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Handbook of Biogeneric Therapeutic Proteins : Regulatory, Manufacturing, Testing, and Patent Issues, EPUB eBook

Handbook of Biogeneric Therapeutic Proteins : Regulatory, Manufacturing, Testing, and Patent Issues EPUB

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More than 20 billion dollars worth of biopharmaceuticals are scheduled to go off-patent by 2006.

Given the strong political impetus and the development of technological tools that can answer the questions regulatory authorities may raise, it is inevitable that the FDA and EMEA will allow biogeneric or biosimilar products.

Even with all the regulato

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