Amneal Highlights Positive Topline Results from Confirmatory Clinical Study of Biosimilar Candidate to XOLAIR(R) (omalizumab), Developed by Kashiv BioSciences
Amneal Pharmaceuticals (Nasdaq: AMRX) announced positive topline results from a Phase 3 clinical trial for ADL-018, a proposed biosimilar to XOLAIR® (omalizumab), developed by Kashiv BioSciences. The study met its primary and secondary endpoints, demonstrating therapeutic equivalence and comparable safety to XOLAIR® in 400 patients with Chronic Idiopathic/Spontaneous Urticaria.
The trial evaluated doses of 150mg or 300mg administered subcutaneously every four weeks over 24 weeks. Amneal holds exclusive U.S. commercialization rights, with a Biologics License Application (BLA) planned for Q4 2025. The biosimilar targets the $3.9 billion U.S. omalizumab market and is part of Amneal's strategy to launch six biosimilars across eight product presentations by 2027.
Amneal Pharmaceuticals (Nasdaq: AMRX) ha annunciato risultati positivi preliminari da uno studio clinico di Fase 3 per ADL-018, un biosimilare proposto di XOLAIR® (omalizumab), sviluppato da Kashiv BioSciences. Lo studio ha raggiunto gli endpoint primari e secondari, dimostrando equivalenza terapeutica e sicurezza comparabile a XOLAIR® in 400 pazienti con orticaria cronica idiopatica/spontanea.
La sperimentazione ha valutato dosi di 150 mg o 300 mg somministrate per via sottocutanea ogni quattro settimane per 24 settimane. Amneal detiene i diritti esclusivi di commercializzazione negli Stati Uniti, con una domanda di autorizzazione biologica (BLA) prevista per il quarto trimestre del 2025. Il biosimilare è destinato al mercato statunitense dell'omalizumab da 3,9 miliardi di dollari ed è parte della strategia di Amneal di lanciare sei biosimilari in otto formulazioni entro il 2027.
Amneal Pharmaceuticals (Nasdaq: AMRX) anunció resultados positivos preliminares de un ensayo clínico de fase 3 para ADL-018, un biosimilar propuesto de XOLAIR® (omalizumab), desarrollado por Kashiv BioSciences. El estudio cumplió sus objetivos primarios y secundarios, demostrando equivalencia terapéutica y seguridad comparable a XOLAIR® en 400 pacientes con urticaria crónica idiopática/espontánea.
El ensayo evaluó dosis de 150 mg o 300 mg administradas por vía subcutánea cada cuatro semanas durante 24 semanas. Amneal posee los derechos exclusivos de comercialización en EE. UU., con una solicitud de licencia biológica (BLA) prevista para el cuarto trimestre de 2025. El biosimilar apunta al mercado estadounidense de omalizumab de 3.900 millones de dólares y forma parte de la estrategia de Amneal para lanzar seis biosimilares en ocho presentaciones para 2027.
Amneal Pharmaceuticals (나스닥: AMRX)는 Kashiv BioSciences가 개발한 XOLAIR®(오말리주맙)의 바이오시밀러 후보인 ADL-018에 대한 3상 임상시험에서 긍정적인 초기 결과를 발표했습니다. 이 연구는 만성 특발성/자발성 두드러기 환자 400명을 대상으로 주요 및 부차 평가변수를 충족하며 XOLAIR®와 치료적 동등성과 안전성이 유사함을 입증했습니다.
시험은 150mg 또는 300mg 용량을 4주마다 피하 주사로 24주간 투여하는 방식으로 진행되었습니다. Amneal은 미국 내 독점 상업화 권리를 보유하고 있으며, 2025년 4분기 생물학적 제제 허가 신청(BLA)을 계획 중입니다. 이 바이오시밀러는 39억 달러 규모의 미국 오말리주맙 시장을 목표로 하며, 2027년까지 6개의 바이오시밀러를 8가지 제형으로 출시하는 Amneal의 전략의 일환입니다.
