Thursday, February 9, 2012

FDA Issue Guidance on Biosimilars

Biosimilars will continue to remain a difficult target, looking at the draft guidelines issued by the USFDA.
The biosimilar industry which is currently worth about $450m, may only continue to have a slow creep rate as FDA has set a considerably difficult path. The cost of developing a biosimilar would be in the range of $200m, keeping most of the generic players out of the race.
The bar for biosimilarity and interchangeability has also been raised. The biosmilars would have to do characterization, besides the animal tox and human PK/PD studies. The results from these studies would determine the size and scope of the clinical studies required. However the good news is that the clinical data generated in  any one indication, could be extrapolated for other indications.
The litigation process may be lengthy and costly, as the USFDA has stated the requirement to hand over their file to the originator upon submission.