In this Presentation:
- BPCIA Refresher
- FDA Developments - Purple Book, FDA Review of Applications, Draft Guidance, Abbott Petition
- The Naming Issue
- State Substitution Laws
- Excerpt from The FDA Draft Guidances:
Three of them released in 2012 – scientific considerations in demonstrating biosimilarity, quality considerations in demonstrating biosimilarity and Q and A regarding implementation (biosimilarity v. interchangeability, exclusivity and definition of a biological product).
- FDA intends to release final versions in 2014.
Please see Full Presentation below for more information.
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