Fluoxetine consistency evaluation: Shanghai Pharmaceutical ranked first in 6.7 billion market

On August 13th, Shanghai pharmaceutical announced that its holding subsidiary, Sinopharm, recently received the approval document for drug supplement application of Fluoxetine Hydrochloride Capsules (20mg) issued by the State Food and drug administration, becoming the first enterprise to declare the product and pass the consistency evaluation Fluoxetine hydrochloride capsule is an antidepressant According to the data of minenet, in 2017, the drug market of terminal antidepressants in public medical institutions in China was 6.744 billion yuan, an increase of 16.9% over the previous year Figure 1: time axis of application for consistency evaluation of fluoxetine hydrochloride capsule (source: medchina drug evaluation database 2.0 of minenet) According to the data of minenet, the application for conformity assessment of fluoxetine hydrochloride capsule (acceptance No cyhb1850001) of Chinese and Western medicine was undertaken by CDE on January 19, 2018, and entered the task sequence of the new report for conformity assessment, and was approved by the State Food and Drug Administration on August 1, 2018 The approval conclusion is that it has passed the conformity assessment of quality and efficacy of generic drugs, and is now in the "issued" state Figure 2: application for consistency evaluation of fluoxetine hydrochloride capsules (source: medchina drug review database 2.0 of minenet) According to the consistency evaluation application of fluoxetine hydrochloride capsule, at present, only one Chinese and Western pharmaceutical enterprise has applied and passed the consistency evaluation; according to the development of the be test of fluoxetine hydrochloride capsule, no enterprise has carried out the be test of this kind; according to the filing of the reference preparation of fluoxetine hydrochloride capsule, Changzhou Huasheng pharmaceutical, Shanxi Qianyuan Pharmaceutical Group and Taiji Group Chongqing Fuling pharmaceutical factory and other enterprises have already filed the reference preparation of this variety Figure 3: Sales of antidepressants in China's public medical institutions in 2013-2017 (unit: 10000 yuan) (source: minernet China's public medical institutions terminal competition pattern) fluoxetine hydrochloride capsule is a selective 5-HT reuptake inhibitor, a nervous system drug, which is mainly used in clinical treatment of depression According to minenet data, in 2017, the drug market of terminal antidepressants in China's urban public hospitals, county-level public hospitals, urban community centers and township hospitals (referred to as China's public medical institutions) was 6.744 billion yuan, an increase of 16.9% over the previous year Figure 4: in 2017, the competition pattern of fluoxetine hydrochloride capsule in China's public medical institutions terminal (source: minenet China public medical institutions terminal competition pattern) fluoxetine hydrochloride capsule was developed by Lilly company of the United States, and was listed in Belgium as early as the end of 1986 In 2017, the sales volume of terminal fluoxetine hydrochloride capsules in China's public medical institutions was 118 million yuan From the perspective of fluoxetine brand pattern, the former manufacturer Lilly's fluoxetine hydrochloride capsules (trade name Baiyoujie) accounted for the majority of the market share, while the Chinese and Western pharmaceutical that passed the consistency evaluation only accounted for 2.9% of the market share According to the relevant national policies, the drug varieties that pass the consistency evaluation will get more support in the fields of medical insurance payment and medical institution purchase Through the consistency evaluation of generic drugs, the fluoxetine hydrochloride capsules of Chinese and Western drugs will help to expand the market share of the drug, improve the market competitiveness, and carry out the consistency evaluation of generic drugs for the follow-up products of the company Valuable experience.