Facts About Generic Drugs
What is a generic drug?
A generic drug is a medication that has exactly the same active ingredient as the brand-name drug, and works the same way. However, a generic drug can only be marketed after the brand-name drug's patent has expired, which may take many years after a brand name drug is first approved. Generic drugs are usually much less expensive than brand name drugs once they reach the market.
A generic drug is the same as a brand-name drug in:
- the way it works
- the way it is taken
- the way it should be used
A drug company develops new drugs as brand-name drugs under patent protection. This in turn protects the investment in the drug's development by giving the drug company the sole right to manufacture and sell the brand-name drug while the patent is in effect.
When patents or other periods of exclusivity expire, other manufacturers can submit an abbreviated new drug application (ANDA) to the FDA for approval to market a generic version of the brand-name drug.
Although generic drug active ingredients are chemically identical to their branded counterparts, they are typically sold at a cheaper price than the brand-name drug. This is because the generic drug manufacturer does not have to duplicate the original clinical trials for effectiveness and safety, which lowers the cost to bring the drug to market.
Are generic drugs as safe as brand-name drugs?
Yes. The FDA must first approve all generic drugs. The FDA requires that generic drugs must be as high in quality, and as strong, pure and stable as brand-name drugs. Generic drugs use the same active ingredients as brand-name drugs and work the same way. They have the same risks and the same benefits as the brand-name drugs.
If brand-name drugs and generic drugs have the same active ingredients, why do they look different?
In the United States, trademark laws do not allow generic drugs to look exactly like the brand-name drug. However, the generic drug must have the same active ingredients. Colors, flavors, and certain other additives may be different but the effectiveness of the drug remains the same.
Does every brand-name drug have a generic drug?
No. New drugs are developed under patent protection, and most drug patents are protected for 17 years giving the drug company the sole right to sell the brand-name drug during that time. When the patent get closer to expiration, other drug companies apply to the FDA for approval to start selling the generic version of the drug. A generic drug can be "tentatively approved" by the FDA prior to patent expiration for the reference brand product. Once the patent expires, the generic drug can then be sold. Multiple companies can manufacture and sell generic versions of the brand name product.
You can search for generic equivalents by using the "Electronic Orange Book" and search by proprietary "brand" name," then search again by using the active ingredient name. If other manufacturers are listed besides the "brand name" manufacturer when searching by the "active ingredient," they are the generic product manufacturers.
Since there is a lag time after generic products are approved and when they appear in the "Orange Book," you should also consult the most recent monthly approvals at Electronic Orange Book.
Is a biosimilar also a generic drug?
No, a biosimilar is not considered a “generic” in the same way that a traditional drug is determined to be a generic. A biosimilar is a biological product that is “highly similar” to a U.S.-licensed reference biological and which has no clinically meaningful differences between the biological product and the original branded product in terms of safety, purity, and potency of the product. The FDA approval process for biologics and biosimilars is somewhat different.
Biosimilars are similar -- but not exact copies of the active ingredients -- as with generics for small-molecule drugs. Under new laws enacted by the FDA, a biological product may be considered “biosimilar” if data show that the product is “highly similar” to an already-approved biological product. However, as with generics, cost savings for the healthcare system and the consumer will occur with biosimilars. Biosimilars that have been approved include Zarxio (filgrastim-sndz), a biosimilar for Neupogen; Inflectra (infliximab-dyyb), a biosimilar for Remicade; and Erelzi (etanercept-szzs), a biosimilar for Enbrel.
What is the best source of information about generic drugs?
Contact your doctor, pharmacist or other healthcare worker for information on your generic drugs. Be aware that your generic drug will not look like the brand name product, and may have a different shape and color.
For more information, you can also visit the FDA website at: http://www.fda.gov/Drugs/default.htm and click on Consumer.
Recommended for you
- Facts About Generic Drugs. US FDA Center for Drug Evaluation and Research. Accessed September 19, 2016 at http://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/UCM219406.pdf
- What are Generic Drugs? Office of Generic Drugs, US FDA Center for Drug Evaluation and Research. Accessed September 19, 2016 at http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/ucm144456.htm
- Information for Consumers (Biosimilars). Biological Products. US Food and Drug Association (FDA). Accessed September 19, 2016 at http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/ucm241718.htm