Industry barriers are too high Bio-similar drug research and development is booming

Research and development of biosynthic drugs is booming. Compared with chemicals, bio-similar drugs market space is large, heavy products, while the industry barriers are higher, related enterprises can obtain higher profits. Several brokerages have forecast that the global biosypolyte market will be $35 billion by 2020.market space
biosypolytes are therapeutic biological products that are similar in quality, safety and ability to approved reference drugs. Compared with chemical generics, the production process and requirements of biosimilars are much higher. In general, manufacturers need to develop new cell line, independently re-establish the manufacturing process, and verify the similar efficacy and safety of the original drug.
2016, seven of the world's top 10 drugs were biologics. Of these, six were single-resistance, with sales of $16 billion, while Roche's top three single-resistance sales revenue was $20.6 billion, accounting for 53% of Roche's drug revenue.
From a global point of view, the current research and development of biosynthic drugs mainly concentrated in EPO, growth hormone, lysoxi monoanti, truper bead monoanti, beval bead monoanti, Adamo monoanti, Inasip and Invlisi monoanti, such as expired patent varieties. Due to the high threshold for the development of biosynthic drugs, participants are concentrated in a small number of giants such as Novarce, Pfizer( Hospira), Amjin, Mercer East and Samsung.
the Chinese market, 2015 was a turning point in the management of biosynthic drugs, and the policy gradually became in line with the European and American markets, greatly improving research and development, production barriers, and protecting the market. At present, Fuhong Hanxuan, Xinda Bio and other enterprises have made rapid progress in research and development, walking in the forefront of peers.
predicts that global biosypolytes will experience a period of rapid growth between 2015 and 2020. Biopharmaceons accounted for 44% of the world's top 200 drugs sold in 2016 for a total of $157.2 billion;
, a pharmaceutical researcher at China Pacific Securities, believes that the biosynthic drug market is on the eve of the outbreak. "2017-2020 will be a golden phase in the development of biosynthic drugs. 2013-2015 is mainly non-mono-resistant biological drugs patent expiration time, long hormones, erythrocytogen, granulocyte collection stimulation factors, interferon, insulin and other products of generic drugs have been listed; From 17 to 2020, mono-resistance will usher in the peak of patent expiration, including Adamu mono-resistance, Invlisi mono-resistance, lytoxi mono-resistance, beval-bead mono-resistance, curto-pearl mono-resistance and other patents will expire. " industry barriers high
" policy gradually became clear, industry barriers significantly increased. The research and development of single resistance will move from innovation declaration to similar drug declaration, which may be a market for only a few players in the future. The requirements of bioethicity have greatly improved the research and development capability, cost and production process of pharmaceutical companies. Mr Zhou said.
2007 version of the Drug Registration Management Measures requires biological products to be declared in accordance with the procedures for applying for new drugs. In the past, approved single-drug drugs are mostly declared according to new drugs, clinical trials and approval process cycle is long, but the overall cost is not high.
provides clear guidance on the definition and development of biosynthic drugs in accordance with the Technical Guidelines for the Development and Evaluation of Biosynthic Drugs (Trial) issued in February 2015. The Measures for the Administration of Drug Registration (Revised Draft), issued in July 2016, regulate the concept of biosynthic drugs and state that "the quality and efficacy of biosypolytic drugs should be highlighted in drug approval". The threshold for the development and declaration of biosypolysts has been raised.
from the current situation, the domestic market biosynthic drug research and development mainly concentrated in lytoxi monoanti, curt bead monoanti, beval bead mono-resistance and other 6 major mono-resistance varieties.
in accordance with the Circular issued in April 2017 by the Office of the Ministry of Human Resources and Social Security on determining the scope of negotiations on the 2017 National List of Essential Medical Insurance, Industrial Injury Insurance and Maternity Insurance Drugs, 44 lists of negotiated drugs, including 7 monoants. This shows the recognition of the clinical value of mono-anti-class drugs by the relevant departments, and Roche's anti-tumor mono-anti-tri-swordsman-curto-bead monoanti, lytoxi monoanti and beva-bead monoantigen are all entered into the negotiating catalogue. The list of health insurance negotiations accepts single anti-drugs, which supports the development of biosynthic drugs in China and is expected to speed up the introduction of the market. (China Securities News, China Securities News)