Generic Drugs

November 13, 2019, 8:14 307

generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active chemical substance is the same, the medical profile of generics is believed to be equivalent in performance. A generic drug has the same active pharmaceutical ingredient (API) as the original, but it may differ in some characteristics such as the manufacturing process, formulationexcipients, colour, taste, and packaging.

Increasing the availability of generic drugs helps to create competition in the marketplace, which then helps to make treatment more affordable and increases access to healthcare for more patients.

The FDA's Office of Generic Drugs (OGD) within the Center for Drug Evaluation in Research ensures that people have access to safe, affordable generic drugs by following a rigorous review process that includes:

  • Managing the regulatory process to facilitate drug approvals,
  • Establishing science initiatives to research generic drugs,
  • Publishing data and reports on generic drug development and review, and
  • Offering educational materials and information.

Information about the generic drug review process, FDA standards and pricing, and answers to frequently asked questions 

Electronic submission forms, requirements, guidance, reports, and other resources to help facilitate generic drug applications and approvals

First-time generic drug approvals, generic drug application review metrics, and Generic Drugs Program reports

FDA generic drug regulatory science initiatives, research priorities and reports, public workshops, and opportunities for collaboration

Infographics, brochures, handouts, posters, presentations, PSAs, and articles about generic drugs for educators, health care professionals, and consumers#

Generic drugs must meet high standards to receive FDA approval

FDA requires drug companies to demonstrate that the generic medicine can be effectively substituted and provide the same clinical benefit as the brand-name medicine that it copies. The abbreviated new drug application (ANDA) submitted by drug companies must show the generic medicine is the same as the brand-name version in the following ways:

  • The active ingredient in the generic medicine is the same as in the brand-name drug/innovator drug.
  • The generic medicine has the same strength, use indications, form (such as a tablet or an injectable), and route of administration (such as oral or topical).
  • The inactive ingredients of the generic medicine are acceptable.
  • The generic medicine is manufactured under the same strict standards as the brand-name medicine.
  • The container in which the medicine will be shipped and sold is appropriate, and the label is the same as the brand-name medicine's label.

 

 

References:

1. https://www.fda.gov/drugs/buying-using-medicine-safely/generic-drugs

2. https://en.wikipedia.org/wiki/Generic_drug

3. https://www.fda.gov/drugs/generic-drugs/generic-drug-facts

 

By Garibli A.