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

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Category Healthcare

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

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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.
• Browse complete Report
• http//www.aarkstore.com/healthcare/118825/latest-
  chinese-guidance-for-development-evaluation-licens
  e-approval-of-biosimilars

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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.

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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

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Latest Chinese Guidance for Development,
Evaluation, License Approval of Biosimilars
Published May 2015  48 Pages

• 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.
• Price

Format Price
PDF 750
Site Licence 3500
Enterprise Wide Licence 4995
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