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For innovator biologics, efficacy and safety must be demonstrated separately for each clinical indication. In contrast, biosimilar clinical trials are not required for all indications approved for the innovator biologic. Indication extrapolation is defined as approval of biosimilars for all indications of the innovator product even though the biosimilar may not have been studied in all indications.⁴² The molecular similarity is the key guiding principle for extrapolation to multiple indications; it is an important concept in biosimilar development and is permitted by regulatory agencies, provided it is scientifically justified.⁴³