Pharmaceutical Alternatives

Pharmaceutical alternatives are Drug products in identical dosage forms that contain the same active ingredient(s), ie, the same salt or ester, are of the same dosage form, use the same route of administration, and are identical in strength or concentration (eg, chlordiazepoxide hydrochloride, 5-mg capsules). Pharmaceutically equivalent drug products are formulated to contain the same amount of active ingredient in the same dosage form and to meet the same or compendial or other applicable standards (ie, strength, quality, purity, and identity), but they may differ in characteristics such as shape, scoring configuration, release mechanisms, packaging, excipients (including colors, flavors, preservatives), expiration time, and, within

The concept of therapeutic equivalence, as used to develop the List, applies only to drug products containing the same active ingredient(s) and does not encompass a comparison of different therapeutic agents used for the same condition (e.g., propoxyphene hydrochloride vs. pentazocine hydrochloride for the treatment of pain). Any drug product in the List repackaged and/or distributed by other than the application holder is considered to be therapeutically equivalent to the application holder's drug product even if the application holder's drug product is single source or coded as non-equivalent (e.g., BN). Also, distributors or repackagers of an 1 application holder's drug product are considered to have the same code as the application holder. Therapeutic equivalence determinations are not made for unapproved, off-label indications. FDA considers drug products to be

A similar definition exists in the text “Approved Drug Products with Therapeutic Equivalence Evaluations” (Orange Book) published by the Food and Drug Administration (FDA) (3). While both the European Agency for the Evaluation of Medicinal Products (EMEA) and the FDA recognize the concept that pharmaceutical alternatives may be shown to be bioequivalent, the Orange Book (3) clearly states that only therapeutic equivalents that are pharmaceutical equivalents can be considered substitutable, whereas the EMEA states that either pharmaceutical equivalents or pharmaceutical alternatives may be considered as therapeutic equivalents provided that the excipients contained in the formulation do not impact on the safety and efficacy profile of the dosage form (2). Pharmaceutical equivalents are defined in the Orange Book (3) as drug products that contain the same active ingredient(s), are of the same dosage form, route of administration and are identical in strength or