Guidance for Overseas Players in Chinese Biosimilars Marketplace Available in Discounted Access China Study Recently Published at

22 May 2015 • by Natalie Aster

LONDON – China is an important biosimilars hub for multinational as well as foreign pharma players. Sales of biosimilars in the country demonstrated fact-paced growth over the last ten years. The Chinese market for biosimilars continues attracting an increasing number of overseas and multinational companies. It may reach USD 2 billion by 2015 and hold a share of approximately 20 percent of the global market.

Companies willing to penetrate the Chinese market face some problems related to development of their products in the country, products evaluation, and their license approval. Local pharma authorities have recently issued a technical guidance for development and evaluation of biosimilars in order to assist market entrants. 

New research study “Latest Chinese Guidance for Development, Evaluation, License Approval of Biosimilars” drawn up by Access China Management Consulting Ltd. offers a comprehensive guide to a process of development, evaluation and license approval of biosimilars in China. The report uncovers general principles of development and evaluation, and focuses on research and evaluation of pharma products. The study covers clinical and non-clinical research and investigation, besides concentrating on instructions of products and pharmacovigilance. The research report contains a detailed overview of marketing license approval in the country and includes the Application Form of Drug Registration.

Report Details:

Latest Chinese Guidance for Development, Evaluation, License Approval of Biosimilars
Published: May, 2015
Pages: 48
Price: US$ 750.00 US$ 638.00

More cutting-edge research reports by the publisher can be found at Access China page.


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Natalie Aster
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