Biosimilar Market Size, Share, Analysis and Forecast 2016 by Radiant Insights

Biosimilar Market Size, Share, Analysis and Forecast 2016 by
Radiant Insights
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.
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,
Browse Complete Summary, Click Here @ http://www.radiantinsights.com/research/latest-chinese-guidancefor-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.
Summary
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.
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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.
Table of Content
Contents.1
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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Responding to strong desire of overseas and multinational pharmaceutical manufacturers and domestic pharmaceutical manufacturers to carry out research and development of biosimilar products Visit Us @ http://www.radiantinsights.com/research/latest-chinese-guidance-for-development-evaluation-license-approval-of-biosimilars

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