Sandoz US launches generic paclitaxel in single-dose vial, further expanding US oncology portfolio
Sandoz, a global leader in generic and biosimilar medicines, has launched a generic paclitaxel formulation in the US. This is the first FDA-approved abbreviated new drug application (ANDA) to reference the original medicine. The product is a single-dose 100 mg vial for intravenous use, approved for metastatic breast cancer treatment.
The launch follows FDA approval on October 8, 2024, and is expected to be a near-term growth driver in the US market. Developed in partnership with Jiangsu Hengrui Pharmaceuticals Co., , this generic version references Abraxane® for Injectable Suspension. Keren Haruvi, President of Sandoz North America, emphasized the company's commitment to providing access to life-changing medicines, noting that an estimated 168,000 women in the US are living with metastatic breast cancer.
Sandoz, leader mondiale nei farmaci generici e biosimilari, ha lanciato una formulazione generica di paclitaxel negli Stati Uniti. Questo è il primo modulo di domanda abbreviato per un nuovo farmaco approvato dalla FDA (ANDA) a fare riferimento al farmaco originale. Il prodotto è una flaconcino monodose da 100 mg per uso endovenoso, approvato per il trattamento del cancro al seno metastatico.
Il lancio segue l'approvazione della FDA dell'8 ottobre 2024 e si prevede che sarà un fattore di crescita a breve termine nel mercato statunitense. Sviluppato in collaborazione con Jiangsu Hengrui Pharmaceuticals Co., questa versione generica fa riferimento ad Abraxane® per sospensione iniettabile. Keren Haruvi, presidente di Sandoz North America, ha sottolineato l'impegno dell'azienda a fornire accesso a farmaci che cambiano la vita, notando che si stima che 168.000 donne negli Stati Uniti stiano vivendo con il cancro al seno metastatico.
Sandoz, líder global en medicamentos genéricos y biosimilares, ha lanzado una formulación genérica de paclitaxel en los EE. UU. Esta es la primera solicitud abreviada de nuevo medicamento aprobada por la FDA (ANDA) que hace referencia al medicamento original. El producto es un vial de 100 mg en dosis única para uso intravenoso, aprobado para el tratamiento de cáncer de mama metastásico.
El lanzamiento sigue a la aprobación de la FDA del 8 de octubre de 2024 y se espera que sea un motor de crecimiento a corto plazo en el mercado estadounidense. Desarrollada en asociación con Jiangsu Hengrui Pharmaceuticals Co., esta versión genérica hace referencia a Abraxane® para suspensión inyectable. Keren Haruvi, presidenta de Sandoz North America, enfatizó el compromiso de la empresa de proporcionar acceso a medicamentos que cambian la vida, señalando que se estima que 168,000 mujeres en los EE. UU. están viviendo con cáncer de mama metastásico.
산도즈(Sandoz)는 전세계 제네릭 및 바이오시밀러 의약품의 선두주자로서 미국에서 제네릭 팩리탁셀 제형을 출시했습니다. 이는 원래 약물에 대한 FDA 승인 아브리비에이티드 뉴 드러그 신청서(ANDA)로, 최초로 승인된 것입니다. 이 제품은 100 mg 단일 투여 주사제로, 전이성 유방암 치료를 위해 승인되었습니다.
이 출시는 2024년 10월 8일 FDA의 승인을 따르며, 미국 시장에서 단기 성장 동력이 될 것으로 예상됩니다. 장쑤 헨거의 제약회와 협력하여 개발된 이 제네릭 버전은 Abraxane® 주사용 현탁액을 참조하고 있습니다. 케렌 하루비(Keren Haruvi) 산도즈 북미 회장은 생명을 변화시키는 의약품에 대한 접근성을 제공하겠다는 회사의 의지를 강조하며, 미국 전역에서 약 168,000명의 여성들이 전이성 유방암과 함께 살고 있다는 점을 지적했습니다.
Sandoz, leader mondial des médicaments génériques et biosimilaires, a lancé une formulation générique de paclitaxel aux États-Unis. Il s'agit de la première demande de nouveau médicament abrégé approuvée par la FDA (ANDA) à faire référence au médicament original. Le produit est un flacon de 100 mg en dose unique pour usage intraveineux, approuvé pour le traitement du cancer du sein métastatique.
Le lancement fait suite à l'approbation de la FDA le 8 octobre 2024 et devrait constituer un moteur de croissance à court terme sur le marché américain. Développée en partenariat avec Jiangsu Hengrui Pharmaceuticals Co., cette version générique fait référence à Abraxane® pour suspension injectable. Keren Haruvi, présidente de Sandoz Amérique du Nord, a souligné l'engagement de l'entreprise à fournir un accès à des médicaments qui changent la vie, notant qu'environ 168 000 femmes aux États-Unis vivent avec un cancer du sein métastatique.
Sandoz, ein globaler Marktführer im Bereich generischer und biosimilarer Medikamente, hat eine generische Paclitaxel-Formulierung in den USA auf den Markt gebracht. Dies ist der erste von der FDA genehmigte verkürzte Antrag auf ein neues Medikament (ANDA), der auf das Originalmedikament verweist. Das Produkt ist eine Einzeldosis-100-mg-Infusion, die zur Behandlung von metastasiertem Brustkrebs zugelassen ist.
