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Along with the continuous development of pharmaceuticals industries, China biological generics market is getting better. Its development potential is completely attractive either in demands or in policy environment.

It is reported that the current global biopharmaceutical products on sale have reached over 100 varieties. In addition, more than 400 kinds of drugs will complete the clinical trial and put on the market. Among 100 best-selling prescription drugs globally, the proportion of biotech drugs increased to 33% in 2010 from 15% in 2002 and it is expected to reach the proportion of 45% in 2016.

From the view of policy environment: new medical reform has brought the demand expansion of pharmaceutical market, especially when a policy on serious illness health insurance introduced, the dosage of antineoplastic agents has lifted, and monoclonal antibody-based generics are expected to seize the market.

In the aspect of approval, SFDA has launched and set out the related guideline for biological generics and the laws and regulations are expected to get it “Pass”.

In the aspect of production control, biological product enterprises will take the lead in passing the new version of GMP in 2013. The level of quality control will be in line with the international advanced level.

In the aspect of price control, the first biological generic will gain the preferential treatment.

In the aspect of cluster development, the biotechnology industry parks in various regions have stretched out olive branches to innovated biotechnology companies.

For China enterprises, the major task, currently, is to perfectly establish the registration channels and specialized teams as soon as possible in order to improve the level of production technology, quality control, clinical research and pharmacovigilance, be fully in accordance with the international standards; seize the opportunities in the biological generic field; and obtain the comparative advantages.


(March 06, 2014     From

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