A potential new biosimilar to Xolair (omalizumab) has had its Biologics License Application (BLA) submitted to the FDA by Amneal Pharmaceuticals and Kashiv BioSciences, expanding more affordable drug options for those with asthma, food allergies and other conditions, according to an announcement released today.

Xolair, developed by Genentech and Novartis, is a humanized monoclonal antibody that works by binding to immunoglobulin E (IgE), a key driver in allergic responses. Approved in multiple therapeutic areas, Xolair is indicated for patients as young as one year old with IgE-mediated food allergies, children as young as six with moderate to severe persistent asthma and adults with chronic rhinosinusitis with nasal polyps (CRSwNP) or chronic spontaneous urticaria (CSU).

These conditio

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