9:15AM – 10:00AM
The Interchangeability Guidance, Recent Developments and Options for Seeking Approval of Interchangeable Biologics
Bruce Leicher, Sr. Vice President and General Counsel, MOMENTA PHARMACEUTICALS, INC.
- Overview of the FDA interchangeability guidance, its implementation, and impact other regulatory guidelines
- Discuss recent industry developments and activities
- Understand differences of the Biosimilar and Interchangeable Biologics Approval Pathway • Consider implications of interchangeability on naming, reimbursement, and substitution