Presently available biosimilars in hematology-oncology — Part II: G-CSF

Abstract Biopharmaceuticals were copies of endogenous human proteins developed in the mid-nineties that were characterized by complex three-dimensional, high-molecularweight compounds. What made them unique was that contrary to classical chemotherapeutical drugs, they were manufactured by living cel...
Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Gascon, P. [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2011

Schlagwörter:	Biosimilars G-CSF Biograstim Ratiograstim Tevagrastim Zarzio Nivestim

Übergeordnetes Werk:	Enthalten in: Oncologie - Paris : Springer France, 2004, 13(2011), 5 vom: Mai, Seite 213-217
Übergeordnetes Werk:	volume:13 ; year:2011 ; number:5 ; month:05 ; pages:213-217

Links:	Volltext

DOI / URN:	10.1007/s10269-011-2014-z

Katalog-ID:	SPR009300384

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allfields	10.1007/s10269-011-2014-z doi (DE-627)SPR009300384 (SPR)s10269-011-2014-z-e DE-627 ger DE-627 rakwb eng 610 ASE 610 ASE 44.81 bkl Gascon, P. verfasserin aut Presently available biosimilars in hematology-oncology — Part II: G-CSF 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Biopharmaceuticals were copies of endogenous human proteins developed in the mid-nineties that were characterized by complex three-dimensional, high-molecularweight 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 someconcerns 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. Biosimilars G-CSF (dpeaa)DE-He213 Biograstim (dpeaa)DE-He213 Ratiograstim (dpeaa)DE-He213 Tevagrastim (dpeaa)DE-He213 Zarzio (dpeaa)DE-He213 Nivestim (dpeaa)DE-He213 Enthalten in Oncologie Paris : Springer France, 2004 13(2011), 5 vom: Mai, Seite 213-217 (DE-627)38748213X (DE-600)2145843-1 1765-2839 nnns volume:13 year:2011 number:5 month:05 pages:213-217 https://dx.doi.org/10.1007/s10269-011-2014-z lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_120 GBV_ILN_151 GBV_ILN_161 GBV_ILN_206 GBV_ILN_267 GBV_ILN_293 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2055 GBV_ILN_2059 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 44.81 ASE AR 13 2011 5 05 213-217
spelling	10.1007/s10269-011-2014-z doi (DE-627)SPR009300384 (SPR)s10269-011-2014-z-e DE-627 ger DE-627 rakwb eng 610 ASE 610 ASE 44.81 bkl Gascon, P. verfasserin aut Presently available biosimilars in hematology-oncology — Part II: G-CSF 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Biopharmaceuticals were copies of endogenous human proteins developed in the mid-nineties that were characterized by complex three-dimensional, high-molecularweight 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 someconcerns 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. Biosimilars G-CSF (dpeaa)DE-He213 Biograstim (dpeaa)DE-He213 Ratiograstim (dpeaa)DE-He213 Tevagrastim (dpeaa)DE-He213 Zarzio (dpeaa)DE-He213 Nivestim (dpeaa)DE-He213 Enthalten in Oncologie Paris : Springer France, 2004 13(2011), 5 vom: Mai, Seite 213-217 (DE-627)38748213X (DE-600)2145843-1 1765-2839 nnns volume:13 year:2011 number:5 month:05 pages:213-217 https://dx.doi.org/10.1007/s10269-011-2014-z lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_120 GBV_ILN_151 GBV_ILN_161 GBV_ILN_206 GBV_ILN_267 GBV_ILN_293 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2055 GBV_ILN_2059 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 44.81 ASE AR 13 2011 5 05 213-217
allfields_unstemmed	10.1007/s10269-011-2014-z doi (DE-627)SPR009300384 (SPR)s10269-011-2014-z-e DE-627 ger DE-627 rakwb eng 610 ASE 610 ASE 44.81 bkl Gascon, P. verfasserin aut Presently available biosimilars in hematology-oncology — Part II: G-CSF 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Biopharmaceuticals were copies of endogenous human proteins developed in the mid-nineties that were characterized by complex three-dimensional, high-molecularweight 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 someconcerns 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. Biosimilars G-CSF (dpeaa)DE-He213 Biograstim (dpeaa)DE-He213 Ratiograstim (dpeaa)DE-He213 Tevagrastim (dpeaa)DE-He213 Zarzio (dpeaa)DE-He213 Nivestim (dpeaa)DE-He213 Enthalten in Oncologie Paris : Springer France, 2004 13(2011), 5 vom: Mai, Seite 213-217 (DE-627)38748213X (DE-600)2145843-1 1765-2839 nnns volume:13 year:2011 number:5 month:05 pages:213-217 https://dx.doi.org/10.1007/s10269-011-2014-z lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_120 GBV_ILN_151 GBV_ILN_161 GBV_ILN_206 GBV_ILN_267 GBV_ILN_293 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2055 GBV_ILN_2059 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 44.81 ASE AR 13 2011 5 05 213-217
