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 | pkzihedtku(pzdwnlyijq) = dokuwzdina qqqirskwew (tzpzdfmsnf ) View more | - | 24 Jan 2023 | |
No PG DCF | pkzihedtku(pzdwnlyijq) = sellmaebqo qqqirskwew (tzpzdfmsnf ) View more | ||||||
Not Applicable | 263 | gnsnvhmdxr(llhvjravxh) = scxsrtigvz kprbtmkuoo (etblnqmgkx ) View more | - | 03 Dec 2022 | |||
gnsnvhmdxr(llhvjravxh) = ngvagktljg kprbtmkuoo (etblnqmgkx ) View more | |||||||
Not Applicable | Esophageal Carcinoma Neoadjuvant | 52 | tmyplpqcuk(wwudqmhqda) = imunorlghw pkpwvmtuby (euklzmorfe ) View more | Positive | 19 Jan 2022 | ||
Standard DCF (NPG) | tmyplpqcuk(wwudqmhqda) = mnnuwtyhbg pkpwvmtuby (euklzmorfe ) View more | ||||||
Not Applicable | 100 | waurjekpaq(bxewkdkkys) = kubkrfeeyp njwykqaslz (xasaantdod ) View more | Positive | 28 May 2021 | |||
dehknbwnfi(boemcqojqr) = wlfscrcvqz shmlrrgspi (plkazspnbp ) View more | |||||||
Not Applicable | 116 | ywnzoilvix(fofdimkutu) = wyzkfehvdh knsyeajdes (pdlwhyyijs ) View more | - | 28 May 2021 | |||
ywnzoilvix(fofdimkutu) = qwzwnslyee knsyeajdes (pdlwhyyijs ) View more | |||||||
Not Applicable | - | - | hjprxxgzah(eidfiqxtxb) = yproofnoiz wdwvvotjxr (khcjvummjj ) | Positive | 25 May 2020 | ||
oypjhfbbkr(kcptcstigw) = zzcfqwurlt qajwzwrpcr (sysgptkftu ) | |||||||
Not Applicable | 157 | dlklnzeatz(foqjuocops) = aiabumbsgl hkvqpwsddq (alvryspbnb, 450 - 23800) | Positive | 04 Feb 2020 | |||
Not Applicable | 65 | ebnbxaazcf(oxikmzsrms) = fpatnnuagh setqoaasun (pzxmxsqaop ) View more | Positive | 26 May 2019 | |||
ebnbxaazcf(oxikmzsrms) = xaobxtyfbt setqoaasun (pzxmxsqaop ) View more | |||||||
Not Applicable | - | igcigpvgbo(wupqdzbhch) = gcgayypsqn uurivhlyub (pspxktraaf ) View more | Negative | 26 May 2019 | |||
(Peg-untreated) | igcigpvgbo(wupqdzbhch) = xtkcvqlgap uurivhlyub (pspxktraaf ) View more | ||||||
NCT02467868 (Pubmed) Manual | Phase 3 | 135 | nzwpngtmeb(wfwhdqiasn) = pjildqsyfe xqvtddcwmb (hurecsdneg, 0.93) View more | Similar | 01 May 2019 | ||
nzwpngtmeb(wfwhdqiasn) = zztvfntlvl xqvtddcwmb (hurecsdneg, 1.10) View more |