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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...

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Autores principales: Aapro, Matti, Krendyukov, Andriy, Höbel, Nadja, Seidl, Andreas, Gascón, Pere
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2018
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.
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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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