Different laws and regulations protect Erbitux (cetuximab), so generic versions are not yet available. It is hard to predict when this situation might change, but since the patent for Erbitux was approved in 2004, the earliest this could even be considered is 12 years from that date. If you cannot afford this product, talk to your healthcare provider about assistance or reimbursement programs the manufacturer offers.
Can I Buy Generic Erbitux?
Erbitux® (cetuximab) is a prescription medication used to treat head and neck cancer and colorectal cancer. It is used alone or in combination with other treatments.
Erbitux is manufactured by ImClone LLC and co-marketed by Bristol-Myers Squibb Company and Eli Lilly and Company. It belongs to a group of medicines called monoclonal antibodies. Like other monoclonal antibodies, Erbitux is considered a "biologic" medicine, which means it is under different laws and regulations than most other prescription medications.
What Is a Biologic?
A biologic product is a medication that is made using living cells or organisms. The living cells or organisms are used to make a complex mixture of proteins or molecules, which are then used to make medications or vaccines.
Vaccines, blood products, and gene therapies are examples of biologic products. Erbitux is a biologic because it is a form of a human antibody.
Because biologics 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 considered identical to the currently approved brand-name product, but are similar enough to be safely substituted for it. Therefore, they are essentially generic versions.
Food and Drug Administration Web site. Vaccines, Blood, and Biologics, Resources for Healthcare Providers. Available at: http://www.fda.gov/BiologicsBloodVaccines/ResourcesforYou/HealthcareProviders/default.htm. Accessed November 4, 2011.
Engelberg AB, Kesselheim AS, Avorn J. Balancing Innovation, Access, and Profits -- Market Exclusivity for Biologics. N Engl J Med 2009; 361:1917-1919.
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