There are currently no generic Boostrix products available. "Biologic" medications such as Boostrix are regulated by different laws and rules than most other medications. These laws prevent any generic versions of these medications from being manufactured in the United States. It is not clear when (or even if) generic versions of the Boostrix vaccine will ever be available.
Is a Generic Version of Boostrix Available?Boostrix® (Tdap vaccine) is a booster vaccine designed to provide protection from diphtheria, tetanus, and pertussis (whooping cough) for adolescents and adults.
The medication is made by GlaxoSmithKline Biologicals and Novartis Vaccines and Diagnostics for GlaxoSmithKline. Technically, Boostrix is considered a "biologic" medication, and is, therefore, under different rules and laws than most other medications. At this point, generic biologics, including generic Boostrix, 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.
When Will Generic Boostrix Be Available?This is a difficult question to answer. The laws are currently changing, and it appears likely that generic biologics will soon be allowed. It is predicted that they will be regulated much like generic medications. However, it is unlikely that a generic version of Boostrix will be available anytime soon, as this is a relatively new vaccine and will likely be protected by certain exclusivity rights for some time.
Understanding Biologics and GenericsBiologics 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; these 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 medicine, but they do not need 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 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 version, but a new and separate drug that would not be equivalent to the brand-name product.
However, recent legislation id aimed at changing these laws. It is predicted that new laws and regulations will allow generic biologics in the near future.