China Today: Biogenerics in China: An Evolving Industry - China's large domestic market potential and its competence in producing biogenerics are driving its future direction - BioPharm International


China Today: Biogenerics in China: An Evolving Industry
China's large domestic market potential and its competence in producing biogenerics are driving its future direction

BioPharm International
Volume 20, Issue 6


The concept of biogenerics in the West is seen as an IP issue. In China it is a healthcare issue. Chinese biogenerics today include both off-patent and generic biological products developed by Chinese biopharmaceuticals before China entered the WTO. Since biogenerics account for over 95% of China's biopharmaceuticals, the biopharmaceutical industry in China today is virtually a biogenerics industry.

China's biopharmaceuticals industry began in the 1980s when the Chinese government introduced a series of national programs (e.g., the 863 Program, 85 and 95 Key Tech R&D Program) and placed biotech and related industry as one of the "major development sectors." Since the first Chinese-developed biotech drug—recombinant human interferon ?1b (produced by Shenzhen Kexing Biotech Co.)— entered the Chinese market in 1989, China's biopharmaceuticals industry has undergone rapid expansion. Today, Chinese biopharmaceutical companies have marketed 361 recombinant biogenerics (including therapeutics and vaccines) and 25 biotech drugs.4 More than 10 innovative biotech drugs have been launched into the market, and more than 100 biopharmaceuticals are currently at clinical trial stages.

Figure 1. China's pharmaceuticals and biopharmaceuticals sales revenue in 2005 (billion RMB)
Biopharmaceutical production value has grown from $30 million in 1986, to $4.2 billion in 2005. China's biopharmaceuticals sales revenue has grown 20–30% over the past five years. In 2005, biopharmaceuticals accounted for 7% of the pharmaceutical market (Figure 1). According to the China Biopharmaceutical Engineering Industry Outline, the country's biopharma industry production value is projected to exceed $12.5 billion by 2015.


Table 4A. Major biogenerics in China
There are over 2,000 biological products made by more than 200 Chinese biopharmaceutical companies, 95% of which could be classified as biogenerics. Chinese biogenerics include a wide range of biologics, such as genetically engineered drugs, vaccines, antibodies, and diagnostic agents. The major biogenerics and manufacturers are summarized in Table 4A and B.

Table 4B. Major biogenerics in China
Some Chinese biogenerics (e.g., rhG-CSF and EPO) have been manufactured and sold legally in China. G-CSF is manufactured by more than 30 Chinese biogenerics companies. Amgen applied for administrative protection for its Neupogen (G-CSF) and Epogen (EPO) in 1993, but did not win approval from the Chinese regulatory authorities. Other court cases are pending.

Some products are more likely to succeed as biogenerics. Several are currently under development by companies and many are already marketed in China and other developing countries. Short to mid-term biogenerics opportunities include hGH (registered), Insulin, IFN?, IFN?, G-CSF, GM-CSF, and FSH. Other longer term opportunities may include: Abciximab, Rituximab, Basiliximab, Infliximab, Trastuzumab, Alemtuzumab, and Adalimumab.5


Generic drugs have made significant contributions to China's healthcare system since the 1950s. In the past few years, China has begun to develop its own innovative drugs; yet generic drugs will continue to play an important role. China's biopharmaceuticals industry continues to expand and is likely to continue its steady growth through the foreseeable future. Chinese state and local governments are making concerted efforts to push for innovation, better R&D, and greater early-stage funding.

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