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Generic Rebif

"Biologic" drugs, which are made using live cells or organisms, are under different laws than most other medications. The laws state that these medicines cannot be made as a generic. Rebif (interferon beta-1a) is considered a biologic drug because it is made in Chinese hamster ovary cells. Unless the laws for biologics are changed in the future, generic Rebif products may never be available.

Generic Rebif: An Overview

Rebif® (interferon beta-1a) is a prescription injectable medication used to treat multiple sclerosis (MS). It is part of a group of medications known as interferons.
 
Rebif is made jointly by Pfizer Inc. and Serono, Inc. It is a "biologic" medication and is, therefore, under different rules and laws than most other medications. At this point, generic biologics, including generic Rebif, are not allowed to be made, due to some technicalities in the laws and regulations.
 

When Will Generic Rebif Be Available?

No one knows the answer to this question. Unless the laws and rules are changed, generic Rebif may never be available. However, it is likely that these rules and laws will be changed in the future.
 

Understanding Biologics and Generic Medications

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." Rebif is considered to be a biologic because it is a synthetic version of a human interferon and is made in Chinese hamster ovary cells.
 
When the patents for regular drugs expire, 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 expensive and time-consuming, and generic medications are less expensive because they do not need all of 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 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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