Generic Kineret

At this time, there are certain laws and rules that prevent generic Kineret from being manufactured. Kineret is a "biologic" medication, which means that a generic version cannot be produced unless the manufacturer completes the human studies necessary to approve a new drug. In that case, even if generic Kineret is approved, it would actually be considered a new and separate medicine rather than a "generic."

 

Generic Kineret: An Overview

Kineret® (anakinra) is a prescription medication used to treat rheumatoid arthritis. It is part of a group of medications known as biological response modifiers.
 
Currently, Kineret is made by Amgen, Inc. Technically, Kineret 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 Kineret) are not allowed to be made.
 

When Will Generic Kineret Be Available?

This is a difficult and confusing question. Unless the laws and rules are changed, generic Kineret will never be available. However, it is likely that these rules and laws will be changed in the future.
 

Biologics and Generics

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, 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 product, 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.
 
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.
 
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;