Generic Drug: How FDA Defines a Generic | Dose Track
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Generic drug

Also called generic, generic medicine, ANDA · Reviewed

Definition: A generic drug is an FDA-approved copy of a brand-name drug. FDA requires it to have the same active ingredient, strength, dosage form and route as the brand, to be bioequivalent to it, and to have the same label with certain exceptions. FDA says generics have the same benefits and risks.

What FDA requires

FDA says a generic applicant must show the medicine is the same as the brand in these ways:

  • the same active ingredient;
  • the same strength, dosage form (such as a tablet or an injectable) and route (such as oral or topical);
  • made under the same manufacturing standards;
  • the same label as the brand, with certain exceptions;
  • bioequivalent to the brand, which means it gets into the body in a matching way (see bioavailability).

Why generics cost less

FDA explains that generic makers do not repeat the animal and human studies the brand needed to prove safety and effectiveness, and that several generics often compete for the same product. FDA cites price drops of about 30% with one generic competitor and nearly 85% with five.

What is not a generic

A copy of a biologic medicine, such as a protein made in living cells, is called a biosimilar, not a generic. A compounded drug is not a generic either: it is made by a pharmacy for a patient and is not FDA-approved (see 503A vs 503B). Some site comparisons, such as glimepiride, cover a generic label directly.

Read more on Dose Track: Glimepiride side effects · Compounded vs brand semaglutide

General education drawn from labels and published studies, not personal medical advice. Your prescriber, pharmacist and the label that came with your product are the final word.
BiosimilarA biosimilar is a biologic medicine that is highly similar to a biologic FDA has already approved, called… BioavailabilityBioavailability is how much of a dose, and how fast, gets absorbed into the body where it can act. The FDA… Prescribing informationPrescribing information is the FDA-approved label for a prescription drug, written mainly for health care… 503A vs 503B503A and 503B are two sections of US drug law that set the rules for compounding. A 503A pharmacy…

Frequently asked questions

Does a generic work the same as the brand?+
FDA says approved generics work the same way and provide the same clinical benefit and risks as their brand-name counterparts.
Is compounded semaglutide a generic?+
No. A generic is FDA-approved as the same as the brand. A compounded drug is made by a pharmacy and is not FDA-approved.

Sources

  1. FDA: Generic drug facts
  2. Glimepiride tablets US prescribing information, DailyMed

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