Two types of puzzles remain to be solved behind bio-similar drugs or "bend oversized" shortcuts for enterprises

Text . . In recent years, the field of biopharmaceuticals has gradually become the center of gravity of the global pharmaceutical industry, due to the growing demand for biological drugs, the expiration of a number of original research biopharmaceutical patents and the rising level of technology research and development and many other factors, bio-similar drugs have also received unprecedented attention, has become a field for pharmaceutical companies to enter.
at the 29th DIA Annual Conference on Bio-Product Innovation and Industrialization, scholars and business people expounded the definition of biosynthic drugs and related policies and market conditions.
2015, there is no clear definition of biosynthic drugs in China, and all applications are managed according to new biological products.
a series of reforms, and in March 2020, registration regulations incorporated biosypolyte-related content.
under the support of national policies and market leadership, perhaps with bio-similar drugs as the grasping hand, into the development boom, enterprises to achieve "bend over-the-ride" shortcut.
biosimilars and generic biosimilars are "and different" from generics.
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.
For the classification of chemical drugs, there are also three levels, namely, chemical innovative drugs, chemical drug-improved new drugs and generic drugs, and biological products classification level is exactly the same, so in a sense, biosimilars and generic drugs have many similarities, but there are differences.
are prominently similar to biosimilars, and chemical generics emphasize the same.
According to the Technical Guidelines for the Development and Evaluation of Biosimilars (Trial) issued by the National Drug Administration (NMPA), Biosimilar refers to therapeutic biological products that are similar in quality, safety and ability to approved reference drugs.
generics refers to the same generics as commodity-name drugs in terms of dosage, safety, pot, quality, effect and adaptive.
the former highlights similarities, while the latter emphasizes the same.
This difference stems from the difference between biological drugs and chemical structures, traditional chemicals have precise chemical molecular forms and molecular structures, while biopharmaceuser molecular weight is large, proteins, amino acids and other substances complex structure and mode of action is difficult to achieve accurate replication.
, the efficacy and safety of biological drugs may vary even if the molecules are the same and are produced through the same cells or microorganisms.
the difference between chemical and biological drugs Global biosynthetic drug market size analysis by virtue of the characteristics of strong specificity, good therapeutic effect and high pharmacological activity, biopharmaceuticals have now become the world's hottest drugs.
recent years, biologics have tended to hold 7-8 seats in the annual Top 10 list of global drug sales.
take the top 10 list of global drug sales in 2019 as an example, the chemicals are only apixaban, lynadamine and devasaban, the rest of the drugs are biological drugs, the drug king Shumeile continues to be proud of the group.
global market is close to $300 billion by 2019.
in the global market, the biopharmace idly drug market has reached new highs and continued to grow at a rate of $286.4 billion in 2019, up 9.4% Year-on-Year.
the growth rate of chemicals compared with the growth rate of nearly 10% in biological drugs, which was only 3.2% year-on-year in 2019.
the future, with the continuous progress of technology and the discovery of new targets, new therapies, the market size of biologics is expected to continue to increase.
(It is worth noting that the market size of chemical drugs is still far larger than that of biopharmaceders, with a global chemical market of $1038 billion in 2019 and only $286.4 billion in biological drugs, three times the size of the latter) The global biopharmaceity market size and growth in 2015-2019 Source: Frost Sullivan Global Biosynthics Growth Faster, but Overall Smaller.
in the biosynthics market, the global market reached US$9.5 billion in 2019 and a compound annual growth rate of 37.5% in 2015-2019, far outstaying the growth rate of the biopharmaceity market.
is not hard to spot that the market for biosynthics is extremely small, at just 3.3 per cent, compared with $286.4bn.
factors contributing to this phenomenon include many aspects, first of all, the market for biopharmaceus that falls off the patent cliff is limited in size.
