Chinese Biosimilar Market

August 15, 2011 9:43 AM

China is the most populous country in the world and there is a growing opportunity for  high uptake of new therapies. China has made several drastic steps to demonstrate its commitment to improving drug safety standards in the country. Plans for concrete measures to improve drug safety and reduce counterfeiting have also been unveiled and effects are seen in the recent years.

China has joined TRIPS and IP regulations have improved since then but enforcement is insufficient. Most of the foreign companies deterring from sourcing APIs of on-patent drugs from the country

The pharmaceutical industry in China is highly fragmented with approximately 6,800 pharmaceutical companies. Of the 1,300 synthetic medicines produced in China, 97% are copies of originators’ products with only around 15% of the firms having GMP certificates.

China’s biopharmaceutical industry has undergone rapid expansion since the 1989 introduction of IFN-alpha-1b, but its focus still remains largely on generics rather than innovation. Generics play a huge role in China’s health economy with some 95% of the Chinese drug market consisting of generics.

The biopharmaceutical industry in China is virtually a biogenerics industry. Since the first biopharmaceutical (Schenzhen Kexing Biotech’s IFN alpha) entered the market in 1989, the market has undergone rapid expansion.

China is a significant force in biosimilar manufacturing and production and is currently able to produce eight of the world’s top 10 genetically engineered drugs and vaccines.

Including the key biologic classes – EPO, IFN, hGH and G-CSF – Chinese companies are active in developing biosimilar vaccines, monoclonal antibodies, human insulin and interleukin products.

EPO
A large market with lots of domestic players. A leading company in this market is Shenyang Sunshine / 3SBio with its Epiao brand.  There are several other biogenerics companies active in this segment.

IFN
A large and competitive market, with lots of domestic players including Shanghai Institute of Biological Products, Beijing Tri-Prime, Changchun Insitute of Biological Products, Shandong Kexing, Changshen Gene Pharma, Sunshine Pharma, Sundiro Pharma.

G-CSF
A fiercely competitive market with more than 20 domestic companies fighting for market share, including Changchun Institute of Biological Products, Beijing SL Pharmaceutical Co., Ltd., Xiamen Amoytop Biotech Co., Ltd. and Beijing Four-rings Biopharmaceutical Co., Ltd

Including the key biologic classes – EPO, IFN, hGH and G-CSF – Chinese companies are active in developing biogeneric vaccines, monoclonal antibodies, human insulin and interleukin products

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