TY - JOUR
T1 - Real-world safety experience of tevagrastim/ratiograstim/biograstim and tbo-filgrastim, short-acting recombinant human granulocyte colony-stimulating factors
AU - Abboud, Camille N.
AU - Lang, Nicole
AU - Fung, Henry
AU - Lammerich, Andreas
AU - Buchner, Anton
AU - Liu, Patrick
AU - Mueller, Udo
AU - Pettengell, Ruth
AU - Diel, Ingo J.
AU - Link, Hartmut
AU - Pathak, Ashutosh
N1 - Funding Information:
Funding information This study as well as the development of this publication was sponsored by Teva Branded Pharmaceutical Products R&D, Inc. Medical writing assistance was provided by Powered 4 Significance LLC, Annandale, NJ, USA, and was funded by Teva Branded Pharmaceutical Products R&D, Inc., Frazer, PA, USA. The data in this manuscript were presented in part at the 58th American Society of Hematology (ASH) Annual Meeting and Exposition; December 3-6, 2016; San Diego, CA, USA.
Funding Information:
Camille Abboud reports research funding from Merck, Teva, Novartis, Pfizer, and Seattle Genetics (clinical trial support); and consulting for Gerson and Lehman Group, Agios, Jazz Pharma, Pfizer, and Cardinal Health. Anton Buchner reports employment of Teva ratiopharm, and reports equity ownership in Teva Branded Pharmaceutical Products R&D, Inc. Andreas Lammerich reports employment and equity ownership in Teva ratiopharm/Teva Pharmaceuticals, Inc. Nicole Lang reports employment with Teva ratiopharm/Teva Pharmaceuticals, Inc. Hartmut Link reports research funding from Amgen and Hexal and honoraria from Teva. Patrick Liu reports employment with Teva Pharmaceuticals, Inc. Udo W. Mueller reports employment and equity ownership with Teva Pharmaceuticals, Inc. Ashutosh Pathak reports employment with Teva Pharmaceuticals, Inc. Henry Fung reports receiving honoraria from Amgen and Teva. Ruth Pettengell reports honoraria from CTI, Servier, Teva, Roche, Takeda and Pfizer.
Publisher Copyright:
© 2018, Springer-Verlag GmbH Germany, part of Springer Nature.
PY - 2019/7/1
Y1 - 2019/7/1
N2 - Purpose: Recombinant granulocyte colony-stimulating factors (rG-CSFs), such as filgrastim, are administered to prevent complications in patients receiving chemotherapy. In Europe, a biosimilar to filgrastim, tevagrastim/ratiograstim/biograstim, was approved in 2008. In the USA, the same product was approved as tbo-filgrastim under a 351(a) biologic license application in 2012 with the brand name Granix®. Postmarket surveillance remains a priority for monitoring the safety of biologics and biosimilars to identify rare and immunogenicity-related events. We report the global and US pharmacovigilance data for tevagrastim/ratiograstim/biograstim and tbo-filgrastim, respectively. Methods: Cumulative exposure and adverse event data from initial approval in Europe to December 31, 2016, were collected globally from spontaneous reports submitted by healthcare professionals and consumers, scientific literature, competent authorities, and solicited case reports from non-interventional studies. A separate search was conducted on the global data set to identify reports originating from the USA and Puerto Rico to describe the US experience. Results: Overall, the global safety profile of tevagrastim/ratiograstim/biograstim in the postmarket, real-world setting was comparable to clinical trial experience. Postmarket safety experience of tbo-filgrastim in the USA was consistent with global data. The most common SAEs were febrile neutropenia and decreased white blood cell count. The most common non-serious event was bone pain. There was no evidence of immunogenicity. Conclusions: This pharmacovigilance analysis indicates that postmarket experience of tevagrastim/ratiograstim/biograstim and tbo-filgrastim is consistent with clinical trials. Adverse reactions associated with the originator rG-CSF (capillary leak syndrome and glomerulonephritis) have not been observed with tevagrastim/ratiograstim/biograstim or tbo-filgrastim during the postmarket period.
AB - Purpose: Recombinant granulocyte colony-stimulating factors (rG-CSFs), such as filgrastim, are administered to prevent complications in patients receiving chemotherapy. In Europe, a biosimilar to filgrastim, tevagrastim/ratiograstim/biograstim, was approved in 2008. In the USA, the same product was approved as tbo-filgrastim under a 351(a) biologic license application in 2012 with the brand name Granix®. Postmarket surveillance remains a priority for monitoring the safety of biologics and biosimilars to identify rare and immunogenicity-related events. We report the global and US pharmacovigilance data for tevagrastim/ratiograstim/biograstim and tbo-filgrastim, respectively. Methods: Cumulative exposure and adverse event data from initial approval in Europe to December 31, 2016, were collected globally from spontaneous reports submitted by healthcare professionals and consumers, scientific literature, competent authorities, and solicited case reports from non-interventional studies. A separate search was conducted on the global data set to identify reports originating from the USA and Puerto Rico to describe the US experience. Results: Overall, the global safety profile of tevagrastim/ratiograstim/biograstim in the postmarket, real-world setting was comparable to clinical trial experience. Postmarket safety experience of tbo-filgrastim in the USA was consistent with global data. The most common SAEs were febrile neutropenia and decreased white blood cell count. The most common non-serious event was bone pain. There was no evidence of immunogenicity. Conclusions: This pharmacovigilance analysis indicates that postmarket experience of tevagrastim/ratiograstim/biograstim and tbo-filgrastim is consistent with clinical trials. Adverse reactions associated with the originator rG-CSF (capillary leak syndrome and glomerulonephritis) have not been observed with tevagrastim/ratiograstim/biograstim or tbo-filgrastim during the postmarket period.
KW - Febrile neutropenia
KW - Filgrastim
KW - G-CSF
KW - Pharmacovigilance
KW - Postmarket surveillance
KW - Tbo-filgrastim
UR - http://www.scopus.com/inward/record.url?scp=85056711336&partnerID=8YFLogxK
U2 - 10.1007/s00520-018-4522-5
DO - 10.1007/s00520-018-4522-5
M3 - Article
C2 - 30443809
AN - SCOPUS:85056711336
SN - 0941-4355
VL - 27
SP - 2569
EP - 2577
JO - Supportive Care in Cancer
JF - Supportive Care in Cancer
IS - 7
ER -