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; these medications are known as "biologics" or "biopharmaceuticals."
When the patents for regular drugs expire, generic 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 medicine, but they do not have to repeat all of the human studies to show the drug to be safe and effective. Human studies are very expensive and time-consuming, and generic medications are less expensive because they do not need all the human studies.
Currently, biologics are governed by 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 has been aiming to change these laws. It is predicted that new laws and regulations will allow generic biologics in the near future.
