Comparison of accessibility of biological analogues between China and Europe: EU is the pioneer, China's commercialization is fast

Wen 1 degrees C It is of special significance to reduce the burden of patients and help life science innovation benefit more people! China, Europe and the United States and other countries and regions, the European Union is a pioneer in the era of bio similar drugs! On April 11, 2006, EMA approved the first bio similar drug, namely, growth hormone omnitrope (somatopin) So far, EMA has approved 53 bio similar drugs, and 2 bio similar drugs have been rejected, including 19 monoclonal antibodies, 16 G-CSF, 5 EPOS, and 2 fusion proteins (etanercept) On March 6, 2015, zarxio (filgrastim sndz) was approved in the United States, opening the prelude of biological similar drugs in the United States FDA has approved 27 biologicals, including 18 monoclonal antibodies, 2 fusion proteins (etanercept), 5 G-CSF and 1 EPO On February 22, 2019, China's first hanlikang declared in accordance with the standards of biological similar drugs was approved and successfully commercialized, which means that the era of biological similar drugs in China officially opened Up to now, four biological analogues have been approved in China, all of which are monoclonal antibodies, and have been commercialized This paper aims to compare the accessibility of bio similar drugs in different countries and regions based on the differences in the review and approval of bio similar drugs between China and Europe In view of the differences in the review policies of biological analogues between China and the United States, this paper only deals with monoclonal antibodies, G-CSF and etanercept In the review and approval of biological similar drugs, the EU started nearly 10 years earlier than the FDA, and nearly 15 years earlier than China It is a pioneer! On April 11, 2006, the biosimilars of growth hormone omnitrope (somatropin) were approved In terms of the number of biosimilars approved for marketing in China and the United States over the years: 1 According to the approval of the first bioequivalent drug, FDA's era of bioequivalent drugs was nearly 10 years late, and nmpa was nearly 15 years late; 2 In 2018, it became a turning point in the review and approval of EU bio similar drugs, reaching a peak, in which 14 bio similar drugs were approved for listing; 3 Since 2015, the review and approval of FDA bio similar drugs have increased steadily year by year, reaching a new peak in 2019, and 10 bio similar drugs have been approved throughout the year; 4 In 2019, the first year of China's bio similar drugs, four monoclonal antibodies were approved for marketing and commercialized rapidly; 5 Despite the differences in review and approval policies, only from the perspective of monoclonal antibodies, fusion proteins and G-CSF products, the approval of biological analogues of global super heavy bomb drugs (McAbs + fusion proteins) in Europe and the United States has been basically the same Based on the public information, the author sorted out the status of the approval and commercialization of monoclonal antibodies, fusion proteins, G-CSF biological analogues in China and the United States, and compared the accessibility from the approved quantity, commercialized quantity, the earliest approved time and commercialized time Comparison of the accessibility of major biological analogues between China and Europe On December 31, 2019, it was officially commercialized; whether ogivri, trazimera and kanjinti were commercialized is not clear; whether fulphila, udenyca and grasustek were commercialized is not clear; * * the publication of online prices is considered to be commercialized Cyltezo, a bioequivalent drug developed by Boehringer Ingelheim, has been approved for listing in the EU, but has abandoned the EU market and focused on the U.S market It is expected to be commercialized in the U.S on July 1, 2023; * * * etanercept is not a similar drug declared for listing according to the standards of bioequivalent drugs The commercialization status of some biological analogues is unknown From the current situation: 1 In terms of the total amount of monoclonal antibodies, fusion proteins and G-CSF biological analogues, there are 36 in the European Union, 25 in the United States and 4 in China; the proportion of successful commercialization is 70%, 44% in the United States and 100% in China; 2 In terms of the accessibility of monoclonal antibodies, fusion proteins and G-CSF biological analogues, at least one biological analogues have been commercialized in Europe and America, except adalimumab and enalapril; 3 China has done the best in the accessibility of etanercept and adalimumab, and yisaipu has been approved earlier than the original drugs in China; 4 Although the number of biological similar drugs in China is still small, the commercialization speed is quite fast, and the accessibility is not too late 5 In 2020, China's first trastuzumab bioequivalent drug will be approved and expected to be commercialized soon Finally, in terms of the recently published online price, the accessibility of bio similar drugs greatly reduces the burden on patients, such as ankinning and amdal Compared with the original drug and medicine negotiation price in 2019, it continues to reduce by 10-16%! Biological similar medicine, let innovation benefit more patients, is of great significance! Price of original research drugs and bio similar drugs in China