Table 1 The FDA-approved targeted drugs for autoimmune diseases
Drug | Mechanisms | Administration routes | Indication | Approval time | Research Unit |
|---|---|---|---|---|---|
Target IL-23 | |||||
TREMFYA (guselkumab) | Human IgG1λ mAb blocking IL-23 (p19) | s.c. | PsO | 2017 | JANSSEN BIOTECH (BLA: 761061) |
SKYRIZI (risankizumab-rzaa) | Humanized IgG1 mAb blocking IL-23 (p19) | s.c./i.v. | PsO/CD | 2019 | ABBVIE INC (BLA: 761105) |
ILUMYA (tildrakizumab-asmn) | Human IgG1κ mAb blocking IL-23 (p19) | s.c./i.v. | PsO | 2018 | SUN PHARMA GLOBAL (BLA: 761067) |
OMVOH (mirikizumab-mrkz) | Humanized IgG4κ mAb blocking IL-23 (p19) | s.c./i.v. | UC | 2023 | ELI LILLY AND CO (BLA: 761279) |
Target IL-17 and related locus | |||||
COSENTYX (secukinumab) | Human IgG1κ mAb blocking IL-17A | s.c./i.v. | PsO/PsA/AS/ nr-axSpA/HS | 2015 | NOVARTIS PHARMS CORP (BLA: 125504) |
TALTZ (ixekizumab) | Humanized IgG4 mAb blocking IL-17A | s.c. | PsO/PsA/AS/ nr-axSpA | 2016 | ELI LILLY AND CO (BLA: 125521) |
BIMZELX (bimekizumab-bkzx) | Humanized IgG1κ mAb blocking IL-17A/F | s.c. | PsO | 2023 | UCB INC (BLA: 761151) |
SILIQ (brodalumab) | Human IgG2κ mAb blocking IL-17RA | s.c. | PsO | 2017 | VALEANT LUXEMBOURG (BLA: 761032) |
Target Integrins | |||||
TYRUKO (natalizumab-sztn) | Humanized IgG4κ mAb blocking α4β1 and α4β7 integrins | i.v. | MS/CD | 2023 | SANDOZ INC (BLA: 761322) |
TYSABRI (natalizumab) | i.v. | MS/CD | 2004 | BIOGEN IDEC (BLA: 125104) | |
ENTYVIO (vedolizumab) | Humanized IgG1 mAb blocking α4β7 interactions with MADCAM-1 and VCAM | s.c./i.v. | UC/CD | 2014 | TAKEDA PHARMS USA (BLA: 761133) |
Target TNF | |||||
AVSOLA (infliximab-axxq) | Humanized IgG1κ mAb blocking TNF-α | i.v. | CD/UC/RA/PsO/PsA | 2019 | AMGEN INC (BLA: 761086) |
INFLECTRA (infliximab-dyyb) | i.v. | CD/UC/RA/AS/PsA/PsO | 2016 | CELLTRION INC (BLA: 125544) | |
IXIFI (infliximab-qbtx) | i.v. | CD/UC/RA/AS/PsA/PsO | 2017 | PFIZER INC (BLA: 761072) | |
REMICADE (infliximab) | i.v. | CD/UC/RA/AS/ PsA/PsO | 1998 | CENTOCOR INC (BLA: 103772) | |
RENFLEXIS (infliximab-abda) | i.v. | CD/UC/RA/AS/ PsA/PsO | 2017 | SAMSUNG BIOEPIS CO LTD (BLA: 761054) | |
ZYMFENTRA (infliximab-dyyb) | s.c. | CD/UC | 2016 | CELLTRION (BLA: 761358) | |
ENBREL (etanercept) | Humanized IgG1 blocking TNF-α and TNF-β | s.c. | RA/PsA/AS/PsO | 1998 | IMMUNEX (BLA: 103795) |
ERELZI (etanercept-szzs) | s.c. | RA/JIA/PsA/AS/PsO | 2016 | SANDOZ (BLA: 761042) | |
ETICOVO (etanercept-ykro) | s.c. | RA/JIA/PsA/AS/PsO | 2019 | SAMSUNG BIOEPIS CO LTD (BLA: 761066) | |
ABRILADA (adalimumab-afzb) | Humanized IgG1κ blocking TNF-α interactions with p55 and p75 | s.c. | RA/JIA/PsA/AS/CD/UC/PsO/HS/UV | 2019 | PFIZER INC (BLA: 761118) |
AMJEVITA (adalimumab-atto) | s.c. | RA/JIA/PsA/AS/CD/UC/PsO/HS/UV | 2016 | AMGEN INC (BLA: 761024) | |
