Biosimilars

Design and Analysis of Follow-on Biologics

By: Shein-Chung Chow

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eText | 29 July 2013 | Edition Number 1

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As many biological products face losing their patents in the next decade, the pharmaceutical industry needs an abbreviated regulatory pathway for approval of biosimilar drug products, which are cost-effective, follow-on/subsequent versions of the innovator's biologic products. But scientific challenges remain due to the complexity of both the manuf