Three first generic drugs approved! Quality is the guarantee of the role of the mainstay of generic drugs


Release time:

2017-01-16

On January 12, the website of the State Food and Drug Administration (CFDA) announced that domestic generic drugs of anti-cancer drug gefitinib tablets, anti-AIDS drug efavirenz tablets and tenofovir disoproxil fumarate tablets were approved for listing. According to the information disclosed by CFDA, the approved gefitinib tablets produced by Qilu Pharmaceutical (Hainan) Co., Ltd., efavirenz tablets produced by Shanghai Diseno Biomedical Co., Ltd., and tenofovir disoproxil fumarate tablets produced by Chengdu Beite Pharmaceutical Co., Ltd. are all the first drugs to be successfully imitated in China, which are basically consistent with the quality and efficacy of the original drugs.

my country is a large producer of generic drugs. At present, the scale of domestic generic drugs is nearly 500 billion yuan, and there are nearly 5000 pharmaceutical companies. The total number of existing drug approval numbers is as high as 189000, and generic drugs account for 95% of the prescription volume. However, China is not a powerful country of generic drugs. A large number of domestic generic drugs are crude and inferior, and their safety is ineffective. The gross profit margin of the industry is less than 10%, which is far below the international average of 40%-50%.

The common people's medication must be safe, effective and accessible. Since the founding of New China, generic drugs have played an irreplaceable role in protecting the health of the people and promoting the development of China's medical and health services. However, it is undeniable that although generic drugs in China can guarantee safety, some varieties are different from the original drugs in terms of quality and efficacy. Through the evaluation of generic drug consistency, the quality of generic drugs in China can be greatly improved, and the effectiveness of drug use by the common people can also be guaranteed. The three first generic drugs were approved, and the quality and efficacy of the original drug were basically consistent, which gave a great affirmation to the improvement of the quality of generic drugs in China.

The consistency of quality and efficacy is a big threshold for domestic generic drug manufacturers, and it is also one of the reasons why domestic generic drugs have been unable to match the original research drugs. In order to achieve rapid development, a number of pharmaceutical manufacturing enterprises have emerged in China to build factories with research and development and technology. Seizing the opportunity of reform in the domestic pharmaceutical industry and aiming at the international market, Baiyang Pharmaceutical Co., Ltd. is an example of looking at the world and improving China's pharmaceutical manufacturing. It is reported that Baiyang Pharmaceutical is positioned in the research and development and production of high-end generic drugs. In October 2016, Baiyang Pharmaceutical passed the cGMP on-site inspection of FDA with zero defects, laying a solid foundation for the internationalization of preparations.

According to statistics, before 2017, nearly 100 best-selling drug patents will expire in the world, and most of the "blockbuster" varieties will face competition from generic drugs. At the same time, generic drugs have long been the "mainstay" of China's pharmaceutical consumer market, accounting for more than 80% of its sales in prescription drugs and more than 60% in the industry as a whole. How to seize the major opportunity of the expiration of the patent of the world's best-selling drugs and realize the improvement and counterattack of generic drugs from quality to efficacy is a major opportunity and challenge for Chinese pharmaceutical enterprises.

Zhang Xuan from the School of Pharmacy of Peking University said: "At present, the research and development of original research drugs in my country is still on the way, and the improvement of the quality of generic drugs is also on the way. I hope that in the near future, people can use better, safer and more economical drugs to improve the entire nation. The level of health."

According to the industry, generic drugs have the same active ingredients, dosage forms, routes of administration and therapeutic effects as the original drugs, but the price of generic drugs is much lower, which has important economic and social benefits such as reducing medical expenditure, improving drug accessibility and improving medical service level. Countries around the world have adopted legislation and other forms to support the development of generic drug industry. At present, the global market size of generic drugs is about 435 billion billion US dollars, and the market share of the industry is expected to grow to 36% by 2017.

For a long time, generic drugs have been the "mainstay" of China's pharmaceutical consumer market. Its sales accounted for 80% of prescription drugs and more than 60% of the industry. For some time to come, it should be said that generic drugs are still the dominant force in China's pharmaceutical market. Therefore, it is very important to improve the quality of generic drugs and ensure that the quality and efficacy of generic drugs are consistent with those of the original drugs. Experts said, "The improvement of the quality of generic drugs and the realization of clinical substitution with the original research drugs can promote structural reforms in the field of drug production".