Tocilizumab - PharmaKB

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

YTD

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 diseases	D009140
nervous system diseases	D009422
cardiovascular diseases	D002318
skin and connective tissue diseases	D017437
immune system diseases	D007154
signs and symptoms pathological conditions	D013568

Trade Name

FDA

EMA

Actemra, Avtozma, Tofidence, Tyenne

Drug Products

FDA

EMA

Reference product - 351(a)

Interchangeable product - 351(k)

Biosimilar product - 351(k)

Tocilizumab

Tradename	Proper name	Company	Number	Date	Products
Actemra	tocilizumab	Genentech	N-125276 RX	2010-01-08	3 products
Actemra	tocilizumab	Genentech	N-125472 RX	2013-10-21	2 products

Labels

FDA

EMA

Brand Name	Status	Last Update
actemra	Biologic Licensing Application	2018-10-01
actemra actemra actpen	Biologic Licensing Application	2024-11-06
avtozma	Biologic Licensing Application	2025-01-31
tocilizumab-anoh	Biologic Licensing Application	2025-01-31
tofidence	Biologic Licensing Application	2025-07-03
tyenne	Biologic Licensing Application	2024-12-30

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
cytokine release syndrome	—	D000080424	D89.83
juvenile arthritis	EFO_1002007	D001171	M08
rheumatoid arthritis	EFO_0000685	D001172	M06.9
giant cell arteritis	EFO_1001209	D013700	M31.6

Agency Specific

FDA

EMA

Expiration	Code
tocilizumab, Actemra, Genentech, Inc.
2028-03-04	Orphan excl.
2024-08-30	Orphan 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

846 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Arthritis	D001168	EFO_0005856	M05-M14	12	9	94	46	86	245
Rheumatoid arthritis	D001172	EFO_0000685	M06.9	8	8	80	44	84	223
Covid-19	D000086382	—	U07.1	4	20	21	4	27	74
Heart failure	D006333	EFO_0003144	I50	—	7	6	8	24	42
Pneumonia	D011014	EFO_0003106	J18	1	8	7	1	10	27
Giant cell arteritis	D013700	EFO_1001209	M31.6	3	8	8	2	6	26
Polymyalgia rheumatica	D011111	EFO_0008518	M35.3	3	8	8	2	6	26
Arteritis	D001167	EFO_0009011	I77.6	3	7	7	4	5	25
Juvenile arthritis	D001171	EFO_1002007	M08	5	2	14	2	3	25
Syndrome	D013577	—	—	1	8	3	2	8	20

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Lymphoma	D008223	—	C85.9	20	16	4	—	—	30
Stroke	D020521	EFO_0000712	I63.9	—	1	3	—	22	25
B-cell lymphoma	D016393	—	—	15	9	2	—	—	17
Leukemia	D007938	—	C95	10	6	1	—	1	17
Coronavirus infections	D018352	EFO_0007224	B34.2	—	6	1	—	8	15
Non-hodgkin lymphoma	D008228	—	C85.9	11	10	1	—	—	14
Ischemic stroke	D000083242	—	—	—	1	2	—	12	14
Vascular diseases	D014652	EFO_0004264	I77	1	1	5	—	7	14
Infections	D007239	EFO_0000544	—	1	5	3	—	6	13
Atherosclerosis	D050197	EFO_0003914	I25.1	1	—	1	—	9	11

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Aneurysm	D000783	—	I72.9	—	1	—	—	11	12
Carcinoma	D002277	—	C80.0	6	5	—	—	2	11
Breast neoplasms	D001943	EFO_0003869	C50	3	3	—	—	4	9
Lymphoid leukemia	D007945	—	C91	6	4	—	—	—	9
Recurrence	D012008	—	—	4	3	—	—	3	8
Graft vs host disease	D006086	—	D89.81	2	6	—	—	—	7
Virus diseases	D014777	—	B34	—	4	—	—	3	7
Hematologic neoplasms	D019337	—	—	2	6	—	—	—	7
Coronary disease	D003327	—	—	—	2	—	—	5	7
B-cell chronic lymphocytic leukemia	D015451	—	C91.1	3	3	—	—	—	6

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Myocardial ischemia	D017202	EFO_1001375	I20-I25	1	—	—	—	5	6
Hemorrhage	D006470	MP_0001914	R58	1	—	—	—	3	4
Pulmonary embolism	D011655	EFO_0003827	I26	1	—	—	—	3	4
Embolism	D004617	—	—	1	—	—	—	3	4
Magnetic resonance imaging	D008279	—	—	1	—	—	—	3	4
Colorectal neoplasms	D015179	—	—	2	—	—	—	1	3
Subarachnoid hemorrhage	D013345	EFO_0000713	I60	1	—	—	—	2	3
Neoplasm metastasis	D009362	EFO_0009708	—	2	—	—	—	—	2
Sarcoma	D012509	—	—	1	—	—	—	1	2
Brain ischemia	D002545	EFO_0003883	I67.82	1	—	—	—	1	2

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Intermittent claudication	D007383	EFO_0003876	I73.9	—	—	—	—	6	6
Intracranial aneurysm	D002532	EFO_0003870	I67.1	—	—	—	—	6	6
Critical illness	D016638	—	—	—	—	—	—	5	5
Headache	D006261	—	R51	—	—	—	—	5	5
Obesity	D009765	EFO_0001073	E66.9	—	—	—	—	4	4
Migraine disorders	D008881	EFO_0003821	G43	—	—	—	—	4	4
Abdominal aortic aneurysm	D017544	EFO_0004214	—	—	—	—	—	4	4
Aortic aneurysm	D001014	EFO_0001666	I71.9	—	—	—	—	4	4
Cerebrovascular circulation	D002560	—	—	—	—	—	—	3	3
Cerebral small vessel diseases	D059345	—	—	—	—	—	—	3	3

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Tocilizumab
INN	tocilizumab
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 class	monoclonal antibodies
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	—