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At present, the country has carried out five batches of six rounds of volume procurement.
Due to the particularity of biosimilar drugs, it has not been involved in related varieties.
However, in recent years, the call for such drugs to be included in centralized procurement has been increasing, and the national level has also released signals for exploration.
Carry out relevant centralized procurement work
.
Due to the particularity of biosimilar drugs, it has not been involved in related varieties.
However, in recent years, the call for such drugs to be included in centralized procurement has been increasing, and the national level has also released signals for exploration.
Carry out relevant centralized procurement work
.
For example, on July 15-16, 2020, relevant departments of the National Medical Security Administration held a symposium to listen to expert opinions and suggestions on the centralized procurement of biological products (including insulin) and Chinese patent medicines, study and improve procurement policies in related fields, and promote procurement methods Reform
.
On January 29, 2021, the Office of the State Council issued [2021] No.
2 document, clarifying that it will explore the merger of different generic drugs with similar indications or functions and indications to carry out centralized procurement
.
Regardless of the generic name, considering the actual indications or functional indications is obviously the procurement principle for the centralized procurement of Chinese patent medicines and biological products
.
.
On January 29, 2021, the Office of the State Council issued [2021] No.
2 document, clarifying that it will explore the merger of different generic drugs with similar indications or functions and indications to carry out centralized procurement
.
Regardless of the generic name, considering the actual indications or functional indications is obviously the procurement principle for the centralized procurement of Chinese patent medicines and biological products
.
In addition, in February this year, the Center for Drug Evaluation issued the "Guiding Principles for the Similarity Evaluation and Indication Extrapolation of Biosimilar Drugs", which is regarded as a "consistency evaluation" document for biological drugs in the industry.
With this blueprint, quality considerations and evaluations are available.
According to the basis, the biosimilar drugs evaluated by the similarity can achieve clinical equivalence with the original research drug, and the marketed biological drugs must carry out head-to-head clinical research with the original research drug, and the efficacy and safety results are the same
.
With this blueprint, quality considerations and evaluations are available.
According to the basis, the biosimilar drugs evaluated by the similarity can achieve clinical equivalence with the original research drug, and the marketed biological drugs must carry out head-to-head clinical research with the original research drug, and the efficacy and safety results are the same
.
The National Medical Insurance Administration attaches great importance to the proposal to explore a procurement mechanism suitable for biological agents
.
The "Opinions of the General Office of the State Council on Promoting the Normalized and Institutionalized Development of Centralized and Volume Procurement of Drugs" clearly stated that we should do everything we can
.
In the next step, the National Medical Insurance Administration will combine the characteristics of the similarity, stability and substitutability of biological preparations, consider the needs of clinical drugs, and fully solicit opinions from clinical and pharmaceutical experts and related companies to find out the production capacity of the company and form suitable biological preparations.
Characteristic rules
.
.
The "Opinions of the General Office of the State Council on Promoting the Normalized and Institutionalized Development of Centralized and Volume Procurement of Drugs" clearly stated that we should do everything we can
.
In the next step, the National Medical Insurance Administration will combine the characteristics of the similarity, stability and substitutability of biological preparations, consider the needs of clinical drugs, and fully solicit opinions from clinical and pharmaceutical experts and related companies to find out the production capacity of the company and form suitable biological preparations.
Characteristic rules
.
On the whole, under the background that the national system should be fully collected, it has become a trend for biological drugs to be included in the national centralized collection
.
Some insiders pointed out that the biopharmaceutical market is large, and some biosimilar drugs have the conditions to be included in centralized procurement
.
For example, in 2019, after China's first biosimilar was developed and marketed by Fuhong Henlius, biosimilars such as Lituximab, Adalimumab, Bevacizumab, and Trastuzumab were approved for marketing
.
Manufacturers involved include complex macro Hanlin, Hisun Pharmaceutical, Bio Integration, Qilu, Cinda biology
.
Among them, Rituximab, Adalimumab, and Befatizumab have met the number of 3 or more companies, and all have reached the conditions for centralized procurement
.
.
Some insiders pointed out that the biopharmaceutical market is large, and some biosimilar drugs have the conditions to be included in centralized procurement
.
For example, in 2019, after China's first biosimilar was developed and marketed by Fuhong Henlius, biosimilars such as Lituximab, Adalimumab, Bevacizumab, and Trastuzumab were approved for marketing
.
Manufacturers involved include complex macro Hanlin, Hisun Pharmaceutical, Bio Integration, Qilu, Cinda biology
.
Among them, Rituximab, Adalimumab, and Befatizumab have met the number of 3 or more companies, and all have reached the conditions for centralized procurement
.
Some people also pointed out that if biological medicines and Chinese patent medicines are included in the centralized procurement, the nearly 600 billion market will be affected
.
Data show that the size of China's pharmaceutical market in 2019 will reach 1,735.
9 billion yuan, of which proprietary Chinese medicines will account for 23.
1%, or about 401 billion yuan, and biological products will account for 9%, or about 156.
2 billion yuan
.
Together, these two pieces have exceeded 577.
2 billion yuan.
It is conceivable that once these varieties are included in the collection, it will affect the nearly 600 billion market!
.
Data show that the size of China's pharmaceutical market in 2019 will reach 1,735.
9 billion yuan, of which proprietary Chinese medicines will account for 23.
1%, or about 401 billion yuan, and biological products will account for 9%, or about 156.
2 billion yuan
.
Together, these two pieces have exceeded 577.
2 billion yuan.
It is conceivable that once these varieties are included in the collection, it will affect the nearly 600 billion market!
Based on the current policy development trend and the management experience of biosimilar drugs at home and abroad, the quality of drugs can be guaranteed through consistency evaluation and stable supply.
It is a general trend for biosimilars to be included in the scope of centralized procurement, which can not only improve national drugs Accessibility can reduce the economic burden and at the same time alleviate the pressure on the medical insurance fund
.
Facing the trend of centralized procurement of biopharmaceuticals, analysts suggested that pharmaceutical companies need to actively deploy centralized procurement strategies to reduce costs and increase efficiency to enhance their own advantages; prudently respond to the trend of centralized procurement, win market share while maintaining profitability; enrich marketing networks through multiple channels and develop Broad market and self-financed market; optimizing generic drug strategy to remain invincible in the wave of centralized procurement
.
It is a general trend for biosimilars to be included in the scope of centralized procurement, which can not only improve national drugs Accessibility can reduce the economic burden and at the same time alleviate the pressure on the medical insurance fund
.
Facing the trend of centralized procurement of biopharmaceuticals, analysts suggested that pharmaceutical companies need to actively deploy centralized procurement strategies to reduce costs and increase efficiency to enhance their own advantages; prudently respond to the trend of centralized procurement, win market share while maintaining profitability; enrich marketing networks through multiple channels and develop Broad market and self-financed market; optimizing generic drug strategy to remain invincible in the wave of centralized procurement
.
