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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Should biosimilars be required to go through clinical trials?

Biosimilars, while created to lower the cost of biologics, are not exact replicas of their original drugs they were created after. Due to their biological composition, side affects and treatments could be different, unlike the generics created for chemical drugs. This is exactly why the National Hemophilia Foundation is asking that clinical trials be a part of the approval process when clotting factors are involved.  Concerns from this community include the possibility of an infectious pathogen contaminating the cells or culture medium the biosimilars are produced in and potential immunogenicity, the ability to trigger an immune response. For those who have bleeding disorders, it is a great concern to change their medication, because the outcome is not known, and changing inhibitors and possible neutralization that could occur.  Hemaware reports that the patient population is clearly skeptical of potential biosimilars that will come out to treat their conditions.

At the Business of Biosimilars and Biobetters Conference during the full day symposium, there will be a discussion about the need of clinical trials between experts in the field.  To find out more about this session and the full program, download the brochure.  Business of Biosimilars and Biobetters will be taking place September 19-21, 2011, in Boston, MA; as a part of the Clinical Business Expo.

What do you think?  Should biosimilars be required to go through clinical trials before they are brought to market?  Or is there a need to have priorities on which biosimilars should go through clinical trials?

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Should biosimilars approvals require clinical trials?

A recent article at TheHill.com notes that there is no mandatory clinical trials for biosimilars. Could this have a direct impact on the ultimate safety and effectiveness of these new generic drugs? Just one impact could be the proper dosage associated in prescribing these drugs. What do you think? Could clinical trials benefit the effectiveness of biosimilars?

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