Thursday, August 25, 2011

FDA realigns to support possible biosimilars change

Image Source: FDA
On August 15, the generics industry stuck a deal with the FDA that could expedite the approval process of generic drugs after fees are paid.  It is believed that first year fees could reach up to $299 million to speed up the review process which typically takes 2 1/2 years currently for approval.

The FDA Office of Generic Drugs has reported they are adding a second Division of Bioequivilance and a fourth Division of Chemistry.  Director Helen Winkle released the plans in a memo from the Office of Pharmaceutical Science.  According to Cutting Edge Information, they believe that the addition of a second Division of Bioequivilence could indicate that there has been an agreement reached after the initial Biologics Price Competition and Innovation Act passed Congress in 2009.

The Business of Biosimilars and Biobetters Conference will be addressing the abbreviated pathway  head on, with a panel of experts examining the pros and cons of paying for expediting the process of the approval of generics.

How do you feel about paying to expedite the review process?

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