Challenges and Lessons Learned in the Regulatory Approval Process for Biosimilars

  • At: 2017 FIP Congress in Seoul (South Korea)
  • Type: Presentation
  • By: SHAH, Vinod (ComCast, ., United States)
  • Co-author(s): Vinod Shah: VPS Consulting, LLC, North Potomax, United States
  • Abstract:

    There are two types of Complex Drug Products: Biological Drug Products and Non-Biological Drug Products (NBCD). The presentation will discuss both, but primarily focus on Biosimilar products. A biosimilar product is a biological product that is highly similar to the reference product not withstanding minor differences in clinically inactive

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