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Drug ReportsTocilizumab
Actemra, Roactemra(tocilizumab)
Actemra, RoActemra, Tofidence, Tyenne (tocilizumab) is an antibody pharmaceutical. Tocilizumab was first approved as Roactemra on 2009-01-15. It is used to treat cytokine release syndrome, giant cell arteritis, juvenile arthritis, and rheumatoid arthritis in the USA. It has been approved in Europe to treat arthritis, cytokine release syndrome, giant cell arteritis, and rheumatoid arthritis.
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COVID-19
Case Study: COVID-19
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
musculoskeletal diseasesD009140
nervous system diseasesD009422
cardiovascular diseasesD002318
skin and connective tissue diseasesD017437
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Actemra, Avtozma, Tofidence, Tyenne
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Tocilizumab
Tradename
Proper name
Company
Number
Date
Products
ActemratocilizumabGenentechN-125276 RX2010-01-08
3 products
ActemratocilizumabGenentechN-125472 RX2013-10-21
2 products
Labels
FDA
EMA
Brand Name
Status
Last Update
actemraBiologic Licensing Application2018-10-01
actemra actemra actpenBiologic Licensing Application2025-12-16
avtozmaBiologic Licensing Application2026-07-27
tocilizumab-anohBiologic Licensing Application2026-01-23
tofidenceBiologic Licensing Application2026-05-22
tyenneBiologic Licensing Application2026-07-23
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
cytokine release syndrome—D000080424D89.83
juvenile arthritisEFO_1002007D001171M08
rheumatoid arthritisEFO_0000685D001172M06.9
giant cell arteritisEFO_1001209D013700M31.6
Agency Specific
FDA
EMA
Expiration
Code
tocilizumab, Actemra, Genentech, Inc.
2028-03-04Orphan excl.
2024-08-30Orphan excl.
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L04: Immunosuppressants
— L04A: Immunosuppressants
— L04AC: Interleukin inhibitors
— L04AC07: Tocilizumab
HCPCS
Code
Description
J3262
Injection, tocilizumab, 1 mg
M0249
Intravenous infusion, tocilizumab, for hospitalized adults and pediatric patients (2 years of age and older) with covid-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ecmo) only, includes infusion and post administration monitoring, first dose
M0250
Intravenous infusion, tocilizumab, for hospitalized adults and pediatric patients (2 years of age and older) with covid-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ecmo) only, includes infusion and post administration monitoring, second dose
Q0249
Injection, tocilizumab, for hospitalized adults and pediatric patients (2 years of age and older) with covid-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ecmo) only, 1 mg
Clinical
Clinical Trials
918 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ArthritisD001168EFO_0005856M05-M1452592060146
Rheumatoid arthritisD001172EFO_0000685M06.923572159142
Juvenile arthritisD001171EFO_1002007M084—62214
Giant cell arteritisD013700EFO_1001209M31.6124119
Polymyalgia rheumaticaD011111EFO_0008518M35.3113117
ArteritisD001167EFO_0009011I77.6112116
Healthy volunteers/patients———2——1—3
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-hodgkin lymphomaD008228—C85.91071——11
LymphomaD008223—C85.9641——8
Covid-19D000086382—U07.1132——6
PneumoniaD011014EFO_0003106J18—32——5
Large b-cell lymphoma diffuseD016403—C83.3311——4
Follicular lymphomaD008224—C82221——3
RecurrenceD012008——111——2
Systemic sclerodermaD012595EFO_0000717M34——2——2
Diffuse sclerodermaD045743EFO_0000404———2——2
SclerosisD012598————2——2
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
B-cell lymphomaD016393——74———7
Multiple myelomaD009101—C90.043———5
Liver neoplasmsD008113EFO_1001513C22.021———2
Non-small-cell lung carcinomaD002289——21———2
Pancreatic neoplasmsD010190EFO_0003860C2521———2
Urologic neoplasmsD014571—C64-C6811———1
Urinary bladder neoplasmsD001749—C6711———1
Transitional cell carcinomaD002295——11———1
Ischemic optic neuropathyD018917EFO_1000809H47.01—1———1
Breast neoplasmsD001943EFO_0003869C5011———1
Show 7 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C803————3
Colorectal neoplasmsD015179——2————2
AdenocarcinomaD000230——2————2
B-cell chronic lymphocytic leukemiaD015451—C91.12————2
CarcinomaD002277—C80.02————2
Systemic lupus erythematosusD008180EFO_0002690M322————2
Myeloid leukemia acuteD015470—C92.01————1
MelanomaD008545——1————1
Uveal neoplasmsD014604EFO_1001230—1————1
Cutaneous malignant melanomaD000096142——1————1
Show 12 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
EmergenciesD004630——————11
Heart failureD006333EFO_0003144I50————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTocilizumab
INNtocilizumab
Description
Tocilizumab, also known as atlizumab, is an immunosuppressive drug, mainly for the treatment of rheumatoid arthritis (RA) and systemic juvenile idiopathic arthritis, a severe form of arthritis in children. It is a humanized monoclonal antibody against the interleukin-6 receptor (IL-6R). Interleukin 6 (IL-6) is a cytokine that plays an important role in immune response and is implicated in the pathogenesis of many diseases, such as autoimmune diseases, multiple myeloma and prostate cancer. It was developed by Hoffmann–La Roche and Chugai.
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL1237022
ChEBI ID—
PubChem CID—
DrugBankDB06273
UNII IDI031V2H011 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Tofidence – Biogen
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Tofidence – Organon
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Actemra – Roche
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 9,999 documents
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Safety
Black-box Warning
Black-box warning for: Actemra, Actemra actemra actpen, Avtozma, Tocilizumab-anoh, Tofidence, Tyenne
Adverse Events
Top Adverse Reactions
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131,369 adverse events reported
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