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
Autor*in: |
Gascon, P. [verfasserIn] |
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Format: |
E-Artikel |
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Sprache: |
Englisch |
Erschienen: |
2011 |
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Übergeordnetes Werk: |
Enthalten in: Oncologie - Paris : Springer France, 2004, 13(2011), 5 vom: Mai, Seite 213-217 |
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Übergeordnetes Werk: |
volume:13 ; year:2011 ; number:5 ; month:05 ; pages:213-217 |
Links: |
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DOI / URN: |
10.1007/s10269-011-2014-z |
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Katalog-ID: |
SPR009300384 |
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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 |
language |
English |
source |
Enthalten in Oncologie 13(2011), 5 vom: Mai, Seite 213-217 volume:13 year:2011 number:5 month:05 pages:213-217 |
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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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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 |
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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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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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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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<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">SPR009300384</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230519094833.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">201005s2011 xx |||||o 00| ||eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1007/s10269-011-2014-z</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)SPR009300384</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(SPR)s10269-011-2014-z-e</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="082" ind1="0" ind2="4"><subfield code="a">610</subfield><subfield code="q">ASE</subfield></datafield><datafield tag="082" ind1="0" ind2="4"><subfield code="a">610</subfield><subfield code="q">ASE</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">44.81</subfield><subfield code="2">bkl</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Gascon, P.</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Presently available biosimilars in hematology-oncology — Part II: G-CSF</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2011</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">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. 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code="a">Nivestim</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="773" ind1="0" ind2="8"><subfield code="i">Enthalten in</subfield><subfield code="t">Oncologie</subfield><subfield code="d">Paris : Springer France, 2004</subfield><subfield code="g">13(2011), 5 vom: Mai, Seite 213-217</subfield><subfield code="w">(DE-627)38748213X</subfield><subfield code="w">(DE-600)2145843-1</subfield><subfield code="x">1765-2839</subfield><subfield code="7">nnns</subfield></datafield><datafield tag="773" ind1="1" ind2="8"><subfield code="g">volume:13</subfield><subfield code="g">year:2011</subfield><subfield code="g">number:5</subfield><subfield code="g">month:05</subfield><subfield code="g">pages:213-217</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">https://dx.doi.org/10.1007/s10269-011-2014-z</subfield><subfield code="z">lizenzpflichtig</subfield><subfield code="3">Volltext</subfield></datafield><datafield tag="912" ind1=" " ind2=" 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