Significant results of drug review reform, comparison of antibody review strategies in China, the United States and the European Union

TextsDrug consulting Guo Lei team from 1975 hybrid tumor technology was born, until 1986 the first antibody drug OKT3 was bornSince then, more than 30 years later, antibody medicine has 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 sales of Top10 (Figure 1)As of April 30, 2020, the FDA has approved 90 new antibody drugs, of which 67 new antibody drugs and 18 antibody biosimilars have been approved after 20102); During the 2010-2020 period, the EU approved 56 new antibody drugs, China approved 9 new drugs (five of which were imported and all approved after 2017) and 4 biosimilarsBetween 2010 and 2020, only 40 percent of fda-approved antibody drugs went through the standard review process; 55 percent of new antibody drugs were approved, accelerating the final review process through orphan drug eligibility, breakthrough progress, priority review, accelerated market approval, and three other financially heavy players used priority review vouchers: Ravulyzumab, Guselab, and Aliro3 (Figure 3)Why are pharmaceutical companies keen to compete for priority review qualifications, orphan drug eligibility and even the use of priority review vouchers? And look at Figure 4 data: Between 2010 and 2020, among the 80 antibody drugs approved by the FDA (including antibody biosimilars), the average review time for antibody drugs qualified for priority review was 191.2 days; Most of the drugs eligible for orphan medicine sedituated with a "priority" qualification in priority review, breakthrough therapy or rapid review, resulting in an average review time of 221.5 days, a significant reduction from the 12-month period for standard reviewsThe EU review is more moderate, not as much as the FDA, so the average review time for the final antibody drug is much longer than that of the FDA (408.8 VS319.8 Day)The average review time for the four antibody drugs qualified for orphan drugs was 243 days, which was also far less than the standard review of 432.7 daysTo focus on the domestic, after 2010 a total of four domestic companies approved the launch of four new antibody drugs, and after 2018It is worth noting that all four drugs were PD-1 monoabandalization and were all qualified for priority review, with an final average review time of 351.5 daysAlthough it seems to get the priority review qualification, time is much longer than the FDA, but considering that, Cinda declaration, withdrawal, in the declaration of the twists and turns, HengRui because of the repeated communication of small hemangioma, not take the usual road of the forili bead singtag, in fact, this achievement has been a lot of good, worthy of praise to China CDE! In the review of antibody biosimilars, the FDA, the European Union and China took an average of 434.2, 447.5 and 388.3 days, respectivelyChina and the FDA are no longer much different in review time, but they are more time-consuming than in the European UnionIn this area, new antibody drugs are faster than biosimilars in FDA reviews, and the EU and FDA have the exact oppositeBetween 2010 and 2020, 18 of the 21 new anti-tumor antibody drugs approved by the FDA were eligible for orphan drugs, breakthrough therapies or priority reviews, and 13 of the 15 antibody drugs counted in the field of autoimmune disease were finally listed through the standard reviewSo at that time the high hopes of CGRP (mainly indications for migraines) and PCSK-9 target of the six new antibody drugs can only be a steady standard review, so there is the above Sanofi "one angry for the red face", a large hand shot of the priority review voucherChina's CDE has made great progress in the review of antibody drugs, in line with the attitude of complementing each otherWe can continue to look at the EU in the review of antibody biosimilars, and we should be able to pool the four accelerated procedures in the FDA review for the approval of new drugsAs a result, ordinary Chinese will be able to use new drugs faster and cheaper biosimilars.