China is a large country of generic drugs. Although it has achieved steady development, China's high-quality drug market has long been occupied by foreign original drug research. Some of the original drug prices are so high that the quality of generic drugs and market competition are becoming more and more serious. Recently, the status quo of the generic drug industry has triggered media attention. The media pointed to the pain point of the generic drug industry, and took the domestic drug gefitinib as an example to deeply analyze the development status of the generic drug industry. So, at present, what is the development stage of China's generic drug industry? What are the challenges? What challenges do generic drug companies need to meet in the future?
What is the status quo of China's generic drug industry?
According to data from the Center for Drug Evaluation (CDE) of the Food and Drug Administration, 239 of the 278 domestically approved drugs approved for sale in 2017 are generic drugs, accounting for 86%. Despite this, some experts have issued the view that “China’s generic drug industry is big but not strong”. On the one hand, it is the quality problem mentioned above, on the other hand, it is the comparison between the drug demand of patients and the drugs currently available. Big gap.
Quality, efficacy and competition are the key words of the status quo of the generics industry. In this regard, the state also gives high attention to the industry from the perspective of policies and regulations. For example, the “Opinions on Reforming and Perfecting the Supply and Guarantee Policy of Generic Drugs” proposed to promote the research and development of generic drugs, focusing on solving the shortage of high-quality generic drugs; highlighting the problem-oriented and improving the quality and efficacy of generic drugs; improving support policies and promoting High-quality generics enter clinical use as soon as possible.
Although the state urges all parties to improve the quality of generic drugs and improve the status quo of the industry from policies and regulations, there are still many factors that restrict the development of the industry. For example, the landing and implementation of policies, the coordination and coordination of various departments, and the marketing of products will become “roadblocks”.
There are still many challenges that need to be met by generic companies.
If the high-quality domestic generic drugs can do the morning market, it will be a huge benefit to patients and enterprises. Some doctors said that the listing of domestic generic drugs has brought great benefits to clinicians and patients, and it is a good thing for the benefit of the country and the people. The generic drug company also stated that the national policy has given great support and enabled the enterprise to have the motivation to improve quality and efficiency and innovate. However, in terms of medical insurance, although the original research drugs and generic drugs can be reimbursed in the hospital, in the pharmacy, generic drugs are not available, and imported drugs can be used.
In this regard, there is a point of view that the generic drug companies actually need to overcome three levels, namely supply, quality and property rights. However, from the market performance of gefitinib, there are opinions that the entry, use and reimbursement are more "realistic." Regardless of the level, in the future, the development of generic drugs in the Chinese market is really as expected, not so simple.
However, generic companies should not be too pessimistic, after all, the concept of generics has changed compared to the past. Relevant experts said that high-quality generic drugs are definitely not simply copied, pasted original drugs, nor cottage drugs, and its effects on patients can be comparable to the original drugs. In addition, the industry is also calling for the imposition of the generics industry to include the same reimbursement criteria.
If domestically produced generic drugs want to weather the storm, there is still a long way to go. At present, the state is pushing the generic drug companies to improve the quality and efficacy and improve the level of innovation through policies, such as access, use and reimbursement. Generic pharmaceutical companies should also do their own work to provide patients with genuine high quality and low price pharmaceutical products. As stated in one point of view: "China's generic drug industry must not only improve the quality of pharmaceutical products from research and development, but also pave the way for market promotion and supply security of generic drugs."