Synopsis

Responding to strong desire of overseas and multinational pharmaceutical manufacturers and domestic pharmaceutical manufacturers to carry out research and development of biosimilar products, this is first time in history, Chinese pharmaceutical authorities, China Food and Drug Administration officially issued a technical guidance for development and evaluation of biosimilars and defined the pathway of license approval for biosimilars. Chinese pharmaceutical authorities require that when conducting the research and development of biosimilar products in China, the applicant of biosimilar registration application and its sponsor should be in compliance with the Guidance and follow the pathway of license approval of biosimilars.

Summary

China has an indispensable biosimilar market for overseas and multinational pharmaceutical companies. Historical data shows 40 per cent of Chinas $1.5bn recombinant biologic product sales come from biosimilars, which have enjoyed approximately 25-30 per cent CAGR over the past decade. If the market continues to grow at 25 per cent per year, the biosimilar market could grow to $2bn, around 20 per cent of the global biosimilar market by 2015. It is attracting more and more overseas and multinational pharmaceutical manufacturers and producers to penetrate such market.

Responding to strong desire of overseas and multinational pharmaceutical manufacturers and domestic pharmaceutical manufacturers to carry out research and development of biosimilar products, this is first time in history, Chinese pharmaceutical authorities, China Food and Drug Administration officially issued a technical guidance for development and evaluation of biosimilars (Trial Implementation) on February 28, 2015, at the same time, announcement concerning implementing the Guidance issued by the CFDA defined the pathway of license approval for biosimilars. Chinese pharmaceutical authorities require that when conducting the research and development of biosimilar products, the applicant of biosimilar registration application and its sponsor should be in compliance with the Guidance and follow the pathway of license approval of biosimilars. There is a gigantically potential market of biosimilar products to meet the demand for Chinese patients. However, In China, the process of application and approval for clinical trials and marketing license approval of imported drug registration is very complex, because the Chinese pharmaceutical authorities administer and control this process by exorbitant administrative measures and regulations, moreover, these exorbitant administrative measures and regulations are variable and lack of transparency. In addition, the cultural difference between China and Western countries as well as the language barriers will increase the challenge faced by overseas and multinational pharmaceutical manufacturers and producers.

Scope

Latest Chinese Guidance for Development, Evaluation, License Approval of Biosimilars provided a comprehensive and thorough knowledge of the latest Chinese guidance for development, evaluation, license approval of biosimilars and guide you use the Chinese trial venues to keep biosimilars development lean and to smoothly operate in China.

Reasons To Buy

China has an indispensable biosimilar market for overseas and multinational pharmaceutical companies. Historical data shows 40 per cent of Chinas $1.5bn recombinant biologic product sales come from biosimilars, which have enjoyed approximately 25-30 per cent CAGR over the past decade. If the market continues to grow at 25 per cent per year, the biosimilar market could grow to $2bn, around 20 per cent of the global biosimilar market by 2015.

This is first time in history, Chinese pharmaceutical authorities, China Food and Drug Administration officially issued a technical guidance for development and evaluation of biosimilars and defined the pathway of license approval for biosimilars. Chinese pharmaceutical authorities require that when conducting the research and development of biosimilar products in China, the applicant of biosimilar registration application and its sponsor should be in compliance with the Guidance and follow the pathway of license approval of biosimilars.

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Table of Contents
Chapter 1 Executive Summary. 4

Chapter 2 Definitions and Applicable Scope.6
2.1. Definitions.6
A. Biosimilar Products. 6
B. Reference Products.7
C. Proposed Biosimilar Products.7
2.2. Applicable Scope.7

Chapter 3 General Principles of Development and Evaluation.8
3.1. Comparative Principle.8
3.2. Gradually Progressive Principle.8
3.3. Consistency Principle.9
3.4. Biosimilarity Evaluation Principle. 9

Chapter 4 Research and Evaluation of Pharmacy .10
4.1. General Considerations.10
4.2. Research of Production Technological Process.10
4.3. Analytical Methods.11
4.4. Characteristic Analyses.11
A. Analyses of Physicochemical Properties.11
B. Analyses of Biological Activities.12
C. Analyses of Purities and Impurities.12
D. Analyses of Immunological Characteristics .13
4.5. Quality Indexes.14
4.6. Stability Study.14
4.7. Other Studies.14
A. Host Cells.14
B. Preparation Prescription.15
C. Specification.15
D. Internal Packaging Materials.15
4.8. Evaluation of Similarity for Pharmaceutical Study.15

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