[PDF.33qn] Biosimilars: Design and Analysis of Follow-on Biologics (Chapman & Hall/CRC Biostatistics Series)

Biosimilars: Design and Analysis of Follow-on Biologics (Chapman & Hall/CRC Biostatistics Series)

[PDF.bp40] Biosimilars: Design and Analysis of Follow-on Biologics (Chapman & Hall/CRC Biostatistics Series)

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 | #2602896 in Books |  Chapman and Hall/CRC |  2013-07-29 | Original language:English | PDF # 1 |  9.21 x1.00 x6.14l,1.72 | File type: PDF | 444 pages

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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 manufacturing process and the structures of biosimilar products.

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