07/09/2018
What are generic drugs?
A generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. These similarities help to demonstrate bioequivalence, which means that a generic medicine works in the same way and provides the same clinical benefit as its brand-name version. In other words, you can take a generic medicine as an equal substitute for its brand-name counterpart.
Do generic medicines work the same as brand-name medicines?
Yes. Any generic medicine modeled after a brand-name medicine must perform the same in the body as the brand-name medicine. This standard applies to all generic medicines. A generic medicine is the same as a brand-name medicine in dosage, safety, effectiveness, strength, stability, and quality, as well as in the way it is taken and the way it should be used. Generic medicines use the same active ingredients as brand-name medicines and work the same way, so they have the same risks and benefits as the brand-name medicines. The FDA Generic Drugs Program conducts a rigorous review to make certain generic medicines meet these standards, in addition to conducting 3,500 inspections of manufacturing plants a year and monitoring drug safety after the generic medicine has been approved and brought to market.
It is important to note that there will always be a slight, but not medically important, level of natural variability—just as there is for one batch of brand-name medicine compared with the next batch of brand-name product. This variability can and does occur during manufacturing, for both brand-name and generic medicines. When a medicine, generic or brand-name, is mass produced, very small variations in purity, size, strength, and other parameters are permitted. FDA limits how much variability is acceptable.
For example, in a very large research study1comparing generics with brand-name medicines, it was found that there were very small differences (approximately 3.5%) in absorption into the body between generic and the brand-name medicines. Some generics were absorbed slightly more, some slightly less. This amount of difference is expected and acceptable, whether for one batch of brand-name medicine tested against another batch of the same brand, or for a generic tested against a brand-name medicine. As a rule, the difference for the generic-to-brand comparison was about the same as the brand-to-brand comparison.
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