[6-K] Alvotech Current Report (Foreign Issuer)
Alvotech reported regulatory progress for multiple biosimilars in September 2025. Fuji Pharma received Japanese marketing authorization for three Alvotech-developed products: AVT03 (referencing Xgeva/denosumab), AVT05 (referencing Simponi/golimumab) and AVT06 (referencing Eylea/aflibercept). Separately, the European Medicines Agency's CHMP adopted positive opinions recommending approval in the European Economic Area for AVT03 (referencing Prolia/Xgeva) and AVT05 (referencing Simponi); final European Commission decisions are pending. The company furnished press releases as Exhibits 99.1–99.3, which are provided for incorporation by reference but are not being "filed" for certain Exchange Act liabilities.
Alvotech ha riportato progressi normativi per diversi biosimilari a settembre 2025. Fuji Pharma ha ottenuto l'autorizzazione all'immissione in commercio in Giappone per tre prodotti sviluppati da Alvotech: AVT03 (riferimento Xgeva/denosumab), AVT05 (riferimento Simponi/golimumab) e AVT06 (riferimento Eylea/aflibercept). Separatamente, lo CHMP dell EMA ha adottato pareri positivi raccomandando l'approvazione nell'AEE per AVT03 (riferimento Prolia/Xgeva) e AVT05 (riferimento Simponi); le decisioni finali della Commissione Europea sono in attesa. L'azienda ha fornito comunicati stampa come Allegati 99.1–99.3, che sono inclusi per riferimento ma non presentati come depositati per alcune obbligazioni conformi al Exchange Act.
Alvotech informó avances regulatorios para múltiples biosimilares en septiembre de 2025. Fuji Pharma recibió la autorización de comercialización en Japón para tres productos desarrollados por Alvotech: AVT03 (referenciando Xgeva/denosumab), AVT05 (referenciando Simponi/golimumab) y AVT06 (referenciando Eylea/aflibercept). Por su parte, el CHMP de la EMA adoptó opiniones positivas recomendando la aprobación en el Espacio Económico Europeo para AVT03 (referenciando Prolia/Xgeva) y AVT05 (referenciando Simponi); las decisiones finales de la Comisión Europea están pendientes. La empresa suministró comunicados de prensa como Exhibits 99.1–99.3, que se incluyen como referencia pero no se presentan como presentados para ciertas obligaciones bajo la Exchange Act.
알보텍은 2025년 9월 여러 바이오시밀러에 대한 규제 진행 상황을 발표했다. Fuji Pharma는 알보텍이 개발한 세 가지 제품 AVT03(참조 Xgeva/denosumab), AVT05(참조 Simponi/golimumab), AVT06(참조 Eylea/aflibercept)에 대해 일본에서 시판허가를 받았다. 또한 EMA의 CHMP는 AVT03(참조 Prolia/Xgeva)와 AVT05(참조 Simponi)에 대해 유럽경제지역 내 승인을 권고하는 긍정적 의견을 채택했다. 최종 유럽위원회 결정은 아직 남아 있다. 회사는 법적 참조용으로 Exhibits 99.1–99.3의 보도자료를 제공했으나, 특정 Exchange Act상의 의무로 면제되어 제출된 것은 아니다.
Alvotech a signalé des progrès réglementaires pour plusieurs biosimilaires en septembre 2025. Fuji Pharma a obtenu au Japon l’autorisation de mise sur le marché pour trois produits développés par Alvotech : AVT03 (référence Xgeva/denosumab), AVT05 (référence Simponi/golimumab) et AVT06 (référence Eylea/aflibercept). Par ailleurs, le CHMP de l’EMA a adopté des avis positifs recommandant l’approbation dans l’Espace économique européen pour AVT03 (référence Prolia/Xgeva) et AVT05 (référence Simponi); les décisions finales de la Commission européenne restent en attente. L’entreprise a fourni des communiqués de presse en tant qu’Exhibits 99.1–99.3, qui sont fournis à titre de référence mais ne sont pas « déposés » pour certaines obligations en vertu de la Exchange Act.
