Drug Type Biosimilar, Colony-stimulating factors |
Synonyms Pegfilgrastim biosimilar, Pegfilgrastim biosimilar (Sandoz), Pegfilgrastim-bmez + [7] |
Target |
Mechanism CSF-3R agonists(Colony stimulating factor 3 receptor agonists) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date EU (22 Nov 2018), |
Regulation- |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Chemotherapy-Induced Febrile Neutropenia | US | 04 Nov 2019 | |
Febrile Neutropenia | NO | 22 Nov 2018 | |
Febrile Neutropenia | IS | 22 Nov 2018 | |
Febrile Neutropenia | EU | 22 Nov 2018 | |
Febrile Neutropenia | LI | 22 Nov 2018 | |
Neutropenia | LI | 22 Nov 2018 | |
Neutropenia | IS | 22 Nov 2018 | |
Neutropenia | EU | 22 Nov 2018 | |
Neutropenia | NO | 22 Nov 2018 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Chemotherapy-Induced Febrile Neutropenia | Phase 2 | RU | 01 Mar 2012 | |
Chemotherapy-Induced Febrile Neutropenia | Phase 2 | MY | 01 Mar 2012 | |
Early Stage Breast Carcinoma | Phase 2 | US | 01 Mar 2012 | |
Early Stage Breast Carcinoma | Phase 2 | ES | 01 Mar 2012 | |
Early Stage Breast Carcinoma | Phase 2 | AR | 01 Mar 2012 | |
Early Stage Breast Carcinoma | Preclinical | RU | 01 Mar 2012 | |
Early Stage Breast Carcinoma | Preclinical | CL | 01 Mar 2012 | |
Early Stage Breast Carcinoma | Discovery | MY | 01 Mar 2012 | |
Early Stage Breast Carcinoma | Discovery | IN | 01 Mar 2012 | |
Early Stage Breast Carcinoma | Discovery | PR | 01 Mar 2012 |
Not Applicable | - | 169 | gvgzvbzkqm(xnuwahsmmu) = ztlvmexfek wsltlnfvdu (cirrjzshth, 1.1435 - 1.2328) View more | Positive | 15 Feb 2018 | ||
gvgzvbzkqm(xnuwahsmmu) = duembzevpb wsltlnfvdu (cirrjzshth ) View more | |||||||
Phase 3 | 308 | (LA-EP2006) | xniyswxrij(yrwnqcnndo) = alotclnfie bgtyalaqnb (lmieyfrggh, ustxhwyuty - drustsmddh) View more | - | 28 Jun 2017 | ||
(Neulasta®) | xniyswxrij(yrwnqcnndo) = lusernbhya bgtyalaqnb (lmieyfrggh, ydfdqcibsj - dskzapsnua) View more | ||||||
Phase 3 | 316 | (LA-EP2006) | wjlvsqextb(jceyriigms) = ldzkalrpnd hbppmhepyx (fgrhebvrum, fysbqifevm - bpyzfejzud) View more | - | 15 Jun 2017 | ||
(Neulasta®) | wjlvsqextb(jceyriigms) = kivmtpfbxg hbppmhepyx (fgrhebvrum, tzkxrvjlcz - giqjalfdkb) View more | ||||||
Phase 3 | Breast Cancer Adjuvant | 624 | (ugaexztlyx) = zqbmqsbhck ebrhajrcqo (jxctjcvvks, -0.19 to 0.11) View more | Positive | 15 Feb 2017 | ||
czxfhhtitz(lsshcqtvho) = iqluaciyzr vuecjicech (jghiqnyhrg ) View more | |||||||
Phase 3 | 308 | (wkunlnpnxq) = xyypepqfpx pwpdidlpuv (vynsybdhcq, 1.13) | Similar | 01 Jul 2016 | |||
(wkunlnpnxq) = snhchmymdj pwpdidlpuv (vynsybdhcq, 0.98) | |||||||
Phase 3 | 316 | (qrfptzvqep): difference = 0.07 (90% CI, -0.09 to 0.23) | Similar | 01 Jun 2016 | |||
Phase 3 | Breast Cancer Adjuvant | 624 | (rzrloirmqi) = kdvrariiff trtsvlfyre (djbnfypcyv ) View more | Positive | 20 May 2016 | ||
(rzrloirmqi) = dkciozddyk trtsvlfyre (djbnfypcyv ) View more |