The market share of drug products manufactured by means of modern biotechnology (Biologicals) is constantly increasing. In Germany, it is close to 31 % by value. Biologicals are accounting for 45 % of all Marketing Authorisations granted for new products in 2020.
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.
Originator companies are redirecting their main focus from APIs manufactured by chemical synthesis to APIs derived from modern biotechnological processes. As a consequence of the higher development costs, the market prizes of Biologicals are high as well. This means that there will be a major cost saving potential for the healthcare systems by introduction of Biosimilar competition directly after patent expiry.
Consequently, it is vital for generic pharmaceutical companies to consider extending their business scope from drug products with chemically synthetized APIs to Biosimilars.
For midsize and smaller companies which do not possess the financial resources or the know how to develop own Biosimilars it is highly recommended to search for cooperations with other companies.
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.