Kashiv BioSciences said Health Canada has validated and accepted the marketing authorization application for ADL-018, the company’s proposed biosimilar to XOLAIR (omalizumab). The company described the acceptance as a key regulatory milestone for its biosimilars portfolio and a step toward making its omalizumab biosimilar available to patients in Canada.
Omalizumab is a humanized monoclonal antibody targeting free IgE and is indicated for moderate to severe persistent asthma in patients 6 years and older, chronic rhinosinusitis with nasal polyps in adults 18 and older, chronic spontaneous urticaria in patients 12 and older, and IgE-mediated food allergy in patients over 1 year of age.
Dr. Sandeep Athalye, global CEO of Kashiv BioSciences, said the submission’s acceptance reflects the company’s development and manufacturing capabilities and aligns with its focus on expanding access to high-quality, cost-effective biologic therapies globally.
Kashiv cited IQVIA data indicating that XOLAIR recorded approximately 135 million Canadian dollars in sales in Canada in the 12 months ending June 2025.
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