Assessing biosimilarity and interchangeability of biosimilar products
โ 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
- DOI
- 10.1002/sim.5577
No coin nor oath required. For personal study only.
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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
## 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