Amneal Launches BORUZU™, First Ready-to-Use Bortezomib Injection for Multiple Myeloma and Mantle Cell Lymphoma
Amneal Pharmaceuticals (NASDAQ: AMRX) has launched BORUZU™, the first ready-to-use subcutaneous formulation of bortezomib for treating multiple myeloma and mantle cell lymphoma in the U.S. This innovative product, developed in partnership with Shilpa Medicare , eliminates the need for traditional compounding preparation steps required with administration.
BORUZU™ references the branded product Velcade® but comes as a ready-to-use injection instead of a lyophilized powder requiring reconstitution. The product features a unique J-code to facilitate reimbursement and represents Amneal's fourth 505(b)(2) injectable product launch in the past year.
Under the partnership agreement, Shilpa developed the molecule while Amneal will handle manufacturing and commercialization. Common adverse reactions reported in clinical studies include asthenic conditions, diarrhea, nausea, peripheral neuropathy, and various blood-related conditions.
Amneal Pharmaceuticals (NASDAQ: AMRX) ha lanciato BORUZU™, la prima formulazione sottocutanea pronta all'uso di bortezomib per il trattamento del mieloma multiplo e del linfoma a cellule mantellari negli Stati Uniti. Questo prodotto innovativo, sviluppato in collaborazione con Shilpa Medicare, elimina la necessità dei tradizionali passaggi di preparazione composti richiesti per la somministrazione.
BORUZU™ fa riferimento al prodotto di marca Velcade®, ma viene fornito come un'iniezione pronta all'uso invece di una polvere liofilizzata che richiede ricostituzione. Il prodotto presenta un codice J unico per facilitare il rimborso e rappresenta il quarto lancio di prodotto iniettabile 505(b)(2) di Amneal nell'ultimo anno.
In base all'accordo di partnership, Shilpa ha sviluppato la molecola mentre Amneal si occuperà della produzione e della commercializzazione. Le reazioni avverse comuni riportate negli studi clinici includono condizioni astheniche, diarrea, nausea, neuropatia periferica e varie condizioni legate al sangue.
Amneal Pharmaceuticals (NASDAQ: AMRX) ha lanzado BORUZU™, la primera formulación subcutánea lista para usar de bortezomib para el tratamiento del mieloma múltiple y del linfoma de células del manto en EE. UU. Este producto innovador, desarrollado en colaboración con Shilpa Medicare, elimina la necesidad de los tradicionales pasos de preparación de compuestos requeridos para la administración.
BORUZU™ hace referencia al producto de marca Velcade®, pero se presenta como una inyección lista para usar en lugar de un polvo liofilizado que requiere reconstitución. El producto cuenta con un código J único para facilitar el reembolso y representa el cuarto lanzamiento de producto inyectable 505(b)(2) de Amneal en el último año.
Según el acuerdo de colaboración, Shilpa desarrolló la molécula mientras que Amneal se encargará de la fabricación y comercialización. Las reacciones adversas comunes reportadas en estudios clínicos incluyen condiciones asténicas, diarrea, náuseas, neuropatía periférica y diversas condiciones relacionadas con la sangre.
암니얼 제약 (NASDAQ: AMRX)이 다발성 골수종 및 맨틀 세포 림프종 치료를 위한 최초의 사용 준비 완료 피하 제형인 BORUZU™를 미국에서 출시했습니다. 이 혁신적인 제품은 Shilpa Medicare와의 협력으로 개발되었으며, 투여에 필요한 전통적인 조제 준비 단계를 제거합니다.
BORUZU™는 브랜드 제품인 Velcade®를 참조하지만 재구성이 필요한 동결 건조 분말 대신 사용 준비 완료 주사제로 제공됩니다. 이 제품은 환급을 용이하게 하기 위해 고유한 J 코드를 특징으로 하며, 지난 1년 동안 암니얼의 네 번째 505(b)(2) 주사제 출시를 나타냅니다.
파트너십 계약에 따라 Shilpa는 분자를 개발하고 암니얼은 제조 및 상업화를 담당합니다. 임상 연구에서 보고된 일반적인 부작용으로는 허약 상태, 설사, 메스꺼움, 말초 신경병증 및 다양한 혈액 관련 상태가 포함됩니다.
Amneal Pharmaceuticals (NASDAQ: AMRX) a lancé BORUZU™, la première formulation sous-cutanée prête à l'emploi de bortezomib pour le traitement du myélome multiple et du lymphome à cellules du manteau aux États-Unis. Ce produit innovant, développé en partenariat avec Shilpa Medicare, élimine le besoin des étapes de préparation traditionnelles requises pour l'administration.
BORUZU™ fait référence au produit de marque Velcade®, mais se présente comme une injection prête à l'emploi plutôt que comme une poudre lyophilisée nécessitant une reconstitution. Le produit dispose d'un code J unique pour faciliter le remboursement et représente le quatrième lancement de produit injectable 505(b)(2) d'Amneal au cours de l'année écoulée.
Dans le cadre de l'accord de partenariat, Shilpa a développé la molécule tandis qu'Amneal s'occupera de la fabrication et de la commercialisation. Les réactions indésirables courantes rapportées dans les études cliniques comprennent des états asthéniques, de la diarrhée, des nausées, une neuropathie périphérique et diverses conditions liées au sang.
Amneal Pharmaceuticals (NASDAQ: AMRX) hat BORUZU™ eingeführt, die erste gebrauchsfertige subkutane Formulierung von Bortezomib zur Behandlung von multiplem Myelom und Mantelzelllymphom in den USA. Dieses innovative Produkt, das in Zusammenarbeit mit Shilpa Medicare entwickelt wurde, beseitigt die Notwendigkeit traditioneller Zubereitungsschritte, die bei der Verabreichung erforderlich sind.
