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【Pharmaceutical Network Market Analysis】It is reported that the eighth batch of national collective procurement is expected to be carried out at the end of 2022, and now it has entered October, which means that the eighth batch of collective procurement is like an arrow
.
So, what drugs will be included in the new round of collective procurement? From the current news, biosimilars may become the next batch of collective procurement targets
.
Recently, the National Health Insurance Administration responded
to the proposal on introducing an access evaluation mechanism for new innovative drugs.
The reply letter clearly stated that the collective procurement rules
of biological drugs will be continuously improved in combination with the characteristics of biological drugs.
Previously, the sixth batch of centralized procurement has carried out special centralized procurement for insulin, with a total of 16 varieties involving 42 products, with an average price reduction of 48%, covering the second and third generation of insulin commonly used in clinical practice, bringing good news
to more than 10 million patients using insulin.
However, there are some difficulties in the centralized procurement of biological drugs: compared with chemical drugs, biological drugs have no consistency evaluation as support, the naming is complex and diverse, and the ramp-up of production capacity is slow
.
In this regard, the National Medical Insurance Administration said that on the basis of the centralized procurement of chemical drugs, the National Medical Insurance Bureau will further adjust and improve the rules, and carefully formulate the rules for the centralized procurement of insulin taking into account the characteristics of biological drugs: First, before the centralized procurement, the medical institution will report the demand according to the brand, and after the selection result is generated, the medical institution will select the selected product according to certain rules, fully respect the clinical choice, and maintain the stability
of clinical drugs.
The second is to combine and group products with similar therapeutic purposes and clinical mechanisms but different generic names, taking into account the needs of clinical use and the adequacy
of competition.
Third, in view of the characteristics of biopharmaceutical production capacity constraints, fully grasp the production capacity of the enterprise through thorough investigation, set the agreed purchase volume not to exceed 50% of the production capacity of the enterprise, and reserve sufficient production preparation time when landing, and take multiple measures to ensure supply
.
In fact, the signal for the centralized procurement of biosimilars has long been launched
.
Previously, the National Medical Insurance Administration has repeatedly issued news that it intends to "include biosimilars in centralized procurement"
.
In February 2021, the Drug Review Center of the State Food and Drug Administration issued the Guidelines for Biosimilar Similarity Evaluation and Indication Extrapolation Technology, which specifically defines
the "similarity" of biosimilars.
This is seen in the industry as a signal
for the initiation of the "consistency evaluation" of biological products.
The industry believes that the reply letter of the National Medical Insurance Bureau means that the promotion of centralized procurement of biological drugs may have entered the agenda, and the market pattern of tens of billions of biosimilars will usher in changes
in the future.
Biosimilars refer to therapeutic biological products
that are similar in quality, safety and efficacy to the original drug (reference drug) that has been approved for registration.
China's biosimilar market is huge, Frost & Sullivan data show that it is expected that by 2030, China's biosimilar market will reach 58.
9 billion yuan
.
At present, biosimilars that have been marketed in China include bevacizumab, adalimumab, trastuzumab, rituximab, desnocumab and infliximab, in addition, about 180 pharmaceutical companies have laid out the product research and development of biosimilars, involving a total of about 400 drugs, and it is expected that nearly 30 domestically produced biosimilar drugs will be listed
within three years.
It is foreseeable that the competition in the biosimilar market will be very fierce in the future, and the inclusion of biopharmaceuticals in the scope of centralized procurement will undoubtedly have a huge impact on
enterprises.
Judging from the results of the sixth batch of centralized procurement, Tonghua Dongbao's 5 products won the bid in class B across the line, and 6 products from Gan & Lee Pharmaceutical were selected, among which insulin glargine injection won the bid with a high order, and the signals released by local companies were generally optimistic, while the quotation strategies of multinational pharmaceutical companies were generally conservative
.
After this centralized procurement, the industry expects that the tens of billions of insulin market will be redivided
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice
to anyone.