ABOUT US

The future of China's generic drugs can be expected!

2023-10-30

Author:

Number of views:

The United States is the world's largest market for generic drugs, and the largest market for the export of Chinese and Indian preparations is the United States. As far as the US market is concerned, the internationalization of generic drugs in China and India is different in terms of industrial development logic, first generic drugs and patent challenges.

1. Actively expand the U.S. market

After the reform and opening up, China's pharmaceutical industry has developed rapidly. Between 2000 and 2015, many pharmaceutical companies began to try to contact overseas markets. Since July 2015, China's drug regulatory authorities have issued a series of policies and measures to encourage the research and development of new drugs, and strengthen the docking of China's drug regulatory laws and regulations with the international community, creating more possibilities for domestic pharmaceutical enterprises to expand the US market. Compared with India, Chinese pharmaceutical companies have long relied on domestic market dividends and entered the US market late, with more opportunities to be developed and great potential.

2,Accelerate the approval of preparations.

Indian pharmaceutical companies are familiar with U.S. regulatory regulations, market rules, especially in the production of documents and document management is very good, to a certain extent even more than the local U.S. pharmaceutical companies, so its number of generic drugs in the United States compared to China's far ahead.

Chinese enterprises started late. In 2002, Huahai Pharmaceutical's nevirapine became the first Chinese preparation variety to pass FDA certification, which marked the official opening of China's preparation to expand the US market. Since 2015, the number of Chinese pharmaceutical companies registered in the United States ANDA has grown rapidly, but the approved dosage forms are still very single, mainly oral preparations and injections.

Currently, the FDA has significantly increased the cost of filing generic drugs. At the same time, with the intensification of competition in the US generic drug market and the decline in generic drug prices, Indian companies are also transforming their declaration of generic drugs in the US in the direction of fewer and better. Chinese enterprises should learn to use the lowest cost to increase the number of generic drugs approved in the United States in order to further develop China's generic drug industry.

RELATED INFORMATION