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Generic Cervarix

Cervarix (Human Papillomavirus Bivalent [Types 16 and 18] Vaccine, Recombinant) is available in brand-name form only. The vaccine is considered a "biologic" medication, which means certain laws prevent any generic versions of Cervarix from being made. Although another HPV vaccine is available, it is not interchangeable with Cervarix.

Can I Buy Generic Cervarix?

Cervarix® (Human Papillomavirus Bivalent [Types 16 and 18] Vaccine, Recombinant) is a vaccine that has been licensed to prevent cervical cancer (as well as precancerous cervical lesions) caused by certain types of human papillomavirus (HPV for short). It is approved for use in girls and women ages 9 through 25.
 
Cervarix is made by GlaxoSmithKline Biologicals. There are no generic versions of Cervarix. The other HPV vaccine available (Gardasil®) is not interchangeable with Cervarix.
 
Technically, Cervarix is considered a "biologic" medication and is, therefore, under different rules and laws than most other medications. At this point, generic biologics, including generic Cervarix, 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 of 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 not-too-distant future.
 
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Cervarix Vaccine Information

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