CHMP positive for Omlyclo (omalizumab biosimilar) to treat asthma, rhinosinusitis and urticaria.- Celltrion.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Omlyclo, intended for the treatment of severe persistent allergic asthma, severe chronic rhinosinusitis with nasal polyps (CRSwNP) and chronic spontaneous urticaria (CSU).
The applicant for this medicinal product is Celltrion Healthcare Hungary Kft.
Omlyclo will be available as 75 mg and 150 mg solution for injection in pre-filled syringe. The active substance of Omlyclo is omalizumab, a drug for obstructive airway diseases (ATC code: R03DX05). Omalizumab is a recombinant DNA-derived humanised monoclonal antibody that selectively binds to human immunoglobulin E (IgE), thereby reducing the amount of free IgE available to trigger the allergic cascade.
Omlyclo is a biosimilar medicinal product. It is highly similar to the reference product Xolair (omalizumab), which was authorised in the EU on 25 October 2005. Data show that Omlyclo has comparable quality, safety and efficacy to Xolair. .
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