Sandoz enters global collaboration license agreement with Henlius to commercialize leading oncology therapy, ipilimumab, in multiple indications
Sandoz has entered a global collaboration agreement with Shanghai Henlius Biotech to commercialize a biosimilar of the cancer therapy ipilimumab. The milestone-based deal is worth up to USD 301 million, including a USD 31 million upfront payment, targeting reference medicine sales of USD 2.5 billion.
The agreement grants Sandoz exclusive commercial rights in key markets including Australia, Canada, Europe, Japan, and the US. Ipilimumab, used in combination with nivolumab in 95% of eligible patients, treats various cancers including melanoma, lung cancer, and kidney cancer.
Henlius will develop and manufacture the biosimilar, while Sandoz will handle registration and commercialization after patent expiry (March 2025 in US, February 2026 in EU). This collaboration strengthens Sandoz's position as the global biosimilar leader, complementing its development of a nivolumab biosimilar and expanding its oncology portfolio which includes Rixathon, Zarzio, Ziextenzo, and Binocrit.
Sandoz ha stipulato un accordo di collaborazione globale con Shanghai Henlius Biotech per commercializzare un biosimilare della terapia oncologica ipilimumab. L'accordo, basato su obiettivi a tappe, ha un valore fino a 301 milioni di dollari USA, inclusi 31 milioni di dollari come pagamento iniziale, puntando a vendite del medicinale di riferimento per 2,5 miliardi di dollari USA.
L'accordo conferisce a Sandoz diritti commerciali esclusivi in mercati chiave come Australia, Canada, Europa, Giappone e Stati Uniti. L'ipilimumab, utilizzato in combinazione con nivolumab nel 95% dei pazienti eleggibili, è impiegato nel trattamento di vari tumori, tra cui melanoma, cancro ai polmoni e ai reni.
Henlius si occuperà dello sviluppo e della produzione del biosimilare, mentre Sandoz gestirà la registrazione e la commercializzazione dopo la scadenza del brevetto (marzo 2025 negli USA, febbraio 2026 nell'UE). Questa collaborazione rafforza la posizione di Sandoz come leader globale nei biosimilari, integrando lo sviluppo di un biosimilare di nivolumab e ampliando il suo portafoglio oncologico che include Rixathon, Zarzio, Ziextenzo e Binocrit.
Sandoz ha firmado un acuerdo de colaboración global con Shanghai Henlius Biotech para comercializar un biosimilar de la terapia contra el cáncer ipilimumab. El acuerdo, basado en hitos, tiene un valor de hasta 301 millones de dólares estadounidenses, incluyendo un pago inicial de 31 millones de dólares, con un objetivo de ventas del medicamento de referencia de 2.5 mil millones de dólares.
El acuerdo otorga a Sandoz derechos comerciales exclusivos en mercados clave como Australia, Canadá, Europa, Japón y Estados Unidos. El ipilimumab, utilizado en combinación con nivolumab en el 95% de los pacientes elegibles, trata varios tipos de cáncer, incluyendo melanoma, cáncer de pulmón y de riñón.
Henlius se encargará del desarrollo y la fabricación del biosimilar, mientras que Sandoz gestionará el registro y la comercialización tras la expiración de la patente (marzo de 2025 en EE. UU., febrero de 2026 en la UE). Esta colaboración fortalece la posición de Sandoz como líder global en biosimilares, complementando su desarrollo de un biosimilar de nivolumab y ampliando su cartera oncológica que incluye Rixathon, Zarzio, Ziextenzo y Binocrit.
산도즈가 상하이 헨리우스 바이오텍과 글로벌 협력 계약을 체결하여 암 치료제 이필리무맙의 바이오시밀러를 상업화합니다. 이 마일스톤 기반 계약은 최대 3억 1천만 달러의 선급금을 포함해 총 3억 1천만 달러 규모이며, 기준 의약품 매출 목표는 25억 달러입니다.
이 계약은 호주, 캐나다, 유럽, 일본, 미국 등 주요 시장에서 산도즈에 독점 상업화 권리를 부여합니다. 이필리무맙은 적격 환자의 95%에서 니볼루맙과 병용해 사용되며, 흑색종, 폐암, 신장암 등 다양한 암 치료에 활용됩니다.
