Springer-Verlag
Paris
11523
1776-2596
1776-260X
Targeted Oncology
Targ Oncol
Medicine & Public Health
Oncology
Biomedicine general
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1
1
Special focus: Biosimilars
9
2012
3
1
2012
3
2012
Springer-Verlag
2012
Mario
Dicato
190
10.1007/s11523-011-0190-9
5
Presently available biosimilars in hematology-oncology: G-CSF
Review
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34
2011
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1
2011
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1
2011
8
1
2012
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19
The Author(s)
2012
Pere
Gascon
GASCON@clinic.ub.es
Division of Medical Oncology, Hospital Clinic, IDIBAPS
University of Barcelona
Barcelona
Spain
Abstract
Biopharmaceuticals were copies of endogenous human proteins developed in the mid-1990s that were characterized by complex three-dimensional, high-molecular weight compounds. What made them unique was that contrary to classical chemotherapeutical drugs, they were manufactured by living cells. One of these biopharmaceuticals was granulocyte-colony stimulating factor (G-CSF). Once their patent expired, generic versions appeared in pharmacies. They are now called biosimilars. There are several biosimilar G-CSFs approved in Europe: Biograstim®/Filgrastim ratiopharm/Ratiograstim®/Tevagrastim® (XM02); Zarzio® and Nivestim®. All these new products are manufactured in facilities with state-of-the-art technology. All products have passed the regulatory requirements for approval, mainly phase I and phase III, with the consequent PD/PK evaluations and studies on efficacy and safety. However, there are still some concerns regarding their long-term evaluation, in particular, the limited experience at the time of approval of these products in terms of efficacy, safety and immunogenicity. For this reason, pharmacovigilance should be rigorous. A lot of work remains to be done in terms of clarification with regard to substituting a biosimilar G-CSF for the innovator product and, finally, information must be provided to physicians, pharmacists and patients to allow for proper decision-making. Ultimately, only clinical trials and effective post-marketing pharmacovigilance will provide definitive evidence that a biosimilar is comparable to the originator-reference product in terms of efficacy and safety.
Keywords
Biosimilars G-CSF
Biograstim
Ratiograstim
Tevagrastim
Zarzio
Nivestim
This article is a reprint of Gascon P (2011) Presently available biosimilars in hematology-oncology—part II: G-CSFP. Oncologie 13(5):213–217
ftp_PUB_12-03-02_05-33-17.zip11523-2011-Article-190.pdfPDF1.4