According to Evaluate, the market for biopharmaceus companies over the patent protection period will be $87.4 billion by 2020, accounting for only one-third of the biopharmaceus market;
The U.S. patent of Semele lapsed in 2016, the U.S. patent of Merseyrail lapsed in 2015, and Hessetine's U.S. patent expired in 2019 for a short period of time;
global market size and growth rate of biosynthic drugs in 2015-2019 Source: Frost Sullivan China Biosynthics Market Size Analysis China Biopharmaceity Market Develops rapidly, with a growth rate significantly higher than the global level.
china's biopharmace products started late, but the development momentum of the biopharmaceder market is good, the market size in 2019 reached 317.2 billion yuan.
a compound growth rate of more than 25% from 2015 to 2019.
compared with the global growth rate of 10%, China's biopharmaceity market is still in the fast track of development.
size and growth rate of China's biopharmace products market in 2015-2019 Source: Frost Sullivan Since 2019, China's biosypolyte market has been completely detonated.
the early years of China's bio-similar drug market growth rate is relatively slow, 2015-2017 compound growth rate of only 15%, less than the overall growth rate of bio-drugs.
this has changed since 2018, especially in 2019, when the biosypole drug market was completely ignited, up 75 per cent year-on-year and with a market size of RMB2.8 billion.
size and growth rate of China's biosynthic drug market in 2014-2019 Source: Frost Sullivan Biosynthic Drug Approval Helps The Market Grow Stronger.
significant increase in the growth rate in 2019 stems from the successive approval of a number of biosynthic drugs, and 2019 is also considered to be the first year of biosynthic drugs in China.
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, China's bio-similar drug market in the future.
approved listed biosynthic drugs China's biosynthic drug research and development currently, China's biosynthic drug research and development is on the rise, a large number of enterprises are in this field of deep cultivation.
from the trend point of view, the research and development of bio-similar drugs mainly show a high enthusiasm for research and development, high concentration, fierce competition development trend.
china's biosynthic drugs in the research volume of the world's leading.
the DIA annual meeting, CDE-related department leaders said that China currently has about 270 biosynthic drugs in the research and development state, half of which are in the preclinical research stage, 65 submitted clinical applications.
looking at the world, the data show that the United States is studying 262 biosynthic drugs, South Korea 147, Europe 80, it is not difficult to find that China is studying the number of biosynthic drugs in the world's leading level.
this reflects the high enthusiasm of pharmaceutical companies for biosimilars, but behind the scenes project a fierce competition to catch up with me.
research and development is highly concentrated and highly competitive.
The research and development of biosynthic drugs in China mainly focuses on the drugs of lytoxi monoanti, quartz monoantigen, Adamo monoantigen, Inasip and Avastin six monoclonal antibody fusion proteins, mainly corresponding to CD20, Her2, TNF-α, VEGF and other targets.
To Adamu single resistance as an example, in addition to the three biosychic drugs that have been listed, Fuhong Hanxuan's HLX-03, Junshi Bio's UPP1211 have all submitted applications for listing, Tonghua Dongbao, Shenzhou Cells, Huahai Pharmaceuticals and other TNF-α biosynamic drugs are in the clinical Phase III research stage.
the challenges and coping strategies faced by biosynthic drugs in China, although the biosynthic drug market has broad prospects for development, it still faces many challenges, and the leaders of the relevant departments of CDE have answered this question.
from the national level, laws, regulations and technical standards system is not perfect, lack of supporting incentives, including priority review, payment system, health insurance policy, lack of a sound drug alert system.
so further improve the legal and regulatory system and technical standards system, the formulation of a full life cycle supporting incentive policies, improve the drug safety monitoring system has become the next focus of work.
at the technical level, there are many uncertainties in this field itself, and there are problems in the evaluation criteria of similarity, the extraterrion of adaptive disorders, the convergence of evaluation between progressive studies 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.
At present, China is in a critical period of strategic opportunity from imitation-oriented to imitation-based combination, in the "major new drug creation" and other scientific and technological special support, China's biosimilar drugs in the research and development of key links of the overall capacity significantly improved, the industrialization chain constantly improved.
hope that pharmaceutical companies can seize the development opportunities of biosimilar drugs, race against time, in the wave of research and development sand sea gold.
the original title: 2020 DIA site bio-similar drugs or into enterprises "bend oversized" shortcut, behind two types of problems to be solved