Eylea (aflibercept) is considered a "biologic" medicine, which means that it falls under different laws and regulations than most other prescription medications. These laws prevent any generic Eylea products from being manufactured at this time. However, these regulations are changing, and a generic version of the drug may be available at some point in the future.
Can I Buy Generic Eylea?Eylea™ (aflibercept) is a prescription medication used to treat "wet" age-related macular degeneration and macular edema due to central retinal vein occlusion. It is injected directly into the eye once every four or eight weeks.
Eylea is manufactured by Regeneron Pharmaceuticals, Inc. It is considered a "biologic" by the U.S. Food and Drug Administration (FDA), and is therefore under different rules and regulations than most other prescription medications. Because it is a biologic therapy, generic versions of Eylea cannot be made by other manufacturers.
What Is a Biologic?Biologics are medications made using living cells or organisms. The living cells or organisms are used to make complex mixtures of proteins or molecules, which are then used to make medications or vaccines.
Biologic products include many different types of medicines, such as vaccines, blood products, and gene therapies. Because they are so complex, it can be difficult for a generic manufacturer to make an identical version of the product. For this reason, generic biologics are sometimes called "biosimilars" or "follow-on biologics." Biosimilars or follow-on biologics have similar properties to the existing biologic product, but are not considered identical to the existing biologic product.
When Will a Generic Version Be Available?It is difficult to predict when generic Eylea might become available. Previously, regulations did not allow generic biologic versions to be made. However, regulations are changing to allow generic manufacturers to create biologic products that are similar to ones already approved by the FDA.
Despite the changing regulations, it is unlikely that a generic version of Eylea will be available in the near future. Eylea was approved in November 2011, and will likely be protected from generic competitions by patents for quite some time.