2020 biosimilars will welcome a blowout

"The pharmaceutical industry is undergoing the third industrial revolution led by life sciences, and biosimilars have become an emerging depression of value. Governments control the rapid growth of medical and health costs to encourage the development of generic drugs. By 2015, there will be $64 billion in bio-patents. The expiration of the drug has left a blowout space for the world's biosimilars. It is predicted that the market size will reach more than 20 billion U.S. dollars in 2020, and the compound growth rate in the next 10 years will reach 56%.” The second session held in Shanghai on October 23 Tao Jianhong, deputy director of SFDA Southern Institute of Pharmaceutical Economics, pointed out at the Biosimilar Summit Forum.
　　 The Chinese biosimilar market is also getting better. Regardless of the policy environment, social needs, and technological environment, its development potential is very attractive. Tao Jianhong said that for Chinese enterprises, the most important task at the moment is to establish and improve the registration channels and professional teams as soon as possible, improve the level of production technology, quality control, clinical research and pharmacovigilance, and fully integrate with international standards to strive for The biosimilar field seizes opportunities and gains comparative advantages.
　　The industry is growing rapidly
　　In recent years, the global biopharmaceutical market has shown rapid growth, with an average annual growth rate of 15%-18%. In 2010, the global biopharmaceutical market has reached 140 billion U.S. dollars. It is estimated that by 2020, biopharmaceutical products are expected to account for 1/3 of global pharmaceutical sales.
　　 It is understood that there are currently more than 100 biopharmaceutical products on the market worldwide, and more than 400 varieties may complete clinical studies and put them on the market. Among the 100 best-selling prescription drugs in the world, the proportion of biotechnology drugs will increase from 15% in 2002 to 33% in 2010, and is expected to account for 45% by 2016.
　　 At the same time, the research and development capabilities of biotechnology companies are also increasing, and the number of new biotechnology drug approvals is constantly increasing. In the past years, the proportion of biotechnology drugs in the new FDA approvals has exceeded 20%, reaching 34% in 2011.
　　 At present, as governments control the growth of medical and health expenses, the development of generic drugs is getting more and more encouragement. The wave of patented drugs expiring has also left huge room for the blowout growth of generic drugs. Tao Jianhong believes that this will make biosimilars a new value depression in the third industrial revolution dominated by life sciences.
　　According to Evaluatepharm's forecast, the global biosimilar market will grow to US$10 billion by 2015, and to US$20 billion in 2020. It will increase by about 90 times in the next 10 years. The compound annual growth rate is expected to reach 56%.
According to Chugai Pharmaceutical's forecast, the United States is still the largest biosimilar market in the seven countries with the largest market size, and it is expected to reach 9 billion US dollars in 2013. This is in line with the expiration of Chinese medicine biopharmaceutical patents in the US market. related. The United States will become the main force in the global biosimilars market and will promote the global biosimilars market to reach 11 to 25 billion U.S. dollars in 2020, thereby making it account for 4% to 10% of the global biosimilars market.
　　 Tao Jianhong said that assuming a price discount of 20% to 30%, by 2020, it is estimated that biosimilars will account for 50% of the non-patent protected biologics market. 2013-2020 will be the golden period for the development of biosimilars. In addition, it is worth mentioning that the current global biosimilar drug market is also highly dependent on policies and relatively concentrated in categories.
　　The Chinese market is getting better
　　 China is a big country in the production and use of generic drugs, and biosimilar drugs are also experiencing rapid development in the Chinese market. It is understood that the proportion of my country's biopharmaceutical output value in the total pharmaceutical output value rose from 7.91% in 2006 to 16.1% in 2011, and the proportion of profit rose from 10.3% in 2006 to 13.7%. However, the degree of intensification of my country's biopharmaceutical companies is currently not high.
　　 Among them, the share of biopharmaceuticals in the pharmaceutical market is mostly driven by large varieties. Among the top 500 sales, large varieties account for about 70%. Among the 13 types of 25 types of 382 different specifications of genetically engineered drugs and genetically engineered vaccine products that China has approved for marketing, only 6 types of 9 types of 21 specifications of products are original, and the rest are generic drugs.
Tao Jianhong pointed out that China’s review system does not have the concept of biosimilars. The review of biosimilars is based on new drug procedures, which are not very different from the original new drug review procedures. Major international products such as EPO, GCSF, Interferon was approved in the 1990s in China, but there are too many manufacturers of the same variety and fierce competition, and no domestically produced "blockbuster" varieties have appeared.