| 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.
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▸ 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. |