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Alvotech (NASDAQ: ALVO) announced that the FDA issued a complete response letter (CRL) regarding its Biologics License Application for AVT05 (prefilled syringe and autoinjector). The CRL cites deficiencies identified during the FDA’s pre-license inspection of Alvotech’s Reykjavik facility, completed in July 2025. These deficiencies must be resolved before approval can be granted. The FDA specified that no other application deficiencies were identified, and the Reykjavik facility retains its FDA approval for manufacturing, allowing for the continued supply of existing commercial products. According to IQVIA data, U.S. sales of Simponi, the reference product for AVT05, were less than $300 million in the first half of 2025. Currently, no biosimilar version of Simponi has been approved for the U.S. market.
Concurrently, Alvotech has adjusted its 2025 financial outlook, projecting revenues of $570–$600 million and an adjusted EBITDA of $130–$150 million. This revision reflects ongoing investments and a temporary slowdown in production initiated to address the identified facility issues.
Alvotech (NASDAQ: ALVO) ha detto che la FDA ha emesso una lettera di risposta completa (CRL) per la sua Domanda di Licenza Biologica per AVT05 (siringa pre-riempita e autoiniettore), citando carenze dall’ispezione pre-licenza FDA presso l’impianto di Reykjavik completata nel luglio 2025 che devono essere risolte prima dell’approvazione. La FDA non ha identificato altre carenze nell’applicazione e l’impianto resta approvato dalla FDA per la produzione e continua a fornire prodotti commerciali. Le vendite di Simponi negli Stati Uniti sono state inferiori a 300 milioni di dollari nel primo semestre 2025 (IQVIA); nessun biosimilare di Simponi è attualmente approvato negli USA.
Alvotech ha rivisto al ribasso la sua previsione per il 2025 a 570–600 milioni di dollari di ricavi e 130–150 milioni di dollari di EBITDA rettificato, citando investimenti e un rallentamento temporaneo della produzione per affrontare le questioni dell’impianto.
Alvotech (NASDAQ: ALVO) dijo que la FDA emitió una carta de respuesta completa (CRL) para su Solicitud de Licencia Biológica para AVT05 (jeringa prellenada y autoinyector), citando deficiencias de la inspección previa a la licencia realizada por la FDA en la instalación de Reykjavik, concluida en julio de 2025, que deben resolverse antes de la aprobación. La FDA no identificó otras deficiencias en la solicitud y la instalación continúa siendo aprobada por la FDA para fabricar y continúa suministrando productos comerciales. Las ventas de Simponi en Estados Unidos fueron menores de 300 millones de dólares en el 1S 2025 (IQVIA); actualmente no hay ningún biosimilar de Simponi aprobado en Estados Unidos. Alvotech redujo su pronóstico para 2025 a 570–600 millones de dólares de ingresos y 130–150 millones de EBITDA ajustado, citando inversiones y una desaceleración temporal de la producción para abordar los problemas de la instalación.
Alvotech (나스닥: ALVO)가 FDA가 AVT05(사전 충전 주사기 및 자동 주사기)용 생물학적 제제 허가 신청서에 대해 완전한 응답 서한(CRL)를 발행했다고 발표했다. 이는 2025년 7월에 완료된 레이캬비크 시설에 대한 FDA의 사전 허가 점검에서 발견된 결함으로, 승인을 위해 해결되어야 한다고 한다. FDA는 추가적인 신청 결함을 확인하지 않았고 해당 시설은 FDA 승인를 받아 제조를 계속하고 상용 제품을 공급한다. 미국에서의 Simponi 매출은 2025년 상반기에 3억 달러 미만이었으며(IQVIA); 현재 미국에서 Simponi의 바이오시밀러는 승인되지 않았다. Alvotech는 2025년 전망치를 5.7–6.0억 달러 매출 및 130–150만 달러의 조정 EBITDA로 하향 조정했고, 시설 이슈를 해결하기 위한 투자와 일시적 생산 지연 때문이라고 한다.
