Generic Botox is currently not available because the laws surrounding the manufacture of generic biologic medications do not allow it. These laws will likely be changed in the future, although whether these medications will be less expensive than the brand-name equivalents is not clear. If it does become available, generic Botox will probably be used for the same cosmetic and medical reasons as the brand-name version.
Generic Botox: An OverviewBotox® (onabotulinumtoxinA, previously known as botulinum toxin type A) is a prescription medication used for various cosmetic and medical purposes. Although the drug is well known for treating facial lines, it is also approved to treat severe sweating and several conditions that cause muscle spasms.
Botox is made by Allergan Pharmaceuticals. Technically, Botox is considered a "biologic" medication and is, therefore, under different rules and laws than most other medications. At this point, generic biologics, including generic Botox, are not allowed to be made.
When Will Generic Botox Be Available?This is a difficult question to answer. Unless the laws and rules are changed, generic Botox will never be available. However, it is likely that these rules and laws will be changed in the future.
Understanding Biologics and Generic MedicationsBiologics 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 then used as medications. Thus, the medications are known as "biologics" or "biopharmaceuticals." Botox is considered a biologic because it is a toxin produced by live bacteria (Clostridium botulinum).
When the patents for regular drugs expire, drug 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 drug, but they do not have to repeat all of the human studies that 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 of the human studies.
However, biologics are governed by a different set of laws. Currently, 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, as mentioned, 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 drug, but a new and separate drug that would not be equivalent to the brand-name product.
Recently, there has been much interest in changing these laws, and it is likely that generic biologics will be allowed in the near future.