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What are Biosimilars? How do they differ from generics?

Biosimilars are becoming more and more common in the United States. While only 1 to 2 percent of patients in the United States in 2015 were treated with specialty medications, these medications, which many are biologics, accounted for 38 percent of drug spending.1

With the high cost of biologic medications, both patients and providers should know a few facts about biosimilars.

What is a biologic?

What is a biosimilar?

How does a biosimilar differ from a generic drug?2

• Biosimilars are not generic drugs

• Generic drugs have identical active ingredients to the brand product and must demonstrate bioequivalence to the brand product

• Biosimilars must demonstrate high similarity to the reference product and that there are no clinically meaningful differences regarding safety and potency

Are biosimilars ‘interchangeable’ with the reference product?2

The FDA commissioner provides an update on biosimilar policy4

Once a biosimilar is approved and available for use, the Quartz Pharmacy and Therapeutics Committee reviews the evidence and determines the formulary status for each product.


References

1. Mulcahy AW, Hlavka JP, Case SR. Biosimilar cost savings in the United States: initial experience and future potential. Rand Health Q. 2018;7(4):3.
2. Food and Drug Administration, “Biosimilar and Interchangeable Products.” (accessed December 10, 2018), available at: Labeling for Biosimilar and Interchangeable Biosimilar Products | FDA
3. Food and Drug Administration, “What is a biosimilar?” (accessed December 10, 2018), available at: https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM585738.pdf
4. Food and Drug Administration, “Statement from FDA Commissioner Scott Gottlieb, M.D., on new actions advancing the agency’s biosimilars policy framework.” (accessed December 13, 2018), available at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628121.htm?utm_campaign=FDA%20issues%20two%20guidances%20and%20other%20documents%20related%20to%20the%20deemed%20to%20be%20a%20license&utm_medium=email&utm_source=Eloqua