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Generic Daptacel
At this time, there are no generic versions of Daptacel available on the market. This is because the vaccine is considered to be a "biologic" medication, and biologics are under certain laws that prevent generic versions from being manufactured. However, it is predicted that new laws will allow generic biologics in the near future.
Is a Generic Version of Daptacel Available?
Is a Generic Version of Daptacel Available?
Daptacel® (DTaP) is a routine childhood vaccine that provides protection against diphtheria, tetanus, and whooping cough (pertussis). Daptacel is made by Sanofi Pasteur, Inc. It is different from Sanofi Pasteur's previous DTaP vaccine (Tripedia®) in that it contains five pertussis antigens (instead of three), does not contain any thimerosal (not even trace amounts), and is not made using bovine (cow) components.
There are no generic versions of Daptacel. There are several other DTaP vaccines on the market (some with just DTaP, some combined with other vaccines). However, none of them are technically equivalent to Daptacel, and none of them are generic vaccines.
Generic Vaccines
Generic Vaccines
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 very expensive and time-consuming, and generic medications are less expensive because they do not need all the human studies.
However, because vaccines are biologics (medications made using live cells or organisms, also known as "biopharmaceuticals"), they 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).
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: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD