USA – FDA offers new guidance on therapeutic equivalence evaluations

In draft guidance issued on Wednesday, the US Food and Drug Administration (FDA) explains its approach to therapeutic equivalence (TE) evaluations and the assignment of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.

“Therapeutic equivalence evaluation have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education in the area of drug product selection and to foster containment of health care costs,” FDA writes.

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

FDA explains that two- or three-character TE codes are assigned to multi-source drug products “to allow users to determine quickly whether the Agency has evaluated a particular approved drug product as therapeutically equivalent to another approved pharmaceutically equivalent drug product.”…