HPV Home > Generic HPV Vaccine

There are currently no generic HPV vaccines available. Certain rules and laws prevent generic versions of "biologics" (such as these vaccines) from being produced. However, these laws are expected to change in the near future. Even so, exclusivity rights will probably keep generic versions of the vaccines from being sold any time soon.

Generic HPV Vaccine: An Overview

There are two different HPV vaccines. Gardasil® is a vaccine that has been licensed to prevent cervical cancer, anal cancer, vulvar and vaginal cancer, genital warts, and various precancerous genital lesions caused by certain types of human papillomavirus (HPV for short). Cervarix® is another HPV vaccine, approved for preventing cervical cancer and precancerous cervical lesions.
Gardasil is approved for use in males and females ages 9 to 26, while Cervarix is approved only for females age 9 through 25.
The Gardasil HPV vaccine is manufactured by Merck & Co., Inc. Cervarix is made by GlaxoSmithKline Biologicals. Technically, these vaccines are considered to be "biologic" products and are, 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.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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