Because it is a "biologic" medication, Tysabri (natalizumab) falls under a different set of rules and laws than most other prescription medications. These regulations currently prevent any generic Tysabri products from being manufactured. Although the regulations may change in the not-too-distant future, brand-name Tysabri could still be protected from generic competition by unexpired patents.
Can I Buy Generic Tysabri?Tysabri® (natalizumab) is a prescription medication used to treat multiple sclerosis and Crohn's disease. It is used in people who are not adequately responding to, or cannot take, other medicines for their condition.
Tysabri is manufactured by Biogen Idec, Inc., for Elan Pharmaceuticals, Inc. It belongs to a class of medicines called immunomodulators.
Tysabri is considered a "biologic" therapy by the U.S. Food and Drug Administration (FDA). Biologics are under different rules and laws than most other prescription medications. Previously, generic versions of biologics, such as Tysabri, could not be made by other manufacturers. However, the regulations are currently changing that will likely allow generic versions in the near future.
What Is a Biologic?Biologics are medications made using living cells or organisms. The living cells or organisms are used to make complex mixtures of proteins or molecules, which are then used to make medications or vaccines. Tysabri is a biologic because it is a form of a human antibody.
Biologic products include many different types of medicines, such as vaccines, blood products, and gene therapies. Because they are so complex, it can be difficult for a generic manufacturer to make an identical version of the product. For this reason, generic biologics are sometimes called "biosimilars" or "follow-on biologics." Biosimilars or follow-on biologics are not identical to the currently approved brand-name product, but have similar properties and can be safely substituted for it.