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Generic Gardasil

At this time, Gardasil is not available in generic form. Gardasil is a "biologic" product, which means that under current laws, generic versions are not permitted. Although the laws are changing, a generic version is not expected any time soon (as Gardasil is likely protected by exclusivity rights).

Generic for Gardasil: An Overview

Gardasil® (Quadrivalent Human Papillomavirus [Types 6, 11, 16, and 18] Recombinant Vaccine) is a vaccine that has been licensed to prevent cervical cancer, vulvar cancer, vaginal cancer, genital warts, and various precancerous genital lesions caused by certain types of human papillomavirus (HPV for short) in girls and women age 9 to 26. For boys and men age 9 to 26, it is approved for the prevention of genital warts. Recently, the vaccine was also approved to prevent anal cancer (as well as precancerous anal lesions) in males and females age 9 to 26.
 
Gardasil is manufactured by Merck & Co., Inc. Technically, Gardasil is considered to be a "biologic" product and is therefore under different rules and laws than most medications. Currently, the laws do not permit generic biologics. However, the laws are changing, and it is likely that generic biologics will be permitted in the near future.
 

Biologics and Generics

Biologics are products that are made using live cells or organisms. The cells or organisms are used to produce certain complex proteins or molecules that are used as medications or vaccines. These products are known as "biologics" or "biopharmaceuticals."
 
Currently, biologics are governed by a different set of laws, compared to most medications. 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 has 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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Gardasil Vaccine

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