Generic Avonex: An Overview
Avonex is made by Biogen Idec. Technically, Avonex is considered to be a "biologic" medication and is, therefore, under different rules and laws than most other medications. At this point, generic biologics, including generic Avonex, are not allowed to be made.
When Will Generic Avonex Be Available?
This is a difficult question to answer. Unless the laws and rules are changed, generic Avonex may never be available. However, it is likely that these rules and laws will be changed in the future.
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 used as medications, and the medications are known as "biologics" or "biopharmaceuticals." Avonex is considered to be a biologic because it is identical to a human glycoprotein and is made in Chinese hamster ovary cells.
When the patents for regular drugs expire, generic 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, but they do not have to repeat all of the human studies to show the drug to be safe and effective. Human studies are very expensive and time consuming, and generic medications are less expensive because they do not need all the human studies.
However, biologics are governed by a different set of laws. Currently, under these laws, there is no way for a generic biologic to be approved, unless the generic 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, 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.