Alvotech meldete regulatorische Fortschritte für mehrere Biosimilars im September 2025. Fuji Pharma erhielt in Japan die Marktzulassung für drei von Alvotech entwickelte Produkte: AVT03 (Referenz Xgeva/denosumab), AVT05 (Referenz Simponi/golimumab) und AVT06 (Referenz Eylea/aflibercept). Separat stellte die CHMP der EMA positive Gutachten auf eine Zulassung im Europäischen Wirtschaftsraum für AVT03 (Referenz Prolia/Xgeva) und AVT05 (Referenz Simponi) aus; endgültige Entscheidungen der Europäischen Kommission stehen noch aus. Das Unternehmen hat Pressemitteilungen als Exhibits 99.1–99.3 zur Bezugnahme bereitgestellt, sie wurden jedoch nicht als eingereicht für bestimmte Verpflichtungen gemäß dem Exchange Act erklärt.
أبلغت ألفوتيك عن تقدم تنظيمي لعدة أدوية حيوية متماثلة (biosimilars) في سبتمبر 2025. حصلت Fuji Pharma على ترخيص التسويق في اليابان لثلاثة منتجات طورتها ألفوتيك: AVT03 (مرجع Xgeva/denosumab)، AVT05 (مرجع Simponi/golimumab) و AVT06 (مرجع Eylea/aflibercept). وبالمثل، اعتمد CHMP التابع لـ EMA آراء إيجابية توصي بالاعتماد في المنطقة الاقتصادية الأوروبية لـ AVT03 (مرجع Prolia/Xgeva) و AVT05 (مرجع Simponi); لا تزال قرارات المفوضية الأوروبية النهائية قيد الانتظار. وفرت الشركة بيانات صحفية كـ Exhibits 99.1–99.3 للمراجعة لكنها لم تُقدَّم كـ مطلوبة بموجب أحكام Exchange Act لبعض الالتزامات.
Alvotech 在 2025 年 9 月就多款生物相似药取得监管进展。 Fuji Pharma 已在日本取得 Alvotech 开发的三款产品的上市许可：AVT03（参照 Xgeva/denosumab）、AVT05（参照 Simponi/golimumab）和 AVT06（参照 Eylea/aflibercept）。另外，欧盟药品管理局的 CHMP 作出积极意见，建议在欧洲经济区批准 AVT03（参照 Prolia/Xgeva）和 AVT05（参照 Simponi）；最终的欧盟委员会决定尚待。公司提供了公告稿作为附件 99.1–99.3 以供引用，但并未就某些依据 Exchange Act 的责任“提交”而备案。
- Japanese marketing authorization granted for AVT03, AVT05 and AVT06 via Fuji Pharma
- CHMP positive opinions recommending approval for AVT03 and AVT05 in the European Economic Area
- Multiple regulatory jurisdictions advanced in a short timeframe (Japan and Europe)
- European approvals are not final: final decisions by the European Commission are pending for AVT03 and AVT05
- Press releases furnished but not filed: exhibits 99.1–99.3 are furnished and not deemed filed for certain Exchange Act liabilities
Insights
TL;DR: Multiple regulatory milestones achieved: three approvals in Japan and CHMP positive opinions for two candidates in Europe, moving products toward market access.
The receipt of Japanese marketing authorization for AVT03, AVT05 and AVT06 demonstrates successful submissions and regulatory acceptance in a key market, enabling commercialization via Alvotech's local partner, Fuji Pharma. CHMP positive opinions for AVT03 and AVT05 are critical EU procedural steps that, pending European Commission decisions, could allow access to the European Economic Area. These developments materially advance regulatory pathways but require final EC approvals and local launch preparations before commercial revenue is realized.
TL;DR: Partner-led commercialization enabled immediate regulatory milestones in Japan and strengthens prospects in Europe pending final approvals.
Approvals in Japan are tied to Alvotech's commercialization partner, indicating partner execution is progressing and allowing market entry for three biosimilars. CHMP positive opinions suggest regulatory alignment in Europe for AVT03 and AVT05; the announcements note that final European Commission decisions remain pending, so commercialization timelines and market launches will depend on those outcomes and subsequent local marketing activities by partners.
