Part II: Market Entry and Commercialization

June 27, 2023 11:45am

Jonathan S. Caplan
Kramer Levin Naftalis & Frankel LLP

Honorable Teresa Rea
Crowell & Moring LLP
(Former Acting Director of the United States Patent and Trademark Office)

An approved biosimilar may not be profitable without the right market entry and commercialization plan. In part II, topics of discussion will include:

  • Timing market entry with data and market exclusivity expirations
  • Meeting manufacturing requirements once exclusivity is decided
  • Devising strategies for achieving preferred access with managed care plans
  • Managing stakeholder education
  • Reconciling post market and pharmacovigilance requirements
  • Mastering distribution and delivery across borders