A generic drug must be identical to the innovator drug in which characteristics?

• A. Dosage form
• B. Strength
• C. Route of administration
• D. All of the above

Answer: (D)

Therapeutic equivalence through bioequivalence means a generic must match the innovator in key aspects that determine how the drug is delivered and absorbed. It must have the same dosage form, so a tablet stays a tablet, a capsule stays a capsule, or a solution stays a solution. It must have the same strength, delivering the same amount of active ingredient per dose, to produce comparable systemic exposure. It must have the same route of administration, so the drug enters the body the same way, ensuring similar absorption and effect.

In practice, while inactive ingredients and manufacturing details can differ, these three characteristics need to be identical to establish interchangeability and ensure the generic produces the same therapeutic outcome. That’s why all of the above is the correct answer.