Biosimilars at the interface of science, medicine and economics

摘要

Biologies have revolutionised medical practice. They have improved the outcomes, the length and quality of life of patients in the diverse fields of endocrinology, haematology, oncology, and inflammatory disorders. As the patents for some of the ground-breaking monoclonal antibodies expire, the door opens for corresponding copies. The distinctive feature of a biologic medicinal product (BMP) is that it is manufactured using living cells. The complexity of these molecules is such that they cannot be synthesized using conventional chemical methods. Recombinant technology makes it possible to selectively introduce specific genetic material into suitable host cells. Under appropriate conditions the genetically modified cells replicate, transcribe and translate the introduced genetic material to synthesise the desired BMP. The BMP is subsequently isolated and purified from the cells and culture medium.