Extrapolation of indications should occur with supporting evidence
- Extrapolation of indications should be allowed if scientifically justified
- A reference biologic product can be approved for several indications. A biosimilar product should be extrapolated to other indications of the reference product without having to duplicate trials if:
- a) High molecular similarity between the biosimilar and reference product has been demonstrated;
- b) the biosimilar has been shown to be of equivalent safety and efficacy to the reference product in one indication that is sensitive to demonstrating any potential differences;
- c) the indication for which the biosimilar has established equivalent safety and efficacy shares the same clinical mode-of-action with the indications for which the extrapolation is sought.
- Appropriate extrapolation under these circumstances prevents unnecessary duplication of clinical studies in humans and ensures economically sustainable development of biosimilars.