Cancer Home > Generic Ontak

Ontak (denileukin diftitox) is a type of "biologic" medicine, meaning it is made using living cells, and is classified under a different set of regulations than most other prescription drugs. These laws currently prevent any generic biologic products, including Ontak, from being manufactured. However, these laws are beginning to change, and a company may be able to manufacture a generic Ontak eventually.

Can I Buy Generic Ontak?

Ontak® (denileukin diftitox) is a prescription medication approved to treat cutaneous T-cell lymphoma, a type of non-Hodgkin's lymphoma that affects the skin. It is given as a slow injection into a vein (an intravenous, or IV, infusion).
Ontak is made by Eisai, Inc. It is considered a "biologic" medicine. Biologic medicines are under different laws and regulations than most other prescription medications. As a biologic, Ontak is largely protected from generic competition, and there are no generic versions currently available. However, this is likely to change in the near future.

Understanding Biologic Medications

Biologics are medications made with living cells or organisms. These living cells or organisms are used to produce complex proteins or molecules, which are then used as the basis for medical products, such as medicines, vaccines, or blood products. Ontak is a protein made by genetically combining parts of the diphtheria toxin with a human protein known as interleukin-2.
Because biologics are made with living cells instead of chemically created like most other prescription medicines, it is not possible for a generic manufacturer to make an identical version of a biologic product already on the market. Therefore, generic biologics are sometimes called "biosimilars" or "follow-on biologics." Biosimilars or follow-on biologics are not considered identical to the currently approved brand-name product, but are similar enough to be safely substituted for it.
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Last reviewed by: Kristi Monson, PharmD;
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