Pneumovax (pneumococcal polysaccharide vaccine) is considered a "biologic" medication, which means that it is regulated somewhat differently than other drugs. Because of the rules and regulations surrounding the vaccine, generic versions of Pneumovax are not allowed to be made at this time. However, these laws are changing, possibly allowing for a generic version to be sold in the not-too-distant future.
Can I Buy Generic Pneumovax?Pneumovax® (pneumococcal polysaccharide vaccine) is a vaccine used to prevent pneumonia and other serious pneumococcal diseases. It is approved for use in people who are at least two years old.
Technically, Pneumovax is considered a "biologic" medication -- this means it is under different rules and laws than most other medications. At this point, generic biologics, including generic Pneumovax, 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 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. Recent legislation is aimed at changing these laws, and it is predicted that new laws and regulations will allow generic biologics in the near future.