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- W2904682164 abstract "Over the last ten years, the development of biosimilars has transitioned from concept into approved products. The mechanisms of action of the molecules had been proven, clinical efficacy and safety profiles established, with large markets and sales margins, making them attractive targets for many biopharmaceutical companies, both large and small. However, inherent properties of the molecules result in higher levels of risk in the eyes of regulatory bodies. Therefore, a major component of the demonstration of biosimilarity is the thorough analytical characterization of the biosimilar in comparison to the reference product. The establishment of analytical biosimilarity can reduce the number of clinical studies required to support product approval." @default.
- W2904682164 created "2018-12-22" @default.
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- W2904682164 date "2018-01-01" @default.
- W2904682164 modified "2023-09-25" @default.
- W2904682164 title "QbD in Biopharmaceutical Manufacturing and Biosimilar Development" @default.
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- W2904682164 doi "https://doi.org/10.1007/978-3-319-99680-6_9" @default.
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