Pharmaceuticals
Biosimilar Development Process
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Biosimilar Development Process

Explore the intricate process of developing biosimilars, from identifying target molecules to initiating commercial production and establishing pharmacovigilance.
1
Identify target biosimilar
2
Analyze reference product characteristics
3
Develop biosimilar molecule
4
Perform comparative analytical characterization
5
Conduct pre-clinical studies
6
Approval: Pre-Clinical Studies Results
7
Commence Phase I Clinical Trial
8
Evaluate Phase I Trial Data
9
Approval: Phase I Trial
10
Commence Phase II Clinical Trial
11
Evaluate Phase II Trial Data
12
Approval: Phase II Trial
13
Commence Phase III Clinical Trial
14
Evaluate Phase III Trial Data
15
Approval: Phase III Trial
16
Prepare and submit Biologics License Application
17
Approval: Regulatory Authority
18
Plan and initiate commercial manufacturing
19
Establish pharmacovigilance program