Biological medicinal products: Specific characteristics, approval and therapeutic applications

Biological medicinal products obtained through the application of recombinant DNA technology (biopharmaceuticals) represent a relatively new generation of medicines. They were developed to improve therapeutic efficacy and reduce toxicity associated with synthetic therapies. As biological medicinal products are produced by living organisms and are characterised by high molecular weight and complex three-dimensional structures that cannot be fully defined by simple chemical formulas, they possess specific characteristics that distinguish them from chemically synthesised medicinal products. Biological medicinal products require specific regulatory approaches throughout the marketing authorisation process. Pharmacists and other healthcare professionals involved in the handling of biological medicinal products must pay particular attention to appropriate storage conditions and handling procedures. Furthermore, careful monitoring of adverse reactions is essential, as these reactions are frequently associated with the immunogenic potential of biological medicinal products. Biopharmaceuticals are often high-cost therapeutic options, and their accessibility remains a significant challenge for many healthcare systems. The development and introduction of biosimilar medicinal products represent an important opportunity to improve patient access by providing more cost-effective therapeutic alternatives, although they also introduce specific regulatory challenges due to the complexity of demonstrating biosimilarity.