South Korea launches biosimilars programme
Since South Korea introduced a regulatory pathway for manufacturing biologics in 2009, the government has raised its stakes in the biosimilars market. It is providing both financial and institutional support to help the market emerge as a global leader by 2020. The market is expected to witness substantial growth during 2013–16, when new products and segments will be launched.
New analysis from Frost & Sullivan of Opportunity Analysis for Biosimilars — South Korea, finds that the market earned revenues of $62.3 million in 2011 and estimates this to reach $89.8 million in 2017, with erythropoietin expected to be the biggest revenue generator.
«The South Korean Government considers biosimilars drug development significantly cheaper than new drug development," said Frost & Sullivan Research Analyst. «Moreover, biosimilars'
However, biosimilars' requirements of huge upfront investments and infrastructure dissuade potential investors. More importantly, biosimilars need to prove that their clinical efficacy is as robust as biologic innovator drugs'. Currently, physicians and doctors are reluctant to prescribe biosimilars because they may not be as familiar with the biosimilar developer’s capabilities and expertise, as they are with the credentials of innovator drug manufacturing companies.
Further, by 2020, the market will be facing a familiar challenge of dwindling pipeline, as newer and more complex originator molecules need to be identified as target markets. With many domestic companies attempting to establish a foothold, the biosimilars market will also witness changing business models. High costs associated with biosimilar development will necessitate partnerships with