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Development and 10-year history of a biosimilar: the example of Binocrit
by
Seidl, Andreas
, Gascón, Pere
, Krendyukov, Andriy
, Aapro, Matti
, Höbel, Nadja
in
Bioequivalence
/ Biological products
/ Oncology
/ Pharmacodynamics
/ Review
2018
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Development and 10-year history of a biosimilar: the example of Binocrit
by
Seidl, Andreas
, Gascón, Pere
, Krendyukov, Andriy
, Aapro, Matti
, Höbel, Nadja
in
Bioequivalence
/ Biological products
/ Oncology
/ Pharmacodynamics
/ Review
2018
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Development and 10-year history of a biosimilar: the example of Binocrit
Journal Article
Development and 10-year history of a biosimilar: the example of Binocrit
2018
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Overview
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.
Publisher
SAGE Publications,Sage Publications Ltd,SAGE Publishing
Subject
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