Arthritis Home > Generic Krystexxa
Because Krystexxa (pegloticase) is considered a "biologic" medication, it is subject to rules and laws that prevent any generic versions from being manufactured. It is likely that these laws will be changed in the future. However, because it is not known when these rules will be changed, it's impossible to estimate when a generic Krystexxa product could become available.
Is a Generic Version of Krystexxa Available?Krystexxa® (pegloticase) is a prescription medication approved for the treatment of gout. It is given intravenously (by IV), and its use is reserved for people who have not responded well to other gout medications.
Krystexxa is made by Savient Pharmaceuticals, Inc. Technically, Krystexxa is considered a "biologic" medication and is, therefore, under different rules and laws than most other medications. At this point, it is unclear when generic biologics, including generic Krystexxa, will be allowed to be manufactured.
When Will a Generic Version Be Available?This is a difficult question. Unless the laws and rules are changed, generic Krystexxa 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 the 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 drug, but they do not have to repeat all of the human studies to show that the drug is safe and effective. Human studies are very expensive and time-consuming, and generic medications are less expensive because they do not require all of the human studies.
However, biologics are governed by a different set of laws. Until recently, there was no way for a generic biologic to be approved unless the generic manufacturer completed many (if not most) of the studies necessary to approve a brand-new drug. This high cost made the possibility of generic biologics (also known as biosimilars) highly unlikely. However, recent changes in the law have set the framework for the possibility of approval of biosimilars with fewer requirements.
Although new laws have cleared a path for the possibility of generic biologics, there is still quite a bit of rulemaking to be done. However, even once all the official business of allowing generic biologics is completed, it is likely that Krystexxa will still be protected from generic competition by patents. It is not exactly clear when the patents expire, as the United States Food and Drug Administration (FDA) does not yet list applicable patents for biologics, as it does for other medications.