The market share of drug products manufactured by means of modern biotechnology is constantly increasing. In Germany, it is close to 25% in value. This means that there will be a major cost saving potential for the healthcare systems by introduction of Biosimilar competition. New therapeutic options are opened for treatment of severe medical conditions and it is obvious that this product category will become even more important in the future. Consequently, it is vital for generic pharmaceutical companies to consider extending their business scope from drug products with classical chemically synthetized API to Biosimilars. The training aims to create deeper understanding why biotechnological products – and as a consequence biosimilars – are a unique product category and what aspects have to be considered in R&D and Drug Regulatory Affairs.