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When will biosimilars be collected and is the time ripe?

 Last Update: 2021-03-24
 Source: Internet
 Author: User

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Recently, the Center for Drug Evaluation (CDE) of the State Food and Drug Administration issued the "Guiding Principles for the Similarity Evaluation and Indication Extrapolation of Biologicals "Sexual evaluation" is here, and it is considered to prepare for the inclusion of biosimilars in centralized procurement.

In fact, on the eve of the Spring Festival, the "Opinions on Promoting the Normalized and Institutionalized Development of Centralized and Volume Procurement of Drugs" issued by the General Office of the State Council clearly stated that unreviewed varieties, proprietary Chinese medicines, and biosimilars will be included in centralized drug procurement.
At the regular policy briefing on January 28, Chen Jinfu, deputy director of the National Medical Insurance Administration, also made it clear that the inclusion of biosimilar drugs and proprietary Chinese medicines in centralized procurement is an institutional requirement, and there is no doubt that they should be included in centralized procurement.
The issuance of the guiding principles further confirms that the inclusion of biosimilars in centralized drug procurement is a foregone conclusion, and the distance from centralized procurement is getting closer and closer.

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So, is the time for centralized procurement of biosimilar drugs really ripe?

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So, is the time for centralized procurement of biosimilar drugs really ripe?

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So, is the time for centralized procurement of biosimilar drugs really ripe?

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So, is the time for centralized procurement of biosimilar drugs really ripe?

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Li Tianquan , co-founder and vice president of Yaozhi.

com, said that biological products have the characteristics of large molecular weight, complex structure, and complex production processes.

Different from chemical generic drugs, generic drugs are small-molecule compounds that can be consistent with the original research; biosimilar drugs have their unique characteristics, and the patented drugs "similar" to biosimilar drugs are biological agents with large structures.
, Need to be produced through bioengineering technology, different production technologies, different manufacturers, the molecular structure of a biosimilar drug with the same generic name cannot be exactly the same as that of the original drug, and it cannot be considered simply to pass the consistency evaluation like a chemical generic drug.
The quality and efficacy of biosimilars are the same as those of the original patented drugs.
Biosimilars not only need to demonstrate the similarities of non-clinical drugs, but also need to be compared with large clinical effectiveness.
Therefore, the inclusion of biosimilars in centralized procurement is not as good as generic drugs.
simple.

According to the content of the national policy documents and the medical insurance leaders' conversations, the inclusion of biological medicines and traditional Chinese medicines in the centralized procurement is affirmative.
Among them, the drugs that are most likely to be included in the centralized procurement are some drugs with sufficient competitive conditions, such as insulin drugs, and the other is biosimilar drugs.
The real biosimilar drugs currently only include adalimumab, rituximab, and treximab.
Several monoclonal antibodies such as Tocilizumab, Bevacizumab, and Infliximab were launched on the market.

Public data shows that there are currently about 300 biosimilar drugs in different stages of research and development in China.
Up to now, 9 biosimilar drugs have been listed in China, involving Fuhong Henlius, Cinda Bio, Biotech, Qilu Pharmaceutical, Five Hisun vPro companies.
In addition, according to global best-selling drug data, in 2020, 5 of the world's top 10 best-selling drugs are biologics, and 14 of the top 20 are biologics.
Adalimumab (Humira), which ranks number one, has continued to top the list.
After 9 years, sales in 2020 will reach 19.
832 billion yuan.

Li Tianquan , co-founder and vice president of Yaozhi.

com, said that biological products have the characteristics of large molecular weight, complex structure, and complex production processes.
Biological analogues are a relatively new term that refers to quality, safety and effectiveness.
A therapeutic biological product that is similar to a reference drug that has been approved for registration.

Li Tianquan , co-founder and vice president of Yaozhi.

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Image source: Qiushi Pharmaceutical Co.
, Ltd.

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Image source: Qiushi Pharmaceutical Co.
, Ltd.

