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Biopharmaceuticals are medical drugs produced by means of biotechnology. In contrast with small-molecule (traditional) drugs, which are usually synthesized chemically, biopharmaceuticals are derived from biological sources, including tissues, cells, or microorganisms. Biopharmaceuticals comprise a wide extent of therapies, such as vaccines, monoclonal antibodies, cell therapies, recombinant proteins, and gene therapies, as well as biosimilars. These products are designed to become important treatment options for different diseases, including cancer, autoimmune pathological disorders, andinfectious diseases. The development of biopharmaceuticals often includes multifaceted processes, involving genetic engineering and cellular culture techniques, to guarantee efficacy and safety. Accordingly, biopharmaceuticals’ legislation is a key component for ensuring the highest quality of medical products, as well as protecting public health. As a rapidly developing area inside the pharmaceutical industry, biopharmaceuticals represent a significant advancing stage in modern medicine, offering targeted therapies that can improve patient outcomes. Accordingly, this paper seeks to provide current state-of-the-art didactic information, including better insight into various challenges related to biopharmaceuticals’ development, classification, medical use, legislation and ethics.
Miroslav Radenković (Wed,) studied this question.