Bexxar (tositumomab) is classified by the FDA as a "biologic" medicine, which means that this drug is not allowed to be made in a generic form because it falls under a different set of laws and regulations than most other prescription medications. Although these laws are beginning to change, it is still uncertain when a generic Bexxar might be available.
Can I Buy Generic Bexxar?Bexxar® (tositumomab) is a prescription medication approved to treat certain people with non-Hodgkin's lymphoma, a type of blood cancer. It is reserved for use after other treatments have been unsuccessful. Bexxar belongs to a group of drugs called monoclonal antibodies.
Bexxar is made by GlaxoSmithKline. It is not available as a generic medication.
When Will a Generic Version Be Available?At this time, it is unclear when generic Bexxar will become available. This is because, like other monoclonal antibodies, Bexxar is considered a "biologic" medication. Examples of biologics include blood products, vaccines, enzymes, and certain medicines produced by biotechnology methods. Biologics are under different regulations than most other prescription medications, which have prevented the availability of generic forms of biologics.
Biologic products are medicinal products made using natural resources, such as human and animal cells or microorganisms. These cells or organisms are used to make a complex mixture of proteins or molecules. While other prescription medicines have known and reproducible chemical structures, most biologics are not so easily characterized because of their complexity. This can make it difficult for manufacturers to produce generic versions of biologics.
Previous regulations did not allow generic versions of biologics to be manufactured. Therefore, it was not possible to buy generic biologics. Recently, new laws have cleared the way for the possibility of generic biologics. However, there is still quite a bit of rulemaking to be done.
At this time, it is not entirely known when a generic version of Bexxar will be available. Even after the laws and regulations are changed to allow the manufacturing of generic biologics, it is likely that Bexxar will still be protected from generic competition by patents for several years.
Bexxar was approved by the U.S. Food and Drug Administration (FDA) in September 2003. It is not clear when the patents will expire, as the FDA does not yet list applicable patents for biologics like it does for other medications.