๐”– Bobbio Scriptorium
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Assessing biosimilarity and interchangeability of biosimilar products

โœ Scribed by Chow, Shein-Chung


Book ID
118767162
Publisher
John Wiley and Sons
Year
2013
Tongue
English
Weight
53 KB
Volume
32
Category
Article
ISSN
0277-6715

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## Purpose To compare the quality of therapeutic erythropoietin (EPO) products, including two biosimilars, with respect to content, aggregation, isoform profile and potency. ## Methods Two original products, Eprex (epoetin alfa) and Dynepo (epoetin delta), and two biosimilar products, Binocrit (e

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## Abstract Biosimilar products are required by regulatory authorities to have appropriate and comparable quality, safety and efficacy with a reference biologic product. The analytical techniques that are available to manufacturers of biosimilar medicines are well advanced and present a range of op