CYLTEZO (adalimumab-adbm) | s.c. | RA/JIA/PsA/AS/CD/UC/PsO/HS/UV | 2017 | BOEHRINGER INGELHEIM (BLA: 761058) | |
HADLIMA (adalimumab-bwwd) | s.c. | RA/JIA/PsA/AS/CD/UC/PsO/HS/UV | 2019 | SAMSUNG BIOEPIS CO LTD (BLA: 761059) | |
HULIO (adalimumab-fkjp) | s.c. | RA/JIA/PsA/AS/CD/UC/PsO/HS/UV | 2020 | MYLAN PHARMS INC (BLA: 761154) | |
HUMIRA (adalimumab) | s.c. | RA/JIA/PsA/AS/CD/UC/PsO/HS/UV | 2002 | ABBVIE INC (BLA: 125057) | |
HYRIMOZ (adalimumab-adaz) | s.c. | RA/JIA/PsA/AS/CD/UC/PsO/HS/UV | 2018 | SANDOZ INC (BLA: 761071) | |
IDACIO (adalimumab-aacf) | s.c. | RA/JIA/PsA/AS/CD/UC/PsO/HS/UV | 2022 | FRESENIUS KABI USA (BLA: 761255) | |
SIMLANDI (adalimumab-ryvk) | s.c. | RA/JIA/PsA/AS/CD/UC/PsO/HS/UV | 2024 | ALVOTECH USA INC (BLA: 761299) | |
YUFLYMA (adalimumab-aaty) | s.c. | RA/JIA/PsA/AS/CD/UC/PsO/HS/UV | 2023 | CELLTRION (BLA: 761219) | |
YUSIMRY (adalimumab-aqvh) | s.c. | RA/JIA/PsA/AS/CD/UC/PsO/HS/UV | 2021 | COHERUS BIOSCIENCES INC (BLA: 761216) | |
SIMPONI (golimumab) | Human IgG1κ mAb blocking TNF-α | s.c. | RA/PsA/AS/UC | 2009 | CENTOCOR ORTHO BIOTECH INC (BLA: 125289) |
SIMPONI ARIA (golimumab) | i.v. | RA/PsA/AS/JIA | 2009 | JANSSEN BIOTECH (BLA: 125433) | |
CIMZIA (certolizumab pegol) | Humanized antibody Fab’ fragment blocking TNF-α | s.c. | CD/RA/PsA/AS/ nr-axSpA/PsO | 2008 | UCB INC (BLA: 125160) |
Target CD20 | |||||
RIABNI (rituximab-arrx) | chimeric murine/human IgG1κ blocking CD20 | i.v. | GPA/MPA | 2020 | AMGEN INC (BLA: 761140) |
RITUXAN (rituximab) | i.v. | RA/GPA/MPA/PV | 1997 | GENENTECH (BLA: 103705) | |
RITUXAN HYCELA (rituximab and hyaluronidase human) | s.c. | GPA/MPA/LN (post-marketing experience) | 2017 | GENENTECH INC (BLA: 761064) | |
RUXIENCE (rituximab-pvvr) | i.v. | RA/GPA/MPA | 2019 | PFIZER INC (BLA: 761103) | |
TRUXIMA (rituximab-abbs) | i.v. | RA/GPA/MPA | 2018 | CELLTRION INC (BLA: 761088) | |
ARZERRA/ KESIMPTA (ofatumumab) | Humanized IgG1 mAb blocking CD20 to enhance CDC relative to rituximab | s.c. | MS | 2009 | NOVARTIS (BLA: 125326) |
OCREVUS (ocrelizumab) | Humanized IgG1 mAb blocking CD20 to reduce CDC relative to rituximab | i.v. | MS | 2017 | GENENTECH INC (BLA: 761053) |
GAZYVA (obinutuzumab) | Humanized IgG1 mAb blocking CD20 to enhance ADCC and apoptosis | i.v. | Serum sickness (post-marketing experience) | 2013 | GENENTECH (BLA: 125486) |
Target IL-1 and related locus | |||||
KINERET (anakinra) | recombinant, nonglycosylated form blocking IL-1α | s.c. | CAPS/RA/DIRA | 2001 | BIOVITRUM AB (BLA: 103950) |
ILARIS (canakinumab) | Human IgG1κ mAb blocking IL-1β | s.c. | PFS/Still’s Disease | 2009 | NOVARTIS PHARMS (BLA: 125319) |
ARCALYST (rilonacept) | Dimeric human IL-1R-IL-1RAcP IgG1 fusion protein blocking IL-1 | s.c. | CAPS/FCAS/MWS/DIRA/RP | 2008 | KINIKSA PHARMACEUTICALS (UK), LTD. (BLA: 125249) |
Target IL-5 and related locus | |||||