Alvotech ha riportato progressi normativi per diversi biosimilari a settembre 2025. Fuji Pharma ha ottenuto l'autorizzazione all'immissione in commercio in Giappone per tre prodotti sviluppati da Alvotech: AVT03 (riferimento Xgeva/denosumab), AVT05 (riferimento Simponi/golimumab) e AVT06 (riferimento Eylea/aflibercept). Separatamente, lo CHMP dell EMA ha adottato pareri positivi raccomandando l'approvazione nell'AEE per AVT03 (riferimento Prolia/Xgeva) e AVT05 (riferimento Simponi); le decisioni finali della Commissione Europea sono in attesa. L'azienda ha fornito comunicati stampa come Allegati 99.1–99.3, che sono inclusi per riferimento ma non presentati come depositati per alcune obbligazioni conformi al Exchange Act.
Alvotech informó avances regulatorios para múltiples biosimilares en septiembre de 2025. Fuji Pharma recibió la autorización de comercialización en Japón para tres productos desarrollados por Alvotech: AVT03 (referenciando Xgeva/denosumab), AVT05 (referenciando Simponi/golimumab) y AVT06 (referenciando Eylea/aflibercept). Por su parte, el CHMP de la EMA adoptó opiniones positivas recomendando la aprobación en el Espacio Económico Europeo para AVT03 (referenciando Prolia/Xgeva) y AVT05 (referenciando Simponi); las decisiones finales de la Comisión Europea están pendientes. La empresa suministró comunicados de prensa como Exhibits 99.1–99.3, que se incluyen como referencia pero no se presentan como presentados para ciertas obligaciones bajo la Exchange Act.
알보텍은 2025년 9월 여러 바이오시밀러에 대한 규제 진행 상황을 발표했다. Fuji Pharma는 알보텍이 개발한 세 가지 제품 AVT03(참조 Xgeva/denosumab), AVT05(참조 Simponi/golimumab), AVT06(참조 Eylea/aflibercept)에 대해 일본에서 시판허가를 받았다. 또한 EMA의 CHMP는 AVT03(참조 Prolia/Xgeva)와 AVT05(참조 Simponi)에 대해 유럽경제지역 내 승인을 권고하는 긍정적 의견을 채택했다. 최종 유럽위원회 결정은 아직 남아 있다. 회사는 법적 참조용으로 Exhibits 99.1–99.3의 보도자료를 제공했으나, 특정 Exchange Act상의 의무로 면제되어 제출된 것은 아니다.
Alvotech a signalé des progrès réglementaires pour plusieurs biosimilaires en septembre 2025. Fuji Pharma a obtenu au Japon l’autorisation de mise sur le marché pour trois produits développés par Alvotech : AVT03 (référence Xgeva/denosumab), AVT05 (référence Simponi/golimumab) et AVT06 (référence Eylea/aflibercept). Par ailleurs, le CHMP de l’EMA a adopté des avis positifs recommandant l’approbation dans l’Espace économique européen pour AVT03 (référence Prolia/Xgeva) et AVT05 (référence Simponi); les décisions finales de la Commission européenne restent en attente. L’entreprise a fourni des communiqués de presse en tant qu’Exhibits 99.1–99.3, qui sont fournis à titre de référence mais ne sont pas « déposés » pour certaines obligations en vertu de la Exchange Act.
Alvotech meldete regulatorische Fortschritte für mehrere Biosimilars im September 2025. Fuji Pharma erhielt in Japan die Marktzulassung für drei von Alvotech entwickelte Produkte: AVT03 (Referenz Xgeva/denosumab), AVT05 (Referenz Simponi/golimumab) und AVT06 (Referenz Eylea/aflibercept). Separat stellte die CHMP der EMA positive Gutachten auf eine Zulassung im Europäischen Wirtschaftsraum für AVT03 (Referenz Prolia/Xgeva) und AVT05 (Referenz Simponi) aus; endgültige Entscheidungen der Europäischen Kommission stehen noch aus. Das Unternehmen hat Pressemitteilungen als Exhibits 99.1–99.3 zur Bezugnahme bereitgestellt, sie wurden jedoch nicht als eingereicht für bestimmte Verpflichtungen gemäß dem Exchange Act erklärt.
FAQ
What approvals did Alvotech (ALVOW) announce in Japan?
Which Alvotech biosimilars received CHMP positive opinions in Europe?
Are the European approvals for Alvotech final?
Were the press releases included in the 6-K filed or furnished?
Who is Alvotech's commercialization partner in Japan?
