Bioequivalence and Bioavailability Forum • Biosimilars

Biosimilars [Design Issues]

posted by Chiku – India, 2012-02-03 07:43 (4901 d 16:40 ago) – Posting: # 8043
Views: 6,813

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:)

Complete thread:

Biosimilars M.Vasu 2011-11-24 14:01 [Design Issues]
- Biosimilars Helmut 2011-11-24 14:44
  - Biosimilars M.Vasu 2011-11-28 12:33
    - Healthy subjects vs. patients Helmut 2011-11-28 12:56
    - Biosimilars drgunasakaran1 2012-02-06 13:57
  - Biosimilars Ben 2011-12-16 19:04
- BiosimilarsChiku 2012-02-03 06:43
  - Biosimilars drgunasakaran1 2012-02-10 11:33
    - Biosimilars Chiku 2012-02-10 12:03
      - Biosimilars Kumarnaidu2 2021-10-22 07:53