As a "biologic" medicine, Xgeva is made using live cells. The current laws and regulations prevent companies from making generic versions of biologic drugs, including Xgeva. Generic versions, however, may be available at some point, as these laws are beginning to change.
Can I Buy Generic Xgeva?Xgeva® (denosumab) is a medication used to prevent bone problems in people who have cancer that has spread to the bones. It is given as a once-a-month injection.
Xgeva is made by Amgen, Inc. Technically, as a monoclonal antibody, Xgeva is considered a "biologic" medication, and is therefore under different rules and laws than most other medications. At this time, a generic version of Xgeva is not available.
Understanding Biologic ProductsBiologics are medications made using live cells or organisms. The living cells or organisms are used to produce complex proteins or molecules, which are then used to make medical products, such as medicines, vaccines, or blood products. Xgeva is a biologic because it is a laboratory-made version of a human antibody, made using genetically engineered Chinese hamster ovary cells.
Because biologics are made with living cells rather than created chemically like most other prescription medicines, it is not possible for a generic manufacturer to make an identical version of a brand-name biologic product already on the market. Therefore, in the past, regulations did not allow generic biologics to be made, and brand-name manufacturers were largely protected from generic competition.
However, it is possible for generic manufacturers to make products that are similar enough to brand-name biologics to have the same effects in the body. These equivalent generic biologic products are called "biosimilars" or "follow-on biologics." Regulations are currently changing that will pave the way for biosimilars to be available as generic versions of biologic medicines.