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
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.. The access to the whole abstract and the presentation file is available to FIP members and to congress participants of that specific congress.