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Generic Infanrix

Infanrix is not available in generic form at this time. There are certain laws that currently prevent any generic versions of biologic medications (including vaccines) from being manufactured in the United States. Until these laws change, no generic Infanrix products will be available.

Is a Generic Version of Infanrix Available?

Infanrix® (DTaP) is a routine childhood vaccine that provides protection against diphtheria, tetanus, and whooping cough (pertussis). It is made by GlaxoSmithKline Biologicals.
 
There are currently no generic versions of Infanrix. Several other DTaP vaccines are on the market (some with just DTaP, some combined with other vaccines). However, none of them are technically equivalent to Infanrix, and none of them are generic vaccines.
 
Technically, Infanrix is considered a "biologic" medication and is, therefore, under different rules and laws than most other medications. At this point, generic biologics (including generic Infanrix) 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 Generic Vaccines

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 that show the drug to be safe and effective.

Human studies are expensive and time-consuming, and generic drugs are less expensive because they do not need all the human studies.
 
However, because vaccines are biologics (medications made using live cells or organisms, also known as "biopharmaceuticals"), they 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 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 in the near future.
 
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Infanrix Vaccine Information

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