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[영문] Vol. 61 (August 7, 2017)
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한국바이오의약품협회 뉴스레터 영문 테스트파일
 

Announcement on the ways to manage approval items of biosimilars

Process of change in biosimilar approval

 
  • In case where there is change in license of reference product

 
Applicable scope

For following cases where there is change in license of reference product

  • Change in precautions in use of reference product
  • Change in indication and dosage and administration of reference product
Method of application Incorporate the changes related to reference product into approval items of biosimilar.
Procedures Classify and handle the case based on the type of changes in approval items of reference products.
 
  • (Addition of safety information) Notify the changes in reference product and ask the biosimilar approval holder to take required additional action.
    * Biopharmaceutical Quality Management Division and Biopharmaceuticals Review Management Division -> Approval holder of the biosimilar.
 
  • (Handling of the re-examination result) Incorporate the result of re-examination on reference product, announce the relevant information to biosimilar approval holder and order the change in approval items.
    *Handling all matters by Biopharmaceutical Quality Management Division / no additional actions required to be taken by biosimilar approval holder.
 
  • (Approval change in indication and dosage and indication) Allow the change after the relevant information on changed items when a biosimilar approval holder applies for approval for the change.
Related to review

Classified as the items necessary for effectiveness of safety as the approval change is related to indication, dosage and administration, and precautions in use

  • Submit reasonable evidence related to application for product approval change
    * Article 3.2 of the regulation on approval and review of biological products

 
  • If safety information is added after the launch of biosimilar
 
Applicable scope In case where safety information is added for reasons including the result of re-examination
Method of application For information included in the approval items, separate the information for biosimilar from information for reference product.
Procedures Notify the result of re-examination and handle approval for changes in license after reviewing the information when re-examination result of biosimilar is requested
*Same procedures as existing re-examination process and approval change process
Related to review (re-review) Submit appropriate document suitable for re-examination application
  (Approval change) Classified as item necessary to review the effectiveness of safety requiring submission of reasonable evidence related to the application. It is the approval for change in cautions
 


 
 
     
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