The Frost & Sullivan report shows that from 2018 to 2023, the compound annual growth rate of China's biological medicine market will reach 74.
2%, and the market size will reach 58.
9 billion yuan by 2030.
Moreover, the industry predicts that the research of biosimilar drugs has not yet reached its peak, and new biosimilar drugs will continue to be launched in the next few years.
It is estimated that more than 30 to 50 biosimilar drugs will be launched in China in the past three years.
The competition for biosimilars in China is fierce.
The degree will be self-evident.

The Frost & Sullivan report shows that from 2018 to 2023, the compound annual growth rate of China's biological medicine market will reach 74.

2%, and the market size will reach 58.

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Source: Frost & Sullivan Report

According to the centralized procurement rules, as long as the number of original research drugs and generic drugs under the same generic name is greater than or equal to 3, centralized procurement can be launched.

Li Tianquan said that it is inevitable for biosimilars to enter the centralized procurement, but whether there will be several biosimilars in the first two batches of biopharmaceuticals is not very likely.

First, because biosimilars have their particularities, quality differences must be considered.

Two major policy difficulties faced by the development of biosimilar drugs

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Two major policy difficulties faced by the development of biosimilar drugs

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Two major policy difficulties faced by the development of biosimilar drugs

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Two major policy difficulties faced by the development of biosimilar drugs

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Du Chen, a strategic management expert and CEO coach of Chushida China, said : Biosimilar drugs are imitations of original biopharmaceuticals.
However, because the molecular weight of biopharmaceuticals is much larger than that of chemical drugs, the molecular structure is also more complex.
It is very difficult to be exactly the same as the original biologic drug.
CDE issued the "Technical Guidelines for Similarity Evaluation and Indication Extrapolation of Biologicalsimilars" to solve this problem and make the actual operation of pharmaceutical companies have rules.
The issuance of the "Guiding Principles", as well as the speeches of state leaders and the State Council's policies concerning medicine have received affirmative answers.
It will be sooner or later that biosimilar drugs will be included in the centralized procurement.

However, he pointed out that the current development of biosimilars is facing two policy difficulties that require the competent authorities to resolve them as soon as possible:

First, biosimilar drugs must have their own application and approval standards.
The standards for original biopharmaceuticals cannot always be used.
The process should be simplified and their own standards for biosimilar drugs should be established so that more biosimilar drugs can benefit the Chinese people.

Second, as soon as possible to determine the standard of similarity between biosimilar drugs and original biopharmaceuticals.
This is also the original intention of the "Guiding Principles", which is tantamount to solving this problem.

If these obstacles are eliminated, China's biosimilar drugs will have a larger and better quality development.
With the increase in the number of biosimilar drugs on the market, conditions have been created for centralized procurement, including accessibility, competition, and room for price reduction.

At the same time, he pointed out that in China's current population and income level, especially our per capita labor productivity level, chemical generic drugs, Chinese patent medicines, and biological analogues are still the main medicines for the people to treat diseases.
The relationship between chemical original research drugs and chemical generic drugs is different from the relationship between biological original research drugs and biosimilar drugs; the scale effect of biological drugs is completely two concepts from chemical drugs and Chinese patent drugs, and the research and development and imitation methods are also very different.
Big, the current biopharmaceutical market is still relatively small compared with the chemical medicine market, and it is still developing, but it is developing very rapidly.
Based on this, he believes that it is inevitable for biosimilars to be incorporated into centralized procurement, but consider the product characteristics of biosimilar With industrial development, the introduction of biosimilars into centralized procurement should be slow and cautious.

Du Chen, a strategic management expert and CEO coach of Transstar China, said Du Chen, a strategic management expert and CEO coach of Transstar China, said

However, he pointed out that the current development of biosimilars is facing two policy difficulties that require the competent authorities to resolve them as soon as possible:

Based on this, he believes that the inclusion of biosimilars in centralized procurement is inevitable, but considering the product characteristics and industrial development of biosimilars, the inclusion of biosimilars in centralized procurement should be slow and cautious.

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