Friday, August 12, 2011

Biosimilars FDA Approval won't be "One Size Fits All"

As the FDA comes closer to releasing guidance on biosimilars, they've found that a "One Size Fits All" guidance won't work in this case.  They will find a way so that the evidence of the performance of the drug is weighted in order to assess whether or not the drug is safe for the market.  With the huge market that is sure to come from these drugs as soon as they are approved for use in the United States, expected to be a compound annual growth rate of 89.1% from 2009-2014 in the United States, many producers are waiting on ruling from the FDA.  Mass High Tech even goes as far as to say that that Americans will dominate the market by the end of that time frame in 2014.

There is one important part to the approval.  The law firm Ropes & Gray of Boston believes under the totality of evidence approach, animal and clinical studies will be required for the foreseeable future for approval of protein biosimilars, but the scope and extent of such studies may be reduced where detailed fingerprint-like characterization is used.  Much of this is due to the fact that the biosimilars aren't exact genetic copies of the drugs.

Suzanne Sensabaugh, MS, MBA, Founder and Member, HartmannWillner LLC will be joining Business of Biosimilars and Biobetters to look at the regulatory update for biosimilars. The event will take place September 19-21, 2011, in Boston, MA as a part of the Clinical Business Expo. For more information on the event and it speakers, download the brochure here.

Do you agree?  Should biosimlars approval be weighted on the findings from the manufacturer on a case by case basis?

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