Because Yervoy (ipilimumab) is a "biologic" medication, it falls under a different set of rules and laws from most other prescription medicines. At this time, these regulations prevent any generic Yervoy products from being manufactured. It is expected that these rules and laws will change in the near future. Until this happens, however, generic versions will not be available.
Can I Buy Generic Yervoy?
Yervoy™ (ipilimumab) is a prescription medication used to treat late-stage melanoma, a type of skin cancer. It belongs to a group of medications known as monoclonal antibodies.
Yervoy is manufactured by Bristol-Myers Squibb Company. It is considered a "biologic" 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 therapy, generic versions of Yervoy cannot be made by other manufacturers.
What Is a Biologic?
Biologics are medications made using living cells or organisms. The living cells or organisms are used to make complex mixtures of proteins or molecules, which are then used to make medications or vaccines. Yervoy is a form of a human antibody. It is grown in the ovary cells of Chinese hamsters.
Biologic products include many different types of medicines, such as vaccines, blood products, and gene therapies. Because they are so complex, it can be difficult for a generic manufacturer to make an identical version of the product.
For this reason, generic biologics are sometimes called "biosimilars" or "follow-on biologics." Biosimilars or follow-on biologics have similar properties to the existing biologic product, but are not considered identical to the existing biologic product.
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 November 4, 2011.
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