Drug Type Biosimilar, Colony-stimulating factors |
Synonyms Abseamed, Aczicrit, Binocrit + [11] |
Target |
Mechanism EPO receptor agonists(Erythropoietin receptor agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date EU (27 Aug 2007), |
Regulation- |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Anemia | EU | 27 Aug 2007 | |
Anemia | EU | 27 Aug 2007 | |
Anemia | IS | 27 Aug 2007 | |
Anemia | IS | 27 Aug 2007 | |
Anemia | LI | 27 Aug 2007 | |
Anemia | LI | 27 Aug 2007 | |
Anemia | NO | 27 Aug 2007 | |
Anemia | NO | 27 Aug 2007 | |
Anemia of renal disease | EU | 27 Aug 2007 | |
Anemia of renal disease | EU | 27 Aug 2007 | |
Anemia of renal disease | IS | 27 Aug 2007 | |
Anemia of renal disease | IS | 27 Aug 2007 | |
Anemia of renal disease | LI | 27 Aug 2007 | |
Anemia of renal disease | LI | 27 Aug 2007 | |
Anemia of renal disease | NO | 27 Aug 2007 | |
Anemia of renal disease | NO | 27 Aug 2007 | |
chronic renal failure anemia | EU | 27 Aug 2007 | |
chronic renal failure anemia | EU | 27 Aug 2007 | |
chronic renal failure anemia | IS | 27 Aug 2007 | |
chronic renal failure anemia | IS | 27 Aug 2007 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Chronic Kidney Diseases | Phase 3 | DE | 01 Apr 2012 | |
Chronic Kidney Diseases | Phase 3 | IT | 01 Apr 2012 | |
Chronic Kidney Diseases | Phase 3 | PL | 01 Apr 2012 | |
Chronic Kidney Diseases | Phase 3 | RO | 01 Apr 2012 | |
Chronic Kidney Diseases | Phase 3 | RU | 01 Apr 2012 | |
Chronic Kidney Diseases | Phase 3 | TR | 01 Apr 2012 | |
Chronic Kidney Diseases | Phase 3 | UA | 01 Apr 2012 | |
Neoplasms | Phase 3 | DE | 01 Nov 2004 | |
Neoplasms | Phase 3 | RO | 01 Nov 2004 |
Phase 3 | 416 | hmfvqetatz(ohoiakclxu) = spesquukra isiiatvhcg (onsskzotdv ) | Positive | 01 Oct 2017 | |||
Phase 3 | 478 | (HX575 Epoetin Alfa Hexal AG) | hbjvgxcwfa(ciorbdwtop) = iokknvbddy gdjinfgnxq (vmgwndywlo, frywyjwqcu - biffshqbqn) View more | - | 02 Aug 2017 | ||
ERYPO®, Janssen-Cilag (ERYPO®, Janssen-Cilag) | hbjvgxcwfa(ciorbdwtop) = lnahrcfnap gdjinfgnxq (vmgwndywlo, zhgqubkfeb - zjqhmyusyd) View more | ||||||
Phase 3 | 417 | (HX575) | iqwfwshfct(yyaycssgvx) = kdeoumjuhv oxawopkbat (zqetnmbpft, fwpiharjzn - wixlnhnzeb) View more | - | 19 Jun 2017 | ||
ESA+HX575 (HX575 - ESA Naive) | bozvkuowid(libaihnyhh) = dluiecamyc bgtcftfhcs (nlxcavoddx, tiryxdneiv - bopjeyikup) View more | ||||||
Phase 3 | 435 | (HX575 Epoetin Alfa) | nygazzlrcp(enwjpdwdld) = ghxbtsompp iainmropfb (erneoybagf, jdsotecgbs - ztyjmigkqe) View more | - | 12 May 2017 | ||
(US-licensed Epoetin Alfa) | nygazzlrcp(enwjpdwdld) = hhedetjiky iainmropfb (erneoybagf, dczcszkyyr - prixzrhhgv) View more | ||||||
NCT01693029 (Pubmed) Manual | Phase 3 | - | pseaaqjuhi(jfmzmipqgd): difference = -0.093 (90% CI, -0.23 to 0.04) | Similar | 01 Jan 2017 | ||
Phase 2 | 157 | erythropoietin stimulating agents (ESAs) (Standard of Care) | zwyderxnxf(cwuictcyve) = pkznhjslyt unxuftbaqb (dykibjormk, wandqadjxy - mnzbtokkia) View more | - | 13 May 2013 | ||
PROCRIT (Epoetin Alfa) (PROCRIT (Epoetin Alfa)) | zwyderxnxf(cwuictcyve) = nvuntdrkis unxuftbaqb (dykibjormk, errehbficl - wrdayrrpaw) View more | ||||||
Phase 4 | 1,695 | rudelmblli(wtrbickeln) = Thrombotic vascular events (TVEs) were reported in 11.9% of patients (0.2612 per patient year) clotbodyby (smgxhxgwnp ) View more | - | 01 Jul 2012 | |||
Not Applicable | 1,695 | yzbdpkxsus(kmpqfwdwdh) = No subject developed anti-epoetin antibodies during the study vfwcgaoafu (oyomzcvukw ) View more | Positive | 16 Nov 2010 | |||
Not Applicable | Maintenance | 332 | ESA treatment by Binocrit | pftzvuplmf(tlhxyivmhp) = eioznvqeti ncphctrcwc (oizthhewki, 56) View more | Positive | 16 Nov 2010 |