Amneal gains exclusive U.S. rights for ADL-018, a biosimilar to XOLAIR®, with BLA filing expected by Q4 2025.
Quiver AI Summary
Amneal Pharmaceuticals has announced positive topline results from a clinical trial for ADL-018, a proposed biosimilar to XOLAIR® (omalizumab), which is being developed by Kashiv BioSciences. The trial demonstrated that ADL-018 was effective and safe for patients with Chronic Idiopathic Urticaria or Chronic Spontaneous Urticaria who were unresponsive to antihistamines. Amneal, which holds exclusive U.S. commercialization rights for the product, anticipates filing a Biologics License Application with the FDA in Q4 2025. The successful outcomes from the trial mark a significant step toward bringing this biosimilar into the U.S. market, valued at approximately $3.9 billion annually. The collaboration with Kashiv BioSciences aims to enhance patient access to cost-effective therapies.
Potential Positives
- Amneal holds exclusive U.S. commercialization rights for ADL-018, a proposed biosimilar to XOLAIR®, which is poised to capitalize on a significant market opportunity worth approximately $3.9 billion.
- The recent positive topline results from the Phase 3 clinical trial confirm the product's efficacy and safety, indicating a strong potential for successful regulatory approval.
- The expected Biologics License Application (BLA) filing in Q4 2025 positions Amneal for timely entry into the biosimilars market, enhancing its growth strategy in a competitive landscape.
- The launch of ADL-018 is anticipated to contribute to Amneal's broader strategy of commercializing multiple biosimilars by 2027, further diversifying and strengthening its product portfolio.
Potential Negatives
- Amneal's reliance on an external partner, Kashiv BioSciences, for the development and submission of the BLA may raise concerns about control over the product's regulatory journey and commercialization.
- The projected submission timeline for the BLA in Q4 2025 could indicate a lag in product availability compared to competitors, reducing the company’s potential first-mover advantage in the biosimilar market.
- Despite positive trial results, pending FDA approval poses a significant risk to Amneal's plans for commercialization, as the outcome remains uncertain and could impact future revenue projections.
FAQ
What is ADL-018?
ADL-018 is a proposed biosimilar to XOLAIR® (omalizumab) developed by Kashiv BioSciences, intended for the treatment of chronic urticaria.
When is the BLA filing expected?
The Biologics License Application (BLA) for ADL-018 is expected to be submitted to the FDA in Q4 2025.
How many patients were involved in the clinical trial?
A total of 600 patients were enrolled in the confirmatory clinical trial for ADL-018.
What are the therapeutic applications of omalizumab?
Omalizumab is indicated for severe allergic asthma, chronic rhinosinusitis with nasal polyps, food allergies, and chronic spontaneous urticaria.
What market is ADL-018 entering?
ADL-018 is poised to enter the $3.9 billion U.S. market for omalizumab, targeting a significant segment of patients.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
Amneal holds exclusive U.S. commercialization rights; BLA filing expected in Q4 2025
Poised to be among the first wave of biosimilars in the $3.9 billion U.S. omalizumab market and an important growth driver for Amneal
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 $3.9 billion for the 12 months ending April 2025. XOLAIR ® is a registered trademark of Novartis AG.
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
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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
[email protected]
Media Contact
Brandon Skop
Sr. Director, Corporate Communications
[email protected]
Kashiv BioSciences Contact:
Dr. Paras Vasanani
Head of Business Development
[email protected]
https://www.kashivbiosciences.com/
