As a type of "biologic" medicine, Pegasys (peginterferon alfa-2a) is classified under a different set of laws and regulations than most other prescription medications. According to these regulations, manufacturers are not allowed to make any generic versions of biologic drugs. Until these laws change, which is expected to happen at some point in the future, generic Pegasys is not likely to be available.
Can I Buy Generic Pegasys?Pegasys® (peginterferon alfa-2a) is a prescription drug that belongs to a group of medications known as interferons. It is approved for treating hepatitis C and hepatitis B. When used to treat hepatitis C, Pegasys is typically used in combination with ribavirin and a hepatitis C protease inhibitor such as Incivek® or Victrelis®, oral medications that improve the effectiveness of Pegasys.
Pegasys is manufactured by Hoffmann-La Roche, Inc., for Genentech USA, Inc. It is considered a "biologic" by the U.S. Food and Drug Administration (FDA), and is under different rules and regulations than most other prescription medications. Because it is a biologic therapy, generic versions of Pegasys 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 another 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.