Several laws and regulations currently prevent a generic version of Havrix (hepatitis A vaccine) from being produced. Other vaccines can be used to provide protection against hepatitis A, but these products are different brand-name drugs, not generics. These rules and regulations are expected to change in the near future, which means that generic versions of biologic medications like Havrix could become available.
Is a Generic Version of Havrix Available?Havrix® is one of a few different hepatitis A vaccines available. It is approved for use in children age 12 months and older, teens, and adults. It is given as two separate injections, with 6 to 12 months between doses.
Havrix is made by GlaxoSmithKline Biologicals. At this time, generic Havrix is not available. Other hepatitis A vaccines are available, but are actually different brand-name products; none of them are a generic version of Havrix.
Technically, Havrix is considered a "biologic" medication and, therefore, is under different rules and laws than most other medications. At this point, generic biologics, including generic Havrix, are not allowed to be made. However, the laws are changing, and it is likely that generic biologics will be permitted in the near future.
Understanding Biologics and GenericsWhen the patents for regular drugs expire, other manufacturers can apply to make generic versions. These companies need to submit a little information proving that their product is equivalent to the brand-name drug, but they do not have to repeat all of the human studies to 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 need all the human studies.
However, biologics (medications made using live cells or organisms, also known as "biopharmaceuticals") are regulated under a different set of laws. 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.
However, recent legislation is aimed at changing these laws. As a result, it is predicted that new laws and regulations will allow generic biologics in the not-too-distant future.