Generic ProQuad

Is There a Generic ProQuad?

ProQuad^® (MMRV) is a combination vaccine. It contains the measles, mumps, and rubella vaccine (MMR) combined with a chickenpox vaccine. This is a live vaccine typically given as two doses in early childhood.

 

ProQuad is made by Merck & Co., Inc. There are no generic versions at this time.

 

Technically, ProQuad is considered a "biologic" medication, and is therefore under different rules and laws than most other medications. At this point, generic biologics, including generic ProQuad, are not allowed to be manufactured. However, the laws are changing, and it is likely that generic versions 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 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 that the drug is 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. However, recent legislation is aimed at changing these laws. It is predicted that new laws and regulations will allow generic biologics in the near future.