The global biosimilars market has grown exponentially over the past few years primarily due to rising medical care costs and the high cost of developing and testing innovative drugs. Asia is fast becoming a center for biosimilars manufacturing, currently responsible for 34.1% of the world market share. With the expiration of several major patents between 2015-2020, South Korea, in particular, is gearing up to introduce its biosimilars into the global market.
Biosimilars Market
In 2009, South Korea first introduced a regulatory pathway for manufacturing biosimilars, which allowed for the exemption of Phase II clinical trials. Since then, the government has been increasingly investing in the country’s biosimilars industry, providing substantial financial support, to help position South Korea as a global leader by 2020. The South Korean Ministry of Economy projects that the country’s biosimilars market will grow to $14.3 billion by 2015. Significantly lower costs and time-to-market (up to half that of innovative drugs) of biosimilars have been major incentives behind the boosting this sector.
Between 2013 and 2016, the South Korean biosimilars market is expected to undergo substantial growth with the launching of several new products, among which erythropoietin is expected to be the the largest revenue generator. Several multinational companies with upcoming patent expiries are collaborating through translation and interpreting services with South Korean companies already in late stage clinical trials for multiple biosimilar candidates.
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