Amneal Pharmaceuticals (Nasdaq : AMRX) a annoncé des résultats positifs préliminaires d'un essai clinique de phase 3 pour ADL-018, un biosimilaire proposé de XOLAIR® (omalizumab), développé par Kashiv BioSciences. L'étude a atteint ses objectifs primaires et secondaires, démontrant une équivalence thérapeutique et une sécurité comparable à XOLAIR® chez 400 patients atteints d'urticaire chronique idiopathique/spontanée.
L'essai a évalué des doses de 150 mg ou 300 mg administrées par voie sous-cutanée toutes les quatre semaines pendant 24 semaines. Amneal détient les droits exclusifs de commercialisation aux États-Unis, avec une demande d'autorisation de mise sur le marché biologique (BLA) prévue pour le quatrième trimestre 2025. Le biosimilaire cible le marché américain de l'omalizumab de 3,9 milliards de dollars et s'inscrit dans la stratégie d'Amneal visant à lancer six biosimilaires répartis en huit présentations d'ici 2027.
Amneal Pharmaceuticals (Nasdaq: AMRX) gab positive Ergebnisse der Phase-3-Studie für ADL-018 bekannt, einen vorgeschlagenen Biosimilar zu XOLAIR® (Omalizumab), entwickelt von Kashiv BioSciences. Die Studie erreichte die primären und sekundären Endpunkte und zeigte therapeutische Äquivalenz sowie vergleichbare Sicherheit zu XOLAIR® bei 400 Patienten mit chronischer idiopathischer/spontaner Urtikaria.
Die Studie bewertete Dosen von 150 mg oder 300 mg, die alle vier Wochen subkutan über 24 Wochen verabreicht wurden. Amneal hält die exklusiven US-Vermarktungsrechte und plant eine Biologics License Application (BLA) für das vierte Quartal 2025. Das Biosimilar zielt auf den 3,9 Milliarden US-Dollar schweren US-Omalizumab-Markt ab und ist Teil von Amneals Strategie, bis 2027 sechs Biosimilars in acht Produktformulierungen auf den Markt zu bringen.
- Successfully met primary and secondary endpoints in Phase 3 trial
- Targeting large $3.9 billion U.S. omalizumab market opportunity
- Positioned to be among first wave of XOLAIR biosimilars
- Exclusive U.S. commercialization rights secured by Amneal
- BLA filing not expected until Q4 2025
- Product requires administration in hospital/clinic setting
- Faces potential competition from other biosimilar developers
Insights
Amneal's biosimilar to XOLAIR shows positive Phase 3 results, targeting $3.9B market with BLA filing expected Q4 2025.
The positive Phase 3 results for ADL-018 represent a significant milestone in Amneal's biosimilar strategy. The study met both primary and secondary endpoints, establishing therapeutic equivalence to XOLAIR® in treating Chronic Idiopathic/Spontaneous Urticaria. With 600 patients enrolled and efficacy evaluated in 400 patients receiving the confirmatory 300mg dose, the trial demonstrated comparable changes in weekly itch severity scores at Week 12.
This development positions Amneal to potentially capture market share in the
The planned BLA submission in Q4 2025 aligns with Amneal's strategic roadmap to commercialize six biosimilars across eight product presentations by 2027. This pipeline expansion represents a meaningful diversification of Amneal's portfolio beyond traditional generics into higher-margin biosimilars. The exclusive U.S. commercialization rights secured by Amneal for this Kashiv-developed product demonstrates the company's commitment to partnering strategically to access complex biologics without bearing the full development costs.
Kashiv's track record with previously approved biosimilars (RELEUKO® and FYLNETRA®) suggests regulatory competence, which may increase confidence in the approval pathway for ADL-018. As one of few U.S.-based companies with both manufacturing capabilities and marketing authorizations for multiple biosimilars, this partnership leverages complementary strengths in development and commercialization.
