South Korea Biosimilar Market Analysis

South Korea has emerged as one of the strategic location for the development of biosimilars
on the global level. Among the various emerging countries identified for development of
biosimilars, South Korea is one of the most promising countries where pharmaceutical
companies have identified huge investment potentials for the drug development process. One
of the major reasons for the attractiveness of South Korea is the end of patent protection for
some blockbuster drugs in the coming years and the need for novel therapeutics. Offering the
advantages of favorable government and business conducive environment, the South Korean
biosimilars market is poised for significant and rapid growth in the future years. There are
many favorable steps undertaken by the government in this regard, some of them being tax
holidays, tax concessions, cash grant, site location support and financial support for
pharmaceutical companies investing in Korea.

Thus, with all the government policies and frameworks, the biosimilars market in South Korea
has become the growth engine of the country attracting huge investments from public and
private companies located in and outside Korea. The South Korean Government has
announced its plans to promote the biosimilars industry and make huge investments in the
industry so as to make Korea a dominant player in the global marketplace.

At present, the share of South Korea in the global biosimilars development is extremely
meager. However, with the aggressive government support, and the increasing focus on
biosimilars development, the government aims that the country would occupy a significant
share of the global market for biosimilars by 2020.

South Korea Biosimilar Market Analysis reports gives comprehensive details on

following aspects related to Biosimilar development in South Korea:
Market Overview
Favorable Market Parameters
Biosimilar Pipeline Analysis by Company, Phase & Disease
Regulation foe Development of Biosimilars
Emerging Market Trends
Competitive Landscape
Agreement & Partnership for Development of Biosimilars

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 South Korea Biosimilar Market Analysis

Table of Contents

1. South Korea Biosimilar Market Overview

1.1 Current Market Scenario

1.2 Favorable Market Dynamics for Development of Biosimilars

1.3 Challenges to be Resolved for Development of Biosimilars

2. South Korea Biosimilar Pipeline (Clinical Phase, Indication, Biochemical Class &
Company)

2.1 Research

2.2 Preclinical

2.3 Phase-I

2.4 Phase-II

2.5 Phase-III

2.6 Preregistration

2.7 Registered

2.8 Marketed

3. Agreement & Partnership for Development of Biosimilars

3.1 Samsung Biologics & Biogen Idec

3.2 Merck & Hanwha Chemical Corporation

3.3 Meiji Seika Pharma and Dong-A Pharmaceutical

3.4 Pharmascience and Korea Kolmar Holdings

4. Emerging Trends

4.1 Government Investments in the Biosimilar Development

4.2 Approval of first Biosimilar Drug of Arthritis Medicine by KFDA

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 South Korea Biosimilar Market Analysis
4.3 Local Firms Dominating the Biosimilar R&D

4.4 Rising Bio Industry Exports

5. South Korea Biosimilar Market Future Outlook

5.1 Domestic Market Opportunity

5.2 Contract Manufacturing Opportunity

6. Regulation for Evaluation of Biosimilars in South Korea

6.1 Terminology

6.2 Selection Of Reference Product

6.3 Evaluation of Quality

6.3.1 Manufacturing Process

6.3.2 Comparability Studies For Quality Evaluation

6.3.3 Specifications

6.3.4 Analytical Procedures

6.3.5 Stability Studies

6.4 Non-Clinical Evaluation

6.5 Clinical Evaluation

6.5.1 Pharmacokinetic Studies

6.5.2 Pharmacodynamic Studies

6.5.3 Efficacy Studies

6.5.4 Confirmatory Pharmacokinetic / Pharmacodynamic Studies

6.5.5 Safety

6.5.6 Immunogenicity

6.5.7 Extrapolation To Other Clinical Indications

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 South Korea Biosimilar Market Analysis

7. Competitive Landscape

7.1 Samsung Biologics

7.2 Celltrion

7.3 Dong-A Pharm

7.4 LG life Sciences

7.5 ISU Abxis

List of Figures
Figure 1-1: Biopharmaceutical Market (US$ Billion), 2008-2011

Figure 1-2: Share of South Korea in Global Biosimilar Market, 2012

Figure 1-3: South Korea Biosimilar Market Revenue (US$ Million), 2011-2013

Figure 1-4: Favorable Market Dynamics for Biosimilar Development in South Korea

Figure 1-5: Key Challenges for Biosimilar Development in South Korea

Figure 1-6: Regulatory Framework for Biosimilar Development in South Korea

Figure 2-1: Number of Biosimilars Development by Phase

Figure 2-2: Number of Biosimilars Development by Disease

Figure 5-1: Targeted Share of South Korea in Global Biosimilar Market, 2020

Figure 5-2: South Korea Biosimilar Market Revenue Forecast (US$ Million), 2014-2018

Figure 5-3: Factors Driving Contract Manufacturing Opportunity in South Korea

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 South Korea Biosimilar Market Analysis

List of Tables

Table 2-1: South Korea Biosimilar Pipeline by Disease, Phase & Company

Table 5-1: Bio Clusters in South Korea- Major Pockets of Opportunities in the Biosimilars
Market

Table 7-1: Celltrion Drug Pipeline

Table 7-2: Dong-A Pharmaceutical Drug Pipeline

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