China's bio-similar drugs "explosion", market competition is becoming more and more intense

Pharmaceutical Network Industry Dynamics Recently, Xinda Bio announced that its Adamo single anti-biosimilar drug (Su Lixin) has been approved for the market for the treatment of rheumatoid arthritis, strong vertebrate and psoriasis.
is unique, and then Dongju Pharmaceuticals also announced that its beval-beaded single anti-injection biosynthic drug market application has been the day before by China's State Drug Administration.
China's biosimilar drug "explosion", the market competition is becoming more and more understood that biosimilar drugs, refers to the quality, safety and effectiveness of the approved reference drugs similar to therapeutic biological products, also known as biosimilars.
February 28, 2015, the Technical Guidelines for the Research and Evaluation of Biosynthic Drugs (Trial) were released, which for the first time clarified the definition of biosynthic drugs and proposed the basic principles for the development and evaluation of biosynthic drugs.
incomplete statistics show that at least seven biosypolisic drugs developed by China Biopharmaceutical Research and Development Corporation have been approved for listing in China.
addition, the Number of new drugs registered for import and approval by the National Drug Administration (NMPA) has reached 14 in 2020, up from 8 in the same period in 2019.
"explosion" of these major advances and breakthroughs means that China's biopharmaceutical industry is booming in the field of biosypharmaceutical research and development and production, and is also moving towards rapid development.
In fact, in recent years, with the expiration of patents for primary biological drugs and the continuous development of biotechnology, research and development of biosynthic drugs based on the quality, safety and ability of biological drugs in primary research has been accelerating and the market size is expanding.
1.7 billion biosypolyphic drugs worldwide in 2014, $7.2 billion in 2018 and expected to reach $164.4 billion in 2030, according to Frost Sullivan.
And based on the global biosynthic drug market, the industry pointed out that with China gradually establishing biosynthic drug regulatory approval path, health care capital cost control, Chinese enterprises manufacturing capacity improvement and a large number of well-known biological agent patents are about to expire, China's biosypolytic drug market size will reach 58.9 billion yuan in 2030, 2018-2030 average compound growth rate is expected to be 35.1%.
but it is worth noting that the sheer size of the market has also led to fierce competition among companies.
, although there are only four biosypolytes approved in China, the number of research and development pipelines is among the highest in the world.
statistics show that as of December 2019, there are about 391 biosynthic drug research and development pipelines in China, about 180 enterprises in the layout of biosynthic drugs, the main targets include CD20, EFGR, VEGF, TNF, RANKL, HER2 and so on, involving lytoxi monoantigen, qutozhu single resistance, beva bead single resistance, Adamo single resistance and other more than 50 popular drugs.
industry based on the current average development and market review time of China's biosynthic drugs forecast that the next three years will be nearly 30 domestic biosynthic drugs approved for market.
, The size of China's biosynthic drug market is expected to show explosive growth as more and more companies add to the market.
, but at the same time, in the next few years, popular varieties of biosynthic drugs will become more and more competitive.