Because PedvaxHIB is a biologic medication, certain rules and regulations currently prevent a generic version from being produced. Legislation that is designed to change these laws means that a generic PedvaxHIB may be available in the near future. In the meantime, parents need to use either this or another Hib vaccine for their child.
Is a Generic Version of PedvaxHIB Available?PedvaxHIB® (Hib vaccine) is a vaccine that provides protection against Haemophilus influenzae type b, a bacterium that can cause life-threatening infections. PedvaxHIB is approved for use in children two months up to six years of age. Ideally, this vaccine is given as a three-part series, although in certain circumstances, fewer doses may be necessary.
PedvaxHIB is made by Merck & Co., Inc. There are no generic versions. Other Hib vaccines are separate brand-name drugs; they are not considered a generic PedvaxHIB.
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 PedvaxHIB, are not allowed to be made. However, the laws are changing, and it is likely that generic versions 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, and it is predicted that new laws and regulations will allow generic biologics in the near future, which would include generic PedvaxHIB.