Alvotech (NASDAQ: ALVO) a indiqué que la FDA a émis une lettre de réponse complète (CRL) pour sa demande de licence biologique pour AVT05 (seringue préremplie et auto-injecteur), citant des déficiences issues de l’inspection pré-licence de la FDA de l’installation de Reykjavik, achevée en juillet 2025, qui doivent être résolues avant l’approbation. La FDA n’a identifié aucune autre déficience de la demande et l’installation reste approuvée par la FDA pour la fabrication et continue à fournir des produits commerciaux. Les ventes de Simponi aux États-Unis ont été inférieures à 300 millions de dollars au premier semestre 2025 (IQVIA); aucun biosimilaire de Simponi n’est actuellement approuvé aux États-Unis. Alvotech a abaissé ses prévisions pour 2025 à 570–600 M$ de revenus et 130–150 M$ d’EBITDA ajusté, citant des investissements et un ralentissement temporaire de la production pour résoudre les problèmes de l’installation.
Alvotech (NASDAQ: ALVO) gab bekannt, dass die FDA einen vollständigen Antwortbrief (CRL) für seinen Biologics License Application für AVT05 (Vorfüllspritze und Autoinjektor) ausgestellt hat, und zwar aufgrund von Mängeln aus der FDA-Inspektion vor der Zulassung der Anlage von Reykjavik, die im Juli 2025 abgeschlossen wurde und vor der Genehmigung behoben werden müssen. Die FDA identifizierte keine weiteren Anwendungsdefizite, und die Anlage bleibt von der FDA genehmigt zur Herstellung und beliefert weiterhin kommerzielle Produkte. Die Verkäufe von Simponi in den USA betrugen im ersten Halbjahr 2025 unter 300 Millionen Dollar (IQVIA); derzeit ist kein Biosimilar zu Simponi in den USA zugelassen. Alvotech senkte seine Prognose für 2025 auf 570–600 Mio. USD Umsatz und 130–150 Mio. USD bereinigtes EBITDA, und führte Investitionen sowie eine vorübergehende Produktionsverlangsamung zur Behebung der Anlagenprobleme an.
Alvotech (NASDAQ: ALVO) قالت إن إدارة الغذاء والدواء أصدرت رسالة رد كاملة (CRL) لطلب ترخيص بيولوجي لـ AVT05 (نَظْمَة حقن مملوءة مسبقاً وجهاز حقن تلقائي)، وذكرت وجود عيوب من تفتيش ما قبل الترخيص من FDA في منشأة ريكيافيك اكتمل في يوليو 2025 ويجب حلها قبل الموافقة. لم تحدد FDA عيوب أخرى في الطلب وتظل المنشأة معتمدة من FDA لتصنيع وتستمر في تزويد المنتجات التجارية. بلغت مبيعات Simponi في الولايات المتحدة أقل من 300 مليون دولار في النصف الأول من 2025 (IQVIA)؛ لا يوجد حاليًا أي biosimilar لـ Simponi معتمد في الولايات المتحدة. خفّضت ألفوتيك توقعاتها لعام 2025 إلى 570–600 مليون دولار من الإيرادات و 130–150 مليون دولار من EBITDA المعدّل، مع ذكر الاستثمارات وتباطؤ إنتاج مؤقت لمعالجة مشاكل المنشأة.
Positive
- Facility remains FDA approved to manufacture and supply products
- Company submitted a detailed CAPA plan to the FDA
- 2025 revenue outlook of $570–$600 million confirms continued commercial sales
Negative
- FDA issued a CRL for AVT05 tied to July 2025 inspection deficiencies
- Alvotech lowered 2025 adjusted EBITDA to $130–$150 million
- Temporary production slowdown required to resolve facility issues
Insights
FDA issued a CRL for AVT05 after a facility inspection; company cut 2025 guidance due to remediation and slower production.
Alvotech received a complete response letter from the FDA for its BLA for AVT05, citing deficiencies tied to the pre‑license inspection of its Reykjavik manufacturing facility that concluded in July 2025. The FDA did not identify other application deficiencies and the facility remains approved to manufacture and supply currently commercialized products.
