Significant achievements in drug review reform Comparison of antibody review strategies between China, the United States and the European Union

From 1975, the hybrid tumor technology was born until the birth of the first antibody drug OKT3 in 1986Since then, more than 30 years, antibody drugs have gradually become an indispensable force in the field of medicineIn the last three years, antibody drugs have steadily become the largest variety in the global top10 sales ranking (Figure 1)Figure 1 List of Global Sales of Top10 Drugs 2017-2019
As of April 30, 2020, the FDA approved 90 new antibody drugs, of which 67 antibody new drugs and 18 antibody biosimilars were approved after 2010 Antibody drugs dominate the total number of new drugs (Figure 2); the European Union approved 56 new antibody drugs in the same period from 2010 to 2020; China approved nine new drugs (five of which were imported, all after 2017) and four biosimilarsFigure 2 Number of new drugs approved by the FDA 1993-2019
In the period 2010-2020, only 40% of fda-approved antibody new drugs followed the standard review process; The final review speed was accelerated through orphan drug eligibility, breakthrough progress, priority review, and faster listing approval, respectively, while three other cash-rich players used priority review vouchers: Ravulizumab, Guselkumab and Alirocumab (figure 3)Gossip Tip
In 2015, Sanofi used $67.5 million of priority review vouchers on Alirocumab to gain a competitive advantage over Amgen at the PCSK-9 target, eventually cutting back the review time by four months and anti-Amgen's Evolocumab a month earlyAfter Sanofi's priority review certificate in 2014, Amgen launched a patent infringement lawsuit against Sanofi, a long-running lawsuit in which Sanofi lost and exited the Japanese marketFigure 3 2010-2020 Fda drug distribution in different review pathways
Why are pharmaceutical companies keen to seek priority review qualifications, orphan drug qualifications and even the use of priority review vouchers? Looking at figure 4 data: In 2010-2020, the average review time for antibody drugs eligible for priority review in 80 antibody drugs approved by the FDA (including antibody biosimilars) was 191.2 days; The average time taken by "honest people" for standard reviews is 361.9 days; orphan medicines are supported by the Orphan Medicine Act, and in reality, most of the drugs that qualify for orphan drugs are combined with priority review, breakthrough therapy or a "priority" qualification in the rapid review, so the average review time is 221.5 days, a significant reduction from the 12-month period of the standard reviewtips
The FDA's four accelerated drug approval procedures: Fast Track, Accelerated Approval, Priority Review, and Breakthrough Therapy, where priority reviews specify that the FDA responds within 60 days of receiving the application and completes the review within six monthsthe EU review comparison, there is not as much pattern as the FDA, so the final antibody drug average review time is much longer than the FDA (408.8 VS319.8 Day)In the four antibody drugs that were awarded orphan drug eligibility, the average review time was 243 days, which was also much less than the standard review of 432.7 days to the domestic focus, after 2010 a total of four domestic enterprises approved the development of antibody drugs, and after 2018 It is worth noting that all four drugs were PD-1 monoantigens and were all eligible for priority review, with an average review time of 351.5 days Although it seems to get the priority review qualification, time is also far longer than the FDA, but considering that Cinda declaration, withdrawal, in the declaration of the week, Hengrui because of the repeated communication of microhenhestation, not the usual road of the Terrei Pearl single resistance, in fact, this achievement has been a lot of good, worthy of praise for China CDE! the average time taken by the FDA, the European Union and China was 434.2, 447.5 and 388.3 days, respectively, for the review of antibody biosimilar drugs China and the FDA are not much different in terms of review time, but they take longer than the European Union In this area, the FDA reviews antibody new drugs faster than biosimilars, and the European Union and the FDA have far-to-reverse Tips - China's Priority Review System In order to strengthen drug registration management and accelerate the development and marketing of new drugs of clinical value, the priority review was established under the guidance of the State Council's Opinions on Reforming the Review and Approval System for Drug Medical Devices in August 2015 and the Opinions of the State Administration of Food and Drug Administration (CFDA) on Encouraging Drug Innovation to Implement Priority Review and Approval in December 2017 For varieties included in the priority review, the Pharmaceutical Administration will give priority to the review and verification of resources, and the time limit for approval is expected to be shortened Figure 4 Average review time for antibody drugs in China, the European Union and the FDA (days) In 2010-2020, 18 of the 21 new anti-tumor antibody drugs approved by the FDA were eligible for orphan drugs, breakthrough therapies or priority reviews; So at that time the high hopes of CGRP (mainly indications for migraine) and PCSK-9 target of the six antibody new drugs can only be stable and proper walk ingested standard review, so there is the above Sanofi "a rage for red face", a large hand shot out of the priority review voucher China CDE has made great progress in the review of antibody drugs, in line with the attitude of making up for each other We can continue to look at the EU in the review of antibody biosimilars, and we should also be able to integrate the four acceleration procedures in the FDA review in the approval of new drugs As a result, ordinary Chinese will be able to use new drugs faster and cheaper biosimilars.