Generic Epogen

Epogen, which is a "biologic" medication, is under a different set of rules and laws from most other drugs. Currently, these regulations prevent any generic Epogen products from being manufactured. It is expected that these rules and laws will change in the near future. Until this happens, however, generic Epogen will not be available.

Generic Epogen: An Overview

Epogen® (epoetin alfa) is a prescription medication used to treat anemia. It is part of a group of medications known as erythropoiesis-stimulating agents (ESAs). It is approved for the following uses:
 
  • Preventing the need for blood transfusions in people with anemia who are undergoing surgery
  • Treating anemia due to chronic kidney failure (renal failure)
  • Treating anemia caused by zidovudine (Retrovir®, Combivir®, Trizivir®), an HIV medication
  • Treating anemia caused by chemotherapy in people with cancer.
     
Epogen is made by Amgen, Inc. It is considered a "biologic" medication. Biologic medications are under different rules and laws from most other medications. At this point, generic biologics, including generic Epogen, are not allowed to be made.
 

Biologics and Generics

Biologics are products that are made using live cells or organisms. The cells or organisms are then used to produce certain complex proteins or molecules that are used as medications. These medications are known as "biologics" or "biopharmaceuticals." Epogen is considered a biologic medication because it is a manufactured version of a human protein (called erythropoietin) and is produced using live cells.
 
When the patents for regular drugs expire, drug companies can apply to make generic versions. These companies need to submit a little information proving that their product is the same as the brand-name version, but they do not have to repeat all of the human studies that show the drug to be safe and effective. Human studies are expensive and time-consuming, and generic medications are less expensive because they do not require all the human studies.
 
However, biologics are governed by a different set of laws. Currently, there is no way for a generic biologic to be approved under these laws, unless the manufacturer completes all of the human studies necessary to approve a brand-new drug. Because such studies are extremely expensive, it is likely that a generic biologic would not be any less expensive than the brand-name product. Essentially, if a generic biologic were to be approved, it would not really be a generic version, but a new and separate drug that would not be equivalent to the brand-name product.
 
Recently, there has been much interest in changing these laws, and it is likely that generic biologics will be allowed in the near future.
 
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Epogen Drug Information

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