Generic Betaseron

Betaseron is currently not available as a generic. Betaseron (interferon beta-1b) is a "biologic" medication that is under a different set of rules and laws than most other drugs. These laws currently prevent any biologic medications from being manufactured in generic form. There has recently been much interest in changing these laws, however, so generic Betaseron could be available in the future.

 

Generic Betaseron: An Overview

Betaseron® (interferon beta-1b) is a prescription medication used to treat multiple sclerosis (also known as MS). It is part of a group of medications known as interferons and must be taken by injection.
 
Betaseron is made by Bayer HealthCare Pharmaceuticals. Betaseron is a "biologic" medication and is, therefore, under different rules and laws than most other medications. Currently, generic biologics, including generic Betaseron, are not allowed to be made, due to some technicalities in the laws and regulations.
 

Biologics and Generics

Biologics are medications that are made using live cells or organisms (often bacteria).
 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." Betaseron is considered to be a biologic because it is a man-made version of a human interferon and is made in Chinese hamster ovary cells.
 
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 medication, 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).
 
(Generic Betaseron Continued: Page 2)
Add this article to your Favorites     Email this article     Print
Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;