Regulation of copy biologicals in China

Category: Regulatory
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Abstract:
How copy biologicals are regulated in China was a subject outlined by Huiguo Hu during his presentation at the Biosimilars Europe Congress, which was held in London, UK on 22-23 November 2016 [1]. 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 was expected to grow to US$2 billion, accounting for around 20% of the global biosimilars market by 2015. 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 [2]. The Technical Guideline was then updated and finalized in 2015 [3]. 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). 

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