There are currently no generic versions of PROVENGE (sipuleucel-T) available. Because this drug is considered a "biologic" medication, it is regulated by different laws and rules than most other medications. These laws prevent any generic versions of biologics from being manufactured in the United States. It is not clear when (or even if) generic versions of this drug will ever be available.
PROVENGE is manufactured by Dendreon Corporation. It is considered a "biologic" medication by the U.S. Food and Drug Administration (FDA) and is, therefore, under different rules and regulations than most other prescription medications. Because it is a biologic medication, generic versions of PROVENGE cannot be made by other manufacturers.
What Is a Biologic Product?
Basically, a biologic product is a medication made using live cells or organisms. The cells or organisms are used to produce certain complex proteins or molecules that are then used as medications or vaccines. Biologic products include many different types of medicines, such as vaccines, blood products, and gene therapies. PROVENGE is considered a biologic product because it uses a person's own live immune cells in the treatment of prostate cancer.
The complexity of biologic products makes it difficult for generic manufacturers to make a product that is identical to the brand-name one. For this reason, generic biologics are sometimes called "biosimilars" or "follow-on biologics." Biosimilars are similar to biologic products already on the market.
Food and Drug Administration Web site. Vaccines, Blood and Biologics, Approved Products. PROVENGE. Available at: http://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm210012.htm. Accessed July 13, 2011.
Food and Drug Administration Web site. Vaccines, Blood and Biologics, Resources for Healthcare Providers. Available at: http://www.fda.gov/BiologicsBloodVaccines/ResourcesforYou/HealthcareProviders/default.htm. Access July 13, 2011.
Food and Drug Administration Web site. Vaccines, Blood and Biologics, Questions and Answers about PROVENGE. Available at: http://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm210037.htm. Accessed July 13, 2011.
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