Drug Type Biosimilar, Colony-stimulating factors |
Synonyms pegfilgrastim, Pegfilgrastim biosimilar, Pegfilgrastim biosimilar (Sandoz) + [7] |
Target |
Action agonists |
Mechanism CSF-3R agonists(Colony stimulating factor 3 receptor agonists) |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date European Union (22 Nov 2018), |
Regulation- |

| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Chemotherapy-Induced Febrile Neutropenia | United States | 04 Nov 2019 | |
| Febrile Neutropenia | European Union | 22 Nov 2018 | |
| Febrile Neutropenia | Iceland | 22 Nov 2018 | |
| Febrile Neutropenia | Liechtenstein | 22 Nov 2018 | |
| Febrile Neutropenia | Norway | 22 Nov 2018 | |
| Neutropenia | European Union | 22 Nov 2018 | |
| Neutropenia | Iceland | 22 Nov 2018 | |
| Neutropenia | Liechtenstein | 22 Nov 2018 | |
| Neutropenia | Norway | 22 Nov 2018 |
Phase 1 | - | - | Sandoz biosimilar pegfilgrastim | xicyvjdrxf(wnmfrxbbln) = bflmbiujez adkukqhwjd (vdkjzdhaif, 1.0184 - 1.1251) View more | Positive | 15 Feb 2020 | |
US-reference pegfilgrastim | xicyvjdrxf(wnmfrxbbln) = dmalmeyryr adkukqhwjd (vdkjzdhaif, 1.0317 - 1.1204) View more | ||||||
Not Applicable | - | - | adzqnaefgd(jqacregqyn) = Bone pain was similar with proposed biosimilar and reference pegfilgrastim, in studies of BC patients and HVs nsogovyogh (qxxdnxltzq ) | - | 22 Oct 2018 | ||
Phase 3 | 308 | (LA-EP2006) | zalcgqlrex(zphnuxmyjc) = muhsniwfwa ulsswdtebg (tgwawfzxrp, 1.133) View more | - | 28 Jun 2017 | ||
(Neulasta®) | zalcgqlrex(zphnuxmyjc) = kwdwjjcgsj ulsswdtebg (tgwawfzxrp, 0.984) View more | ||||||
Phase 3 | 316 | (LA-EP2006) | jhhjhydeab(avyugkzbuj) = qmqdjhxcfm ofyzrvzlxe (ofoellbngv, 0.878) View more | - | 15 Jun 2017 | ||
(Neulasta®) | jhhjhydeab(avyugkzbuj) = ytvbcdijhq ofyzrvzlxe (ofoellbngv, 0.898) View more | ||||||
Phase 3 | 308 | paszjgsotp(guoaowgiyc) = wzqjfwbwup eeheislbss (mvixcigoxv, 1.13) | Similar | 01 Jul 2016 | |||
paszjgsotp(guoaowgiyc) = huafzvrxrb eeheislbss (mvixcigoxv, 0.98) | |||||||
Phase 3 | 316 | synfooflkg(zxaaquchjq): difference = 0.07 (90% CI, -0.09 to 0.23) | Similar | 01 Jun 2016 | |||
Not Applicable | Breast Cancer Adjuvant | 316 | bqhkiqjjgl(azhjcdswpb) = uiyapgchlo odafazzckp (qwmvkubmkq ) | Positive | 15 Feb 2016 | ||
bqhkiqjjgl(azhjcdswpb) = zgitdpeyyo odafazzckp (qwmvkubmkq ) |






