Biosimilars USA 2018 is a conference dedicated to biosimilar manufacturing and commercialization considerations specific to the United States.
Topics
- Different device design options
- Challenges to gaining the FDAs Interchangeability status
- The FDAs CMC finger print comparability that requires a minimum of 10 batches for statistical considerations
- Routes to take if your biosimilar has a better formulation and/or administration than the originator
- How to meet high GMP compliance when manufacturing outside of the US
- Whether more batches lead to better clinical trial outcomes
- How to get onto patient formularies, and the important role pharmacy benefit manages have in achieving this
- Whether the biosimilar industry can provide co-payments and other healthcare benefits to patients to successfully complete with originators
Who should Attend
Biosimilar experts and industry including:
- Scientific Directors
- Medical Directors
- Directors
- VP’s
- Team Leaders
- Managers
- Consultants
- Partners
- Attorneys
