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Tosmova (previously Tocilizumab STADA and Tofidence) (tocilizumab)

Biosimilar
Region
🇪🇺 EU
Active substance
tocilizumab
Company
STADA Arzneimittel AG
Status
Authorised
Therapeutic area
Arthritis, Rheumatoid; COVID-19 virus infection; Arthritis, Juvenile Rheumatoid
CHMP opinion
Thu 25 Apr 2024
EU approval
Thu 20 Jun 2024
Designations
Biosimilar
Application
EMEA/H/C/005984
ATC
L04AC07
Official record
www.ema.europa.eu

Indication

Tosmova, 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, Tosmova can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Tosmova 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.  Tosmova is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.  Tosmova is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids.  Tosmova can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX.  Tosmova in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (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.  Tosmova can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.

Regulatory milestones

No milestones recorded in the last year.

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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.