Onkológia 3/2008

BIOPHARMACEUTICALS IN ONCOLOGY

Modern drug discovery explores challenging methods, e. g. „molecular targeting“ for development of tailored drugs and uses recombinant technology for the production of proteins as drugs. The biological medicinal drug products (biopharmaceuticals) used in today´s oncology practice are hematopoetic growth factors, interleukins, inteferons and monoclonal antibodies. Biopharmaceuticals are also used for gene therapy. Therapeutic proteins are produced using genetically engineered cells by expression and translation of the inserted genetic code. With the expiry of several patents for biological medicinal products (human insulin, growth hormon, erythropoietin, granulocyte colony-stimulating factor) the so called biosimilars (similar biological medicinal products) are introduced to the market. Similar biological medicinal products (biosimilars) are not generic medicinal products as it is in the case of low molecular weight drugs. For these reasons regulatory agencies as European Medicines Agency (EMEA) and Food Drug Administration (FDA) in USA developed special guidelines on biosimilars concerning approval requirements.

Keywords: biological medicinal products, biopharmaceuticals, biotechnology-derived medicinal products, recombinant DNA technology, similar biological medicinal products, biosimilars