헨리우스는 바이오시밀러 개발 및 제조를 담당하고, 산도즈는 특허 만료 후(미국 2025년 3월, 유럽 2026년 2월) 등록 및 상업화를 맡습니다. 이번 협력은 산도즈가 글로벌 바이오시밀러 리더로서의 입지를 강화하며, 니볼루맙 바이오시밀러 개발과 함께 Rixathon, Zarzio, Ziextenzo, Binocrit 등 종양학 포트폴리오 확장에 기여합니다.
Sandoz a conclu un accord de collaboration mondiale avec Shanghai Henlius Biotech pour commercialiser un biosimilaire de la thérapie anticancéreuse ipilimumab. Ce contrat basé sur des étapes clés représente jusqu'à 301 millions de dollars US, incluant un paiement initial de 31 millions de dollars, avec un objectif de ventes du médicament de référence de 2,5 milliards de dollars.
L'accord confère à Sandoz des droits commerciaux exclusifs sur des marchés clés tels que l'Australie, le Canada, l'Europe, le Japon et les États-Unis. L'ipilimumab, utilisé en combinaison avec le nivolumab chez 95 % des patients éligibles, traite divers cancers, notamment le mélanome, le cancer du poumon et le cancer du rein.
Henlius développera et fabriquera le biosimilaire, tandis que Sandoz prendra en charge l'enregistrement et la commercialisation après l'expiration du brevet (mars 2025 aux États-Unis, février 2026 dans l'UE). Cette collaboration renforce la position de Sandoz en tant que leader mondial des biosimilaires, complétant son développement d'un biosimilaire de nivolumab et élargissant son portefeuille oncologique comprenant Rixathon, Zarzio, Ziextenzo et Binocrit.
Sandoz hat eine globale Kooperationsvereinbarung mit Shanghai Henlius Biotech geschlossen, um einen Biosimilar des Krebsmedikaments Ipilimumab zu vermarkten. Der meilensteinbasierte Vertrag hat einen Wert von bis zu 301 Millionen US-Dollar, einschließlich einer Vorauszahlung von 31 Millionen US-Dollar, mit einem Ziel von 2,5 Milliarden US-Dollar Umsatz des Referenzmedikaments.
Die Vereinbarung gewährt Sandoz exklusive Vertriebsrechte in wichtigen Märkten wie Australien, Kanada, Europa, Japan und den USA. Ipilimumab wird bei 95 % der geeigneten Patienten in Kombination mit Nivolumab eingesetzt und behandelt verschiedene Krebsarten, darunter Melanom, Lungenkrebs und Nierenkrebs.
Henlius wird den Biosimilar entwickeln und herstellen, während Sandoz nach Ablauf des Patentschutzes (März 2025 in den USA, Februar 2026 in der EU) für Zulassung und Vermarktung zuständig ist. Diese Zusammenarbeit stärkt Sandoz' Position als globaler Marktführer im Bereich Biosimilars und ergänzt die Entwicklung eines Nivolumab-Biosimilars sowie das Onkologie-Portfolio, das Rixathon, Zarzio, Ziextenzo und Binocrit umfasst.
- Global licensing deal worth up to $301M, including $31M upfront payment
- Target market size of $2.5B in reference medicine sales
- Exclusive commercial rights in major markets (US, Europe, Japan, Canada, Australia)
- Strategic complement to existing Sandoz nivolumab biosimilar development
- 95% of eligible patients use combination therapy of ipilimumab and nivolumab
- Sandoz has risen to third position in US biosimilars market
- Large pipeline of 28 biosimilar molecules and 450 generic medicines
- Milestone-based payments structure means full $301M is not guaranteed
- Commercial rights dependent on patent expiry (2025 US, 2026 EU)
- Clinical trials still ongoing - success not guaranteed
MEDIA RELEASE
- Agreement offers rights to commercialize proposed biosimilar of Yervoy®* for treatment of variety of cancer types, targeting net reference medicine sales of USD 2.5 billion[1]
- Henlius to develop and manufacture biosimilar, with Sandoz to register and commercialize after expiry of relevant patents across global markets
- Combination therapy of ipilimumab and nivolumab used in
95% of eligible patients[2]; ipilimumab highly complementary to proposed Sandoz nivolumab biosimilar - Potential to address considerable unmet medical needs and increase worldwide access; reinforces Sandoz commitment to expand patient access and drive sustainable savings for healthcare systems
Basel, April 29, 2025 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, announced today that it has signed a global collaboration agreement with Shanghai Henlius Biotech, Inc. (Henlius, HKEX:02696) to commercialize a biosimilar of leading oncology therapy, ipilimumab. The agreement is milestone-based for a total consideration of up to USD 301 million, including an upfront payment of USD 31 million, and will target net reference-medicine sales of USD 2.5 billion[1].
