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Efficacy of Generics

Lab Technician Doing Inspections

Sensible and Effective Treatment Options

Generic medications go through a rigorous review process to receive FDA approval. The FDA ensures a generic medication provides the same clinical benefit and is as safe and effective as the brand-name medicine that it duplicates.1

What Are Generic Drugs?2

A generic drug is a medication created to be the same as an already marketed brand-name product in:

  • Dosage
  • Safety
  • Quality
  • Performance
  • Strength

 

  • A generic FDA-approved drug uses the same active ingredient, has the same intended use, and is taken the same way (oral, injection, patch, etc.) as its brand-name drug or version or product.
  • These similarities help to demonstrate that the generic medicine works in the same way and provides the same clinical benefit as the brand-name version. An approved AB generic medicine should be considered substitutable.
  • The FDA Generic Drugs Program conducts a thorough review to be sure generic medicines meet the standards mentioned above. In addition, it inspects 3,500 manufacturing plants a year and continues to monitor drug safety after the generic medicine is in the market.
  • When any product is mass produced, there can be a certain level of difference between the batches. This is true of both brand drugs and generic medicines. FDA defines how much variability is acceptable.
  • Even though generic medicines have the same therapeutic effect as the branded product, they are usually sold at a substantial discount (80-85% less). Generics are not required to invest in the upfront clinical research that the brand did to get approved. This results in a significant savings to consumers.

References

  1. FDA, Generic Drug Facts Handout https://www.fda.gov/media/107601/download (Opens in a New Window)
  2. Source: https://www.fda.gov/drugs/questions-answers/generic-drugs-questions-answers (Opens in a New Window)