Revisiting Interchangeability: Does the Designation Benefit Biosimilars?
Lawrence M. Brown Ph.D., J.D.
Associate General Counsel, Head of Legal (FUSION BioVenture)
Fosun Pharma USA Inc.
Foley Hoag LLP
- Balancing the cost of procuring and providing additional information to obtain an interchangeable designation against the one-year exclusivity
- Will the interchangeable designation hold competitors at bay, or set off a new race for all contenders in the biosimilar space to obtain interchangeable status?
- Analyzing whether interchangeable designation will sufficiently offset the costs of developing the product and ongoing patent litigation?
- Understanding the nature and type of information needed to support a post-approval manufacturing change for a licensed biosimilar product