Abrilada, Amgevita, Amjevita, Amsparity, Cyltezo, Hadlima, Halimatoz, Hefiya, Hukyndra, Hulio, Humira, Hyrimoz, Idacio, Imraldi, Kromeya, Libmyris, Solymbic, Trudexa, Yuflyma, Yusimry (adalimumab)

Abrilada, Amgevita, Amjevita, Amsparity, Cyltezo, Hadlima, Halimatoz, Hefiya, Hukyndra, Hulio, Humira, Hyrimoz, Idacio, Imraldi, Kromeya, Libmyris, Solymbic, Trudexa, Yuflyma, Yusimry (adalimumab) is an antibody pharmaceutical. Adalimumab was first approved as Humira on 2002-12-31. It is used to treat ankylosing spondylitis, crohn disease, hidradenitis suppurativa, juvenile arthritis, and psoriatic arthritis amongst others in the USA. It has been approved in Europe to treat ankylosing spondylitis, arthritis, crohn disease, hidradenitis suppurativa, and juvenile arthritis amongst others. The pharmaceutical is active against tumor necrosis factor.

Commercial
Therapeutic Areas
Therapeutic Area MeSH
Infections D007239
Musculoskeletal Diseases D009140
Digestive System Diseases D004066
Eye Diseases D005128
Skin And Connective Tissue Diseases D017437
Immune System Diseases D007154

Trade name (FDA)
Abrilada, Amjevita, Cyltezo, Hadlima, Hulio, Humira, Hyrimoz, Yusimry
Drug products (FDA)

Ingredient: Adalimumab

Tradename Proper name Company Number Date Products
Reference product - 351(a)
Humira adalimumab AbbVie Inc. FDA 2017-04-28 2 products, True
  • 10: 20mg/0.2ml injection (subcutaneous, RX)
  • 11: 10mg/0.1ml injection (subcutaneous, RX)
2017-04-21 1 products, True
  • 9: 80mg/0.8ml injection (subcutaneous, RX)
2016-10-17 1 products, True
  • 8: 80mg/0.8ml injection (subcutaneous, RX)
2016-03-09 1 products, True
  • 7: 40mg/0.4ml injection (subcutaneous, RX)
2015-11-23 1 products, True
  • 6: 40mg/0.4ml injection (subcutaneous, RX)
2014-09-23 1 products, True
  • 5: 10mg/0.2ml injection (subcutaneous, RX)
2013-04-24 1 products, True
  • 4: 40mg/0.8ml injection (subcutaneous, RX)
2008-02-21 1 products, True
  • 3: 20mg/0.4ml injection (subcutaneous, RX)
2002-12-31 2 products, True
  • 1: 40mg/0.8ml injection (subcutaneous, RX)
  • 2: 40mg/0.8ml injection (subcutaneous, RX)
Interchangeable product - 351(k)
Cyltezo adalimumab-adbm Boehringer Ingelheim Pharmaceuticals, Inc. FDA 2018-07-13 1 products, True
  • 2: 20mg/0.4ml injection (subcutaneous, RX)
2017-08-25 1 products, True
  • 1: 40mg/0.8ml injection (subcutaneous, RX)
Biosimilar product - 351(k)
Amjevita adalimumab-atto Amgen, Inc. FDA 2016-09-23 3 products, True
  • 1: 20mg/0.4ml injection (subcutaneous, RX)
  • 2: 40mg/0.8ml injection (subcutaneous, RX)
  • 3: 40mg/0.8ml injection (subcutaneous, RX)
Yusimry adalimumab-aqvh Coherus BioSciences, Inc. FDA 2021-12-17 1 products, True
  • 1: 40mg/0.8ml injection (subcutaneous, RX)
Hulio adalimumab-fkjp Mylan Pharmaceuticals Inc. FDA 2020-07-06 3 products, True
  • 1: 40mg/0.8ml injection (subcutaneous, RX)
  • 2: 40mg/0.8ml injection (subcutaneous, RX)
  • 3: 20mg/0.4ml injection (subcutaneous, RX)
Abrilada adalimumab-afzb Pfizer Inc. FDA 2019-11-15 5 products, True
  • 1: 40mg/0.8ml injection (subcutaneous, RX)
  • 2: 40mg/0.8ml injection (subcutaneous, RX)
  • 3: 20mg/0.4ml injection (subcutaneous, RX)
  • 4: 10mg/0.2ml injection (subcutaneous, RX)
  • 5: 40mg/0.8ml injection (subcutaneous, RX)
Hadlima adalimumab-bwwd Samsung Bioepis Co., Ltd. FDA 2019-07-23 2 products, True
  • 1: 40mg/0.8ml injection (subcutaneous, RX)
  • 2: 40mg/0.8ml injection (subcutaneous, RX)
Hyrimoz adalimumab-adaz Sandoz Inc. FDA 2018-10-30 2 products, True
  • 1: 40mg/0.8ml injection (subcutaneous, RX)
  • 2: 40mg/0.8ml injection (subcutaneous, RX)
Exclusivity (FDA)
Expiration Code
Adalimumab, Cyltezo, Boehringer Ingelheim Pharmaceuticals, Inc.
Date TBD Interchangeable excl.
Adalimumab, Humira, AbbVie Inc.
2028-02-24 Orphan excl.
Patent expiration (FDA)
Labels (FDA)
Brand Name Status Last Update
Humira Biologic Licensing Application 2021-02-24
Imraldi Export only 2018-01-23
Indications (FDA)
Indication MeSH Ontology ICD-10
Ankylosing Spondylitis D013167 EFO_0003898 M45
Crohn Disease D003424 EFO_0000384 K50
Hidradenitis Suppurativa D017497
L73.2
Juvenile Arthritis D001171 EFO_0002609 M08
Psoriatic Arthritis D015535 EFO_0003778 L40.5
Rheumatoid Arthritis D001172 EFO_0000685 M06.9
Ulcerative Colitis D003093 EFO_0000729 K51
Uveitis D014605 EFO_1001231 H20.9

