Centralized procurement to normalize a batch of pharmaceutical companies out

Centralized procurement is normalized, the cancellation of drug approvals by pharmaceutical companies accelerates, and the number of companies continues to decline

Centralized procurement is one of the major policies that have affected the pharmaceutical industry in the past two years.
One of the incidents has attracted the attention of thousands of pharmaceutical companies.
According to the author's statistics, after centralized procurement has become normalized, the cancellation of drug approvals for some pharmaceutical companies has accelerated
.

Judging from the statistics of the State Drug Administration, the number of drug approvals has decreased from more than 190,000 at the peak three or four years ago to the current 150,000, a reduction of more than 20%
.

According to the national drug regulatory policy, this is not the end point, and the trend of decreasing drug approvals will continue

1.
Varieties and companies are all "injured"

1.
Varieties and companies are all "injured"

After the announcement of the "National Drug Centralized Procurement Document (Insulin Special) (GY-YD2021-3)" and the "Notice on Carrying out the Sixth Batch of National Organized Drug Centralized Procurement (Insulin Special) Drug Information Filling Work" on November 5 , Recently released the "National Drug Centralized Procurement (Insulin Special) Corporate Training Conference Notice".
Special training is planned to be carried out on November 15th.
The sixth batch of centralized procurement is in rapid progress and is expected to be implemented in early 2022 at the earliest
.

Note: According to the Shanghai Pharmaceutical Sunshine Purchasing Network, online public information materials inquiries and collation, for reference
.

With the continuous advancement of centralized procurement and the actual implementation, the market share of most centralized procurement products has declined significantly, and the sales of original research pharmaceutical companies and domestic leading companies have declined significantly
.

From the perspective of varieties, due to the sharp price cuts of centralized procurement varieties, the terminal market sales and proportion have fallen sharply
.

Take the commonly used blood pressure lowering drugs with huge usage as an example.
Before the implementation of the national centralized procurement, amlodipine accounted for more than 31% of the sales of similar products in 2018.
After the centralized procurement of drugs in the alliance region, its market share fell to 2020 At 16.
7% of the year, the market share has shrunk by nearly half; in contrast, the uncollected variety of nifedipine preparations had market share in 2018
.

From the perspective of enterprises, most of the companies that were already major suppliers in the market, whether they are companies that have won the bid or those that have not won the bid, their market share will drop significantly, and the new entrants are the biggest winners
.

Still based on the comparison of the market share before and after the centralized procurement of another major manufacturer of irbesartan and hydrochlorothiazide preparations for blood pressure lowering drugs, the original research company Sanofi won the bid at a lower price, but its market share fell from 61.
36% before the centralized procurement to the centralized procurement The latter 36.
8%, and the new entrant, Huahai Pharmaceutical, won half of the market in one fell swoop
.

In the process of centralized procurement, companies that have not won the bid have also experienced a huge decline in their market share
.

For example, Beijing Jialin Pharmaceutical, where atorvastatin is the main sales revenue of the company, has not won the bid in the centralized procurement process.

It is also in this context that many pharmaceutical companies voluntarily withdrew from the relevant drug market and continue to cancel drug approvals
.

2.
The number of applications for cancellation approvals by pharmaceutical companies has increased

2.
The number of applications for cancellation approvals by pharmaceutical companies has increased

In the past few years, the number of drug approvals registered in the State Drug Administration has exceeded 190,000, but currently there are only 150,000
.

According to the author’s preliminary statistics, the State Food and Drug Administration issued three cancellation approval notices in 2020 involving 400 drug approvals, and as of 2021, it has issued five cancellation approval notices, involving 670 approvals, which is likely to be accelerated
.

The latest batch is the "Announcement of the National Medical Products Administration on the Cancellation of 34 Drug Registration Certificates including Mercury Bromide Solution (2021 No.
132)" issued on November 4, involving more than 20 products
.

Many of them original research clinical dosage larger species, such as Johnson & Johnson injection risperidone (Janssen Pharmaceutica) with microsphere preparation, Pfizer amlodipine atorvastatin formulations like compound
.

