Generic Neulasta: An Overview
Neulasta is made by Amgen, Inc. Technically, Neulasta is considered to be a "biologic" medication. Biologic medications are under different rules and laws than most other medications. At this point, generic biologics (including generic Neulasta) are not allowed to be manufactured.
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." Neulasta is considered a biologic medication because it is a man-made version of a human protein and is produced using bacteria.
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 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 very expensive and time consuming, and generic medications are less expensive because they do not require all 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 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.