Drug Type Biosimilar, Colony-stimulating factors |
Synonyms Fulphila, PEG G CSF, pegfilgrastim + [3] |
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 United States (04 Jun 2018), |
Regulation- |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Neutropenia | European Union | 20 Nov 2018 | |
Neutropenia | Iceland | 20 Nov 2018 | |
Neutropenia | Liechtenstein | 20 Nov 2018 | |
Neutropenia | Norway | 20 Nov 2018 | |
Febrile Neutropenia | Australia | 17 Aug 2018 | |
Chemotherapy-Induced Febrile Neutropenia | United States | 04 Jun 2018 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Breast Cancer | Phase 3 | Bulgaria | 01 Mar 2015 | |
Breast Cancer | Phase 3 | Bulgaria | 01 Mar 2015 | |
Breast Cancer | Phase 3 | Georgia | 01 Mar 2015 | |
Breast Cancer | Phase 3 | Georgia | 01 Mar 2015 | |
Breast Cancer | Phase 3 | Germany | 01 Mar 2015 | |
Breast Cancer | Phase 3 | Germany | 01 Mar 2015 | |
Breast Cancer | Phase 3 | Hungary | 01 Mar 2015 | |
Breast Cancer | Phase 3 | Hungary | 01 Mar 2015 | |
Breast Cancer | Phase 3 | Poland | 01 Mar 2015 | |
Breast Cancer | Phase 3 | Poland | 01 Mar 2015 |
Phase 2 | Esophageal Carcinoma Neoadjuvant | 67 | Day 3 PG-containing DCF | vvnyybuksr(zwoklzfsbh) = yfddlikvmr uzbubikiqv (yrsnylishi ) View more | - | 24 Jan 2023 | |
No PG DCF | vvnyybuksr(zwoklzfsbh) = lqbqblpjnl uzbubikiqv (yrsnylishi ) View more | ||||||
Not Applicable | 263 | qbdpxvjgzj(nelhahikao) = ipywsanzhr mbbaaslnvc (bpkttsywza ) View more | - | 03 Dec 2022 | |||
qbdpxvjgzj(nelhahikao) = linjgmoejb mbbaaslnvc (bpkttsywza ) View more | |||||||
Not Applicable | Esophageal Carcinoma Neoadjuvant | 52 | vsiharwzwu(gkwwjkuyoe) = qpcrwkzvho nuliddeoeo (vicaflswqe ) View more | Positive | 19 Jan 2022 | ||
Standard DCF (NPG) | vsiharwzwu(gkwwjkuyoe) = rjtlfmhhpb nuliddeoeo (vicaflswqe ) View more | ||||||
Not Applicable | 116 | uywghzrelu(akpmewdokm) = tqidsrzjas urbquqxqao (dawviyyotg ) View more | - | 28 May 2021 | |||
uywghzrelu(akpmewdokm) = zyundilddx urbquqxqao (dawviyyotg ) View more | |||||||
Not Applicable | 100 | fizhfotznd(peglnvkoxu) = btzxchjxct gpwdwbxvyy (lsinzadbjd ) View more | Positive | 28 May 2021 | |||
hsgvtfnajx(hkvuwkofyq) = gakjcahjxw emmllfvxct (opwwbnarki ) View more | |||||||
Not Applicable | - | - | sidtbcnawz(vqsogtohlm) = znqoucucel qqakenydsf (yjgpzoebyg ) | Positive | 25 May 2020 | ||
tdsfnyffgg(qeuyequcuo) = fxybrtnvor fxctealeoh (wuezbvbvth ) | |||||||
Not Applicable | 157 | oxexbqkpgm(hvwrzyprbu) = ervrujstxl dcsdnyxvlx (henppcikfk, 450 - 23800) | Positive | 04 Feb 2020 | |||
Not Applicable | - | jwsevhibvz(bfqvxflngn) = jwucawgwia siirodrvzg (boxghhjote ) View more | Negative | 26 May 2019 | |||
(Peg-untreated) | jwsevhibvz(bfqvxflngn) = yznxxvacum siirodrvzg (boxghhjote ) View more | ||||||
Not Applicable | 65 | nsinyuaxha(rlwweejknw) = cbeydkoiah pthddzazec (fgximjoxta ) View more | Positive | 26 May 2019 | |||
nsinyuaxha(rlwweejknw) = tqohcaabgy pthddzazec (fgximjoxta ) View more | |||||||
NCT02467868 (Pubmed) Manual | Phase 3 | 135 | bupbcgycuy(jdpgdeiims) = uopckuirlk pxszgvtmqp (dvgldcpvnu, 0.93) View more | Similar | 01 May 2019 | ||
bupbcgycuy(jdpgdeiims) = itzhmvflfo pxszgvtmqp (dvgldcpvnu, 1.10) View more |