Generics: how to innovate in imitation?

With the increasing proportion of generic drugs in the drug market, its dominant advantage in emerging markets is more and more obvious China is a big country of generic drugs, and more than 95% of the chemical drugs on the market are generic drugs In the pyramid of pharmaceutical manufacturing industry, generic drugs and generic drugs become the mainstay of Chinese pharmaceutical market However, in clinical application, it is still found that the clinical efficacy and quality of generic drugs are not as good as those of imported original products, especially the same drugs produced by different enterprises in China also have significant differences At the 2017 (second) pharmaceutical industry innovation forum hosted by China Pharmaceutical Industry Research Institute on April 14-15, Chen Guiliang, director of Shanghai drug review and verification center, introduced the current status of generic drug R & D application At present, the quality of drug application materials is uneven In 2016, the main problems found in the process of generic drug evaluation were as follows: first, the research on pharmaceutical technology and quality standards had major defects, and the stability research was insufficient; second, the preliminary research was not sufficient, and the gap between the evaluation requirements was too large, resulting in the applicant failed to complete the supplementary information on schedule or gave up the supplementary information in the later stage In terms of the number of registrations, in 2016, generic drug applications were mainly concentrated in the first half of the year, with an overall decreasing trend throughout the year Under the new drug policy reform, more enterprises will re-examine drug development and application, and find a balance between consistency evaluation and new product development How to "intensive cultivation"? So, in the face of the difficulty and cost surge of generic drug development, how can enterprises go out of the low-level replication stage and change to high-level and high-level drug research and development? Quality is the first thing Chen said that drug quality standards play an important guiding role in product design, formulation of production process control measures and product release In the research and development and production of pharmaceutical process, quality can be given by design In order to get a good design, we must increase the awareness of products and control the whole process of production Develop green technology Zhang Xumu, a professor at South University of science and technology, said that precise catalysis and green drug synthesis technology will make China a world pharmaceutical power How to improve the "atomic economy" in the production of chiral drugs is the key to the transformation and upgrading of the production process According to the medical geography reporter, there are about 2000 kinds of drugs used in the world at present, and more than 50% of them are chiral drugs, such as clopidogrel, benazepril and so on Therefore, the green preparation and industrialization of major drugs become a major task demand Pay attention to drug crystal Lu Yang, director of the National Center for analysis and research of drugs and metabolites, pointed out that the control of "dominant pharmaceutical crystal" in solid preparations is the key problem to ensure the consistency between generic drugs and original research imports Due to the different formulation and production process of the same generic pharmaceutical products produced by different enterprises in China, there are great differences in the crystalline state of the effective pharmaceutical ingredients, and 80% of the crystalline problems need to be solved Selection of superior varieties Wang Guan, an associate researcher of Shanghai Pharmaceutical Industry Research Institute, believes that the idea of innovative chemical drug research and development lies in "selective", that is, to imitate the optimization of innovation, so as to avoid the defects and deficiencies of optimizing and innovating original drugs, and to obtain drug characteristics and market advantages Among them, the selection of characteristic varieties of generic drugs can be evaluated through the comparison of similar drugs, clinical application advantages, market prospects, technical barriers and applicability, development risks, etc The research and development of generic drugs is a science and an art, from "follow run" to "parallel run", and then to "leading" in some fields Perhaps thinking about drug R & D innovation and decision-making on product development are the key to an enterprise's invincible position.