Steps for Biosimilar local formulation project Phase 1: Commercial agreement & Feasibilities studies

Steps for Biosimilar local formulation project

Phase 1: Commercial agreement & Feasibilities studies

1. 
   Both parties sign the commercial agreement.
   
2. 
   Payment terms / installment of license fee etc.
   
3. 
   Feasibilities studies like:
   

1. 
   Transfer of Formulation manufacturing process documents by manufacturer
   
2. 
   Purchase and Delivery of Etanercept bulk solution for trail batch manufacturing by both sides.
   

• 
  Training of formulation manufacturing process (on site) by manufacturer small scale production.
  
• 
  Pilot scale production.
  
• 
  Commercial production.
  

Phase 2: Documents exchanges & support

1. 
   Transfer of CTD dossier and supporting documents by company.
   
2. 
   Mutual discussion and arrangement of Dossier by both sides.
   
3. 
   Dossier submission to FDA for triggering the Phase 3 comparative clinical study protocol approval for locally produced Etanercept by Zuma.
   

Phase 3 : Technology transfer on site & Implementation

• 
  Transfer of Formulation testing method by
  
• 
  List of analytical equipment and it’s availability by both side.
  
• 
  Analytical reagents confirmation (including reference standard)
  
• 
  Training for analytical method (On site).
  
• 
  Training of Method validation (On Site).
  

Phase 4 : registration & launch

1. 
   Conduct Phase 3 comparative clinical study of locally produced Etanercept by Zuma..
   
2. 
   Product approval and commercial launch..