Generic Orthoclone OKT3
Orthoclone OKT3 (muromonab-CD3) is considered a "biologic" medicine, which means it is under different laws and regulations than most other prescription medications. According to these regulations, companies are unable to make generic versions of biologic products, including Orthoclone OKT3. However, these regulations are changing, and a generic version of the drug may be available in the future.
Can I Buy Generic Orthoclone OKT3?Orthoclone OKT®3 (muromonab-CD3) is a prescription medication used to treat transplant rejection in people who have received a kidney, heart, or liver transplant. It is a monoclonal antibody. Monoclonal antibodies are manufactured antibodies that are designed to attach to specific cells in the body.
Orthoclone OKT3 is manufactured by Centocor Ortho Biotech Products, L.P.
Like other monoclonal antibodies, Orthoclone OKT3 is considered a "biologic" medication by the U.S. Food and Drug Administration (FDA). Biologic medications are under different rules and regulations than most other prescription medications. Because it is a biologic medication, Orthoclone OKT3 cannot be made into a generic product.
What Is a Biologic?Biologics are medications made using live cells or organisms. The living cells or organisms are used to produce complex proteins or molecules, which are then used to make products such as medicines, vaccines, blood products, and gene therapies. Orthoclone OKT3 is a biologic because it is a synthetic (laboratory-made) antibody designed to attach to the cell differentiation cluster 3 (CD3) protein found on T-cells (a type of white blood cell). It is made from mouse proteins.
Because biologics are so complex, it can be quite difficult for a generic manufacturer to make an identical version of a biologic product already on the market. 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.