Trade name (EMA)
Amgevita, Amsparity, Hefiya, Hukyndra, Hulio, Humira, Hyrimoz, Idacio, Imraldi, Libmyris, Yuflyma (discontinued: Cyltezo, Halimatoz, Kromeya, Solymbic, Trudexa)
Drug products (EMA)

Ingredient: Adalimumab

Tradename Company Number Date Products
New drug Application (NDA)
Humira AbbVie Deutschland GmbH Co. KG EMEA/H/C/000481 RX 2003-09-08 1 products
Trudexa Abbott Laboratories Ltd. EMEA/H/C/000482 DISCN 2003-09-01 1 products
Abbreviated New Drug Application (ANDA)
Amgevita Amgen Europe B.V. EMEA/H/C/004212 RX 2017-03-21 1 products
Yuflyma Celltrion Healthcare Hungary Kft. EMEA/H/C/005188 RX 2021-02-11 1 products
Idacio Fresenius Kabi Deutschland GmbH EMEA/H/C/004475 RX 2019-04-02 1 products
Amsparity Pfizer Europe MA EEIG  EMEA/H/C/004879 RX 2020-02-13 1 products
Imraldi Samsung Bioepis NL B.V. EMEA/H/C/004279 RX 2017-08-24 1 products
Hyrimoz Sandoz GmbH EMEA/H/C/004320 RX 2018-07-26 1 products
Hefiya Sandoz GmbH EMEA/H/C/004865 RX 2018-07-26 1 products
Hukyndra Stada Arzneimittel AG EMEA/H/C/005548 RX 2021-11-15 1 products
Libmyris Stada Arzneimittel AG EMEA/H/C/005947 RX 2021-11-12 1 products
Hulio Viatris Limited EMEA/H/C/004429 RX 2018-09-17 1 products
Solymbic Amgen Europe B.V. EMEA/H/C/004373 DISCN 2017-03-22 1 products
Cyltezo Boehringer Ingelheim International GmbH EMEA/H/C/004319 DISCN 2017-11-10 1 products
Kromeya Fresenius Kabi Deutschland GmbH EMEA/H/C/005158 DISCN 2019-04-02 1 products
Halimatoz Sandoz GmbH EMEA/H/C/004866 DISCN 2018-07-26 1 products
Indications (EMA)
Indication MeSH Ontology ICD-10
Ankylosing Spondylitis D013167 EFO_0003898 M45
Arthritis D001168 EFO_0005856 M05-M14
Crohn Disease D003424 EFO_0000384 K50
Hidradenitis Suppurativa D017497
L73.2
Juvenile Arthritis D001171 EFO_0002609 M08
Papulosquamous Skin Diseases D017444
L40-L45
Psoriasis D011565 EFO_0000676 L40
Psoriatic Arthritis D015535 EFO_0003778 L40.5
Rheumatoid Arthritis D001172 EFO_0000685 M06.9
Ulcerative Colitis D003093 EFO_0000729 K51
Uveitis D014605 EFO_1001231 H20.9

ATC codes
L: Antineoplastic And Immunomodulating Agents
- L04: Immunosuppressants
- L04A: Immunosuppressants
- L04AB: Tumor necrosis factor alpha (TNF-alpha) inhibitors
- L04AB04: Adalimumab
HCPCS
Injection, adalimumab, 20 mg
Clinical
Clinical trials
440 clinical trials

