Challenges and Lessons Learned in the Regulatory Approval Process for Biosimilars

• In: Biosimilars for all: Research, regulation and responsible use on Thursday, 14 September 2017, 09:00-12:00
• At: Seoul (South Korea) (2017)
• 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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