[Basics of the pharmacology of biopharmaceuticals].

Biopharmaceuticals are pharmaceutical drug products or preparations of pharmaceutical drugs that are of biological origin or are manufactured from biological material. The spectrum of biological drugs is extensive and includes substances isolated from biological material, recombinant RNA molecules, proteins as well as full antibodies, antibody fragments or antibody-drug conjugates. The special features of the molecular properties and functions of biopharmaceuticals require a highly complex, variable structure. Due to the specificity of intended pharmacodynamic effects on a complex biological regulatory system, particularities regarding undesired effects, pharmacokinetics, and safety have to be considered both regulatory and clinical.