Biosynthic drugs usher in a period of development opportunities, but three major problems still need to be solved

In recent years, the field of biopharmaceuticals is gradually becoming the focus of the development of the global pharmaceutical industry.
At the same time, due to the growing demand for biological drugs, the expiration of patents for many original biological drugs and the rising level of technology research and development, biosynthic drugs have also begun to attract more and more attention, becoming a field for pharmaceutical companies to enter.
it is understood that biosypolytic drugs are therapeutic biological products, including monoantials, recombinant proteins, blood products, etc., that are similar in quality, safety and ability to approved reference drugs.
biosimilars are "different" from generic drugs.
July 1, 2020, the Measures for the Administration of Drug Registration were officially implemented.
Article 4, it is clear that biological products shall be classified according to innovative biological products, new drugs for improved biological products, listed biological products (including biosics), etc.
In fact, in recent years, with the expiration of patents for primary biological drugs and the continuous development of biotechnology, the research and development of biosynthic drugs based on the quality, safety and ability of biological drugs in primary research is accelerating and its 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.
Based on the good development of the global biosynthic drug market, as well as China's gradual establishment of 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, the size of China's biosynthic drug market may also be from a compound annual growth rate of 35.1% growth rate, reaching 58.9 billion yuan by 2030.
expanding domestic biosynthic drug market, thanks to the successive approval of biosynthic drugs.
it is understood that 2019 can be called the first year of China's bio-similar drugs.
February 2019, Fuhong Hanxuan's Lytoxi Single Resistance (Hanlikang) was approved for listing, with sales of 79 million yuan in 2019 and 95.8 million yuan in the first half of 2020.
same year, Baiotai and Haizheng Pharmaceuticals' Adamo single resistance, Qilu Pharmaceutical's Beval bead monoantiton resistance has been approved for market.
as of October 29, 2020, a total of eight biosic drugs had been approved for the market.
with a number of heavy-weight products have been listed, the industry forecast that China's bio-similar drug market in the future.
, it is worth noting that, despite the promising prospects of the biosynthic drug market, there are still many challenges, three of which need to be addressed urgently.
First, from the national level, in fact, China's current laws and regulations and technical standards system for biosynthic drugs is not perfect, lack of supporting incentives, including priority review, payment system, health insurance policy.
, further improving the legal and regulatory system and technical standards system, formulating a full life cycle supporting incentive policies, and improving the drug safety monitoring system will become the next important work.
Second, from a technical point of view, there are many uncertainties in this field itself, and there are problems in the evaluation criteria of similarity, the extraterrence of adaptation, the convergence of evaluation between progressive research and so on.
needs regulatory agencies, academic institutions and enterprises to communicate with each other, issue relevant guidelines to strengthen post-market risk control and safety monitoring.
from the market competition level, the huge market size has also brought fierce competition between enterprises.
, although there are only four biosypolytes approved in China, the number of research and development pipelines is among the highest in the world.
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.
also means that the market for biosynthics of popular varieties will become increasingly competitive in the future, with only drugs with stronger efficacy and more adaptive conditions able to stand out.
, with the broader coverage of health care and the significant increase in patients' ability to pay, will provide strong support for the development of biosypolytic drugs in China and accelerate the pace of market release.
, but at the same time, in the next few years, the bio-similar drug market war will be on the rise.