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Generic Zaltrap
There are no generic Zaltrap (ziv-aflibercept) products available at this time. It is a type of biologic medicine that is made using live cells or organisms. At this time, certain regulations prevent companies from making generic versions of biologics. However, these laws are beginning to change, so a generic Zaltrap might become available at some point in the future.
from eMedTV.comZaltrap® (ziv-aflibercept) is a prescription medication approved for the treatment of colorectal cancer that has not adequately responded to previous treatment. It is used in combination with other chemotherapy medicines.
Zaltrap is manufactured by sanofi-aventis U.S., LLC., and comarketed by sanofi-aventis and Regeneron Pharmaceuticals, Inc. It is considered a "biologic" medicine and is, therefore, under different laws and regulations than most other prescription medications.
A biologic product is a medication made using live cells or organisms. The living cells or organisms are used to make a complex mixture of proteins or molecules. These are then used to make medications or vaccines.
Vaccines, blood products, and gene therapies are examples of medical biologic products. Zaltrap is a biologic because it is a form of a human antibody.
Because of the complexity of these biologics, it can be difficult for a generic manufacturer to make an identical version of a biologic product. For this reason, generic biologics are sometimes called "biosimilars" or "follow-on biologics," rather than generics. Biosimilars or follow-on biologics are not considered identical to the currently approved brand-name product (as a generic product would be), but are similar enough to be safely substituted for it.
It is difficult to predict when, or even if, a generic (or biosimilar) version of Zaltrap will be available. Regulations have not allowed manufacturers to make generic versions of biologics. However, these regulations are currently changing to allow a pathway for generic versions in the near future.
Despite the changing regulations, it is unlikely that generic Zaltrap will be available in the near future. Zaltrap was approved in August 2012 and will, therefore, be protected from generic competition by patents for quite some time.
Written by/reviewed by: Susan Lakey, PharmD, MPH, BCPP
Last reviewed by: Kristi Monson, PharmD