EMA — authorised 14 February 2025
- Application: EMEA/H/C/006196
- Marketing authorisation holder: Celltrion Healthcare Hungary Kft.
- Local brand name: Avtozma
- Indication: Avtozma, in combination with methotrexate (MTX), is indicated for: the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX. the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. In these patients, Avtozma can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Avtozma has
- Pathway: biosimilar
- Status: approved
The European Medicines Agency (EMA) granted marketing authorisation for AVTOZMA, a biosimilar, on 14 February 2025. AVTOZMA is indicated for the treatment of severe, active, and progressive rheumatoid arthritis in adults, either as monotherapy or in combination with methotrexate. It is also indicated for the treatment of COVID-19 in adults requiring supplemental oxygen or mechanical ventilation, active systemic juvenile idiopathic arthritis in patients 2 years of age and older, and Giant Cell Arteritis in adult patients.