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Biopharm Development & Manufacturing Korean government announced an ambitious initiative to attempt to capture 22% of the global biosimilar market by 2020. Unlike India, Brazil, Russia, and China, which are focused on domestic markets, the main objective of the Korean initiative is to become a leading regional and global biosimilar manufacturer and exporter over the next 5 to 10 years. "I think South Korea's strategy is to develop highquality products to penetrate domestic and regional Asian markets and then attempt to get those products on the more-regulated U.S., European, and Japanese markets. It's a nice, sleek-tiered approach," said Ivo Abraham, a professor at the Center of Health Outcomes and Pharmacoeconomics Research at the University of Arizona. There may be as many as 25 companies developing biosimilars in Korea. However, the Korean biosimilar industry is dominated by five key players, including Dong-A Pharmaceuticals, Samsung Biologics, LG Life Sciences, Celltrion, and Hanwha Chemical Company. While biosimilar versions of EPO, G-CSF, and several reproductive biologics products are commercially available in Korea (and exported to foreign countries), the main focus of these companies is to develop biosimilar versions of Humira, Herceptin, Avastin, Rituxan, Remicade, Enbrel, and several other mAb-based products. In 2012, Celltrion's biosimilar version of Remicade (infliximab) called Remsima was approved in South Korea. Remsima is currently being evaluated for marketing authorization in Europe, and a decision is expected before the end of 2013. THE FUTURE Early biosimilar market entrants included some of the world's largest pharmaceutical and generic companies (e.g. Sandoz, Teva, Hospira, Pfizer, and Merck). Conventional wisdom suggested that these companies had the financial and scientific resources to dominate the global biosimilar landscape. However, missteps with biosimilar product launches, ongoing manufacturing challenges, ill-conceived marketing strategies, and global biosimilar regulatory ambiguity prevented development of a vibrant global biosimilar market. Instead, it now appears likely that domestic and regional biosimilar companies located in emerging markets will assume leadership roles as the global biosimilar market continues to develop. Unlike the multinationals, these companies have a much better understanding of the regulatory ambiguities, drug pricing and healthcare costs, and the medical needs of the domestic and regional markets that they serve. July 2013 LifeScienceLeader.com 31