Flyer Biosimilars

3 Introduction to the subject Biosimilars are attractive products for providers, insurers, physicians and patients. However, each of the four beneficiaries of biosimilars is pursuing different motives and often oppo- sing strategies. Above all, the health insurance funds want to reduce expenses, the physici- ans want to relieve their budgets, the patients want to be provided with an innovative supply of biosimilars, and the manufacturers want to earn back their investments and, in addition, generate profit for new projects and products. The first biosimilar in Europe ( Omnitrope® ) was approved in 2006 - there are now over 40 biosimilars with EU approval. 24 of these have already been launched on the German phar- maceutical market. In view of the patent expirations of numerous biological drugs, many more biosimilars will enter the German pharmaceutical market in the coming years. A biosi- milar is a biological drug that contains a version of the active ingredient of a biological drug already approved in the European Economic Area (reference drug, biologicals) as the active pharmaceutical ingredient. It is similar to the original, but not identical. In contrast, bioidenticals , which are produced in the same manufacturing process by the same manufacturer, are the same as the original product. The marketing of bioidenticals can be outsourced to another pharmaceutical company. A biobetter has mostly been improved over two realistic approaches: • Change in the molecular structure of the reference drug and • Change in dosage form. This pursues several goals: Optimization of the half - life of the molecule, adapted to a specific indication spectrum, improvement of efficacy in a specific indication, reduction of toxicity and reduction of immunogenicity. Compared to a "classic" generic drug, a biosimilar is subject to very high development and approval requirements, which is why the development of a biosimilar takes significantly lon- ger and is many times more expensive. Details can be found in the figure below. Content of the Value Dossier Original / Reference Original / Reference Clinical research phase III Clinical research phase II Clinical research Phase I Preclinical Characterization of the molecule Clinical research PK/PD Modeling Preclinical Functional (biological) Characterization Physicochemical characterization High regulatory emphasis Low regulatory emphasis