Drug Type Biosimilar, Colony-stimulating factors |
Synonyms Pegfilgrastim biosimilar, Pegfilgrastim biosimilar (Sandoz), Pegfilgrastim-bmez + [6] |
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 | IS | 22 Nov 2018 | |
Febrile Neutropenia | LI | 22 Nov 2018 | |
Febrile Neutropenia | NO | 22 Nov 2018 | |
Febrile Neutropenia | EU | 22 Nov 2018 | |
Neutropenia | LI | 22 Nov 2018 | |
Neutropenia | EU | 22 Nov 2018 | |
Neutropenia | IS | 22 Nov 2018 | |
Neutropenia | NO | 22 Nov 2018 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Breast Cancer | Phase 2 | US | 01 Mar 2012 | |
Breast Cancer | Phase 2 | AR | 01 Mar 2012 | |
Breast Cancer | Phase 2 | CL | 01 Mar 2012 | |
Chemotherapy-Induced Febrile Neutropenia | Phase 2 | RU | 01 Mar 2012 | |
Chemotherapy-Induced Febrile Neutropenia | Phase 2 | AR | 01 Mar 2012 | |
Chemotherapy-Induced Febrile Neutropenia | Phase 2 | ES | 01 Mar 2012 | |
Chemotherapy-Induced Febrile Neutropenia | Phase 2 | CL | 01 Mar 2012 | |
Chemotherapy-Induced Febrile Neutropenia | Phase 2 | IN | 01 Mar 2012 | |
Chemotherapy-Induced Febrile Neutropenia | Phase 2 | MY | 01 Mar 2012 | |
Chemotherapy-Induced Febrile Neutropenia | Phase 2 | PR | 01 Mar 2012 |
Phase 3 | 308 | (LA-EP2006) | amliuxujmi(lvniduzqqj) = csjkktzalu gupeetqpsz (mjvztniicp, equgbnikcq - ffwmktovgn) View more | - | 28 Jun 2017 | ||
(Neulasta®) | amliuxujmi(lvniduzqqj) = gmbwsyouhw gupeetqpsz (mjvztniicp, sqpnbhgery - abdbgthjng) View more | ||||||
Phase 3 | 316 | (LA-EP2006) | gfbogwzaqg(papbkqgjwb) = ekcmfxesfi jwzvygvmry (afveopakyo, ooymaajrsx - nlvdbddyhm) View more | - | 15 Jun 2017 | ||
(Neulasta®) | gfbogwzaqg(papbkqgjwb) = nvogapqrhx jwzvygvmry (afveopakyo, tjchetjaam - umsumjamcm) View more | ||||||
Phase 3 | 308 | (tcfhcczejk) = wqzrcydiig pbelribucg (cnzrcknkyc, 1.13) | Similar | 01 Jul 2016 | |||
(tcfhcczejk) = addxtgzhep pbelribucg (cnzrcknkyc, 0.98) | |||||||
Phase 3 | 316 | (nrkmbhzugd): difference = 0.07 (90% CI, -0.09 to 0.23) | Similar | 01 Jun 2016 | |||
Phase 3 | Breast Cancer Adjuvant | 624 | (iqexipefpx) = upirrogdhs ksfjlaumgv (vwcdiusqqe ) View more | Positive | 20 May 2016 | ||
(iqexipefpx) = qdvledvawf ksfjlaumgv (vwcdiusqqe ) View more |