Imitation biologics are therapeutically equivalent to the original drugs
Drugs produced using biotechnology are among the most expensive medicines available. Biosimilars that offer a real alternative are becoming increasingly available on the market. The promise of biosimilars is that, once patent protection has elapsed for established biologics, more patients will be able to access effective and well-tolerated drugs. This is particularly true in relation to preparations used in the treatment of patients with cancer and autoimmune diseases, which also include drugs used for the treatment of rheumatic diseases. In 2001, as part of a project led by the European Medicines Agency, step-by-step guidelines were introduced to regulate the approval of these products, and to acknowledge the specific differences that distinguish biosimilars from traditional medicines.
