Hepatitis Home > Generic Engerix-B

Engerix-B (hepatitis B vaccine) is currently available as a brand-name drug only. Generic versions are not allowed to be made because Engerix is a "biologic" medication that is under different laws than other drugs. However, these laws likely are changing, and generic Engerix-B could become available in the future.

Can I Buy Generic Engerix-B?

Engerix-B® is one of a few available hepatitis B vaccines. It is approved for use in people of all ages and is given as a series of three doses, although sometimes a healthcare provider may recommend a fourth dose.
 
Engerix-B is made by GlaxoSmithKline Biologicals. There are no generic versions available.
 
Technically, Engerix-B is considered a "biologic" medication and, therefore, is under different rules and laws than most other medications. At this point, generic biologics, including generic Engerix-B, 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, 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.
 
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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