20 July 2022 - In draft guidance issued on Wednesday, the US FDA explains its approach to therapeutic equivalence evaluations and the assignment of therapeutic equivalence codes, which are listed in the agency’s Orange Book and provide information about whether drugs are bioequivalent and can be substituted for one another.

To be considered therapeutically equivalent to another drug, a product must be pharmaceutically equivalent, bioequivalent and have the same clinical effect and safety profile.

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