There are currently no generic Prolia (denosumab) products available. "Biologic" medications, such as Prolia, are regulated by different laws and rules than most other medications. These laws prevent any generic versions of these medications from being manufactured in the United States. It is not clear when (or even if) generic versions of Prolia will ever be available.
Can I Buy Generic Prolia?Prolia® (denosumab) is an osteoporosis medication available only by prescription. It is a "monoclonal antibody" medication that is given as an injection twice a year.
Prolia is made by Amgen, Inc. Technically, as a monoclonal antibody, Prolia is considered a "biologic" medication and is, therefore, under different rules and laws than most other medications. At this point, generic biologics, including generic Prolia, are not allowed to be manufactured.
When Will Generic Prolia Be Available?This is a difficult question. Unless the laws and rules are changed, generic Prolia will never be available. However, it is likely that these rules and laws will be changed in the future.
Biologics and GenericsBiologics are products that are made using live cells or organisms. The cells or organisms are used to produce certain complex proteins or molecules that are used as medications, and such medications are known as "biologics" or "biopharmaceuticals."
When the patents for regular drugs expire, generic companies can apply to make generic versions. These companies need to submit information proving that their product is the same as the brand-name product, but they do not have to repeat all of the human studies to show the drug is safe and effective. Human studies are very expensive and time-consuming, and generic medications are less expensive because they do not need all the human studies.
However, biologics are governed by a different set of laws. Currently, under these laws, there is no way for a generic biologic to be approved, unless the generic manufacturer completes many of the human studies necessary to approve a brand-new drug. Because such studies are extremely expensive, it is likely that a generic biologic would not be any less expensive than the brand-name product.
Essentially, if a generic biologic were to be approved, it would not really be a generic, but a new and separate drug (that would not be equivalent to the brand-name product). Such products are known as "biosimilars."
Recently, there has been much interest in changing these laws, and it is possible that new laws may make conditions more favorable for producing biosimilar medications.