Preparing for Biosimilar Carve Outs: Will Skinny Labelling Work for Biosimilars?
Axinn, Veltron & Harkrider LLP
Global Head of Litigation
Vishal C. Gupta
Steptoe & Johnson LLP
Hassen A. Sayeed
O’Melveny & Myers LLP
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?