It is difficult to say for certain when a generic version of Orthoclone OKT3 will be available. Previous regulations did not allow generic versions of biologics to be manufactured. The regulations are currently changing to allow generic biologics to be made in the near future. However, much work is still needed and, at this time, it is unknown when the process will be finalized.
Even when generic biologics are allowed, a generic manufacturer will have to decide to make a generic version of Orthoclone OKT3 before it will be available.
Is Muromonab-CD3 a Generic Orthoclone OKT3?
No, it isn't. Muromonab-CD3 is the name that describes the active component of Orthoclone OKT3, not a generic version of it. Orthoclone OKT3 is a murine (from a mouse) monoclonal antibody that recognizes the CD3 protein of T-cells. The name muromonab-CD3 is derived from this description.
What can be confusing is that the active ingredient of a drug is often referred to as the "generic name." The generic name is different from a generic version of a medicine. In order for there to be a generic version, the original medicine must have gone off-patent, and another company besides the original manufacturer must make the product.
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. Access September 30, 2011.
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