At this time, generic versions of Hiberix are not allowed to be manufactured. This is the case with all vaccines, which are considered to be "biologic" medications (made using live cells or organisms). Current laws are changing, however, and a generic version of the vaccine could be permitted in the near future.
Is a Generic Version of Hiberix Available?
Hiberix® (Hib vaccine) is a booster vaccine that provides protection against Haemophilus influenzae type b, a type of bacteria that can cause life-threatening infections. Hiberix is approved as a booster vaccine for children ages 15 months through four years of age (before the fifth birthday).
Hiberix is made by GlaxoSmithKline Biologicals. There are currently no generic versions of Hiberix.
Technically, vaccines are considered to be "biologic" medications and are, therefore, under different rules and laws than most other medications. At this point, generic biologics (including generic Hiberix), 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.
Biologics and Generics
When 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 very 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 has aimed at changing these laws. It is predicted that new laws and regulations will allow generic biologics in the near future.