Generic Recombivax HB
At this time, Recombivax HB (hepatitis B vaccine) is not available in generic form. This is because the vaccine is considered a "biologic" medication. It is under special rules and laws that prevent generic versions from being made. However, these laws could be changing, making generic Recombivax HB available in the not-too-distant future.
Can I Buy Generic Recombivax HB?Recombivax HB® 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 two or three doses.
Recombivax HB is made by Merck & Co., Inc. There are no generic versions. Other hepatitis B vaccines are available, but they are actually different brand-name products; none can be considered a generic Recombivax HB.
Technically, Recombivax HB is considered a "biologic" medication and, therefore, is under different rules and laws than most other medications. At this point, generic biologics, including generic Recombivax HB, 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 that the drug is 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.