Biosimilars and interchangeable biologics : strategic elements

Biosimilars and interchangeable biologics : strategic elements

Bibliographic Details
Main Author: Niazi, Sarfaraz , 1949- (Author)
Format: Book
Language:English
Published: Boca Raton, Florida : CRC Press c2016
Subjects:
Biosimilar Pharmaceuticals > Standards
Drug Approval
Drug Discovery > Standards
Drug Evaluation > Standards
Drug Industry > Standards
Table of Contents:
  • 1. Introduction to biosimilar and interchangeable products
  • 2. Intellectual property issues
  • 3. The EMA regulatory guidance
  • 4. EMA approved biosimilars
  • 5. The FDA regulatory guidance
  • 6. The ROW regulatory guidance
  • 7. US commercialization
  • 8. Global commercialization
  • 9. Quality and lifecycle management

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