• The Science & Technology
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• s.506
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• pp.24-28
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• 2011

• The Korean Journal of Applied Statistics
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• v.25 no.1
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• pp.125-138
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• 2012

Recent assessments of the biosimilarity of biologic products have received considerable global attention. A clinical trial should be conducted to assess the biosimilarity of a biosimilar product and a innovator biological product. In this paper we will describe several methods for the implementation of clinical trials and statistical analysis, a real international case and related international guidelines.

• The Science & Technology
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• s.506
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• pp.14-18
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• 2011

• The Science & Technology
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• s.506
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• pp.19-23
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• 2011

• Journal of Life Science
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• v.30 no.11
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• pp.1012-1020
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• 2020

Remicade is a therapeutic biosimilar natural antibody in which the mouse variable domain has been linked to the human constant domain. It is a chimeric monoclonal antibody specific to tumor necrosis factor-alpha (TNF-α) and has been developed for the treatment of rheumatoid arthritis. To investigate the biological activity of the Remicade antibody, we carried out a bioinformatics study using a protein data bank to characterize the TNF-α antigen binding mechanism of the Remicade natural antibody. Because the production of the Remicade antibody is often limited by genetic instability of the natural antibody-producing cell, we generated a Remicade single-chain variable domain fragment antibody (Remicade) in which a heavy chain variable domain (VH) is joined with a light chain variable domain (VL) by a polypeptide linker. Furthermore, Remicade was fused to a leucine zipper (RemicadeScZip) for higher production and higher antigen-binding activity than Remicade. The Remicade and Remicade ScZip were expressed in Escherichia coli and purified by a Ni⁺-NTA-agarose column. As expected, the purified proteins had migrated as 28.80 kDa and 33.96 kDa in sodium dodecyl sulfate-polyacrylamide electrophoresis. The TNF-α antigen binding activity of Remicade was not observed by ELISA and western blot. In contrast, RemicadeScZip showed antigen-binding activity. Additional bio-layer interferometry analysis confirmed the antigen-binding activity of RemicadeScZip, suggesting that the leucine zipper stabilized the folding of RemicadeScZip in a denatured condition and improved the TNF-α antigenbinding activity.

• Journal of The Korean Ophthalmological Society
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• v.59 no.11
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• pp.1039-1048
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• 2018

Purpose: To evaluate the effects of anti-vascular endothelial growth factor (VEGF) treatment on the healthcare-related finances of patients with age-related macular degeneration. Methods: Changes in health care financing due to newly introduced benefit standards were predicted over the coming 5-year period (2018-2022). We also analyzed the financial impact of scenarios in which agents similar to anti-VEGF, such as the over-licensed drug bevacizumab, were introduced. For this purpose, the future number of patients receiving anti-VEGF treatments was estimated for various scenarios based on National Health Insurance Corporation claims data followed by an estimate of the financial burden. Results: In the case of age-related macular degeneration, the current standard of care (14 times in a lifetime) was maintained in scenario 1. In 2018, the insurance budget for the coming 5-year period was estimated at approximately 440.3 billion won. The insurance cost for that period was estimated at approximately 560.1 billion won under the revised standard of December 2017 (scenario 2). For scenarios wherein, after 2020, similar treatments (scenario 3) and bevacizumab (scenario 4) were introduced, the estimated health insurance costs were 521 billion won and 419.7 billion won, respectively. Conclusions: Health insurance costs are projected to increase substantially due to the elimination of the 14 time pay standard; however, the actual budget will only moderately increase, due to new limitations of visual acuity ${\leq}0.1$ or in case of scarring/atrophic lesions. Clinically similar agents and bevacizumab could be considered as alternatives to anti-VEGF treatment for age-related macular degeneration.

• International Commerce and Information Review
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• v.18 no.4
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• pp.165-193
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• 2016

This paper conducts a comparative analysis of the KORUS FTA and the TPP Agreement to assess the current state of affairs in international trade rules for the pharmaceutical industry. Intellectual property rights as well as public health related regulations have evolved to strengthen the position of innovator drug companies. In particular, the TPP Agreement which adopted data exclusivity for biologics for the first time, will set the standard for the future. Apart from this however, the TPP Agreement has not gone further than the KORUS FTA and in some respects, even contains greater policy flexibilities and provisions for market access than the KORUS FTA. Korea should take advantage of such differences when and if she must engage in negotiations to join the TPP Agreement or a renegotiation of the KORUS FTA.

• Journal of Life Science
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• v.21 no.11
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• pp.1652-1657
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• 2011

The production of blood cells is regulated by more than 20 different growth factors, called hematopoitic growth factors. These factors have been produced in prokaryotic and mammalian systems for their clinical use. Glranulocyte-Colony Stimulating Factor (G-CSF) is an important therapeutic factor for cancer patients as well as patients with congenital conditions. These patients do not have enough neutrophils and have a high risk of infection. Two groups of recombinant G-CSF have been used to specially treat cancer patients after chemotherapy because chemotherapy induces neutropenia, a major side effect of chemotherapy drugs. Here, structural and biological characteristics of G-CSF are presented. In addition, the relationship between chemotherapy and neutropenia, which is a severe reduction of neutrophils in the blood, and clinical application of G-CSF is discussed. Recombinant G-CSFs are grouped in two forms. Non-glycosylated G-CSF, filgrastim, is produced in Escherichia coli and glycosylated G-CSF, lenograstim, is produced in Chinese hamster ovary cells. Differences in structure and biological activity are compared and challenges for biosimilar production are also highlighted.