Biosimilars [Design Issues]

posted by Chiku – India, 2012-02-03 07:43 (4022 d 14:27 ago) – Posting: # 8043
Views: 4,380

Hi Vasu,

As far as FDA is concerned i am not able to find specific guideline for biosimiler. But from my very little experience i can say: u will require to have
1) Sameness
a) Bilogical sameness---PK/PD study either in Human or Animal model case by case basis
b) analytical sameness by Size exclusion, Elisa etc suitable method for structure elucidation depends on molecule charecteristics

2) Bioequivalence with PK end point

3) Immunogenesity if applicable


Regards

Chiku:)

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