allfieldsGer	10.1007/s10269-011-2014-z doi (DE-627)SPR009300384 (SPR)s10269-011-2014-z-e DE-627 ger DE-627 rakwb eng 610 ASE 610 ASE 44.81 bkl Gascon, P. verfasserin aut Presently available biosimilars in hematology-oncology — Part II: G-CSF 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Biopharmaceuticals were copies of endogenous human proteins developed in the mid-nineties that were characterized by complex three-dimensional, high-molecularweight 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 someconcerns 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. Biosimilars G-CSF (dpeaa)DE-He213 Biograstim (dpeaa)DE-He213 Ratiograstim (dpeaa)DE-He213 Tevagrastim (dpeaa)DE-He213 Zarzio (dpeaa)DE-He213 Nivestim (dpeaa)DE-He213 Enthalten in Oncologie Paris : Springer France, 2004 13(2011), 5 vom: Mai, Seite 213-217 (DE-627)38748213X (DE-600)2145843-1 1765-2839 nnns volume:13 year:2011 number:5 month:05 pages:213-217 https://dx.doi.org/10.1007/s10269-011-2014-z lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_120 GBV_ILN_151 GBV_ILN_161 GBV_ILN_206 GBV_ILN_267 GBV_ILN_293 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2055 GBV_ILN_2059 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 44.81 ASE AR 13 2011 5 05 213-217
allfieldsSound	10.1007/s10269-011-2014-z doi (DE-627)SPR009300384 (SPR)s10269-011-2014-z-e DE-627 ger DE-627 rakwb eng 610 ASE 610 ASE 44.81 bkl Gascon, P. verfasserin aut Presently available biosimilars in hematology-oncology — Part II: G-CSF 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Biopharmaceuticals were copies of endogenous human proteins developed in the mid-nineties that were characterized by complex three-dimensional, high-molecularweight 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 someconcerns 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. Biosimilars G-CSF (dpeaa)DE-He213 Biograstim (dpeaa)DE-He213 Ratiograstim (dpeaa)DE-He213 Tevagrastim (dpeaa)DE-He213 Zarzio (dpeaa)DE-He213 Nivestim (dpeaa)DE-He213 Enthalten in Oncologie Paris : Springer France, 2004 13(2011), 5 vom: Mai, Seite 213-217 (DE-627)38748213X (DE-600)2145843-1 1765-2839 nnns volume:13 year:2011 number:5 month:05 pages:213-217 https://dx.doi.org/10.1007/s10269-011-2014-z lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_120 GBV_ILN_151 GBV_ILN_161 GBV_ILN_206 GBV_ILN_267 GBV_ILN_293 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2055 GBV_ILN_2059 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 44.81 ASE AR 13 2011 5 05 213-217
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author	Gascon, P.
spellingShingle	Gascon, P. ddc 610 bkl 44.81 misc Biosimilars G-CSF misc Biograstim misc Ratiograstim misc Tevagrastim misc Zarzio misc Nivestim Presently available biosimilars in hematology-oncology — Part II: G-CSF
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topic_title	610 ASE 44.81 bkl Presently available biosimilars in hematology-oncology — Part II: G-CSF Biosimilars G-CSF (dpeaa)DE-He213 Biograstim (dpeaa)DE-He213 Ratiograstim (dpeaa)DE-He213 Tevagrastim (dpeaa)DE-He213 Zarzio (dpeaa)DE-He213 Nivestim (dpeaa)DE-He213
topic	ddc 610 bkl 44.81 misc Biosimilars G-CSF misc Biograstim misc Ratiograstim misc Tevagrastim misc Zarzio misc Nivestim
topic_unstemmed	ddc 610 bkl 44.81 misc Biosimilars G-CSF misc Biograstim misc Ratiograstim misc Tevagrastim misc Zarzio misc Nivestim
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title	Presently available biosimilars in hematology-oncology — Part II: G-CSF
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title_full	Presently available biosimilars in hematology-oncology — Part II: G-CSF
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title_sort	presently available biosimilars in hematology-oncology — part ii: g-csf
title_auth	Presently available biosimilars in hematology-oncology — Part II: G-CSF
abstract	Abstract Biopharmaceuticals were copies of endogenous human proteins developed in the mid-nineties that were characterized by complex three-dimensional, high-molecularweight 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 someconcerns 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.
abstractGer	Abstract Biopharmaceuticals were copies of endogenous human proteins developed in the mid-nineties that were characterized by complex three-dimensional, high-molecularweight 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 someconcerns 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.
abstract_unstemmed	Abstract Biopharmaceuticals were copies of endogenous human proteins developed in the mid-nineties that were characterized by complex three-dimensional, high-molecularweight 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 someconcerns 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.
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title_short	Presently available biosimilars in hematology-oncology — Part II: G-CSF
url	https://dx.doi.org/10.1007/s10269-011-2014-z
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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 someconcerns 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. 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Presently available biosimilars in hematology-oncology — Part II: G-CSF

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