Amneal holds exclusive U.S. commercialization rights; BLA filing expected in Q4 2025
Poised to be among the first wave of biosimilars in the
BRIDGEWATER, N.J., June 25, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today highlighted positive topline results from a confirmatory clinical efficacy and safety clinical trial evaluating ADL-018, a proposed biosimilar to XOLAIR® (omalizumab), developed by Kashiv BioSciences, LLC. The randomized, double-blind, multicenter study was conducted by Kashiv to assess the efficacy, safety, and immunogenicity of ADL-018 compared to XOLAIR® in patients with Chronic Idiopathic Urticaria (CIU) or Chronic Spontaneous Urticaria (CSU) who remained symptomatic despite treatment with H1 antihistamines.
Omalizumab, a humanized monoclonal antibody that targets free IgE, is indicated for the treatment of severe allergic asthma (>6 years old), chronic rhinosinusitis with nasal polyps (CRSwNP) (>18 years old), food allergies (>1 year old), and chronic spontaneous urticaria (>12 years old). It is typically administered in a hospital or clinic setting. The clinical study achieved its primary and secondary endpoints by establishing equivalence of therapeutic endpoints and comparable safety between ADL-018 and XOLAIR®. Participants received subcutaneous doses of either 150 mg or 300 mg every four weeks for a 24-week period. A total of 600 patients were enrolled, and efficacy and safety were evaluated in 400 patients who received the confirmatory dose of 300 mg. The primary efficacy measure was the change from baseline in the weekly itch severity score (ISS7) at Week 12 between the treatment arms of ADL-018 and the reference product.
“We are pleased with the positive Phase 3 results for ADL-018, which represents an important step towards making a biosimilar to XOLAIR® available to U.S. patients,” said Sean McGowan, Senior Vice President, Biosimilars and Branded Oncology at Amneal Pharmaceuticals. “Pending FDA approval, we believe this will be a key addition to our biosimilars portfolio and part of our broader strategy to commercialize six biosimilars across eight product presentations by 2027.”
“This marks a positive advancement for Kashiv’s growing biosimilar pipeline in addition to its current portfolio of RELEUKO® (filgrastim-ayow) and FYLNETRA® (pegfilgrastim-pbbk). We look forward to collaborating with regulatory authorities to make this treatment available to patients,” said Dr. Sandeep Athalye, Chief Executive Officer at Kashiv BioSciences. “Kashiv is among the few U.S.-based companies to both manufacture and receive marketing authorization for multiple biosimilars. We remain focused on delivering cost-effective, high-quality therapies to improve patient outcomes globally, working with commercial partners such as Amneal.”
A Biologics License Application (BLA) for this product is expected to be submitted to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2025 by Kashiv BioSciences. Amneal holds exclusive U.S. commercialization rights for the product, pending regulatory approval.
According to IQVIA®, U.S. annual sales for XOLAIR® totaled approximately
About Amneal
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceuticals, primarily within the United States. In its Affordable Medicines segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com and follow us on LinkedIn.
About Kashiv BioSciences
Kashiv BioSciences, LLC is a vertically integrated biopharmaceutical company with numerous commercial and advanced clinical-stage assets. Kashiv BioSciences, LLC in the USA, and its subsidiaries in India (together “Kashiv BioSciences”) operate together with robust infrastructure and highly skilled teams that provide global R&D, clinical, manufacturing, regulatory, and IP capabilities. We believe our people, partners, and shared purpose fuel our work to advance patient care and access to important medicines.
Cautionary Statement on Forward-Looking Statements
Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.
Investor Contact
Anthony DiMeo
VP, Investor Relations
anthony.dimeo@amneal.com
Media Contact
Brandon Skop
Sr. Director, Corporate Communications
Brandon.skop@amneal.com
Kashiv BioSciences Contact:
Dr. Paras Vasanani
Head of Business Development
paras.vasanani@kashivbio.com
https://www.kashivbiosciences.com/
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