South Korea-based biopharmaceutical company Celltrion announced on Sunday that it has received approval from the US Food and Drug Administration (FDA) for the company's OMLYCLO (omalizumab-igec) as the first and only biosimilar with an interchangeability designation referencing XOLAIR (omalizumab).

This interchangeability designation is based on comprehensive clinical evidence, including a Phase three trial with 619 patients with chronic spontaneous urticaria (CSU) up to Week 40.

OMLYCLO is indicated for the treatment of moderate to severe persistent asthma in adults and paediatric patients six years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids. It is also indicated for the treatment of Chronic rhinosinusitis with nasal polyps (CRSwNP) in adults less than or equal to 18 years of age with inadequate response to nasal corticosteroids, IgE-mediated food allergy in adult and paediatric patients aged one year and older for the reduction of allergic reactions (Type I), including anaphylaxis, that is likely to occur with accidental exposure to one or more foods, and Chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment.

Hetal Patel, Celltrion USA vice president of Medical Affairs, said, 'We are proud to achieve the approval of the first biosimilar to omalizumab in the U.S., which will help broaden access to this important medicine for patients with allergic and respiratory conditions, as well as for physicians, payers and providers. The interchangeability designation of OMLYCLO reinforces confidence among physicians and patients that there is no decrease in effectiveness or increase in safety risk associated with switching between OMLYCLO and the reference product.'