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Presently available biosimilars in hematology-oncology: G-CSF

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...

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Detalles Bibliográficos
Autor principal: Gascon, Pere
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer-Verlag 2012
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3291849/
https://www.ncbi.nlm.nih.gov/pubmed/22258705
http://dx.doi.org/10.1007/s11523-011-0190-9
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author Gascon, Pere
author_facet Gascon, Pere
author_sort Gascon, Pere
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description 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.
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spelling pubmed-32918492012-03-21 Presently available biosimilars in hematology-oncology: G-CSF Gascon, Pere Target Oncol Review 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. Springer-Verlag 2012-01-19 2012 /pmc/articles/PMC3291849/ /pubmed/22258705 http://dx.doi.org/10.1007/s11523-011-0190-9 Text en © The Author(s) 2012 https://creativecommons.org/licenses/by-nc/4.0/ This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited.
spellingShingle Review
Gascon, Pere
Presently available biosimilars in hematology-oncology: G-CSF
title Presently available biosimilars in hematology-oncology: G-CSF
title_full Presently available biosimilars in hematology-oncology: G-CSF
title_fullStr Presently available biosimilars in hematology-oncology: G-CSF
title_full_unstemmed Presently available biosimilars in hematology-oncology: G-CSF
title_short Presently available biosimilars in hematology-oncology: G-CSF
title_sort presently available biosimilars in hematology-oncology: g-csf
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3291849/
https://www.ncbi.nlm.nih.gov/pubmed/22258705
http://dx.doi.org/10.1007/s11523-011-0190-9
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