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Generic ActHIB

At this time, generic ActHIB is not available. This childhood vaccination is a biologic medication, and specific regulations and laws prohibit the production of generic biologics. If legislation is passed that changes these rules and laws, generic versions can be manufactured.

Is a Generic Version of ActHIB Available?

ActHIB® (Hib vaccine) is a vaccine that provides protection against Haemophilus influenzae type b, a type of bacteria that can cause life-threatening infections. ActHIB is approved for use in children two months through five years of age. Typically, this vaccine is given as a four-part series, although in certain circumstances, fewer doses may be necessary.
ActHIB is made by Sanofi Pasteur, Inc. There are no generic versions of ActHIB.
Technically, vaccines are considered "biologic" medications and, therefore, are under different rules and laws than most other medications. At this point, generic biologics, including generic ActHIB, 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 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 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 version, 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. It is predicted that new laws and regulations will allow generic biologics to be made in the near future.
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ActHIB Vaccine Information

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