Generic Lucentis: An Overview
Lucentis® (
ranibizumab) is a prescription medication used to treat
macular degeneration. Specifically, it is used to treat "wet" macular degeneration, a less common but particularly damaging form of macular degeneration.
Lucentis is made by Genentech. Technically, Lucentis is considered to be a "biologic" medication and is, therefore, under different rules and laws than most other medications. At this point, generic biologics (including generic Lucentis) are not allowed to be made.
When Will Generic Lucentis Be Available?
This is a difficult question. Unless the laws and rules are changed, generic Lucentis will never be available. However, it is likely that these rules and laws will be changed in the future.
Understanding Biologics and Generic Medicines
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, and the medications are known as "biologics" or "biopharmaceuticals."
When the patents for regular drugs expire, 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 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 are governed by a different set of laws. Currently, there is no way for a generic biologic to be approved under these laws, 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.
Recently, there has been much interest in changing these laws, and it is likely that generic biologics will be allowed in the near future.
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