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

by Sarfaraz K. Niazi

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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
  • ISBN10 1420037935
  • ISBN13 9781420037937
  • Publish Date 15 August 2002 (first published 1 January 2002)
  • Publish Status Active
  • Publish Country US
  • Publisher Taylor & Francis Inc
  • Imprint CRC Press Inc
  • Format eBook
  • Pages 584
  • Language English