However, compared with the biopharmaceutical industry in advanced countries in the world, China's biopharmaceutical industry is still in the early stage of development, and its development is also facing a series of challenges.
Attach importance to the development strategy of generic drugs
According to the data of FiercePharma, an American pharmaceutical and biotechnology information agency, the sales of drugs with invalid patents reached $34 billion in 20 14, which was higher than $28 billion in 20 13 and lower than $55 billion in 20 12. It is estimated that this figure will climb to 66 billion in 20 15. In 20 14 years, there are 10 patented drugs that can be copied. For example, Novartis will lose the patents of Sandostatin and Exforge at the same time. Allergan's Lumigan will also expire in August 20 14. All the drugs of WarnerChilcott will basically expire on 20 14. Therefore, timely selection of expired generic drugs and preparation of declaration documents in advance will certainly gain profitable business opportunities.
For small molecular generic drugs, it is an important task of the Twelfth Five-Year Plan for national drug safety to evaluate the quality consistency and clinical consistency of generic drugs and comprehensively improve the quality of generic drugs. It is also an effective means to continuously improve the quality of drugs, which is of great significance to improve the overall level of the pharmaceutical industry and ensure the safety of public medication.
Pharmaceutical companies are the main body to carry out quality consistency evaluation of generic drugs. We must fully realize that it is of great significance to carry out the quality consistency evaluation of generic drugs to ensure drug quality and safety, promote the adjustment of pharmaceutical economic structure and industrial upgrading, and will also enhance the international competitiveness of China's pharmaceutical industry.
Because China's new drug research and development and innovation ability is the shortcoming of the whole industry, China's pharmaceutical industry has always maintained the status quo of "a big generic drug country". The quality consistency evaluation of generic drugs actually requires enterprises to re-examine the scientificity and rationality of products. If the country can fully reflect the value of generic drugs in terms of evaluation, pricing, bidding, medical insurance, etc., establish a catalogue of generic drugs reference preparations, gradually improve the quality evaluation system of generic drugs, and eliminate varieties whose internal quality and clinical efficacy can not meet the requirements, it will undoubtedly promote the overall level of generic drugs in China, thus reaching or approaching the international advanced level.
China pharmaceutical companies are not competitive internationally, so they should start with generic drugs. At present, the patented drugs of multinational pharmaceutical companies in China only account for 30% of the drugs circulating in the market. The more realistic way for pharmaceutical companies is to start with the imitation of international drugs and improve the imitation level. In this regard, pharmaceutical companies in Israel and India have done a good job with high quality, and some of them have passed the FDA certification in the United States and gained international recognition.
The models of pharmaceutical companies such as Israel and India are worth learning. They will prepare for scientific research two or three years before the patent expires, and launch new drugs as soon as the patent expires. Only when China pharmaceutical companies accumulate profits through imitation and have certain strength can they slowly develop real original drugs and seek higher profits.
In order to avoid homogeneous competition, China pharmaceutical enterprises need to consider the following issues: first, identify large varieties, track and analyze the information of expired or about to expire products, make full use of patented technology, patent invalidation and claim points, at the same time, pay attention to studying the international rules of the game of intellectual property rights, pay attention to the conflict between intellectual property law and generic drugs, and make use of the problems existing in international regulations and bilateral laws related to intellectual property rights. Secondly, we should attach importance to the development strategy and organize the demonstration of talent training programs in medicine, pharmacy, economics and intellectual property rights, which is particularly important for the research and development of complex biologically similar drugs. Third, improve the comprehensive development capacity, make use of domestic low human capital and production costs, and conduct research and development with foreign enterprises, so as to quickly accumulate experience and enhance the development and production capacity. The fourth is to introduce laws, regulations and guidelines related to biologically similar drugs to promote the foundation of scientific research and development and the sustainable development of the industry. Fifth, cultivate the habit of doctors, pharmacists and patients to use biosimilars, and introduce relevant policies to encourage the use of generic drugs instead of original drugs, so as to reduce medical expenses. Finally, we should attach importance to international production certification, actively use multi-channel financing models such as venture capital, actively explore the international market, merge and reorganize, and form international enterprises.
Attach importance to the research and development of pharmaceutical preparations
Drug release technology is the key to the development of high-end pharmaceutical preparations in China. From the strategic point of view of industrial development, preparation is a high-tech industry, a low-energy and low-pollution industry and a high value-added industry. It is also the only way for China to develop from a big producer of raw materials to a powerful pharmaceutical industry.
From the development strategy of pharmaceutical industry, we should develop high-end innovative preparations with core competitiveness, adopt various flexible cooperation methods, make full use of domestic and foreign resources and cost advantages, and find new development directions and ideas.
Combined with the development trend and frontier of international pharmaceutical preparations, we should pay attention to the following problems in developing new preparations in China.
First, attach importance to transformation and development. Pharmaceutical companies in the world have successively reduced R&D funds, closed R&D institutions or fired R&D personnel. Most of them are concerned about the development of new drug delivery system (DDS). The newly-added DDS market in the United States has reached1153.5 billion US dollars, with an average annual growth rate close to 16% compared with the previous five years. Therefore, it can be considered that DDS is obviously superior to the research and development of new entity drugs in improving research and development speed, shortening research and development cycle, reducing research and development risks and improving enterprise profits. For example, five nano-preparations, such as Hapamune developed by Elan, a small American company, have been approved by FDA continuously.
The second is to encourage basic enterprises to go out. In the process of going abroad, the state key laboratory of the enterprise can play a leading role. For example, many new preparations introduced by Shandong Luye Company have been approved by China FDA and US FDA, and can be used for clinical research. Under the background of globalization, the varieties with independent intellectual property rights of the company may become international new drugs.
The third is to study the application basis and industrialization development of new preparations. There are still many shortcomings in the research and development of DDS in China, and the key problems restricting its development are theory, technology, auxiliary materials, technology and equipment. During the "Eleventh Five-Year Plan" and "Twelfth Five-Year Plan" period, the state increased its support for this, which greatly mobilized the enthusiasm of R&D institutions and enterprises. In terms of nano-pharmaceutical preparations, FDA has approved the listing of many kinds of nano-drugs, and small companies can also carry out innovative research and development through preparations. Although China is a big producer of "nano-research papers", so far, no nano-drug has been approved in China.
Finally, strengthen the research and development and industrialization of pharmaceutical excipients. At present, domestic drugs are basically generic drugs, of which more than 95% are ordinary tablets and capsules. There are often more than 100 or even more than 200 companies producing similar drugs, but there are few companies producing high-end products such as sustained-release, controlled-release and intelligent preparations, and there are not many companies producing children's preparations, and there are even fewer professional institutions engaged in research and development.
Pharmaceutical excipients are the key to affect the quality, safety and effectiveness of preparations. At present, China's pharmaceutical excipients are still relatively backward. First, the quantity is small. Second, there are no research institutions for auxiliary materials in China. Third, the quality of auxiliary materials is poor and the selectivity is small. At the same time, there are many laws and policies on the quality management of pharmaceutical excipients in China, which are difficult to implement.
The author believes that the research and development of pharmaceutical excipients in China should start from the aspects of foundation, application, materials, technology and quality, and cannot rely on foreign countries. It is suggested that the country start research and development. In addition, the restrictions on using foreign useful materials and technologies to serve domestic enterprises should be reduced, international cooperation should be encouraged, and the principle that "recognized safe substances" can be used as auxiliary materials in the United States should be used for reference to give more freedom to research and develop new drugs.