Biotech Values

[DewDiligence]

The other 2nd-line agents are pretty clearly somewhat superior efficacy-wise to Gleevec based on head-to-head trials. All that Gleevec has going for it is much more long-term data and greater familiarity by doctors. Nevertheless, once Gleevec goes generic, I expect most insurers to require Gleevec be tried first in some sort of step-therapy approach.

There’s an outside chance that Sprycel could be available as a generic in the US market around the same time as a Gleevec generic. An undisclosed party submitted a Sprycel ANDA and Paragraph-IV challenge in Jun 2011:

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm047676.htm