Revisiting Interchangeability: Does the Designation Benefit Biosimilars?

June 28, 2023 8:15am

Lawrence M. Brown Ph.D., J.D.
Associate General Counsel, Head of Legal (FUSION BioVenture)
Fosun Pharma USA Inc.

Tina Papagiannopoulos
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