The overall initiation rate of the evaluation in the generic drug was 11.18%

After the time limit for consistency evaluation was cancelled at the end of last year, the consistency evaluation of generic drugs involving 4185 varieties is still accelerating. With the recruitment policies of various provinces and municipalities continuing to land, many provinces and municipalities have implemented the policy of purchasing products that have not been evaluated, and products that have not been evaluated are facing the situation of being kicked out of the national market. The generic medicine war is on the horizon. According to the data of Clove Garden Insight database, as of July 30, there were 300 varieties and 1334 generic drug consistency evaluation applications accepted. Only 464 varieties were in the progress of BE experiment, and the start-up rate was only 11.18%. Among them, 230 acceptance numbers were passed, involving 87 varieties and 106 pharmaceutical enterprises. Among them, Qilu Pharmaceutical has surpassed Huahai Pharmaceutical Industry as the biggest winner of consistency evaluation, with 14 varieties passed, followed by Fuxing Pharmaceutical (13), Huahai Pharmaceutical (11) and China Biopharmaceutical (11). According to the previous policy, generic drugs in the "289 Catalogue" must complete the consistency evaluation before December 31, 2018, otherwise they will lose the chance to be purchased by medical institutions. However, on December 28, 2018, the State Drug Administration issued the Notice on Consistency Assessment of Quality and Efficacy of Generic Drugs (hereinafter referred to as "Notice"), which no longer sets a unified time limit for consistency evaluation of generic drug varieties that have been included in the national essential drug catalogue. Chemical generic drugs should be evaluated within 3 years after the first variety has passed the consistency evaluation. If the time limit is not completed, it may be appropriately postponed (in principle, no more than five years) after the application has been confirmed. If it is overdue and has not been completed, it shall not be re-registered.

The consistency evaluation process includes five steps: reference preparation filing, pharmaceutical research, BE filing, BE testing and supplementary application. The BE test is an important node signal for enterprises to prepare to declare consistency evaluation. According to data from Insight database of Clove Garden, as of July 30, 3473 of the 4 185 varieties to be evaluated had not made any progress yet. Based on the start-up point of BE test, only 464 varieties have been in the progress of BE test, the start-up rate is only 11.18%, and the average time of BE test is 237 days. "At present, there are too few institutions that can do BE test, and many enterprises are queuing up. It is necessary to increase the admission of these institutions, which will help to speed up the work of consistency evaluation." Shi Lichen, head of Beijing Dingchen Medical Consultation and Management Center, said.

In terms of the number of BE test varieties, Shangyuan Pharmaceutical Group has 38 varieties, followed by Yangzijiang Pharmaceutical Industry (25), Fuxing Pharmaceutical (24), Shiyao Group (19), Baiyunshan Pharmaceutical (18). As of July 30, there were 1334 acceptance numbers for consistency evaluation, 338 of which were approved, 7 of which were not approved, 32 of which were approved for clinical practice, 69 of which were not concluded, and 68.05% for consistency evaluation. It takes an average of 224 days for the drug evaluation center of the State Drug Administration to be undertaken and approved. 

In terms of the enterprises involved in the adoption of the varieties, the top ranking is all the pharmaceutical enterprises with strong pharmaceutical R&D strength in China, among which Qilu Pharmaceutical has become the biggest winner at present, a total of 14 varieties have been approved, including adefovir dipivoxil tablets, olanzapine tablets, tenofovir dipivoxil fumarate tablets. Fuxing Pharmaceutical followed closely, with 13 varieties overrated. Last year, Huahai Pharmaceutical Industry ranked third with 11 varieties overrated. In addition, according to the statistics of listed drug catalogue, 82 approval numbers were included on the basis of new registration and classification declaration, and were regarded as passed the consistency evaluation.