China to release biosimilars guidelines

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China, one of the largest pharmaceutical markets in the world, is ready to issue biosimilars guidelines.

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The country is reportedly moving its pharmaceutical regulations closer to international standards, with the aim to speed up drug registration. Toward this end Dr Haifeng Hu, Vice President of the Shanghai Institute of Pharmaceutical Industry said that a new Drug Registration Regulation would be released by the China State Food and Drug Administration (SFDA) after the 18th National Congress of the Communist Party, which was held in Beijing on 8–14 November 2012.

The biosimilars guidelines are then expected to be finalized after the new drug registration regulation is released.

China’s healthcare reform of 2009, which aims to offer affordable medical care to more than 90% of its residents by the end of 2011 and to the entire population by 2020 [1], is expected to bring growing demand for cheaper biosimilars.

Domestic copy biologicals have been on the market in China for 20 years, according to data from the Southern Medicine Economic Research Institute (SMEI) of SFDA. The first recombinant human interferon 1 beta was launched in 1989. Domestic erythropoietins, granulocyte colony-stimulating factors and monoclonal antibodies are also commercialized in China. The country has approved 382 genetically engineered drugs and genetically engineered vaccines, but only 21 products are innovative and the rest are copy biologicals, according to SMEI data.

At present there are no specific guidelines for biosimilars in China, and therefore they have to go through a new drug approval process, meaning that phase III trials have to be carried out for all copy biologicals. China also only accepts global multi-centre trials for chemical drugs, not for biosimilars/copy biologicals. The new biosimilars guidelines are expected to be similar to US biosimilars guidelines, as SFDA has been working more closely with FDA, but are also expected to refer to EU regulations.

The biosimilars guidelines will further improve regulations on technical requirements and the quality control of biologicals to streamline the approval process, speeding up drug registration. Industry groups have welcomed the news, which they hope can reduce the cost and duration of clinical studies required for biosimilars.

China’s medical spending over the past five years has been double its massive GDP growth rate. According to industry researcher IMS Health, China was expected to become the world’s third-largest prescription drug market by 2011 and China’s medical spending is expected to grow 22% a year through 2013.

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1.  GaBI Online - Generics and Biosimilars Initiative. China’s Healthcare reform in 2010 []. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Nov 23]. Available from:

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Source: Financial Times

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