Posted by Michael Wonder on 05 Jun 2026
Kashiv BioSciences announces validation and acceptance of market authorisation application by Health Canada for ADL-018, a proposed biosimilar to Xolair (omalizumab)
4 June 2026 - Kashiv BioSciences today announced that Health Canada has validated and accepted the marketing authorisation application for ADL-018, the Company’s proposed biosimilar for Xolair (omalizumab).
ADL-018, a humanised 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 chronic spontaneous urticaria in individuals aged 12 and older who continue to have hives uncontrolled by H1 antagonists.
