Wednesday, July 6, 2011

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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1 comment :

Sanclayver Ara├║jo said...


The regulatory agencies such as ANVISA in Brazil, require clinical trials for every new presentation of a drug either generic or similar. When known drug seems to have another therapeutic action, it is needed to fill a NDA and all further regulatory requirements.
Specially biosimilars which have new processes of manufacturing, clinical trials become strategic to reinforce the effectiveness of the product.

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