FAQ
General / market: * Generics are subject to different legal definitions in different countries. The definition of generics as used in this context does not make reference to any particular legal definition.
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Biosimilars are available in much the same way as other prescription medicines. However, one major difference between biosimilars and generics is that pharmacists do not have the right to “substitute” biosimilars for reference biopharmaceuticals prescribed by a physician. In other words, the pharmacist has to provide the product prescribed by the physician.07-12-2007
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There are potentially as many types of biosimilars as there are types of reference biopharmaceuticals. These range from relatively simple proteins through to highly complex molecules such as monoclonal antibodies (mAbs) and fusion proteins. 07-12-2007
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Monoclonal antibodies are antibodies that are identical because they were produced by one type of immune cell and are all clones of a single parent cell. As tools for binding to specific protein molecules, they are invaluable in research, medicine, and industry. They can be produced in commercial quantities using biotechnology methods. Scientists today are able to produce antibodies that are fully human.
07-12-2007 -
Monoclonal antibodies have particular relevance in treating cancer, but also other ailments where a specific protein is targeted, because they enable development of target-specific medicines. The antibody produced through genetic recombination can be manipulated to incorporate a cell toxin, i.e. a radioisotope. This can then be administered to, i.e., a cancer patient, killing the cancer cells to which the antibodies are attached, but leaving others intact.07-12-2007
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Fusion proteins, also know as chimeric proteins, are proteins created through the joining of two or more genes that originally coded for separate proteins. Naturally occurring fusion proteins are known to play a role in the development of certain types of cancer. Recombinant fusion proteins can also be created artificially using recombinant DNA technology. 07-12-2007
