Biosimilar Road Bump: Teva Filgrastim's Complete Response Shows Even Full BLAs Can Stumble
This article was originally published in The Pink Sheet Daily
FDA issued a complete response letter requesting "several items" from Teva to finish review of its biological license application.
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With 45 new molecular entities and novel biologics cleared in 2012, FDA approvals have reached a level not seen since the mid-1990s, the golden age of modern medicine. The group reflects a boom in oncology; other drug development trends like orphan diseases and personalized medicine held steady. Big pharma contributed just over a third of the 2012 class, with Pfizer regaining the lead with five novel approvals.
Teva is the first company to get FDA approval of a version of Amgen’s Neupogen; one biosimilar expert questions why Teva did not switch its BLA to a biosimilar application when that pathway became available.
Under a settlement with Amgen, Teva can begin selling its G-CSF product in November 2013; the launch may be sooner if a third party launches or wins an infringement suit.