Preparing for Biosimilar Carve Outs: Will Skinny Labelling Work for Biosimilars?

Director J.C. Rozendaal will moderate the panel “Preparing for Biosimilar Carve Outs: Will Skinny Labelling Work for Biosimilars?” at ACI’s 14th Summit on Biosimilars & Innovator Biologics in Boston, MA on Tuesday, June 27, 2023. This two-day event will bring together government, PTAB, and association leaders with in-house and outside counsel to discuss legal, regulatory, and commercial strategies for the innovator and biosimilars marketplace.

Panel Overview

• Balancing the cost savings resulting from lowered litigation risk with the loss of market opportunities resulting from a carve-out
  • How does this impact affordability to patients?
• Considering how the skinny label regime will work with biosimilar products that have interchangeable designation
• Considering whether the language of press releases, web pages and other marketing materials require more scrutiny
• Analyzing potential liability faced by insurers for placement of skinny label on formularies
• Whether carve-outs will add to the perception that the biosimilar product is different than and not as effective as the reference product
  • When will stakeholder education cross the line into potential evidence of inducement of off-label, infringing uses?