  • El documento fue firmado por Tanya Zharov, Asesora General de Alvotech

Este avance representa un hito significativo en el programa de desarrollo de biosimilares de Alvotech, potencialmente ampliando su portafolio de alternativas biológicas en el mercado farmacéutico.

Alvotech는 AVT23이라는 자사의 바이오시밀러와 기준 생물학적 제제인 Xolair® (오말리주맙)을 비교한 확인 효능 연구에서 긍정적인 초기 결과를 발표했습니다. 이 발표는 2025년 6월 25일 보도 자료를 통해 이루어졌습니다.

이번 Form 6-K 제출에는 중요한 행정 업데이트가 포함되어 있습니다:

  • 보고서는 Alvotech의 여러 등록 서류에 포함될 예정이며, 여기에는 Form F-3(파일 번호 333-266136, 333-273262, 333-275111, 333-281684)과 Form S-8(파일 번호 333-266881)이 포함됩니다.
  • Exhibit 99.1(보도 자료)은 증권거래법 섹션 18에 따라 '제출'이 아닌 '제공' 형식입니다.
  • 문서는 Alvotech의 법률 고문인 Tanya Zharov가 서명했습니다.

이번 성과는 Alvotech의 바이오시밀러 개발 프로그램에서 중요한 이정표를 의미하며, 제약 시장에서 생물학적 대체제 포트폴리오를 확장할 가능성을 열어줍니다.

Alvotech a annoncé des résultats préliminaires positifs issus d'une étude d'efficacité confirmatoire comparant AVT23, leur biosimilaire proposé à Xolair® (omalizumab), au biologique de référence. L'annonce a été faite via un communiqué de presse le 25 juin 2025.

Ce dépôt du formulaire 6-K comprend des mises à jour administratives importantes :

  • Le rapport sera intégré dans plusieurs déclarations d'enregistrement d'Alvotech, y compris les formulaires F-3 (numéros de dossier 333-266136, 333-273262, 333-275111 et 333-281684) et le formulaire S-8 (numéro de dossier 333-266881)
  • L'exhibit 99.1 (communiqué de presse) est fourni mais non "déposé" conformément à la section 18 du Securities Exchange Act
  • Le document a été signé par Tanya Zharov, conseillère juridique générale d'Alvotech

Cette avancée représente une étape majeure dans le programme de développement de biosimilaires d'Alvotech, pouvant potentiellement élargir leur portefeuille d'alternatives biologiques sur le marché pharmaceutique.

Alvotech hat positive Zwischenergebnisse aus einer bestätigenden Wirksamkeitsstudie bekannt gegeben, in der AVT23, ihr vorgeschlagenes Biosimilar zu Xolair® (Omalizumab), mit dem Referenzbiologikum verglichen wurde. Die Bekanntgabe erfolgte per Pressemitteilung am 25. Juni 2025.

Diese Einreichung des Formulars 6-K enthält wichtige administrative Aktualisierungen:

  • Der Bericht wird in mehrere Registrierungserklärungen von Alvotech aufgenommen, einschließlich der Formulare F-3 (Aktenzeichen 333-266136, 333-273262, 333-275111 und 333-281684) und Formular S-8 (Aktenzeichen 333-266881)
  • Anlage 99.1 (Pressemitteilung) wird bereitgestellt und nicht gemäß Abschnitt 18 des Securities Exchange Act "eingereicht"
  • Das Dokument wurde von Tanya Zharov, General Counsel von Alvotech, unterzeichnet

Diese Entwicklung stellt einen bedeutenden Meilenstein im Biosimilar-Entwicklungsprogramm von Alvotech dar und könnte deren Portfolio biologischer Alternativen auf dem Pharmamarkt erweitern.

 

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 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 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, and 333-275111 and 333-281684) 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 June 25, 2025, Alvotech issued a press release announcing the positive topline results from a confirmatory efficacy study comparing AVT23 a proposed biosimilar to Xolair® (omalizumab), with the reference biologic. A copy of the Press Release is furnished herewith as exhibit 99.1.


EXHIBIT INDEX

 

Exhibit Number Description
  
99.1 Press Release dated June 25, 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: June 25, 2025     /s/ Tanya Zharov    
  Tanya Zharov
  General Counsel
  

FAQ

What did Alvotech (ALVO) announce in their June 25, 2025 Form 6-K filing?

Alvotech (ALVO) announced positive topline results from a confirmatory efficacy study comparing AVT23, their proposed biosimilar to Xolair® (omalizumab), with the reference biologic.

What registration statements will ALVO's June 2025 6-K be incorporated into?

The Form 6-K will be incorporated into Alvotech's registration statements on Forms F-3 (File Nos. 333-266136, 333-273262, 333-275111 and 333-281684) and Form S-8 (File No. 333-266881), except for Exhibit 99.1.

Who signed ALVO's June 2025 Form 6-K filing?

The Form 6-K was signed by Tanya Zharov, General Counsel of Alvotech, on June 25, 2025.

Is ALVO's June 2025 press release (Exhibit 99.1) considered 'filed' under the Exchange Act?

No, Exhibit 99.1 (the press release) is being furnished and is explicitly stated as not being 'filed' for purposes of Section 18 of the Securities Exchange Act of 1934, nor will it be incorporated by reference in any Securities Act or Exchange Act filings.
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