Die Markteinführung erfolgt nach der Genehmigung durch die FDA am 8. Oktober 2024 und soll ein kurzfristiger Wachstumsfaktor im US-Markt sein. In Zusammenarbeit mit Jiangsu Hengrui Pharmaceuticals Co. entwickelt, bezieht sich diese generische Version auf Abraxane® zur Injektionssuspension. Keren Haruvi, Präsidentin von Sandoz Nordamerika, betonte das Engagement des Unternehmens, den Zugang zu lebensverändernden Medikamenten zu ermöglichen, und merkte an, dass schätzungsweise 168.000 Frauen in den USA mit metastasiertem Brustkrebs leben.
- First FDA-approved generic version of paclitaxel for metastatic breast cancer treatment
- Expected to be a near-term growth driver in the US market
- Expands Sandoz's oncology portfolio in the US
- None.
MEDIA RELEASE
- First FDA-approved abbreviated new drug application (ANDA) to reference medicine
- Single-dose 100 mg vial for intravenous use, approved for metastatic breast cancer
- Launch expected to be near-term growth driver in US market
Princeton, NJ, October 11, 2024 – Sandoz, the global leader in generic and biosimilar medicines, today announced that it has launched a generic paclitaxel formulation in the US, the first generic to its reference medicine to be approved by the US Food and Drug Administration (FDA).
Sandoz paclitaxel protein-bound particles for injectable suspension (albumin-bound) is indicated for the treatment of patients with metastatic breast cancer. The launch of the lyophilized powder for injection containing 100 mg of paclitaxel in a single-dose vial for intravenous use follows approval by the FDA on October 8, 2024.
Keren Haruvi, President, Sandoz North America, said: “An estimated 168,000 women in the US are living with metastatic breast cancer. [1] While rare, men can also develop metastatic breast cancer. [2] This milestone is another proof point of our commitment to provide access to life-changing medicines for all who need them.”
Sandoz paclitaxel protein-bound particles for injectable suspension (albumin-bound) was developed in partnership with Jiangsu Hengrui Pharmaceuticals Co., Ltd., and is the first FDA-approved ANDA to reference product Abraxane®* for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension, albumin-bound).
*Abraxane® is a registered trademark of Abraxis BioScience LLC, a Bristol-Myers Squibb Company.
About paclitaxel protein-bound particles for injectable suspension (albumin-bound)
INDICATIONS
Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is a microtubule inhibitor indicated for the treatment of: Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
SELECT IMPORTANT SAFETY INFORMATION
WARNING: SEVERE MYELOSUPPRESSION
See full prescribing information for complete boxed warning.
- Do not administer paclitaxel protein-bound particles for injectable suspension (albumin-bound) therapy to patients with baseline neutrophil counts of less than 1,500 cells/mm3.
- Monitor for neutropenia, which may be severe and result in infection or sepsis.
- Perform frequent complete blood cell counts on all patients receiving paclitaxel protein-bound particles for injectable suspension (albumin-bound).
CONTRAINDICATIONS
Neutrophil counts of < 1,500 cells/mm3; and severe hypersensitivity reactions to paclitaxel protein-bound particles for injectable suspension (albumin-bound).
WARNINGS AND PRECAUTIONS
Sensory neuropathy occurs frequently and may require dose reduction or treatment interruption. Sepsis occurred in patients with or without neutropenia who received paclitaxel protein-bound particles for injectable suspension (albumin-bound) in combination with gemcitabine; interrupt paclitaxel protein-bound particles for injectable suspension (albumin-bound) and gemcitabine until sepsis resolves, and if neutropenia, until neutrophils are at least 1,500 cells/mm3, then resume treatment at reduced dose levels. Pneumonitis occurred with the use of paclitaxel protein-bound particles for injectable suspension (albumin-bound) in combination with gemcitabine; permanently discontinue treatment with paclitaxel protein-bound particles for injectable suspension (albumin-bound) and gemcitabine. Severe hypersensitivity reactions with fatal outcome have been reported. Do not rechallenge with this drug. Exposure and toxicity of paclitaxel can be increased in patients with hepatic impairment, consider dose reduction and closely monitor patients with hepatic impairment. Paclitaxel protein-bound particles for injectable suspension (albumin-bound) contains albumin derived from human blood, which has a theoretical risk of viral transmission. Paclitaxel protein-bound particles for injectable suspension (albumin-bound) can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.
ADVERSE REACTIONS
The most common adverse reactions (≥
DRUG INTERACTIONS
Use caution when concomitantly administering paclitaxel protein-bound particles for injectable suspension (albumin-bound) with inhibitors or inducers of either CYP2C8 or CYP3A4.
USE IN SPECIFIC POPULATIONS
Lactation: Advise not to breastfeed.
This is not the complete list of all the safety information for Paclitaxel protein-bound particles for injectable suspension (albumin-bound). Please click to see the full Prescribing Information for Paclitaxel protein-bound particles for injectable suspension (albumin-bound).
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 update or revise any forward-looking statements, except as required by law.
References
[1] National Institutes of Health. NIH MedlinePlus Magazine. Quick Facts on Metastatic Breast Cancer. Available at Quick facts on metastatic breast cancer | NIH MedlinePlus Magazine. [Last accessed: September 2024]
[2] American Cancer Society. Treatment of Breast Cancer in Men, by Stage. Available at Treatment of Breast Cancer in Men, by Stage | American Cancer Society. [Last accessed: September 2024]
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 800 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,500 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 2023, Sandoz recorded sales of USD 9.6 billion.
CONTACTS
| US Media Relations contacts | Investor Relations contacts |
| MediaInfo@sandoz.com | Investor.Relations@sandoz.com |
| Leslie Pott +1 609 422 4150 | Laurent de Weck +41 79 795 7364 |
| Vicki Crafton +1 201 213 6338 | Tamara Hackl +41 79 790 5217 |
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