The bioequivalence test of bosentan tablet, an imitative drug for pulmonary disease treatment in Zhejiang Province, will be carried out soon

According to the information on the website of the State Food and Drug Administration (CFDA), the evaluation status of bosentan tablet, a heavy-duty generic drug for lung disease declared by Zhejiang medicine, has changed to "completed the preparation of the certificate - issued the approval document in Zhejiang Province" On Tuesday, the head of the company told the big smart news agency that bosentan tablet has been approved for clinical use, that is to say, bioequivalence test will be carried out soon Bosentan tablet is used to treat pulmonary hypertension Its original research is actelion pharmaceuticals Ltd At present, no generic drugs have been listed in China, and Zhejiang medicine has taken the lead in obtaining clinical approval According to the application procedure of generic drugs, the oral preparations of generic drugs need to carry out bioequivalence test According to the insiders, the bioequivalence test of generic drugs is faster than the general clinical test, and Zhejiang medicine is expected to complete the test in 1-2 years IMS data shows that from 2004 to 2012, the global market size of PAH has increased from 636 million US dollars to 4 billion US dollars, with a compound annual growth rate of 28%, and the main varieties are bosentan, anlishentan, etc According to the data of Nanfang Institute, in 2011, the market amount of drugs for pulmonary hypertension in sample hospitals of 16 cities in China doubled over the previous year, and the main varieties are bosentan and iloprost; in 2013, the market scale of PAH prescription drugs in domestic hospitals will reach 500 million yuan Domestic companies applying for generic drugs include Zhejiang Pharmaceutical, Yuanda pharmaceutical, Chongqing Huabang pharmaceutical, Chongqing shenghuaxi pharmaceutical and Beijing Wansheng pharmaceutical, all of which are queuing up to apply It is worth mentioning that pulmonary hypertension (PAH) is a rare disease There are about 146000 patients with PAH in the world With the gradual implementation of the opinions on deepening the reform of drug review and approval and further encouraging innovation, clinical drugs for rare diseases and drugs for special population have been included in the "green channel" of priority acceptance and review.