In this Presentation:

- Agenda

- 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- FDA Developments - Purple Book, FDA Review of Applications, Draft Guidance, Abbott Petition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.