Is a Generic Version of Menveo Available?
) is one of a few available vaccines approved to provide protection against invasive meningococcal diseases such as bacterial meningitis
. The injection is given as a single dose and is approved for people between the ages of 2 months and 55 years.
Menveo is made by Novartis Vaccines and Diagnostics, Inc. There are no generic versions of Menveo. Two other meningococcal vaccines are available -- Menomune®
, both made by Sanofi Pasteur -- but these products are not interchangeable with Menveo. Neither of these is available in generic form.
Technically, Menveo is considered a "biologic" medication and is, therefore, under different rules and laws than most other medications. At this point, generic biologics, including generic Menveo, 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.
However, as mentioned, recent legislation is aimed at changing these laws. It is predicted that new laws and regulations will allow generic biologics, perhaps including generic Menveo, in the near future.