China is one of the largest pharmaceutical markets in the world, and has seen rapid growth in the biopharmaceuticals industry in recent years. However, it is still lacking guidance when it comes to biosimilars. Authors Li and Tuan from the Shenyang Pharmaceutical University, China, discuss how this affects biologicals companies in China [1].
A whopping 361 of the 382 biologicals approved in China are ‘copy biologicals’. 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 the China State Food and Drug Administration (SFDA) [2]. However, despite this fact, the country has yet to release biosimilars guidance. It was stated that a new Drug Registration Regulation, which would include biosimilars, would be released by the SFDA after the 18th National Congress of the Communist Party, which was held in Beijing on 8–14 November 2012, however, as yet nothing has emerged.
Problems for China’s biologicals industry include the fact that the scale of China’s biological companies is mostly small and medium, and their single financing channels lead to a shortage of funds for research and development.
In recent years, with more biologicals patents expiring, companies have simultaneously chosen the same reference monoclonal antibodies to imitate. This repeated investment of small-scale domestic enterprises has caused a huge waste of resources, resulting in low profit margins for ‘copy biologicals’ in China.
Another problem is the lack of a clear policy for biosimilars in China, with no definition of biosimilars or guidance is yet to release. The 2007 edition of the ‘Drug Registration’ Article XII declared that biological drug applications should be in accordance with new drug applications, with no mention of biosimilars.
Authors Li and Tuan therefore urge the Chinese Government to develop national policies and regulations for biosimilars ‘as soon as possible’. They also call on biologicals companies to ‘actively expand’ their financing channels and ‘strengthen cooperation with research institutions’ in order to increase innovation, while encouraging them to re-structure in order to enhance competitiveness.
The authors conclude that China, as a country that has embraced generics, should now grab the opportunity to develop biosimilars. They therefore urge the government to enact guideline principles for biosimilars soon, to fuel the biosimilars industry in China.
Conflict of interest
The authors of the research paper [1] did not declare any conflicts of interest.
Editor’s comment
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 EMA (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.
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References
1. Li Y, Tian L. Biosimilars: Current Status and Countermeasures. Asian Journal of Social Pharmacy. 2014;9(2):60-3.
2. GaBI Online - Generics and Biosimilars Initiative. China to release biosimilars guidelines [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 26]. Available from: www.gabionline.net/Guidelines/China-to-release-biosimilars-guidelines
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