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
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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. |
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- (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.
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- (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.
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- (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.
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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
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