BORUZU™ bezieht sich auf das Markenprodukt Velcade®, wird jedoch als gebrauchsfertige Injektion anstelle eines gefriergetrockneten Pulvers geliefert, das eine Rekonstitution erfordert. Das Produkt verfügt über einen einzigartigen J-Code zur Erleichterung der Erstattung und stellt Amneals vierten 505(b)(2) Injektionsproduktlaunch im letzten Jahr dar.
Im Rahmen der Partnerschaftsvereinbarung entwickelte Shilpa das Molekül, während Amneal die Herstellung und Kommerzialisierung übernimmt. Häufig berichtete Nebenwirkungen in klinischen Studien umfassen asthenische Zustände, Durchfall, Übelkeit, periphere Neuropathie und verschiedene blutbezogene Erkrankungen.
- First-to-market ready-to-use bortezomib injection, providing competitive advantage
- Unique J-code facilitating reimbursement process
- Fourth 505(b)(2) injectable product launch in last year, showing consistent portfolio expansion
- Dual administration options (subcutaneous and IV) offering flexibility
- Multiple significant adverse reactions reported in clinical studies
- Faces competition from established brand Velcade
Insights
Amneal's launch of BORUZU™ represents a significant strategic advancement in their injectables business. This ready-to-use formulation addresses key pain points in oncology drug administration by eliminating reconstitution steps—a meaningful workflow improvement for healthcare providers treating multiple myeloma and mantle cell lymphoma patients.
This product launch carries several commercial advantages. The unique J-code is particularly noteworthy as it streamlines reimbursement processes, potentially accelerating adoption among oncology practices where billing efficiency is crucial. As Amneal's fourth 505(b)(2) injectable launch within a year, this demonstrates consistent execution of their specialty pharmaceutical strategy focused on differentiated products with higher margins than traditional generics.
The partnership structure with Shilpa Medicare showcases Amneal's capital-efficient approach—leveraging external development expertise while maintaining manufacturing and commercialization control. This model allows them to expand their complex product portfolio without bearing the full R&D burden.
BORUZU™ fits perfectly into Amneal's broader portfolio transformation toward higher-value injectables. Ready-to-use oncology products typically command premium pricing compared to products requiring preparation, potentially delivering stronger profit margins while addressing genuine clinical workflow challenges.
BORUZU™ addresses a significant practical challenge in cancer care settings. Bortezomib (Velcade®) is a cornerstone proteasome inhibitor for multiple myeloma and mantle cell lymphoma treatment, but its traditional lyophilized formulation requires precise reconstitution—a process that introduces preparation time, potential dosing errors, and workflow inefficiencies.
The clinical value of this ready-to-use formulation extends beyond convenience. Pharmacy preparation of oncology medications is a recognized bottleneck in treatment delivery. Patients often experience extended wait times while medications are being prepared, particularly in busy infusion centers. BORUZU™ potentially reduces these delays while minimizing preparation-related errors.
The subcutaneous administration option is particularly valuable as it's associated with reduced peripheral neuropathy compared to IV administration while maintaining efficacy. Having both administration routes available in a ready-to-use format provides flexibility for clinicians based on patient-specific factors.
The side effect profile mentioned matches established bortezomib safety data, suggesting bioequivalence to the reference product. With no new safety signals reported, oncologists can confidently integrate this formulation into existing treatment protocols with minimal adaptation required, supporting rapid market uptake.
- First ready-to-use, subcutaneous formulation of Bortezomib now available
- Marks Amneal’s fourth 505(b)(2) injectable product launch in the last year
BORUZU™ (bortezomib injection), a proteasome inhibitor, is used for the treatment of multiple myeloma and mantle cell lymphoma. This product references the branded product Velcade®, a lyophilized powder requiring reconstitution before use. Shilpa developed the molecule and Amneal will manufacture and commercialize the product. BORUZU has a unique J-code.
"As we advance our broader strategy to build a leading injectables portfolio with durable, high-impact complex products, we are excited to announce the
“This second NDA product being launched in the US market from our novel injectable portfolio demonstrates our capabilities and commitment to introduce pharmacy efficient solutions that enhance compliance and have the potential to reduce patient wait times. This development exemplifies Shilpa’s constant endeavor to work towards introducing novel first of its kind pharmaceutical products that help improve the healthcare requirements of a large patient pool,” said Vishnukant Bhutada, Managing Director of Shilpa Medicare.
The most commonly reported adverse reactions for BORUZU™ in clinical studies include asthenic conditions, diarrhea, nausea, constipation, peripheral neuropathy, vomiting, pyrexia, thrombocytopenia, psychiatric disorders, anorexia and decreased appetite, neutropenia, neuralgia, leukopenia and anemia.
For full prescribing information, see package insert located here.
About Amneal
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in
About Shilpa
Shilpa is an integrated pharmaceutical group with business interests in niche Oncology & Non-oncology APIs, Peptides, Polymers, differentiated finished dosage formulations including novel injectables, orally dispersible films & transdermal patches along with carefully crafted biological portfolio. Shilpa also provides end-to-end CDMO services to global pharmaceutical companies across all its business segments based on its strong R&D and manufacturing capabilities backed by four R&D units and seven manufacturing facilities. For more information, please visit www.vbshilpa.com.
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Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the
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Investor Contact
Anthony DiMeo
VP, Investor Relations
anthony.dimeo@amneal.com
Shilpa Contact
Monish Shah
Head Strategic & Investor Relation
monish.shah@vbshilpa.com
Source: Amneal Pharmaceuticals, Inc.
FAQ
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