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Generic Sylatron

As a type of "biologic" medicine, Sylatron is under a different set of rules and regulations than most other prescription drugs. These laws prevent any generic Sylatron products from being manufactured at this time. It is expected that these laws will change in the near future. However, until this happens -- and the patents for the drug expire -- generic versions of Sylatron will not be available.

Can I Buy Generic Sylatron?

Sylatron™ (peginterferon alfa-2b) is a prescription medication that belongs to a group of medications known as interferons. It is approved for preventing the return of malignant melanoma after surgery to remove the cancer.
Sylatron is manufactured by Schering Corporation. It is considered a "biologic" by the U.S. Food and Drug Administration (FDA), and is therefore under different rules and regulations than most other prescription medications. Because it is a biologic therapy, generic versions of Sylatron cannot be made by other manufacturers.

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.
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 have similar properties to the existing biologic product, but are not considered identical to the existing biologic product.

When Will a Generic Version Be Available?

It is difficult to predict when generic Sylatron might become available. Previously, regulations did not allow generic biologic versions to be made. However, regulations are changing to allow generic manufacturers to create biologic products that are similar to ones already approved by the FDA.
Despite the changing regulations, it is unlikely that a generic Sylatron version will be available in the near future. Sylatron was approved in March 2011, and will likely be protected from generic competitions by patents for quite some time.
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Sylatron Medication Information

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