SY11-5 - Current status, issue and future perspectives for biosimilars in Japan from the viewpoint of cost-effectiveness.

In Japan, maintaining the universal health insurance system has become a major social issue in our rapidly aging society with soaring expense of social security contributions and skyrocketing medical costs, etc. Nowadays generic medicines have become standard therapeutic medicines even in the field of cancer treatment. In terms of cost-effectiveness, biosimilars are expected to enhance patients' access to beneficial treatment and so contribute to patients' quality of life as well as reducing the economic burden and total medical expenses while providing equivalent therapeutic outcomes inexpensively compared to the original biologics. Regarding the approval requirements of biosimilars, unlike generic products, they need a Phase III clinical trial in addition to the characterization study which proves similarity to the originals. Biosimilars have been approved through a review process of an application package which is similar to that of new drugs. However, in Japan, biosimilars have not become standard therapeutic choices yet. Approvals of biosimilars and their prevalence in the medical front have been proceeding in Europe and those products have grown in popularity as standard therapeutic choices. In European countries, the European Medicines Agency, academic societies and governmental authorities in each country have implemented a variety of measures to facilitate use of biosimilars. As part of such efforts, the EMA published a guideline on similar biological medicinal products containing G-CSF in 2006. In overseas ASCO and ESMO have already issued a position paper and statement on biosimilar products. In Japan, the Japan Society of Clinical Oncology recommends the biosimilars in its guideline for acceptable use in 2013. This presentation covers the initiatives for biosimilars in Europe and the US, the situation and the challenges in Japan as well as the activities of the Japan Biosimilar Association. [ABSTRACT FROM AUTHOR]