Generics and Biosimilars

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2. Biosimilars

2.3. Production process

Biosimilars are developed in the same way as the original biologic medicine they copy. They are manufactured using living cells that have had a vector carrying genetic information (deoxyribonucleic acid; DNA) inserted into them. This vector contains specific information that allows cells to produce the proteins that form the active components of biosimilars (see the Biologics section for more details). The exact source of the living cells (i.e. microorganism, animal or human) and the specific production techniques used to manufacture biosimilars may, however, vary from those used to manufacture the original biologic medicine. Nevertheless, biosimilars are produced to the same high standards required of the original biologic medicines.