Praktické lekárnictvo 2/2021

Generic drugs: theory and praxis

Generic drugs are copies of original medicinal products that do not have to undergo a demanding preclinical and clinical research process for their approval. They must be chemically identical to the original product and have the identic drug formulation. The main benefit of generic medicines is their significantly lower cost, which results from cost savings on preclinical and especially clinical research and development. Without generic medicines, current health systems could not work or be funded. The very concept of generic medicines has never been challenged and the principles of their registration have in principle fully proved its worth. Changing treatment with one medicinal product for another may pose some risks, but such situations are quite exceptional. Doctors and pharmacists should be well informed about them and should not underestimate the patient‘s education in this regard.

Keywords: generic medicinal products, original medicinal products, biosimilars, generic substitution