Submitted: 3 May 2018; Revised: 8 May 2018; Accepted: 15 May 2018; Published online first: 25 May 2018
China has a huge market for copy biologicals, with 40% of China’s US$1.5 billion recombinant biologicals sales coming from copy biologicals, which have enjoyed compound annual growth rate (CAGR) of approximately 25–30% over the past decade. With predicted market growth of 25% per year, the Chinese copy biologicals market is expected to grow to US$2 billion. This makes it an attractive market to move into for more and more multinational biosimilars makers.
China first introduced draft guidelines for copy biologicals back in 2014 . The Technical Guideline was then updated and finalized in 2015 . The legal structure of the current Chinese copy biologicals guideline is based on the Drug Administration Law (Revised 2015) issued by the Chinese Government and on the Drug Registration Regulation (Revised 2007) issued by the China Food and Drug Administration (CFDA).
CFDA (simplified Chinese: 国家食品药品监督管理局) has been the Chinese authority that oversees all drug manufacturing, trade and registration in the country since 2003 .
The Drug Registration Regulation (Revised 2007) pathway classifies therapeutic biologicals into 15 categories :
The Chinese copy biologicals guideline is based on four principles:
These core principles should be used across the entire R & D and evaluation process, see Figure 1.
The updated and finalized Technical Guideline for copy biologicals  provides a relatively clear regulatory pathway for development of copy biologicals in China. It clarifies some confusion and provides the principles of R & D and evaluation for copy biologicals. It also helps to regulate activities and speed up the entire process. The guideline is also intended to raise the bar for entry into the copy biologicals field, avoiding low quality competition.
The Technical Guideline follows similar standards and principles as guidelines from other major markets. This, it is hoped, will increase the quality of products produced in the country and make them more competitive, as well as increase the possibility of marketing Chinese copy biologicals in other countries.
The main challenges with respect to the guideline include:
It should be noted that ‘copy biologicals’ approved in China might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The European Medicines Agency regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.
Competing interests: None.
Provenance and peer review: Commissioned; externally peer reviewed.
Michelle Derbyshire, PhD, GaBI Online Editor
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2. GaBI Online – Generics and Biosimilars Initiative. Chinese guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 May 8]. Available from: www.gabionline.net/Guidelines/Chinese-guidelines-for-biosimilars
3. Hu H. Challenges & strategies to enter the emerging markets for biosimilars. Biosimilars Europe Congress; 22–23 November 2016; London, UK.
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