The company lowered its 2025 outlook to total revenues of $570-$600 million and adjusted EBITDA of $130-$150 million, attributing the reduction to continued investments to resolve the facility issues and a temporary production slowdown. U.S. sales of the reference product Simponi were reported at less than $300 million in H1 2025, and no biosimilar approval to Simponi exists in the U.S.
Key dependencies and near‑term items to watch include the completeness and execution of the stated Corrective and Preventive Action plan, the timeline for the FDA’s satisfactory resolution of the cited deficiencies, and whether the production slowdown materially affects supply of current products. Expect updates on CAPA progress and any FDA correspondence over the coming quarters; resolution timing will determine when AVT05 could re‑enter an approval path.
11/02/2025 – 05:10 PM
REYKJAVIK, ICELAND (November 2, 2025) — Shares of Alvotech (ALVO) are under pressure today after the company reported receiving a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for AVT05, its proposed biosimilar to Simponi (golimumab). The CRL follows a pre-license inspection of Alvotech’s Reykjavik manufacturing facility conducted in July 2025.
The FDA’s letter cited specific deficiencies identified during the inspection that must be addressed before the application can be approved. While this presents a setback to Alvotech’s ambitions in the lucrative biosimilars market, the agency clarified that no other deficiencies were found in the application itself. The Reykjavik facility maintains its FDA approval status, allowing Alvotech to continue manufacturing and supplying its existing portfolio of commercial products.
According to data from IQVIA, Simponi generated less than $300 million in U.S. sales during the first half of 2025. Currently, no biosimilar alternatives to Simponi have been approved in the U.S., making this a key strategic target for biosimilar manufacturers like Alvotech. The potential market access for AVT05 is substantial, but heavily reliant on successfully addressing the FDA’s concerns.
Robert Wessman, Chairman and CEO of Alvotech, stated that the company has already submitted a comprehensive Corrective and Preventive Action (CAPA) plan to the FDA addressing the facility’s shortcomings. “While we are disappointed in receiving the CRL,” Wessman noted, “we expect to resolve any outstanding issues and will continue to work with the FDA to bring this first-to-market biosimilar to patients in the U.S.”
In light of the CRL, Alvotech has revised its financial guidance for 2025. The company now expects total revenues to fall between $570 million and $600 million, with adjusted EBITDA projected at $130 million to $150 million. The downward revision reflects ongoing investments required to resolve the facility issues, as well as a temporary reduction in production output. These investments, according to the company, will also support future growth initiatives and new product launches.
The competitive landscape for biosimilars is intensifying, with companies racing to bring lower-cost alternatives to market. Manufacturing quality and regulatory compliance are paramount for success in this sector. Alvotech’s experience underscores the challenges and complexities involved in biosimilar development and commercialization, particularly in meeting stringent FDA standards. Investors will be closely monitoring the company’s progress in addressing the FDA’s concerns and the potential impact on its long-term growth trajectory.
About Alvotech
Alvotech is a biotech company focused solely on the development and manufacture of biosimilar medicines. The company aims to be a global leader in the biosimilar space, delivering high quality and cost-effective products and services. Alvotech’s current pipeline includes eight 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.
Alvotech’s commercial partners include Teva Pharmaceuticals, STADA Arzneimittel AG, Fuji Pharma Co., Ltd, Advanz Pharma, Cipla/Cipla Gulf/Cipla Med Pro, JAMP Pharma Corporation, Yangtze River Pharmaceutical (Group) Co., Ltd., DKSH, YAS Holding LLC , Abdi Ibrahim, Kamada Ltd., Mega Labs, Stein, Libbs, Tuteur and Saval and Lotus Pharmaceuticals Co., Ltd. Each commercial partnership covers a unique set of product(s) and territories. Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.
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. 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.
ALVOTECH INVESTOR RELATIONS AND GLOBAL COMMUNICATIONS
Benedikt Stefansson, VP
[email protected]
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