Biosimilars USA 2018

Biosimilars USA 2018 is a conference dedicated to biosimilar manufacturing and commercialization considerations specific to the United States.

Key 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