Omalizumab biosimilar for treating chronic spontaneous urticaria

Omalizumab biosimilar is in development as a biosimilar medicine to the approved reference medicine, omalizumab for the treatment of chronic spontaneous urticarial (CSU) in patients who have symptoms despite antihistamine treatment. CSU is debilitating skin condition that causes red, raised, itchy and sometimes painful hives or wheals (raised rash or patches) on the skin. In CSU, the wheals (urticaria) are present daily for at least six weeks and the symptoms are not triggered by a known cause, hence considered ‘spontaneous’. Urticaria is caused by an immune response. Aggravating factors can include medication, stress, infection, and autoimmune diseases. A biosimilar medicine is a biological medicine which has not shown any clinically meaningful differences in quality, safety and efficacy from the reference medicine. Biosimilars offer a cost saving alternative to biologics, potentially increasing patient access to biologic therapy.