Zevalin is made by Spectrum Pharmaceuticals, Inc. At this time, it is not available in generic form.
When Will a Generic Version Be Available?
Zevalin belongs to a group of medications known as monoclonal antibodies. Like other monoclonal antibodies, Zevalin is considered a "biologic" product. 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.
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 Zevalin will be available. Even after the laws and regulations are changed to allow the manufacturing of generic biologics, it is likely that Zevalin will still be protected from generic competition by patents for several years.
The medicine was approved by the U.S. Food and Drug Administration (FDA) in February 2002. 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.