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KMID : 1142220060010020029
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Regulatory Research on Food, Drug & Cosmetic
2006 Volume.1 No. 2 p.29 ~ p.38
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Trend and Strategy in Biopharmaceutical Product Development
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Song Dong-Ho
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Abstract
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Bio-industry is a new type of biotechnology-based industry, producing commercial therapeutics by bioengineering technology utilizing information and function of biomaterials. USA is a leader in the bio-industry with a growing market whereas Korea is in the early stage of development. Currently biopharmaceutical field leads the bio-industry with increasing market size due to expansion of indications and increasing demand. Biopharmaceuticals’market portion is about 2/3 of bio-industry and became a core of the bio-industry market. Growth rate of biopharmaceuticals is two fold of that of traditional chemical pharmaceuticals, and biopharmaceutical market size in USA, Japan and Europe is about 90% of the global market. The size of biopharmaceutical industry in Korea is about 2% of global market due to difficulty in discovering new candidate products, shortage in infrastructure related to development of biopharmaceuticals and insufficient experiences in development of new drugs to get into advanced market. Furthermore, Korean products are less competitive in worldwide market because biopharmaceuticals in Korea are mostly localized products developed in advanced countries rather than products of new function and new type of drug. However, for the first time in the world, products of cell therapy and tissue-based therapy were approved in Korea in 2000 and diagnostic DNA chips for detection of human papilloma virus was approved in Korea in 2004. By considering the technical and industrial standard of Korea, product development strategy could be divided into three terms. The short-term strategy is to improve manufacturing technology to increase competitiveness in price. The mid-term strategy is to improve formulation technology to increase product value. The long-term strategy is actually a development strategy to develop widely recognizable new drugs or drugs with new functions. Since patents of the most major biopharmaceutical drugs were expired in 2006, Korea should drive forward to enter global market by developing and commercializing biogenerics. Biogenerics are biopharmaceutical products which are already available in Asia, Eastern Europe and South America excluding USA, Europe and Japan. According to a market research, global market for biogenerics will reach up to $8~11billion by 2009. As an example of biogenerics in market, Omnitrope, human growth hormone which was developed by Sandoz in Switzerland was approved in USA and EU in 2006. In Korea, LG Biotech Science is a leader in development of biogenerics. Valtropin, human growth hormone, of LG was approved by EMEA in 2006, and LG expects to receive an approval from US FDA within a few months.
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KEYWORD
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biopharmaceuticals, development strategy, biogenerics
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Listed journal information
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