Generic drugs enter the "open hanging" mode

Source: on August 15, 2014, "Herceptin", a kind of "big brand" imported biological medicine with outstanding efficacy, often makes people "love and hate" It is effective in the treatment of breast cancer and other serious diseases Users will not have upset, vomiting and other adverse reactions seen in conventional chemotherapy, but the cost of treatment is amazing The price of a 440mg preparation is as high as 23000 yuan For domestic patients, there is now good news: "Herceptin" and a large number of biological drugs will usher in the "patent lifting" period next year At that time, domestic enterprises will provide generic drugs with similar efficacy and significantly reduced price Data from Datamonitor, a market research institution, shows that within half a year when generic drugs are market-oriented, the price will generally fall to about 20% of the price of the original patented drugs The followers welcome the opportunity of "counter attack" and "Shanzhai" commodities, and the approved generic drugs are reasonable and legal Because it is beneficial to reduce the cost of expensive patented drugs and medical insurance, and related to social welfare, it has been widely supported by governments In 1984, the United States Congress passed the drug price competition and patent period Compensation Act, officially opening the era of generic drugs The bill cleverly balances the relationship between generic drugs and innovative drugs, not only encourages the development of generic drugs, but also extends the patent protection period, providing sufficient impetus for the research and development of new drugs At present, the protection period of innovative drug patents is usually 20 years from the date of patent application China has always been a big country in the use of generic drugs In the nearly $100 billion pharmaceutical market, the proportion of generic drugs is more than 90%, but in the production of generic drugs, it is in a dilemma of high repetition of "inferior imitation" According to the data of the State Food and drug administration, 1039 drugs with more than 20 approval numbers have been newly declared in 2013, accounting for 42.8%, which to some extent leads to waste of resources and excessive competition However, with the decline of chemical generic drugs from the peak of patent expiration to the bottom in 2013, a new round of heavy biopharmaceutical patent expiration is coming, and the "white hot" competition may ease Many experts hope that the high level of bio pharmaceutical imitation can make a change in the current situation of China's generic pharmaceutical industry and enable enterprises to find a differentiated way to survive through technological upgrading Compared with chemical generic drugs, biological generic drugs are often compared to the crown of high-tech industry, which has two characteristics: high technical barriers and high investment threshold Its research time is long, and it needs more rigorous analysis and testing to prove that it has similar molecular structure with reference products It also needs more long-term clinical trials to prove that it has similar quality, safety and effectiveness with reference products, and the research cost is up to US $100 million In addition, imitation enterprises should pay attention to external trends at any time If they are not careful, they may "step on thunder" due to lax technical control or improper application timing Last year, Roche filed a lawsuit against breast cancer drugs jointly developed by mylan and Baikang in the Indian market The high court of New Delhi finally ruled that the two companies were prohibited from referring to the production process and sales process of Herceptin when promoting generic drugs It is not easy to copy, but the high profit margin still attracts competitors from all sides Recently, the State Food and drug administration has accepted the clinical project of "Herceptin" generic drugs, which means the domestic competition of the generic drugs has been upgraded Before that, Fosun medicine, CITIC Guojian, etc were all ahead of others in the application of the medicine, and a "post Herceptin" war was about to start The battle to join in the business process reengineering "Herceptin" of multinational companies is only a microcosm of the era of post patent biopharmaceuticals According to the latest data of AMR, an international pharmaceutical industry research organization, 10 influential biopharmaceuticals will lose patent protection in the next four years, with a total sales volume of 60 billion US dollars Multinational pharmaceutical companies are facing more and more operating pressure due to the gradual expiration of heavy drug patent rights, the rising cost of innovative drug research and development, and the low price of medical reform Multinational pharmaceutical giants such as Johnson & Johnson, Bayer, Roche and Pfizer have to adjust their original vertical integration mode to return their business to the core On the one hand, before the expiration of the patent, we should actively authorize generic drugs to the cooperative companies to resist the competition of generic drugs and continue to share the market harvest; at the same time, we should gradually decompose the research, development, production, sales and other business links of innovative drugs and outsource some projects The Asian market has relatively cheap factor prices and huge market space, and relevant institutions in India, China and other markets often become their preferred partners Indian pharmaceutical companies are undoubtedly the big stars in the emerging generic pharmaceutical market Before 2000, they were mainly engaged in the production of low-cost APIs and pharmaceutical products, and the export countries were mainly in Russia, Africa and other non-standard markets In 2005, the large local pharmaceutical enterprises completed the transformation and transformation quickly Now it seems that many practices of Indian pharmaceutical companies at that time were far sighted, such as increasing investment in research and development, laying out bio medicine with heavy money, and gradually accumulating advantages in the development of original research drugs For another example, it actively seeks opportunities for cross-border M & A, and constantly integrates resources, thereby successfully entering mature standard markets such as the United States, Germany and the United Kingdom Last year, India's drug exports totaled between $13 billion and $14 billion, making it the second largest source of us generic imports "China's pharmaceutical enterprises are also facing a rare strategic opportunity to actively cooperate with multinational giants and learn relevant technology, business and capital operation experience, which is conducive to improving the future development space." Wang Zhuowei of Shennong private equity medicine has been observing the pharmaceutical industry all the year round In his opinion, constantly adjusting the internationalization path is the key to the success of Indian pharmaceutical enterprises, which is worth learning from in China How should Chinese pharmaceutical enterprises participate in the world market? Luo Jiarong, an industry analyst at Shenyin Wanguo, summed up several "moves" Starting from the product side, in the future, enterprises can choose to join the global production chain of multinational enterprises or obtain overseas market standard certification to form high value-added exports in the form of preparations, etc.; the development of business side can be completed by merging or being merged with overseas enterprises; In the field of technology, project cooperation can speed up the acquisition of the latest R & D technology Of course, enterprises with patented technology can also be authorized to expand their business; in terms of capital, enterprises listed overseas can easily obtain the required capital services It is understood that some domestic first mover enterprises have taken action recently For example, the establishment of Haizheng Pfizer Pharmaceutical Co., Ltd by Haizheng pharmaceutical and Pfizer is an important attempt of cooperation between China and the United States in the pharmaceutical field In May this year, Fuyang production base of the joint venture company was officially put into production, dedicated to the production of generic drugs under the two companies The announced cooperation plan is very interesting Pfizer and Haizheng will respectively inject 7 and more than 70 of their products The joint venture company is responsible for the production and sales of these products, including the marketing of Pfizer's best-selling drug Viagra after the expiration of the patent In addition, about 20 of them need to be registered and listed by Haizheng "The joint venture has built a good platform With the help of the new product line, it is not difficult for Haizheng to complete the transformation from a low-end API enterprise to a pharmaceutical enterprise Next, how to make good use of Pfizer's powerful marketing network to open up the international market is the key " Wang Zhuowei said