Biopharmaceutical collection is coming soon

At the bid opening site of the fifth batch of national procurement, some experts bluntly said that the centralized procurement of injections can be successful, which to some extent indicates that the centralized procurement of biological preparations and proprietary Chinese medicines will also gradually advance.

1.

Recently, Gong Bo, director of the Pharmaceutical Price and Bidding Purchasing Department of the Shanghai Medical Insurance Bureau, told the media that there are now more than 620 clinical drugs, which can cover 80% of all purchases

Among the 620 kinds of medicines, chemicals account for about 490 kinds

On the eve of the fifth batch of national procurement bids, the "Notice on Issuing the Key Tasks for Deepening the Reform of the Medical and Health System" issued by the General Office of the State Council also emphasized once again-the normalization and institutionalization of centralized procurement of nationally organized drugs, and the gradual expansion of drugs and high Value the scope of centralized procurement of medical consumables

Regarding the promotion of national centralized procurement, Jin Chunlin, director of the Shanghai Municipal Hygiene and Health Development Research Center, told Cybernet that although the speed of companies’ over-consistency evaluation will limit the advancement of national procurement of chemical medicines, companies are also speeding up the development of consistency evaluations.

In addition, there are provincial-level purchases with volume for products that have not met the national procurement requirements in the number of companies reviewed, such as Shanghai's GPO and so on

It is believed that biosimilar drugs will gradually enter the framework of centralized procurement after the centralized procurement of commonly used clinical chemicals is completed

As for the start time of the centralized procurement of biological agents, Professor Ding Jinxi’s team from China Pharmaceutical University believes that, therefore, it is unlikely that biosimilar drugs will participate in the centralized procurement within 1-2 years.

2.

On January 29, at a regular policy briefing held by the Information Office of the State Council, Chen Jinfu, deputy director of the National Medical Insurance Administration, said: Biosimilar drugs, including large varieties of proprietary Chinese medicines, are included in the centralized procurement.

It can be boiled down to two sentences: there is no doubt that it is included in centralized procurement, quality must be a priority consideration, and rules must be more in line with market requirements

Chen Jinfu said bluntly, “There are differences in the quality evaluation methods of biosimilar drugs and chemical drugs, but they have strict quality standards.

Earlier, the National Medical Insurance Administration stated in its response to related proposals that it was studying policies related to the centralized procurement of biological products.

It is worth noting that at the end of July last year, the industry has circulated a list of Top 500 products that may be included in the collection, and multiple monoclonal antibodies, insulin and other biological drugs are listed-such as rituximab injection formulations, trastole Bevacizumab injection dosage form, bevacizumab injection dosage form
.

In addition, the content of a recent national drug procurement-related conference came out-the current clinical use is large, and the varieties that are not covered by centralized procurement, a total of 240 kinds, accounting for 39%; of which 130 kinds of chemical drugs, biological preparations There are 19 kinds of Chinese patent medicines, 91 kinds of Chinese patent medicines, these varieties may be targeted by volume purchases; 6 insulin varieties, the state will launch special volume purchases in due course
.

Tao Libo, a researcher at the Health Policy and Technology Evaluation Center of Peking University Health Science Center, stated in an article published recently that the rule of centralized procurement with quantity is the competitive competition of homogeneous products
.

Returning to biological preparations, how to prove the consistency of biosimilar drugs and original research drugs in order to achieve the competition of homogenized products has become a proposition that needs to be leaped
.

Regarding this issue, some experts said to Cyberlan that the similarity evaluation of biosimilar drugs can basically be regarded as the principle of consistency evaluation of biopharmaceuticals
.

At the beginning of 2021, the Drug Evaluation Center of the State Food and Drug Administration issued the "Technical Guidelines for Similarity Evaluation and Indication Extrapolation of Biosimilar Drugs (Draft for Comment)", in which the concept of similarity evaluation of biopharmaceuticals-namely: based on Comprehensive evaluation of biological drugs is carried out on the basis of various evidences such as pharmaceutical research, non-clinical research, and clinical comparison research, so as to determine the overall similarity between the biological similar drugs and the original (reference) drugs
.

It is worth noting that the "similarity" mentioned in the guidelines refers to the overall similarity between the candidate drug and the reference drug that has been approved for registration, and there are no clinically significant differences in quality, safety, and effectiveness
.

Some commentators pointed out that the release of this document laid the foundation for the alternative evaluation of biosimilar drugs and further centralized procurement
.
In the future, based on the comprehensive evaluation of experts, biological drugs and biological analogues that have similarity can be replaced in the clinic, and the centralized collection work can be carried out smoothly
.

3.
Possible forms of centralized procurement of biological agents

The above-mentioned experts told Cyberlan that the difference between the centralized procurement of biological agents and the existing centralized procurement is that it will be carried out in the form of special centralized procurement? Will there be any changes to the rules of the game? Whether quality stratification will be carried out may be a question that needs to be considered when collecting biopharmaceuticals
.

For example, due to the controversy about the consistency of biosimilar drugs and original research drugs, when conducting centralized procurement, whether it is necessary to set a quality score to properly layer the original research drugs and biosimilar drugs, or is it still only in the form of price points
.

For another example, due to the small number of production companies involved, there is uncertainty about whether the participating companies use bidding or negotiation
.

It further stated to Cyberland that volume purchase is for companies to gain market share through bidding, and price reduction negotiations are to obtain more market access qualifications through price reductions
.
When carrying out centralized procurement of biological drugs, some new payment methods or reforms in negotiation methods can be adopted by combining the advantages of national talks with the advantages of volume
.

It is not necessary to adopt the method of complete price competition, because biopharmaceuticals is still a relatively new industry in China.
If blindly lowering prices, it may have a certain negative impact on the industry.
After all, the investment of enterprises is very large, and it needs to be In the long run, it may be necessary to adopt some flexible ways to prevent out-of-control bidding
.

In addition, in the settlement process, the price is linked to the sales volume of the product, allowing the companies involved to comprehensively measure it
.
Instead of letting companies use market methods and out-of-control methods to make quotations, relevant parties set a framed quotation for the company, which might be better
.

A downward spiral in prices rather than a one-step approach may also be considered.
After all, the development of biopharmaceuticals in China is still in its infancy, and production capacity and output have to be developed and cultivated
.

In addition, biopharmaceuticals have extremely high requirements on the production process, and the quality of each batch of products may vary, so strict quality supervision is required
.

Indeed, due to the high technical content and complex processes of biopharmaceuticals, ensuring clinical substitutability in the centralized collection of biopharmaceuticals has become more and more important
.
Many experts pointed out that due to the complexity of biological drugs, biological analogues usually cannot fully replicate the manufacturing process of the original drug, and there may be differences in efficacy and safety in the end
.

IQVIA Ai Kunwei also pointed out in a policy analysis on volume procurement that for biological products, centralized procurement by local alliances and centralized procurement at the provincial level will become the main forms of procurement.
For individual products, the amount is relatively high, the competition is sufficient, and the quality standards are accurate.
The categories (such as insulin and antibody drugs) may enter the national special collection scope in batches
.