NULOJIX (belatacept) is a "biologic" medication and falls under a different set of rules and laws than most other drugs. As this time, these regulations prevent any generic NULOJIX products from being manufactured. It is expected that these rules and laws will change in the near future. Until this happens, however, generic versions of NULOJIX will not be available.
Can I Buy Generic NULOJIX?NULOJIX® (belatacept) is a prescription medication used in combination with other medicines to prevent kidney transplant rejection. It is given as an injection into a vein (an intravenous, or IV, injection).
NULOJIX is manufactured by Bristol-Myers Squibb Company. It is considered a "biologic" medication by the U.S. Food and Drug Administration (FDA) and is, therefore, under different rules and regulations than most other prescription medications. Because it is a biologic medication, generic versions of NULOJIX cannot be made by other manufacturers.
What Is a Biologic?Biologics are medications that are made by using live cells or organisms. The living cells or organisms are used to produce certain complex proteins or molecules, which are then used to make medications or vaccines. Biologic products include many different types of medicines, such as vaccines, blood products, and gene therapies.
Because biologics are so complex, it can be difficult for a generic manufacturer to make an identical version of a biologic product already on the market. For this reason, generic biologics are sometimes called "biosimilars" or "follow-on biologics." Biosimilars are similar to, but not considered exactly the same, as certain brand-name biologic products.
When Will Generic NULOJIX Be Available?At this time, it is difficult to predict when a generic NULOJIX medication will become available. Previously, regulations did not allow generic biologic versions to be made. However, the regulations are currently changing to allow generic manufacturers to create biologic products that are similar to ones already approved by the FDA.
Despite the changing regulations, it is unlikely that a generic NULOJIX version will be available in the near future. NULOJIX was approved in June 2011, and will likely be protected by certain exclusivity rights for some time.