← Drug database

Tuyory (tocilizumab)

Region

🇪🇺 EU

Active substance

tocilizumab

Company

Chemical Works of Gedeon Richter Plc. (Gedeon Richter Plc.)

Status

Authorised

Therapeutic area

Arthritis, Rheumatoid; Arthritis, Juvenile; Cytokine Release Syndrome; Giant Cell Arteritis; COVID-19 virus infection

CHMP opinion

Thu 26 Feb 2026

EU approval

Mon 27 Apr 2026

Designations

Biosimilar, Additional monitoring

Application

EMEA/H/C/006416

ATC

L04AC07

Official record

www.ema.europa.eu

Indication

Rheumatoid arthritis (RA) Tuyory, in combination with methotrexate (MTX), is indicated for:- the treatment of severe, active and progressive 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, Tuyory can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.Tocilizumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate. Coronavirus disease 2019 (COVID-19) Tuyory is indicated for the treatment of COVID-19 in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. Systemic juvenile idiopathic arthritis (sJIA) Tuyory is indicated for the treatment of active sJIA in patients 1 year of age and older, who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids. Tuyory can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX.Polyarticular juvenile idiopathic arthritis (pJIA) Tuyory in combination with MTX is indicated for the treatment of pJIA (rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX. Tuyory can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.Cytokine release syndrome (CRS) Tuyory is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening CRS in adults and paediatric patients 2 years of age and older. Giant cell arteritis (GCA) Tuyory is indicated for the treatment of GCA in adult patients.

Regulatory milestones

Same substance in other markets

• 🇪🇺 Tosmova (previously Tocilizumab STADA and Tofidence) Authorised · STADA Arzneimittel AG
• 🇪🇺 Avtozma Authorised · Celltrion Healthcare Hungary Kft.
• 🇪🇺 Tyenne Authorised · Fresenius Kabi Deutschland GmbH
• 🇪🇺 RoActemra Authorised · Roche Registration GmbH
• 🇺🇸 Avtozma Approved · Celltrion Inc

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.