|As we have seen in this paper, the uncertainty of the biosimilar licensing System are obstacles to the growth of the biosimilar industry in Korea and the expansion of global competitiveness. In order to grow the biosimilar industry and strengthen international competitiveness, it is necessary to develop the quality and management regulations of the biosimilar industry in Korea to the same level as in Europe and the US, and to improve the licensing system in order to reduce unnecessary procedures and costs. If the establishment of such a system is delayed, the international competitiveness of the biosimilar industry in Korea will be weakened.
Therefore, the following efforts are needed to enhance export competitiveness of biosimilar-related industry. First, it is necessary to develop biopharmaceutical and build regional portfolio strategies. Second, it is necessary to secure opinion leaders and excellent partners to strengthen overseas sales capabilities. Third, it is necessary to preemptively build biosimilar-related systems.