At this time, generic Zostavax products are not allowed to be manufactured. Zostavax is a "biologic" medication that is under different rules and laws than most other drugs; these laws require generic manufacturers to complete all of the human studies necessary to approve a brand-new drug. Unless these human studies (which are very expensive) are completed, a generic Zostavax cannot be manufactured.
Generic Zostavax: An Overview
Zostavax® (shingles vaccine) is a vaccine used in the prevention of shingles. It is approved for use in people 50 years old and older.
Currently, Zostavax is made by Merck & Co., Inc. Technically, Zostavax 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 Zostavax, are not allowed to be made.
When Will Generic Zostavax Be Available?
This is a difficult question. Unless the laws and rules are changed, generic Zostavax may never be available. However, it is likely that these rules and laws will be changed in the future.
Biologics and Generics
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." Zostavax is considered to be a biologic because it contains a live virus.
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 version, 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, there is no way for a generic biologic to be approved under these laws, 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.