At this time, it is difficult to predict when a generic PROVENGE medication might become available. Previously, regulations did not allow generic versions of biologics to be made. However, the regulations are currently changing to allow generic manufacturers to create biologic products that are similar to ones already approved by the FDA.
Despite the changing regulations, it is unlikely that a generic PROVENGE version will be available in the near future. PROVENGE was approved in April 2010 and will likely be protected by certain exclusivity rights for some time.
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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