Generic Simulect

Simulect (basiliximab) is a "biologic" medicine and is classified under a different set of laws and regulations than most other prescription drugs. These regulations currently prevent any generic biologic products, including Simulect, from being manufactured. It is expected that these rules and laws will change in the near future. However, until these laws change, generic Simulect is not likely to be available.

Can I Buy Generic Simulect?

Simulect® (basiliximab) is a prescription medication used in combination with other medicines to prevent kidney transplant rejection. It belongs to a group of medicines known as monoclonal antibodies.
 
Simulect is manufactured by Novartis Pharmaceuticals Corporation. 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 Simulect cannot be made by other manufacturers.
 

What Is a Biologic?

Biologics are medications made 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. Simulect is a biologic because it is a manufactured version of a human protein.
 
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.
 
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Written by/reviewed by: Susan Lakey, PharmD, MPH, BCPP
Last reviewed by: Kristi Monson, PharmD
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