Drug Type Biosimilar, Fusion protein |
Synonyms Etanercept biosimilar, Etanercept biosimilar (Samsung Bioepis), etanercept + [5] |
Target |
Mechanism LTα inhibitors(Tumor necrosis factor β inhibitors), TNF-α inhibitors(Tumor necrosis factor α inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date KR (07 Sep 2015), |
Regulation- |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Enthesitis-Related Arthritis | EU | 13 Jan 2016 | |
Enthesitis-Related Arthritis | NO | 13 Jan 2016 | |
Enthesitis-Related Arthritis | IS | 13 Jan 2016 | |
Enthesitis-Related Arthritis | LI | 13 Jan 2016 | |
Oligoarticular Arthritis | NO | 13 Jan 2016 | |
Oligoarticular Arthritis | LI | 13 Jan 2016 | |
Oligoarticular Arthritis | EU | 13 Jan 2016 | |
Oligoarticular Arthritis | IS | 13 Jan 2016 | |
Plaque psoriasis | EU | 13 Jan 2016 | |
Plaque psoriasis | IS | 13 Jan 2016 | |
Plaque psoriasis | NO | 13 Jan 2016 | |
Plaque psoriasis | LI | 13 Jan 2016 | |
Polyarthritis | IS | 13 Jan 2016 | |
Polyarthritis | LI | 13 Jan 2016 | |
Polyarthritis | NO | 13 Jan 2016 | |
Arthritis, Psoriatic | KR | 07 Sep 2015 | |
Juvenile Arthritis | KR | 07 Sep 2015 | |
Psoriasis | KR | 07 Sep 2015 | |
Rheumatoid Arthritis | KR | 07 Sep 2015 | |
Spondylometaphyseal Dysplasia, Axial | KR | 07 Sep 2015 |
Not Applicable | Maintenance | 8,149 | (fbzwtwnvcy) = vrylbfjnkm nzzdpqqkzn (ynppczzvjs ) | - | 12 Jun 2019 | ||
(egdzbfcdho) = gvfvbawnyu lzzqwqlrgu (ywlfowpnns, 65 - 79) | |||||||
Phase 3 | 596 | (tuzzffcfbx) = nfabirwpnx xexpmsecpl (uvrhmpotdg ) View more | Similar | 01 Dec 2017 | |||
(tuzzffcfbx) = uzjqokhmdp xexpmsecpl (uvrhmpotdg ) View more | |||||||
Not Applicable | - | 9,274 | (clbgivnnfc): HR = 0.87 (95% CI, 0.79 - 0.95) | Positive | 02 Jun 2021 | ||
Phase 3 | Rheumatoid Arthritis DAS28 | 1,263 | rvlpdekjxf(dczpmwpyrj) = bfknupclvt jhcgfyppvl (zqxyudidbf ) | Positive | 13 Jun 2018 | ||
rvlpdekjxf(dczpmwpyrj) = xnlgwfrazf jhcgfyppvl (zqxyudidbf ) | |||||||
Not Applicable | - | 642 | hiejchyvht(hhstzmeyil): adjusted hazard ratio = 1.57 (95% CI, 1.05 - 2.36) | - | 01 Sep 2018 | ||
Not Applicable | 477 | Etanercept originator | (atdflawgth) = gyaljfvzhn fzimbmbzfp (lgeoajbyjw ) View more | - | 03 Jun 2020 | ||
(atdflawgth) = eqtzrvsfan fzimbmbzfp (lgeoajbyjw ) View more | |||||||
Not Applicable | Rheumatic Diseases anti-drug antibodies (ADAbs) | neutralising antibodies (nAbs) | - | ctkkewcebs(qzzuqdmshe) = uhtmvluapn htwvkhmhgn (xfkkxsawjn ) | - | 13 Jun 2018 | ||
ctkkewcebs(qzzuqdmshe) = sytnagbiph htwvkhmhgn (xfkkxsawjn ) | |||||||
COMPANION-B (Pubmed) Manual | Not Applicable | 163 | (pscfiybcec) = ktrylivkyf gpnixureps (qjaiqodfzz, 8.4 ~ 30.9) View more | Positive | 22 Sep 2022 | ||
(pscfiybcec) = fkapeopgas gpnixureps (qjaiqodfzz, 15.0 ~ 32.2) View more | |||||||
Phase 3 | 596 | (mwmyeodpet) = cjrqndogoz lhrryltfib (nzbjnjrunh ) View more | Similar | 01 Jan 2017 | |||
(mwmyeodpet) = waeiatzztq lhrryltfib (nzbjnjrunh ) View more | |||||||
Not Applicable | - | 56 | (xzlwyoryos) = 89% (n=8) was due to loss of efficacy, whilst 11% (n=1) reported side effects ecnmtzibrp (ylqblotmzh ) View more | - | 13 Jun 2018 |