Indications Phase 4
Indication MeSH Ontology ICD-10 Ph 1 Ph 2 Ph 3 Ph 4 Other Total
Rheumatoid Arthritis D001172 EFO_0000685 M06.9 3 23 48 49 23 143
Crohn Disease D003424 EFO_0000384 K50 2 8 29 16 14 65
Psoriasis D011565 EFO_0000676 L40 3 10 32 12 11 64
Ulcerative Colitis D003093 EFO_0000729 K51 2 1 13 8 8 32
Psoriatic Arthritis D015535 EFO_0003778 L40.5 1 1 11 6 8 27
Ankylosing Spondylitis D013167 EFO_0003898 M45 1 1 9 8 6 24
Uveitis D014605 EFO_1001231 H20.9 1 6 7 2
15
Hidradenitis Suppurativa D017497
L73.2 1 5 4 3 1 14
Inflammatory Bowel Diseases D015212 EFO_0003767
1 2 5 6 13
Spondylarthritis D025241
1 5 1 7
Arthritis D001168 EFO_0005856 M05-M14
1 3 2
6
Cardiovascular Diseases D002318 EFO_0000319 I98
4
4
Takayasu Arteritis D013625 EFO_1001857 M31.4
2
2
Coronary Artery Disease D003324
I25.1
2
2
Connective Tissue Diseases D003240 EFO_1001986 M35
1
1
Type 2 Diabetes Mellitus D003924 EFO_0001360 E11
1
1
Hypertension D006973 EFO_0000537 I10
1
1
Spondylarthropathies D025242 EFO_0000706 M47
1
1
Therapeutics D013812
1
1
Obstructive Sleep Apnea D020181 EFO_0003918 G47.33
1
1
Enterocolitis D004760 EFO_1001481
1
1
Joint Diseases D007592 HP_0003040 M12.9
1
1
Rectal Fistula D012003
K60.3
1
1
Anterior Uveitis D014606 EFO_1000811 H20.0
1
1
Thromboembolism D013923 HP_0001907
1
1

Indications Phase 3
Indication MeSH Ontology ICD-10 Ph 1 Ph 2 Ph 3 Ph 4 Other Total
Healthy Volunteers/patients
23 1 1
24
Juvenile Arthritis D001171 EFO_0002609 M08
5
1 6
Inflammation D007249
1 1
1 3
Pyoderma Gangrenosum D017511 EFO_0006835 L88
2 1
3
Osteoarthritis D010003 EFO_0002506 M15-M19 1 2 1
3
Pain D010146 EFO_0003843 R52 1 1 1
1 3
Behcet Syndrome D001528 EFO_0003780 M35.2
2
2
COVID-19 D000086382
U07.1
1
1
Pouchitis D019449 EFO_0003921 K91.850
1
1
Intervertebral Disc Displacement D007405 EFO_1001800
1
1
Interstitial Cystitis D018856 EFO_1000869 N30.1
1
1
Giant Cell Arteritis D013700 EFO_1001209 M31.6
1
1
Pharmacokinetics D010599
1 1
1
Bursitis D002062 EFO_1000941 M71.9
1 1
1

Indications Phase 2
Indication MeSH Ontology ICD-10 Ph 1 Ph 2 Ph 3 Ph 4 Other Total
Sarcoidosis D012507
D80-D89
4
4
Focal Segmental Glomerulosclerosis D005923 EFO_0004236
1 2
3
Autoimmune Diseases D001327 EFO_0000540 M30-M36 1 2
2
Choroidal Neovascularization D020256
1 1
2
Mucopolysaccharidosis VI D009087 Orphanet_583 E76.2 2 2
2
Mucopolysaccharidosis I D008059 Orphanet_579 E76.0 2 2
2
Mucopolysaccharidosis II D016532 Orphanet_580 E76.1 2 2
2
Diabetes Mellitus D003920 EFO_0000400 E08-E13 1 1
1
Type 1 Diabetes Mellitus D003922 EFO_0001359 E10 1 1
1
Hypoglycemia D007003 HP_0001943 E16.2 1 1
1
Hermanski-pudlak Syndrome D022861
E70.331
1
1
Colitis D003092 EFO_0003872 K52.9
1
1
Lymphocytosis D008218
1
1
Drug Evaluation D004341
1
1
Cytokinesis D048749
1
1
Macular Degeneration D008268 EFO_0001365 H35.30
1
1
Biological Therapy D001691
1
1
Lipoid Nephrosis D009402 EFO_1001020 N04
1
1
Injection Site Reaction D000075662
1 1
1
Dupuytren Contracture D004387 EFO_0004229 M72.0
1
1
Knee Osteoarthritis D020370 EFO_0004616 M17
1
1
Netherton Syndrome D056770
1
1
Asthma D001249 EFO_0000270 J45
1
1
Sciatica D012585 HP_0011868 M54.3
1
1

