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Development and 10-year history of a biosimilar: the example of Binocrit(®)
Patent expirations for several biological products have prompted the development of alternative versions, termed ‘biosimilars’, which have comparable quality, safety and efficacy to a licensed biological medicine (also referred to as the ‘reference’ medicine). The first biosimilars developed in onco...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
SAGE Publications
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5912267/ https://www.ncbi.nlm.nih.gov/pubmed/29707043 http://dx.doi.org/10.1177/1758835918768419 |
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author | Aapro, Matti Krendyukov, Andriy Höbel, Nadja Seidl, Andreas Gascón, Pere |
author_facet | Aapro, Matti Krendyukov, Andriy Höbel, Nadja Seidl, Andreas Gascón, Pere |
author_sort | Aapro, Matti |
collection | PubMed |
description | Patent expirations for several biological products have prompted the development of alternative versions, termed ‘biosimilars’, which have comparable quality, safety and efficacy to a licensed biological medicine (also referred to as the ‘reference’ medicine). The first biosimilars developed in oncology were the supportive-care agents filgrastim and epoetin. Binocrit(®) (HX575) is a biosimilar version of epoetin alfa, indicated in the oncology setting for the treatment of chemotherapy-induced anemia (CIA). The process for development and approval of Binocrit(®) as a biosimilar included extensive analytical characterization and comparison with the reference epoetin alfa. This was followed by a clinical development program comprising phase I pharmacokinetic/pharmacodynamic studies to show bioequivalence to the reference medicine and a confirmatory phase III study to confirm therapeutic effectiveness in CIA. Since its approval, Binocrit(®) has been extensively used and studied in real-world clinical practice. The accumulated data confirm that Binocrit(®) is an effective and well-tolerated option for the treatment of CIA in patients with cancer. |
format | Online Article Text |
id | pubmed-5912267 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | SAGE Publications |
record_format | MEDLINE/PubMed |
spelling | pubmed-59122672018-04-27 Development and 10-year history of a biosimilar: the example of Binocrit(®) Aapro, Matti Krendyukov, Andriy Höbel, Nadja Seidl, Andreas Gascón, Pere Ther Adv Med Oncol Review Patent expirations for several biological products have prompted the development of alternative versions, termed ‘biosimilars’, which have comparable quality, safety and efficacy to a licensed biological medicine (also referred to as the ‘reference’ medicine). The first biosimilars developed in oncology were the supportive-care agents filgrastim and epoetin. Binocrit(®) (HX575) is a biosimilar version of epoetin alfa, indicated in the oncology setting for the treatment of chemotherapy-induced anemia (CIA). The process for development and approval of Binocrit(®) as a biosimilar included extensive analytical characterization and comparison with the reference epoetin alfa. This was followed by a clinical development program comprising phase I pharmacokinetic/pharmacodynamic studies to show bioequivalence to the reference medicine and a confirmatory phase III study to confirm therapeutic effectiveness in CIA. Since its approval, Binocrit(®) has been extensively used and studied in real-world clinical practice. The accumulated data confirm that Binocrit(®) is an effective and well-tolerated option for the treatment of CIA in patients with cancer. SAGE Publications 2018-04-17 /pmc/articles/PMC5912267/ /pubmed/29707043 http://dx.doi.org/10.1177/1758835918768419 Text en © The Author(s), 2018 http://www.creativecommons.org/licenses/by-nc/4.0/ This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage). |
spellingShingle | Review Aapro, Matti Krendyukov, Andriy Höbel, Nadja Seidl, Andreas Gascón, Pere Development and 10-year history of a biosimilar: the example of Binocrit(®) |
title | Development and 10-year history of a biosimilar: the example of Binocrit(®) |
title_full | Development and 10-year history of a biosimilar: the example of Binocrit(®) |
title_fullStr | Development and 10-year history of a biosimilar: the example of Binocrit(®) |
title_full_unstemmed | Development and 10-year history of a biosimilar: the example of Binocrit(®) |
title_short | Development and 10-year history of a biosimilar: the example of Binocrit(®) |
title_sort | development and 10-year history of a biosimilar: the example of binocrit(®) |
topic | Review |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5912267/ https://www.ncbi.nlm.nih.gov/pubmed/29707043 http://dx.doi.org/10.1177/1758835918768419 |
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