Kashiv BioSciences Announces Validation and Acceptance of Market Authorization Application by Health Canada for ADL-018, a Proposed Biosimilar to XOLAIR® (omalizumab)

PISCATAWAY, N.J.--(BUSINESS WIRE)--Kashiv BioSciences, LLC (“Kashiv”), a vertically integrated biopharmaceutical company, today announced that Health Canada has validated and accepted the marketing authorization application (MAA) for ADL-018, the Company’s proposed biosimilar for XOLAIR^® (omalizumab).

Omalizumab, a humanized monoclonal antibody that targets free IgE, is indicated for the treatment of moderate to severe persistent asthma (6 years and older patients), chronic rhinosinusitis with nasal polyps (CRSwNP) (18 years and older patients), chronic spontaneous urticaria (12 years and older patients), and IgE-mediated food allergy (>1 year and older patients).

“The acceptance of this submission by Health Canada marks a key regulatory milestone for Kashiv’s biosimilars portfolio,” said Dr. Sandeep Athalye, Global CEO of Kashiv BioSciences. “It reflects the strength of our development and manufacturing capabilities and brings us closer to making the omalizumab biosimilar available to patients in Canada. We remain focused and committed to expanding access to high-quality, cost-effective biologic therapies globally.”

According to IQVIA^®, annual sales of XOLAIR^® in Canada were approximately $135 million for the 12-month period ending June 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 for the market in the European Economic Area, UK, Switzerland, Australia, New Zealand and Canada.

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. For more information, visit www.kashivbiosciences.com and follow us on LinkedIn.