Generic Prevnar 13
Because Prevnar 13 (pneumococcal conjugate vaccine) is considered a "biologic" medication, it is regulated somewhat differently than other drugs. The rules and regulations surrounding the vaccine do not permit generic versions of Prevnar 13 to be made at this time. However, it is predicted that these laws will be changing in the near future, possibly allowing for a generic version to be sold.
Prevnar 13® (pneumococcal conjugate vaccine) is a vaccine given routinely to infants and toddlers. It provides protection against 13 different types of Streptococcus pneumoniae bacteria that can cause meningitis, bloodstream infections, pneumonia, and ear infections. It is a "new-and-improved" version of Prevnar, which provided protection against only seven types of the bacteria. Prevnar 13 is also approved to prevent pneumonia and other serious pneumococcal diseases in adults over the age of 50.
Prevnar 13 is made by Wyeth Pharmaceuticals, Inc. Technically, Prevnar 13 is considered a "biologic" medication, and is, therefore, under different rules and laws than most other medications. At this time, generic biologics, including generic Prevnar 13, 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.
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, and the medications are known as "biologics" or "biopharmaceuticals."
When the patents for regular drugs expire, companies can apply to make generic versions. These companies need to submit a little information proving that their product is the same as the brand-name version, 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.
Currently, biologics are governed by 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 has aimed at changing these laws. It is predicted that new laws and regulations will allow generic biologics -- including generic Prevnar 13 -- in the near future.