Kashiv BioSciences Announces Positive Topline Results from Confirmatory Efficacy Study of ADL-018, Biosimilar Candidate to XOLAIR® (omalizumab)

• Positive results from the confirmatory clinical efficacy and safety study of ADL-018, proposed biosimilar to XOLAIR^®
• The clinical study met its primary endpoint in Chronic Spontaneous Urticaria (CSU) as well as secondary endpoints demonstrating comparable efficacy and safety between ADL-018 and XOLAIR^® based on change in weekly Itch Severity Score (ISS7)
• Potential to be one of the first-wave biosimilar entrants in the ~$4.5 billion global omalizumab market, indicating a long-term growth opportunity

Kashiv BioSciences, LLC today announced positive topline results from its confirmatory clinical efficacy and safety clinical trial evaluating ADL-018, a proposed biosimilar to XOLAIR^® (omalizumab). The randomized, double-blind, multicenter study assessed the efficacy and safety of ADL-018 compared to XOLAIR^® (reference product) in patients with Chronic Idiopathic Urticaria (CIU) or Chronic Spontaneous Urticaria (CSU) who remained symptomatic despite treatment with H1 antihistamines.

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 over 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 groups of ADL-018 and reference product.

“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, “We remain focused on delivering cost-effective, high-quality therapies to improve patient outcomes globally, working with commercial partners including Amneal, Alvotech, and Advanz Pharma.”

“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.”

“The positive results from the confirmatory patient study represent an important step in the development of the XOLAIR^® biosimilar candidate, and we look forward to working with our partners to increase global patient access to this important medicine,” said Joseph McClellan, Chief Scientific Officer of Alvotech.

“The successful confirmatory efficacy results for the proposed biosimilar to XOLAIR^® mark an important milestone in Advanz Pharma’s ambition to expand patient access to specialty medicines across our core geographies, Europe, Canada, and Australia,” said Nick Warwick, Chief Medical Officer at Advanz Pharma.

The Biologics License Application (BLA) for this product is expected to be filed with the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2025. The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has already validated and accepted the marketing authorization application (MAA) for ADL-018 earlier this year, and the filing of an MAA with the European Medicines Agency (EMA) is expected in the fourth quarter of 2025.

About ADL-018

ADL-018, a humanized monoclonal antibody designed to inhibit the binding of IgE to FcεR on the surface of mast cells and basophils, is being developed as a biosimilar to XOLAIR^® (omalizumab), an injectable prescription medicine approved to treat CSU in individuals aged 12 and older who continue to have hives uncontrolled by H1 antagonists. Omalizumab is also approved for treating moderate to severe persistent asthma in individuals aged 6 and older whose asthma symptoms are not well controlled with inhaled corticosteroids, chronic rhinosinusitis with nasal polyps in individuals aged 18 and older, and IgE-mediated food allergy in adult and pediatric patients aged 1 year and older.

ADL-018 matches the pharmaceutical presentations, dosage strength, route of administration, and dosing regimen of the U.S. and E.U.-approved omalizumab reference product. XOLAIR^® is a registered trademark of Novartis AG.

Alvotech partnered with Kashiv BioSciences for the development of the proposed XOLAIR^® biosimilar, which is referred to as AVT23 by Alvotech and ADL-018 by Kashiv BioSciences and Amneal Pharmaceuticals.

About Kashiv BioSciences:

Kashiv BioSciences, LLC is a vertically integrated biopharmaceutical company with numerous commercial and advanced clinical-stage assets and is among the few U.S.-based companies to both manufacture and receive marketing authorization for multiple biosimilars. 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250625166139/en/

Positive results from the confirmatory clinical efficacy and safety study of ADL-018, proposed biosimilar to XOLAIR® The clinical study met its primary and secondary endpoints demonstrating comparable efficacy and safety between ADL-018 and XOLAIR®