At this time, generic Procrit is not available. Procrit is a "biologic" medication that is under different rules and laws from most other drugs. These rules prevent a generic version of the medication from being manufactured. Unless the laws and rules are changed, generic Procrit products may never be available; however, it is expected that these regulations will change in the future.
Generic Procrit: An Overview
Procrit® (epoetin alfa) is a prescription medication used to treat anemia. It is approved to treat anemia caused by a variety of factors. It is part of a group of medications known as erythropoiesis-stimulating agents (ESAs).
Procrit is made by Amgen, Inc. and is marketed by Ortho Biotech Products. Procrit is considered to be a "biologic" medication. Biologic medications are under different rules and laws from most other medications. At this point, generic biologics (including generic Procrit) are not allowed to be made.
Biologics and Generic Medications
Biologics are products that are made using live cells or organisms. The cells or organisms are used to produce certain complex proteins or molecules that are then used as medications, and the medications are known as "biologics" or "biopharmaceuticals." Procrit is considered a biologic medication because it is a manufactured version of a human protein 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.