EMA — authorised 16 May 2024
- Application: EMEA/H/C/005958
- Marketing authorisation holder: Celltrion Healthcare Hungary Kft.
- Local brand name: Omlyclo
- Indication: Allergic asthma Omlyclo is indicated in adults, adolescents and children (6 to <12 years of age). Omlyclo treatment should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma (see section 4.2). Adults and adolescents (12 years of age and older) Omlyclo is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1 <80%) as well as frequent daytime symptoms or night-time awakenings an
- Pathway: biosimilar
- Status: approved
On 16 May 2024, the European Medicines Agency (EMA) granted marketing authorisation for Omlyclo (omalizumab injection) in the European Union. Omlyclo is indicated for the treatment of severe persistent allergic asthma in adults, adolescents, and children aged 6-12 years, chronic rhinosinusitis with nasal polyps in adults, and chronic spontaneous urticaria in adults and adolescents. The marketing authorisation was granted to Celltrion Healthcare Hungary Kft. as a biosimilar product.