Skin Cancer Home > Generic Proleukin

Because Proleukin (aldesleukin) is made using live cells, it is considered a biologic medicine. Current laws and regulations do not allow companies to make generic versions of biologic drugs, including Proleukin. Generic versions, however, may be available in the future, as these laws are beginning to change to allow companies to make a product that would be similar to a brand-name biologic drug.

Can I Buy Generic Proleukin?

Proleukin® (aldesleukin) is a prescription immunotherapy medication approved for the treatment of kidney cancer and skin cancer. It is used when the cancer has spread to other areas of the body (metastasized).
Proleukin is made by Prometheus Laboratories, Inc. As a biologic medication, Proleukin is under different rules and laws than most other prescription medicines. At this time, it is not available in generic form.

Understanding Biologic Products

Biologics are medications made using live cells or organisms. The living cells or organisms are used to produce complex proteins or molecules, which are then used to make medical products, such as medicines, vaccines, or blood products. Proleukin is a biologic because it is a laboratory-made version of a human protein known as interleukin-2. It is made from bacteria called Escherichia coli (E. coli).
Because biologics are made with living cells rather than created chemically like most other prescription medicines, it is not possible for a generic manufacturer to make an identical version of a brand-name biologic product already on the market. Therefore, in the past, regulations did not allow generic biologics to be made, and brand-name manufacturers were largely protected from generic competition.
However, it is possible for generic manufacturers to make products that are similar enough to brand-name biologics to have the same effects in the body. These equivalent generic biologic products are called "biosimilars" or "follow-on biologics." Regulations are currently changing that will pave the way for biosimilars to be available as generic versions of biologic medicines.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
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