By Liu Changxiao
A new low of the output of innovative drugs
The 2016 Novel Drugs Summary issued by the U.S. Food & Drug Administration (FDA) shows that FDA approved 22 new molecular entities (NDE) in total by the end of December 2016, including 15 new drug applications (NDA) and 7 biologics license applications (BLA), which created a new low since 2007.
The quantity of the new drugs approved by FDA in 2016 was less than a half of the 45 new drugs approved in 2015. The industry in general believed that the quality of the new drugs was high and the proportion of biologics approved had increased, but the quantity of biologics was far less than that in 2015. 2016 was also a year witnessing the fewest new drugs approved to be marketed in the recent decade, with only 31 novel drugs approved to be marketed in the world, including 19 in the U.S., 10 in the EU, 2 in Japan, and none in China.
FDA’s Center for Drug Evaluation and Research (CDER) approved 22 novel drugs in total in 2016, including 15 NDEs and 7 new BLAs, wherein, 8 were first-in-class drugs, accounting for 36% of the total quantity approved, and 9 were approved for rare diseases, accounting for about 41% of the total quantity approved.
Quality of the new drugs had bright spots, in spite of the quantity less than previous years: the 22 new drugs included many first-in-class drugs, new-generation drugs and accurate diagnostic agents, such as Venclexta, the first protein interaction inhibitor in a real sense, and Tecentriq, the first PD-L1 antibody. Antibody drugs were back to the mainstream stage and had strong performance.
From the perspective of the therapeutic field, the anti-virus infection drugs and cancer drugs were also eye-catching. The new HCV drug Epclusa of Gilead was the variety with the largest potential among the 4 anti-infective drugs approved by FDA in 2016, which is used to treat all 6 genotypes of HCV. Regarding cancer drugs, those noteworthy included Lartruvo to treat soft tissue sarcoma, Rubraca to treat ovarian cancer, Tecentriq to treat bladder cancer, and Venclexta to treat certain patients with chronic lymphocytic leukemia.
In addition, small and medium-sized pharmaceutical enterprises were active in innovation and R&D. Pfizer and Novartis, the top 2 in global pharmaceutical sales rankings, had none in the list of new drugs marketed in 2016, while, 9 small and medium-sized pharmaceutical enterprises represented by Jazz and Clovis each had one new drug marketed, Roche, MSD and Eli Lilly each had 2 new drugs approved, and giants like AbbVie, Sanofi, Gilead and Teva each had 1 new drug approved.
The leading position of the generic drugs not shaken in the world
The history record of the new molecular drugs approved by the U.S. and EU in 2015 made 2016 full of hope. The panic for new drug patent expiration continued to spread in 2015 and 2016. The competition from generic drugs is so important to the market and patients’ demand ability that it cannot be replaced by innovative drugs. Each country has put generic drugs in an important position especially under the situation of reduction of the medical expenses. The strategy of developing generic drugs to achieve access to and economy of drug treatment is an important strategy to reduce the medical burden in many ways.
More than 95% of drugs used clinically in the U.S. are generic drugs, and so are the more than 95% drugs applied by enterprises. More than 90% drugs approved by FDA to be marketed every year are also generic drugs; Japan also gives first place to generic drugs: only the top 50 enterprises in the 1600 pharmaceutical enterprises are able to make innovative drugs, and the other more than 1500 enterprises steadily make generic drugs to reduce the diagnosis and treatment expenses of Japan and meet the needs of Japanese people; but the new drugs approved in China are behind the U.S., regardless of the NMEs or generic drugs.
There were more than 6000 generic drug varieties backlogged for approval in the U.S. in 2015. The Office of Generic Drugs (OGD) of the FDA spent a rough time in 2016 for achieving the review target, with the varieties of gen...
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