On April 13, the National Medical Products Administration announced on its official website that Amoxicillin capsules, Azithromycin tablets, Clopidogrel bisulfate tablets, enalapril Maleic acid tablets, enalapril Maleic acid tablets, Irbesartan Hydrochlorothiazide tablets and other six varieties, a total of seven specifications, had passed the consistency evaluation of generic drugs. From the statistics of the first three batches, a total of 29 product specifications and 22 varieties have passed the consistency evaluation, which makes people feel the pressure among them.

Previously, the General Office of the State Council issued the "Opinions on Reforming and Improving the Supply Guarantee and Use Policy of Generic Drugs", which clearly proposed to promote the substitution of generic drugs and include generic drugs that are consistent with the quality and efficacy of original research drugs in the list of interchangeable drugs with original research drugs. It has also increased the enthusiasm of domestic pharmaceutical companies to conduct consistency evaluations.

2018 is the deadline for consistency evaluation. There are 289 varieties, 17740 approval numbers, 1817 domestic enterprises, and 42 import enterprises. This is a revolution with a hundred billion yuan investment and a competition of strategy and speed.

According to the latest progress statistics from the China Medical Industry Center, as of April 12, a total of 47 applications for 289 basic drug catalog varieties (31 enterprises, 27 varieties after de duplication) have been accepted, including 38 domestic generic drugs, 3 imported generic drugs, 1 exemption from consistency evaluation, and 5 production lines; Accepted 56 applications for non 289 basic drug catalog varieties (26 enterprises, 30 varieties after de duplication), including 40 domestic generic drugs, 3 exempted from consistency evaluation, and 13 produced on the same line. The evaluation rate of 289 varieties is not high.

     The "289 Catalogue" refers to the list of oral varieties of generic drugs that must be evaluated for quality and efficacy consistency before the end of 2018, as published in the CFDA Announcement on Implementing the Opinions of the General Office of the State Council on Conducting Consistency Evaluation of Generic Drug Quality and Efficacy (2016 No. 106).

So, is the consistency evaluation over 289 or not?

We found that from the consistency evaluation BE filing situation, 82 varieties and 166 enterprises were involved in 289. Among the 29 product specifications that have been evaluated for consistency, only 10 are 289 varieties, while among the top ten batches of reference formulations, the catalog varieties in 289 account for nearly 26%. It can be seen that most enterprises are under 289. According to relevant sources, a large part of this is due to the "three changes" that make it difficult to produce varieties, while another part is due to the inability to produce characteristic varieties or the fact that eliminated varieties are not worth doing. In addition, there are 19 nationally unique varieties in the consistency evaluation, which are basically low-priced varieties. Many companies adopt a first observation attitude to see if clinical needs are truly needed and consider appropriate evaluation methods.

From the perspective of time constraints, a large number of enterprises have to give up due to time constraints, which means there is a risk of "closing down" the so-called 289 variety. Cost is a traditional Chinese medicine factor that many companies consider when it comes to 289 and non 289. Insiders told reporters, "There are many low-priced drugs in 289, but the evaluation fees are quite high. Before doing so, it is necessary to weigh them carefully. In addition, if there are many manufacturers, they will definitely not 'join the fun', and if there is only one, it will definitely be in demand." Indeed, for the 289 variety, there are not many companies with "wealth and wealth".

For non 289 exclusive varieties, with the promotion of graded diagnosis and treatment, the use of non base drugs at the grassroots level will be relaxed, and varieties outside the 289 catalog may be more popular for enterprises to imitate. This also means that the 289 varieties that are not attractive enough to enterprises may be impacted and given a cold shoulder. A pharmaceutical company candidly stated, "Following the footsteps set by the national bureau to conduct consistency evaluation is indeed too much pressure, and taking precautions, hoping to win a place in the long-term market of non 289 catalog varieties

From the perspective of the promotion of consistency evaluation, the government is a Carrot and stick, and the enterprises are rolling forward. Every family has exhausted their wisdom, hoping to squeeze out a survival gap on the very crowded track. From a strategic perspective, whether it is a 289 variety or a non 289 variety, the layout of the enterprise is more important to combine its own advantages and integrate key resources for centralized breakthroughs. After all, passing first means a significant tilt in the market.