Under the terms of the agreement, Sandoz has exclusive commercial rights for a biosimilar of ipilimumab in Australia, Canada, Europe, Japan and the US. The core sequence patent for ipilimumab expired in March 2025 in the US and will expire no later than February 2026 in the EU.
Richard Saynor, CEO of Sandoz, said: “The global burden of cancer continues to grow and the potential to address unmet patient needs has never been greater.[3] This agreement offers us the chance to reach many more millions of patients, while helping to drive the long-term sustainability of healthcare systems.”
The reference medicine, ipilimumab, is a monoclonal (CTLA-4) antibody-blocking medication, which is used alone or with other medicines to treat certain types of colorectal cancer, esophageal cancer, hepatocellular carcinoma (a type of liver cancer), malignant pleural mesothelioma, melanoma, non-small cell lung cancer, and renal cell carcinoma (a type of kidney cancer).[4,5,6]
Henlius is developing its own proposed biosimilar of ipilimumab in an integrated Phase I/III trial in the unresectable hepatocellular carcinoma setting, targeting 656 patients to be enrolled (NCT06841185).
Sandoz is developing its own proposed biosimilar of nivolumab in an integrated Phase I/III trial in the advanced melanoma setting, targeting 720 patients to be enrolled (NCT06587451). The reference medicine, nivolumab, (Opdivo®**) is a monoclonal (PD-1) antibody-blocking medication, which is used alone or with other medicines to treat more than 10 different cancer types. In combination with ipilimumab, nivolumab is indicated for the treatment of melanoma, malignant pleural mesothelioma, renal cell carcinoma, certain types of colorectal cancer, esophageal cancer, non-small cell lung cancer and hepatocellular carcinoma.[7,8]
Sandoz is the leading biosimilar provider globally and has recently moved up to third position in the US, with a strategic ambition to occupy the leading position in that market.[9] The Company’s industry-leading biosimilars pipeline comprises 28 molecules, complemented by around 450 generic pipeline medicines to support its goal of sustainable and broadly-based long-term growth. The marketed biosimilar oncology portfolio includes Rixathon®, Zarzio®, Ziextenzo®, and Binocrit®. This year, Sandoz expects to launch its biosimilars Wyost®/Jubbonti® (denosumab) in the US in the second quarter and in Europe in the fourth quarter.
* Yervoy® is a registered trademark of Bristol-Myers Squibb (US)
** Opdivo® is a registered trademark of Bristol-Myers Squibb (US)
DISCLAIMER
This Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly revise any forward-looking statements, except as required by law.
REFERENCES
1. Loss-of-exclusivity (LoE) dates based on IP databases; originator-sales data at LoE-1 from internal analysis and Evaluate Pharma [November 2024]
2. Decisions Resource Group (DRG) database of total treated population with Yervoy® (G7 markets) [accessed April 2025]
3. Cancer Today [accessed March 2025]
4. Yervoy® US Prescribing Information [accessed March 2025]
5. Yervoy® EMEA Summary of Product Characteristics [accessed March 2025]
6. Definition of Yervoy® - NCI Dictionary of Cancer Terms - NCI [accessed March 2025]
7. Opdivo® US: Prescribing Information [accessed March 2025]
8. Opdivo® EMEA Summary of Product Characteristics [accessed March 2025]
9. IQVIA [download February 2025]
ABOUT SANDOZ
Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 900 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2024, Sandoz recorded net sales of USD 10.4 billion.
CONTACTS
| Global Media Relations | Investor Relations |
| Global.MediaRelations@sandoz.com | Investor.Relations@sandoz.com |
| Alex Kalomparis +41 79 279 0285 | Craig Marks +44 7818 942 383 |
| Joerg E. Allgaeuer +49 171 838 4838 | Rupreet Sandhu +41 79 410 5472 |
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