Indications Phase 1
Indication MeSH Ontology ICD-10 Ph 1 Ph 2 Ph 3 Ph 4 Other Total
Uveal Neoplasms D014604 EFO_1001230
1
1
Immune System Diseases D007154
D89.9 1
1
Therapeutic Equivalency D013810
1
1
Anaplastic Thyroid Carcinoma D065646
1
1
Innate Immunity D007113
1
1
Diabetic Retinopathy D003930 EFO_0003770 H36.0 1
1

Indications Without Phase
Indication MeSH Ontology ICD-10 Ph 1 Ph 2 Ph 3 Ph 4 Other Total
Infections D007239 EFO_0000544
1 1
Encephalitis D004660
1 1
Drug Monitoring D016903
1 1
Fatigue D005221 HP_0012378 R53.83
1 1
Irritable Bowel Syndrome D043183 EFO_0000555 K58
1 1

Epidemiology
Epidemiological information for investigational and approved indications
Drug
Drug common name
adalimumab
INN
adalimumab
Trade name (FDA)
Abrilada, Amjevita, Cyltezo, Hadlima, Hulio, Humira, Hyrimoz, Yusimry
Trade name (EMA)
Amgevita, Amsparity, Hefiya, Hukyndra, Hulio, Humira, Hyrimoz, Idacio, Imraldi, Libmyris, Yuflyma (discontinued: Cyltezo, Halimatoz, Kromeya, Solymbic, Trudexa)
Description
Adalimumab, sold under the brand name Humira among others, is a medication used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriasis, hidradenitis suppurativa, uveitis, and juvenile idiopathic arthritis. Use is generally only recommended in people who have not responded to other treatments. It is used by injection under the skin.
Classification
Antibody
Drug class
Monoclonal antibodies
Image (chem structure or protein)
PDB
Structure (InChI/SMILES or Protein Sequence)
>6CR1:H|Heavy chain of adalimumab EFab (VH-IgE CH2)
EVQLVESGGGLVQPGRSLRLSCAASGFTFDDYAMHWVRQAPGKGLEWVSAITWNSGHIDYADSVEGRFTISRDNAKNSLY
LQMNSLRAEDTAVYYCAKVSYLSTASSLDYWGQGTLVTVSSASTKGPTVKILQSICDGGGHFPPTIQLLCLVSGYTPGTI
QITWLEDGQVMDVDLSTASTTQEGELASTQSELTLSQKHWLSDRTYTCQVTYQGHTFEDSTKKCAHHHHHH
>6CR1:L|Light chain of adalimumab EFab (VL-IgE CH2)
DIQMTQSPSSLSASVGDRVTITCRASQGIRNYLAWYQQKPGKAPKLLIYAASTLQSGVPSRFSGSGSGTDFTLTISSLQP
EDVATYYCQRYNRAPYTFGQGTKVEIKRTVAAPTVKILQSSCDGGGHFPPTIQLLCLVSGYTPGTIQITWLEDGQVMDVD
LSTASTTQEGELASTQSELTLSQKHWLSDRTYTCQVTYQGHTFEDSGKKCA
CAS-ID
331731-18-1
RxCUI
327361
ChEMBL ID
ChEBI ID
PubChem CID
DrugBank
DB00051
UNII ID
FYS6T7F842 (ChemIDplus, GSRS)
Target
Agency approved target
Organism
Homo sapiens
Gene name
TNF
Gene synonyms
TNFA, TNFSF2
NCBI Gene ID
Protein name
Tumor necrosis factor
Protein synonyms
APC1 protein, cachectin, macrophage-derived TNF, monocyte-derived TNF, TNF-a, TNF-alpha, tumor necrosis factor ligand 1F, tumor necrosis factor ligand superfamily member 2, tumor necrosis factor-alpha
Domain
Tumor necrosis factor, membrane form (PRO_0000034423)
Uniprot ID
Mouse ortholog
Tnf (21926)
Tumor necrosis factor (P06804)
Variants
Clinical Variant
Financial
Humira - AbbVie Inc.
Imraldi - BIOGEN INC.
Safety
Black-box warning
Black box warning for: Humira, Imraldi
Adverse events
Top Adverse Reactions
556,467 adverse events reported

Top