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

June 27, 2023 4:15pm

Aziz Burgy
Axinn, Veltron & Harkrider LLP

Mike Cottler
Global Head of Litigation

Vishal C. Gupta
Steptoe & Johnson LLP

Hassen A. Sayeed
O’Melveny & Myers LLP


J.C. Rozendaal
Sterne Kessler Goldstein & Fox

  • 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?