Will the eighth batch of collective procurement include biosimilars? One article combs 180 enterprises such as Qilu, Cinda, and Chia Tai Tianqing to compete for the 10 billion market!

The National Health Insurance Bureau said in its reply letter that at present, 6 batches of chemical drugs and 1 batch of biological drugs (insulin special) have been purchased in a centralized manner, and positive progress
has been made.

At the same time, the National Medical Insurance Administration also pointed out the 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
.
Therefore, the National Medical Insurance Bureau, together with relevant departments, has further adjusted and improved the rules on the basis of the centralized procurement of chemical drugs, and carefully formulated the rules for the centralized procurement of insulin taking into account the characteristics of biological drugs:

First, before the collection, 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 medication.

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 maximum production capacity of the enterprise, and reserve sufficient production preparation time when landing, and take multiple measures to ensure supply
.

In fact, the National Health Insurance Administration has also issued news many times before, intending to "include biosimilars in centralized procurement"
.
This time, the National Medical Insurance Bureau clearly revealed the idea and guidance
of "including biosimilars in centralized procurement".
The reply letter stated that in the next step, on the basis of the existing successful experience of collective procurement, combined with the characteristics of biological drugs, the rules for collective procurement of
biological drugs will be continuously improved.
This also means that the promotion of centralized procurement of biopharmaceuticals may have entered the agenda
.

In February last year, the Drug Review Center (CDE) of the State Food and Drug Administration issued the Guidelines for Biosimilar Similarity Evaluation and Indication Extrapolation Technology, which specifically defined
the "similarity" of biosimilars.
This is considered by the industry to be the "consistency evaluation" of biosimilars, and it is also considered to be a preparation for biosimilars to be
included in centralized procurement.

The exploration and practice of insulin collection has also accumulated certain experience
for biosimilar tissue collection.
As a typical biological drug, insulin macromolecular products are different from small molecule chemical drugs, and cannot be simply evaluated for consistency, but compared with complex biological drugs, peptide insulin and insulin analogues have their special properties
.

In November 2021, the national special centralized procurement of insulin was opened, and the centralized procurement varieties of drugs this time were mealtime human insulin, basal human insulin, premixed human insulin, mealtime insulin analogues, basal insulin analogues, and premixed insulin analogues, a total of 6 procurement groups
.
It is estimated that the procurement demand for insulin collection in the first year of the national insulin collection was 210 million, involving an amount of 17 billion, and the average price of selected products decreased by 48%.

In fact, the centralized procurement of biosimilars has landed in Guangdong
.
On March 10, the quotation of 276 drugs such as diclofenac (the first batch) of Guangdong Alliance was launched
online.
From the published qualified declaration product information form, the batch covers 146 drugs, involving a total of 579 enterprises and 1608 specifications, of which rituximab, human growth hormone for injection, and recombinant human coagulation factor for injection are three biological drugs, hormonal drugs and blood products that the industry is more concerned about
.

Among them, the most concerned is rituximab, monoclonal antibody biosimilar domestic production, research in the number of enterprises, this Guangdong alliance centralized procurement, the industry believes that this type of biosimilar "first shot"
.

With the successive approval of biosimilars, the domestic biosimilar market continues to expand
.
Frost & Sullivan data shows that it is expected that by 2030, China's biosimilar market will reach 58.
9 billion yuan, and nearly 30 domestically produced biosimilars will be listed
within three years.

From the perspective of the competition pattern of the domestic biosimilar market, many products have met the conditions of full competition of 3 companies and have a certain market scale, with the medical insurance bureau clarifying the next step in the rules of biodrug collective procurement, the next batch of biosimilar centralized procurement is on the line
.

The herd is chasing the deer, and domestic biosimilars are developing rapidly