Xolair is considered a "biologic" medication, which means that it is under different rules and laws than most other medications. As a result, there won't be a generic Xolair available unless the laws and rules regarding this type of medication are changed. You should be cautious of places claming to sell a "generic Xolair," as these medicines are fake, substandard, and potentially dangerous.
An Overview of Generic Xolair
Xolair® (omalizumab) is a prescription medication used to treat allergic asthma. It is also approved to treat chronic hives. It is part of a class of drugs known as monoclonal antibodies.
Xolair is manufactured by Genentech, Inc. Technically, Xolair is considered to be a "biologic" medication, and is therefore under different rules and laws that most other medications. At this point, generic biologics (including generic Xolair) are not allowed to be manufactured.
Yet, if you search the Internet for "generic Xolair," you may find a number of Web sites selling it. The fact is that these medicines are fake, substandard, and potentially dangerous. There may be generic Xolair available from another country, but there is really no way of knowing if you are getting genuine Xolair or not. Therefore, you should not buy any generic Xolair until there is an approved generic available.
When Will Generic Xolair Be Available?
This is a difficult question. Unless the laws and rules are changed, generic Xolair may never be available. However, it is likely that these rules and laws will be changed in the future.
Is Omalizumab a Generic Xolair?
The answer is no. Omalizumab is the active ingredient in Xolair, but it is not a generic version of Xolair. What can be confusing is that, oftentimes, the active ingredient of a drug is referred to as its "generic name." The generic name of a medicine is different from a generic version of it. In order for there to be a generic version of a drug, the original medicine must have gone off patent and another company (besides the original manufacturer) must have made the product.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Xolair [package insert]. South San Francisco, CA: Genentech, Inc.;2014 March.
Xolair [package insert]. South San Francisco, CA: Genentech, Inc.;2007 July.
Food and Drug Administration, Center for Drug Evaluation and Research. Electronic orange book: Approved drug products with therapeutic equivalence evaluations. FDA Web site. Available at: http://www.fda.gov/cder/ob/. Accessed May 23, 2007.
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