According to the "Measures for the Administration of Drug Registration", drug approvals will be cancelled under six circumstances, including enterprise active application, legal revocation, and serious adverse reactions
.

In addition, a large number of zombie approvals, supplementary and monitoring drug catalogues, continued advancement of anti-resistance orders, etc.
, and the cost of re-registration and routine maintenance of drugs every five years will also cause companies to actively apply for cancellation of some parts that have no actual sales or cannot be Pharmaceutical approvals that bring value to the company
.

3.
Increased barriers to drug access

3.
Increased barriers to drug access

According to the national centralized procurement policy, passing the consistency evaluation of generic drugs is the ticket to enter the national centralized procurement
.

The actual status of the domestic generic drug market is a mixed bag, and product quality is uneven for a long time

The concentration of China's generic drug industry is low, and the approvals are serious: China has more than 4,000 pharmaceutical companies, far more than the United States and other developed countries, and there is overcapacity
.

The sales of Top 10 companies in the sample hospital market accounted for less than 30%.
If imported patent drugs are excluded, the proportion is even lower
.

Taking the first batch of 289 varieties requiring consistency evaluation as an example, the total number of approvals was as high as 17,740, of which the number of approvals for compound sulfamethoxazole tablets reached 895
.

Previously low approval standards led to a pile of approval documents for generic drugs, with uneven quality and efficacy, which in turn reduced the efficiency of the use of medical insurance funds

Judging from the intensity and rhythm of the state's centralized procurement, it can be said that it is intensive
.

However, the progress and scope of the promotion of centralized procurement are subject to the promotion of the consistency evaluation of generic drugs

4.
Accelerate the cancellation of drug approval documents and reshuffle of pharmaceutical companies

4.
Accelerate the cancellation of drug approval documents and reshuffle of pharmaceutical companies

Consistency evaluation will be a long-term policy, and it will also be a stage of cleaning up drug approvals
.

From the history and experience of the United States and Japan in promoting the consistency evaluation of generic drugs, we can also see that this is also a long-term process

Relevant information shows that Japan has experienced 22 years and the United States has 23 years.
In the end, both countries have updated and released the Orange Book of generic drugs from time to time
.

It can be seen that the consistency evaluation of generic drugs is a long-term policy that China will implement for many years in the future

At the same time, drugs and drug approvals will also be significantly reduced
.

Based on the drug approval status before and after passing the consistency evaluation in Japan, the quantity situation was basically similar in the 1970s and China now.

In the United States, the "Drug Effectiveness Research Implementation Project (DESI)" was implemented in 1968, and the evaluation of drugs that only conducted safety studies and did not conduct efficacy studies during 1938-1962
.

DESI is not a bioequivalence evaluation of generic drugs, but a retrospective review based on historically imperfect drug review regulations and re-evaluation of drug effectiveness
.

The expert team reviewed the drugs based on the tripartite evidence from the FDA, drug manufacturers, and scientific literature, and divided the drugs into "effective for the indications listed on the label" and "unclear efficacy for the indicated indications" according to their efficacy.
There are three categories of "completely ineffective against the listed indications".
Only drugs that have been proven effective are allowed to be produced.
As of 1984, nearly 4,000 drugs have been assessed, the number of drug approvals has been greatly reduced, and there are only dozens of manufacturers left
.

For the United States, since the "Generic Drugs Act" was promulgated and formally implemented, the Act created a modern approval system for generic drugs
.
After that, the generic drug industry in the United States entered a stage of rapid development.
The sales volume of generic drugs accounted for the increasing proportion of total prescriptions.
The proportion of generic drugs in prescription drugs increased from 10% in the early 1980s to more than 80% today
.

At present, there are more than 4,000 chemical pharmaceutical companies in China, of which 2,200 are above designated size, and there are about 900 biological products companies, and the total is about 3,000
.

It is expected that after the continuous advancement of volume purchases and the completion of the consistency evaluation of generic drugs, it is optimistically estimated that the total number of chemical drug companies and biological companies in China will be left about 500, and the drug approvals will also be greatly reduced
.