Is a Generic Version of Adacel Available?
Adacel® (
Tdap vaccine) is a vaccine designed to provide "booster" protection from diphtheria, tetanus, and pertussis (
whooping cough) for adolescents and adults 11 to 64 years of age. It is given as a single, one-time injection.
Adacel is made by Sanofi Pasteur Limited for Sanofi Pasteur, Inc. Technically, Adacel is considered to be a "biologic" product and is, therefore, under different rules and laws than most medications. At this point, generic biologics (including generic Adacel) 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 or vaccines. These products are known as "biologics" or "biopharmaceuticals."
When the patents for regular drugs expire, generic 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 have to repeat all of the human studies to show the drug to be safe and effective.
Human studies are very 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 the same as the brand-name drug). 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.
