Biologicals and Biosimilars in Hematology: The Case of Rituximab

Biological medicines have shaped dramatic advances in the treatment of serious acute and chronic diseases like rheumatoid arthritis, inflammatory bowel disease, cancer, and hematological malignancies. However, this success has come at a price. Biological medicines can cost 10,000 euros or more per year, causing ‘financial toxicity’ for the patients concerned. As a consequence, many countries in the world struggle with their drug budget as use of pharmaceuticals increases and new drugs, in particular biologicals, are very expensive. The total spend on biological drugs in many countries is increasing by 5% to 10% per year. This situation is unsustainable in healthcare systems. After expiration of market exclusivity, alternative versions of innovative medicines introduce competition and this will drive prices down, increase access to formerly (too) expensive medicines and create headroom for innovation. For generic medicines this has been a very successful strategy. When it comes to biosimilars–equally effective and safe alternatives for innovative biological medicines–barriers appear to exist for prescribers and patients. The main reason is lack of knowledge of the essentials of biological medicines on the one hand and the new drug development paradigm for biosimilars on the other hand. This creates uncertainty among prescribers and patients alike, and hence reluctance to accept biosimilars. That is a pity, as the competition made possible by biosimilars is the single most effective way to drive down the overall costs of medicines, improve patient access and create headroom for new innovative therapies.