Pregled bibliografske jedinice broj: 682505
Use of granulocyte colony-stimulating factor biosimilars in hematology
Use of granulocyte colony-stimulating factor biosimilars in hematology // Periodicum Biologorum / Vitale, Branko (ur.).
Zagreb: Hrvatsko prirodoslovno društvo, 2013. str. 56-56 (poster, nije recenziran, sažetak, ostalo)
CROSBI ID: 682505 Za ispravke kontaktirajte CROSBI podršku putem web obrasca
Naslov
Use of granulocyte colony-stimulating factor biosimilars in hematology
Autori
Mandac Rogulj, Inga ; Radić Krišto, Delfa ; Ostojić Kolonić, Slobodanka ; Planinc-Peraica, Ana
Vrsta, podvrsta i kategorija rada
Sažeci sa skupova, sažetak, ostalo
Izvornik
Periodicum Biologorum
/ Vitale, Branko - Zagreb : Hrvatsko prirodoslovno društvo, 2013, 56-56
Skup
7th Croatian Congress of Pharmacology
Mjesto i datum
Zagreb, Hrvatska, 18.09.2013. - 21.09.2013
Vrsta sudjelovanja
Poster
Vrsta recenzije
Nije recenziran
Ključne riječi
biosimilari; G-CSF; hematologija
(granulocyte colony-stimulating factor biosimilars; hematology)
Sažetak
Introduction: The World Health Organization (WHO) defines biosimilars as “a biotherapeutic product which is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product”. The first biosimilar granulocyte colony-stimulating factor (G-CSF) was licensed by EMA in 2008. In hematology, G-CSF can be used to mobilize peripheral blood stem cells in patients undergoing autologous stem cell transplantation, in healthy donors , or to reduce the depth and duration of neutropenia and incidence of severe infection after intense chemotherapy regimen and stem cell transplantation. Materials and methods: We did a systematic review using data that were obtained by searches of MEDLINE, PubMed and guidelines from the European Medicines Agency. Results: Several studies found no difference between the use of brand-name or biosimilar G-CSF to aid neutrophil recovery and reduce the number of days with fever in lymphoma or myeloma patients when evaluating the number of G-CSF injections, the number of days of hospitalization, the days on which body temperature exceeded 38°C and the hospitalization costs. In one recent study, investigators analyzed 154 consecutive patients undergoing peripheral blood stem cell harvest using the biosimilar G-CSF and compared the outcomes with control group of 131 consecutive patients who had received Neupogen(®). No statistically significant difference was found when comparing CD34 predictors, total number of CD34(+) stem cells collected, number of days required for collection, or for time to engraftment. The use of biosimilar G-CSF in healthy donors is still under investigation and we have no enough sufficient and certain data about potential risks due to biosimilar G-CSF. Conclusion: Only clinical trials and effective pharmacovigilance will provide definitive evidence that a biosimilar G-CSF is comparable to the reference product in terms of quality, efficacy and safety.
Izvorni jezik
Engleski
Znanstvena područja
Kliničke medicinske znanosti
POVEZANOST RADA
Projekti:
044-1081873-1281 - Hematološki poremećaji u bolesnika sa kardiomiopatijama (Planinc-Peraica, Ana, MZOS ) ( CroRIS)
Ustanove:
Klinička bolnica "Merkur"
Profili:
Ana Planinc-Peraica
(autor)
Inga Mandac Smoljanović
(autor)
Slobodanka Ostojić Kolonić
(autor)
Delfa Radić Krišto
(autor)