Europe1 | In certain cases, it may be possible to extrapolate therapeutic similarity shown in one indication to other indications of the reference medicinal product. Case-by-case decision based on the ‘totality of evidence’. Possible safety issues in different subpopulations should also be addressed.
| Justification will depend on, for example, clinical experience, available literature data, whether or not the same mechanisms of action or the same receptor(s) are involved in all indications. |
Canada4 58 | Indication of a biosimilar must be the same as its reference product. Similarity must be demonstrated by comprehensive comparative characterisation. Type and design of trials using sensitive populations and end points must be capable of detecting changes in the end points chosen. Consider route of administration; posology and PK/PD profiles in each indication considered.
| Minor differences in active ingredients or mechanism of action. Differences in pathophysiology of the disease/s. Differences in clinical experience compared with reference drug.
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Australia59 | In certain cases, it may be possible to extrapolate therapeutic similarity shown in one indication to other indications of the reference medicinal product. Possible safety issues in different subpopulations should also be addressed.
| Justification will depend on, for example, clinical experience, available literature data, whether or not the same mechanisms of action or the same receptor(s) are involved in all indications. |
Japan5 33 | Extrapolation to the Japanese population should be justified according to the ICH guidelines. | Japanese guideline describes that it may be possible to extrapolate from one indication to other indications of the reference product if the mechanism of action is the same. |
USA28 | Use a study population and treatment regimen adequately sensitive. Sufficient scientific justification for each condition. Only for conditions of use previously licensed for the reference product. Demonstration requires detailed information regarding similar mechanism of action between biosimilar and reference product.
| Extrapolation based on totality of the evidence. |