NUCALA (mepolizumab) | Humanized IgG1κ mAb blocking IL-5 | s.c. | Asthma/CRSwNP/EGPA/HES | 2015 | GLAXOSMITHKLINE LLC (BLA: 125526) |
CINQAIR (reslizumab) | Humanized IgG4κ mAb blocking IL-5 | i.v. | Asthma | 2016 | TEVA RESPIRATORY LLC (BLA: 761033) |
FASENRA (benralizumab) | Humanized IgG1κ mAb blocking IL-5R | s.c. | Asthma | 2017 | ASTRAZENECA AB (BLA: 761070) |
Target IL-6 and related locus | |||||
ACTEMRA (tocilizumab) | Humanized IgG1κ mAb blocking IL-6R | s.c./i.v. | RA/GCA/SSc-ILD/JIA | 2010 | GENENTECH (BLA: 125276) |
TOFIDENCE (tocilizumab-bavi) | i.v. | RA/JIA | 2023 | BIOGEN MA (BLA: 761354) | |
TYENNE (tocilizumab-aazg) | s.c./i.v. | RA/JIA/GCA | 2024 | FRESENIUS KABI USA (BLA: 761275) | |
KEVZARA (sarilumab) | Human IgG1 mAb blocking IL-6R | s.c. | RA/PMR | 2017 | SANOFI SYNTHELABO (BLA: 761037) |
ENSPRYNG (satralizumab) | Humanized IgG2 mAb blocking IL-6R | s.c. | NMOSD | 2020 | GENENTECH (BLA: 761149) |
SYLVANT (siltuximab) | Humanized IgG1κ mAb blocking IL-6 | i.v. | MCD | 2014 | EUSA PHARMA LIMITED (BLA: 125496) |
Target IL-13+/- IL-4 | |||||
DUPIXENT (dupilumab) | Human IgG4κ mAb blocking IL-4Rα to inhibit IL-13 and IL-4 signaling | s.c. | AD/Asthma/ CRSwNP/EoE/PN | 2017 | REGENERON PHARMACEUTICALS (BLA: 761055) |
ADBRY (tralokinumab) | Human IgG4 mAb blocking IL-13 | s.c. | AD | 2021 | LEO PHARMA AS (BLA: 761180) |
Target IL-12/23 | |||||
SELARSDI (ustekinumab-aekn) | Human IgG1κ mAb blocking IL-12 and IL-23 | s.c. | PsO/PsA | 2024 | ALVOTECH USA INC (BLA: 761343) |
STELARA (ustekinumab) | s.c./i.v. | PsO/CD/PsA/UC | 2009 | CENTOCOR ORTHO BIOTECH INC (BLA: 125261) | |
WEZLANA (ustekinumab-auub) | s.c./i.v. | PsA/Ps/CD/UC | 2023 | AMGEN INC (BLA: 761285) | |
Target other loci | |||||
ZINBRYTA (daclizumab) | Humanized IgG1κ mAb blocking IL-2Rα (CD25) | s.c. | MS | 2016 | BIOGEN (BLA: 761029) |
CAMPATH/ LEMTRADA (alemtuzumab) | Humanized IgG1κ mAb blocking CD52 | i.v. | MS | 2001 | GENZYME (BLA: 103948) |
ORENCIA (abatacept) | selective costimulation modulator blocking CD80/CD86 | s.c./i.v. | RA/JIA/PsA/ aGVHD/ | 2005 | BRISTOL MYERS SQUIBB (BLA: 125118) |
XOLAIR (omalizumab) | Humanized IgG1κ mAb blocking free IgE | s.c. | Asthma/IgE-Food Allergy/CSU | 2003 | GENENTECH (BLA: 103976) |
TEZSPIRE (tezepelumab-ekko) | Humanized IgG2λ mAb blocking TSLP | s.c. | Asthma | 2021 | ASTRAZENECA AB (BLA: 761224) |
BENLYSTA (belimumab) | Humanized IgG1λ mAb blocking BAFF | s.c./i.v. | SLE/LN | 2011 | HUMAN GENOME SCIENCES INC (BLA: 125370) |
Antigen mimetic products | |||||
COPAXONE (glatiramer acetate) | Synthetic copolymer based on the structure of myelin basic protein | s.c. | MS | 1996 | TEVA PHARMS USA (ANDA: 020622) |
GLATIRAMER ACETATE (glatiramer acetate) | s.c. | MS | 2017 | MYLAN (ANDA: 091646) | |
GLATOPA (glatiramer acetate) | s.c. | MS | 2015 | SANDOZ (ANDA: 090218) | |
