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市場調查報告書

中國國內的生技仿製藥開發、評估、認證的最新指南

Latest Chinese Guidance for Development, Evaluation, License Approval of Biosimilars

出版商 Access China Management Consulting 商品編碼 330441
出版日期 內容資訊 英文 48 Pages
商品交期: 最快1-2個工作天內
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中國國內的生技仿製藥開發、評估、認證的最新指南 Latest Chinese Guidance for Development, Evaluation, License Approval of Biosimilars
出版日期: 2015年05月18日 內容資訊: 英文 48 Pages
簡介

中國是全球最大的生技仿製藥市場,吸引來自國外的製藥企業和跨國公司的注目。中國的基因改造型生物產品的市場規模達到15億美元,其中的40%來自生技仿製藥項,這10年以25∼30%年複合成長率(CAGR) 擴大。一般認為今後若也以年率20%繼續成長,今後的市場規模將達到20億美元為。

本報告提供中國國內的生技仿製藥及生物醫藥品的最新評估、認證過程相關分析,藥局/製藥企業階段在研究、強化項目,及臨床現場/非臨床地點的評估項目、過程,產品登記制度的概要與實施情形等的相關調查。

第1章 摘要整理

第2章 與定義適用範圍

  • 定義
    • 生技仿製藥產品
    • 參照產品
    • 預定開發的生技仿製藥產品
  • 適用範圍

第3章 開發、評估的一般原則

  • 比較原則
  • 階段性進步的原則
  • 一貫性的原則
  • 生技仿製藥的評估原則

第4章 藥局的調查與評估

  • 整體考慮事項
  • 生產技術工程的調查
  • 分析方法
  • 特性分析
    • 物理化學的特性分析
    • 生物學的活動分析
    • 純度/不純度分析
    • 免疫上的特性分析
  • 品質指標
  • 穩定性的研究
  • 其他的研究
    • 宿主細胞
    • 調合劑的處方
    • 規格
    • 內部包裝用材料
  • 藥學性研究的相似性評估

第5章 非臨床調查、評估

  • 一般的考察
  • 藥物動力學學 (PD) 研究
  • 藥效學 (PK) 研究
  • 免疫抗原性的研究
  • 毒性的多劑量的研究
  • 相似性相關非臨床研究的評估

第6章 臨床調查、評估

  • 一般考察
  • 臨床藥理學研究
    • 藥物動力學學研究
    • 藥效學研究
    • 藥物動力學/藥效學 (PK/PD) 的研究
  • 功效的研究
  • 安全性的研究
  • 免疫抗原性的研究
  • 適應症的估計

第7章 產品的說明書和市售後醫藥品安全性監視

  • 產品的說明書
  • 市售後醫藥品安全性監視

第8章 中國的生技仿製藥的登記認證

  • 定義
  • 中國國內的生物來源物質的登記類別
  • 進口商品的生技仿製藥的登記用專用認證途徑
  • 生物產品的登記認證的申請文件和資料

第9章 附錄、藥物登記的申請書表格

目錄
Product Code: ACMC201505008

China has an indispensable biosimilar market for overseas and multinational pharmaceutical companies. Historical data shows 40 per cent of China's $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.

How to grasp the opportunity to smoothly conduct the research and development of biosimilar products in China and speed up your biosimilar product approval time? The overseas and multinational pharmaceutical manufacturers and their senior executive officers engaging in regulatory affairs must have a comprehensive and thorough knowledge of the latest Chinese guidance for development, evaluation, license approval of biosimilars, 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.

The organizations of this guidebook are arranged as follows. Chapter 2 introduces the applicable scope of the Guidance and some definitions involving to the Guidance. Chapter 3 gives an overview of general principles of development and evaluation of biosimilar products in China. Chapter 4 elaborates the research and evaluation of pharmacy. Chapter 5 elaborates the requirements for non-clinical research and evaluation. Chapter 6 elaborates the requirements for clinical research and evaluation in detail, from clinical pharmacology study covering pharmacokinetics study, pharmacodynamics study and (PK/PD) study, efficacy study, safety study, immunogenicity study to extrapolation of indications to smoothly navigate complex regulatory requirements step by step. Chapter 7 introduces the regulatory provisions for instructions of product and pharmacovigilance. Chapter 8 addresses the license approval of biosimilars in China, from China's registration category of biological products, specific pathway of license approval for imported biosimilar registration to application dossiers and data for license approval of biological products to guide you achieve a successful entry into the Chinese drug market, and smoothly operate your biosimilar products in China. Chapter 9 Appendix provides the China's Application Form of Drug Registration in English.

