Introduction. Biological drugs are one of the most important innovations in the field of medicine. The basis of this phenomenon is the dynamic development of biotechnology using the achievements in the field of genetic engineering to design new drug therapies. Aim of the study. The main purpose of the work was to assess the level of knowledge of Polish and European legal regulations concerning the introduction, use and monitoring of biotechnological drugs among medical university students in the following courses: medical, medical biotechnology and pharmacy. Material and methods. An anonymous questionnaire for students of selected medical faculties was used as a research tool. The study involved 189 students, including 145 women and 44 men. Among the respondents of selected medical faculties, the largest percentage were medical students (45.5%), followed by pharmacy (30.2%) and biotechnology (24.3%) students. Results. Based on the conducted research, it was found that the level of knowledge about the basic legal regulations of the biotechnology drug market is unsatisfactory among the surveyed students, in particular medical faculties and pharmacy. Conclusions. Based on the conducted research, it can be concluded that mandatory subject courses in the field of biotechnological drugs for medical and pharmacy students should be introduced in order to prepare them for work with new generation drugs, because the results of the research indicate their unsatisfactory level of knowledge in the field of biotechnological drugs.

Key words: students’ knowledge, biological medicines, biosimilars, law regulations.