How should domestic enterprises meet the development of generic medicine

After experiencing the pains of transformation, upgrading and structural adjustment, the generic pharmaceutical industry in China is entering a new stage of development. How should domestic enterprises prepare for the development of generic pharmaceutical industry? Because generic drugs play an important role in the pharmaceutical market in China, consistency evaluation is bound to be an important work of many pharmaceutical enterprises in China, and even an important strategic decision-making in the future. Although the number of varieties passed consensus evaluation in 2018 is far lower than expected, the determination of the state to promote consistency evaluation will remain unchanged. From oral preparations to injection preparations, from basic drugs to non-basic drugs, from chemical drugs to biological drugs, consistency evaluation will become a persistent event of long-term existence and concern in China's pharmaceutical industry. For generic pharmaceutical enterprises, it is more rational to decide which varieties to carry out consistency evaluation research. Compared with 2017, 2018 has more rational considerations and more complex factor analysis, and the supporting policies of consistency evaluation are more perfect. The resources of enterprises are limited. For enterprises, blindly developing or blindly waiting may be severely punished by the market. Some of the punishments are even fatal to enterprises. In the new era, it is more important to grasp the variety market information more accurately and quickly, to evaluate objectively its own strength and advantages and disadvantages, to seek more objective and in-depth evaluation from experts or professional organizations, and to make strategic decision of consistency evaluation for enterprises, which is also an important turning point from blindness to rationality in China's market. With the development of information technology, the world has entered the era of big data and artificial intelligence. For the pharmaceutical industry, whether it is government policy-making or enterprise market decision-making, the past era of relying solely on expert subjective evaluation and lacking objective evidence has passed. Enterprises should conform to the development of the new era, more based on objective evidence and large data support to analyze and demonstrate, so as to make decision more rational.

Using the policy dividend of generic consistency evaluation, Chinese pharmaceutical companies have further accelerated the pace of opening up the generic drug market in the United States. Sino-US double newspapers can not only save R&D resources, but also obtain priority review from the Drug Administration, or be regarded as a consistent evaluation. In the first half of 2018, 31 ANDA approvals were granted to Chinese enterprises, of which 8 were temporary approvals. Guangdong Dongguang, Huahai Pharmaceutical and Hengrui Pharmaceutical were the most approved. It is gratifying that the application enterprises of ANDA have also ushered in a new face. For the first time, Ling Pharmaceutical, Tianjin Tianyao, Shandong New Age, Hainan Shuangcheng, Boyaxinhe and other enterprises have been approved by ANDA. By the end of 2018, the number of Chinese enterprises applying for the approval number of ANDA has expanded to 21. With China's increasingly close international contacts, the future of high-quality generic drugs will usher in a broader international market demand. For a long time, there has been a big gap between the quality of generic drugs in China and that of the original drugs. In the eyes of the Chinese people, the original drugs have brand names, generic drugs have no brand, and the price of generic drugs is very low compared with that of the original drugs. Most generic enterprises are the same. When producing many kinds of generic drugs, the market share of each kind of generic drugs is very low, and there is not enough profit to invest in the brand building of specific generic drugs, resulting in the phenomenon of "generic drugs without brands". However, with the continuous promotion of generic consistency evaluation and other major reform initiatives, the market competition structure of products will undergo tremendous changes in the future. Only a few powerful companies may compete in the generic drug market for specific products. In this new situation, the value of generic drug brands will be highlighted.

Many large international generic pharmaceutical companies, such as Teva, Mylan, have their own internationally recognized brands. Most enterprises in China start from chemical generic drugs and gradually transform to innovative drugs and biological drugs. At the moment of the restructuring of domestic generic pharmaceutical enterprises, it is an excellent opportunity for enterprises to rebuild their own brand. With the gradual opening of the domestic market, more international brand generic pharmaceutical enterprises will enter the Chinese market and compete with domestic generic drugs and original research drugs. If domestic generic drugs want to occupy the market, they must take the road of brand development.

The establishment of the National Medical Insurance Bureau is the key point of this institutional adjustment. It brings together the functions of medical insurance catalogue, medical product pricing and medical insurance fund payment, opens a new situation of specialized management, and significantly enhances the discourse power of medical insurance fund payment in medical reform. At the beginning of its establishment, we successfully completed the negotiation of "Special Access to Medical Insurance for Extra-Catalogue Anticancer Drugs". Seventeen kinds of anticancer drugs which are clinically necessary, effective and urgently needed by insured personnel were included in the medical insurance reimbursement catalogue. The payment standard of most imported drugs after negotiation was lower than the market price of the surrounding countries or regions, with an average of 36% lower. This move made the majority of the countries lower. The insured really enjoy medical insurance