The audiences of this guidebook are overseas pharmaceutical manufacturers wishing to enter into the Chinese drug market, and multinational pharmaceutical companies have penetrated into the Chinese drug market, and their senior executive officers engaging in regulatory affairs expecting to understand how to apply for clinical trials and marketing license approval of their biosimilar products in China, how to comply with the latest Chinese guidance for development, evaluation, license approval of biosimilars.

After having skimmed through this guidebook, audiences can clearly acquire not only a comprehensive and thorough knowledge of the latest Chinese guidance for development, evaluation, license approval of biosimilars but also the practical operation how to comply with the latest Chinese guidance for development, evaluation, license approval of biosimilars. Access China Management Consulting Ltd hopes this guidebook, based on full and accurate regulations, can guide overseas and multinational pharmaceutical manufacturers and producers to achieve a successful entry into the Chinese drug market, and smoothly operate their products in China.

Report Highlights

  • The applicable scope of Guidance.
  • An overview of general principles of development and evaluation of biosimilar products in China.
  • The detailed requirements for research and evaluation of pharmacy.
  • The detailed requirements for non-clinical research and evaluation.
  • The detailed requirements for clinical research and evaluation, from clinical pharmacology study covering pharmacokinetics study, pharmacodynamics study and (PK/PD) study, efficacy study, safety study, immunogenicity study to extrapolation of indications to smoothly navigate complex regulatory requirements step by step.
  • An overview of marketing license approval of biosimilars in China, from China's registration category of biological products, specific pathway of license approval for imported biosimilar registration to application dossiers and data for license approval of biological products to guide you achieve a successful entry into the Chinese drug market, and smoothly operate your biosimilar products in China.
  • China's Application Form of Drug Registration in English.

Who should buy this report?

  • Overseas pharmaceutical manufacturers wishing to enter into the Chinese drug market.
  • Multinational pharmaceutical companies have penetrated into the Chinese drug market.
  • Companies interested in understanding the latest Chinese guidance for development, evaluation, license approval of biosimilars.
  • Senior executive officers engaging in regulatory affairs for exporting biosimilars into Chinese lucrative drug market.
  • Senior executive officers engaging in applying for registration and conducting clinical trials for exporting biosimilars into Chinese lucrative drug market.

Table of Contents

Chapter 1 Executive Summary

Chapter 2 Definitions and Applicable Scope

  • 2.1. Definitions
    • A. Biosimilar Products
    • B. Reference Products
    • C. Proposed Biosimilar Products
  • 2.2. Applicable Scope

Chapter 3 General Principles of Development and Evaluation

  • 3.1. Comparative Principle
  • 3.2. Gradually Progressive Principle
  • 3.3. Consistency Principle
  • 3.4. Biosimilarity Evaluation Principle

Chapter 4 Research and Evaluation of Pharmacy

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

Chapter 5 Non-Clinical Research and Evaluation

  • 5.1. General Considerations
  • 5.2. Pharmacodynamics (PD) study
  • 5.3. Pharmacokinetics (PK) Study
  • 5.4. Immunogenicity Study
  • 5.5. Multiple Dosing Study for Toxicity
  • 5.6. Other Studies for Toxicity
  • 5.7. Evaluation of Similarity for Non-Clinical Study

Chapter 6 Clinical Research and Evaluation

  • 6.1. General Considerations
  • 6.2. Clinical Pharmacology Study
    • A. Pharmacokinetics Study
    • B. Pharmacodynamics Study
    • C. Pharmacokinetics/ Pharmacodynamics (PK/PD) Study
  • 6.3. Efficacy Study
  • 6.4. Safety Study
  • 6.5. Immunogenicity Study
  • 6.6. Extrapolation of Indications

Chapter 7 Product's Instructions and Pharmacovigilance

  • 7.1. Instructions of Product
  • 7.2. Pharmacovigilance

Chapter 8 License Approval of Biosimilars in China

  • 8.1. Definitions
  • 8.2. Registration Category of Biological Products In china
  • 8.3. Specific Pathway of License Approval for Imported Biosimilar Registration
    • Figure 8.3. An Entire Process of License Approval for Imported Biosimilar Registration
  • 8.4. Application Dossiers and Data for License Approval of Biological Products

Chapter 9 Appendix. Application Form of Drug Registration

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