市場調査レポート

中国国内のバイオシミラー開発・評価・認証の最新ガイドライン

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

発行 Access China Management Consulting 商品コード 330441
出版日 ページ情報 英文 48 Pages
納期: 即日から翌営業日
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中国国内のバイオシミラー開発・評価・認証の最新ガイドライン Latest Chinese Guidance for Development, Evaluation, License Approval of Biosimilars
出版日: 2015年05月18日 ページ情報: 英文 48 Pages
概要

中国は世界最大のバイオシミラー市場であり、国外の製薬企業や多国籍企業からの注目を集めています。中国の遺伝子組み換え型バイオ製品の市場規模は15億米ドルに達していますが、そのうちの40%がバイオシミラーからのもので、この10年間に25〜30%もの年平均成長率 (CAGR) で拡大してきました。今後も年率20%もの成長が続くとすると、今後の市場規模は20億米ドルにまで達する、と考えられています。

当レポートでは、中国国内でのバイオシミラーおよびバイオ医薬品の最新の評価・認証過程について分析し、薬局/製薬企業の段階での研究・強化項目や、臨床現場/非臨床地点での評価項目・過程、製品登録制度の概要と実施状況などについて調査しております。

第1章 エグゼクティブ・サマリー

第2章 定義と適用範囲

  • 定義
    • バイオシミラー製品
    • 参照製品
    • 開発予定のバイオシミラー製品
  • 適用範囲

第3章 開発・評価の一般原則

  • 比較原則
  • 段階的進歩の原則
  • 一貫性の原則
  • バイオシミラーの評価の原則

第4章 薬局の調査と評価

  • 全体的な考慮事項
  • 生産技術工程の調査
  • 分析手法
  • 特性分析
    • 物理化学的特性の分析
    • 生物学的活動の分析
    • 純度/不純度の分析
    • 免疫上の特性の分析
  • 品質指標
  • 安定性の研究
  • その他の研究
    • 宿主細胞
    • 調合剤の処方
    • 仕様
    • 内部包装用素材
  • 薬学的研究の類似性の評価

第5章 非臨床調査・評価

  • 一般的考察
  • 薬物動態学 (PD) 研究
  • 薬力学 (PK) 研究
  • 免疫原性の研究
  • 毒性の複数回投与の研究
  • 類似性に関する非臨床研究の評価

第6章 臨床調査・評価

  • 一般的考察
  • 臨床薬理学研究
    • 薬物動態学研究
    • 薬力学研究
    • 薬物動態学/薬力学 (PK/PD) の研究
  • 効能の研究
  • 安全性の研究
  • 免疫原性の研究
  • 適応症の推計

第7章 製品の説明書と市販後医薬品安全性監視

  • 製品の説明書
  • 市販後医薬品安全性監視 (ファーマゴビジランス)

第8章 中国におけるバイオシミラーの登録認証

  • 定義
  • 中国国内の生物由来物質の登録カテゴリー
  • 輸入品のバイオシミラーの登録用の専用認証経路
  • バイオ製品の登録認証のための申請書類とデータ

第9章 付録・薬剤登録の申請書フォーム

目次
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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