123rd General Meeting of the KCS

Type Symposium
Area Recent Trends in Biopharmaceuticals Research
Room No. Room 303
Time THU 15:40-16:10
Code LIFE1-1
Subject Core Competences in the Biopharmaceutical Development
Authors Young-Phil Lee
Samsung Bioepis, Korea
Abstract The biopharmaceuticals account for 27% of the pharmaceutical market. Moreover, seven biopharmaceuticals are listed on the top 10 best-selling drugs. However, such seemingly promising market presents obstacles for market entry. Larger molecular weight of biopharmaceuticals in comparison to that of synthetic drugs makes biopharmaceuticals difficult to develop manufacturing processes and more vulnerable to quality changes by subtle process changes. Topping off the developmental hurdles, the pharmaceutical sector is one of the most regulated industries. Hence, in order to link science and knowledge gained from basic research to commercialization, it is necessary not only to overcome developmental hurdles, but also to obtain a marketing approval in compliance with the regulations of health authorities.
Until now, most domestic pharmaceutical and bio-venture companies have repeatedly taken a cycle of licensing out candidate drugs to global pharmaceutical companies in the early stages due to lack of global development capabilities and experience and limited development costs. Under such circumstances, Samsung Bios and Celltrion have been striving to establish the commercialization capabilities of biopharmaceuticals in Korea, and achieved great success comparable to global standards in terms of the development, production and regulatory approval. Established in 2012, Samsung Bioepis is a biopharmaceutical company focused on increasing patient access to high-quality medicines through the development of biosimilars. Samsung Bioepis has launched 4 biosimilar products in Europe and in the U.S over the past 6 years. In this session, I will review the core competencies of Samsung Bioepis and present a vision to promote symbiosis for the globalization of the Korean pharmaceutical industry.
E-mail yp321.lee@samsung.com