Save tens of billions of every year, where is the "volume" of generic drugs?

Save tens of billions of every year, where is the "volume" of generic drugs?

Source: Bo Ya/Red Pepper

Imitation drugs refer to the same drug in the aspects of dosage formation, safety, specifications, administration channels, quality, performance characteristics and expected uses as the original research drugs. Any generic drugs must be the same as the original research drugs (some limited exceptions) in terms of dosage, dosage form, dosage formation, administration pathway, safety, effectiveness, medicinal power, and labels. It must achieve the same high quality and manufacturing standards as the original research products, and the quality, use and use method must be the same. But although so similar, the generic drug is not as good as the original medicine, just like the six -eared macaque is not as good as the Great Saint.

Imitation drug vs original research medicine

Price "wounded"

The root causes of generic drugs are different from the development model. The original research drugs need to go through a long R & D cycle (10-15 years), high R & D expenses (nearly 2 billion US dollars), and ultra-high failure rate (90%), which can be described as a lot of money. The generic drugs are different. It only needs to prove that it is the "shadow" of the original research drug, which corresponds to the great shortened R & D cycle (2-4 years), and low R & D costs (1%of innovative drugs).

Judging from the end point of the development model, it is never a technical issue between the original research drugs and generic drugs, but patents. In 1984, the U.S. "Hatch -WAXMAN Act" stipulated that the patent period of the original research medicine was extended to 20 years. If the application was applied before clinical trials, it was actually over half of the time for the new drugs to be approved. The cost of recycling costs and income, the price is naturally low.

Therefore, although the life -saving medicine like Ziwei Star has appeared on the market, the high prices are still expected to be incompatible for ordinary people. It was a great thing, but the final result did not satisfy everyone. Price reduction? Open patent? It is impossible, the foundation of saving wounds is based on the economy, and it has not yet achieved a communist society. A study by Mansfield, a well -known American economist, pointed out that 60%of new drugs will not be invented without patent protection.

On the one hand, it is the innovation that drives social progress, and on the other hand, the people who need to be rescued are urgently needed. The back of the hand is meat, but there are always choices, and this folding point is generic drugs. There are poor people everywhere, and the original research medicines are tingling every country. Because of this, obtaining most people affordable for the people is a very important public health undertakings in various countries.

New generic drugs are approved

Patients can save tens of billions of dollars

According to a report entitled "2018, 2018, 2019, and 2020 Estimation New Imitation Pharmaceutical Approval" reports, the generic drugs have saved $ 10.7 billion for patients in 2020, of which 1.8 billion US dollars came from the first quantities of imitation. Pharmaceutical approval contribution. In 2019, it was about 24.8 billion US dollars, of which 9.4 billion US dollars came from the first batch of generic drug approval. In 2018, it was about $ 17.8 billion, of which 4 billion US dollars came from the first batch of generic drug approval. In the past three years, the first batch of generic drug approval accounted for 29%of the total savings.

Picture source: Reference materials 1

In addition, the annual changes are mainly due to the product portfolio approved by the generic drugs in these years. For example, when new generic drugs enter the market, high -priced and large market products often make more conservation than products in small markets. For example, compared with 2018 or 2020, the significant increase in 2019 is mainly due to the approval of a few high -income products. These include Viatris's neural and muscle pain drug Lyrica's generic drug Pregabalin, which saves $ 6.6 billion, accounting for 27%of all generic drugs approved by generic drugs in 2019. In these years with a large number of high -income products, the total savings of new generic drugs may be significantly higher than those who have relatively few generic drugs approved by high -income products. The approval time of these first generic drugs is often determined by the patent date of brand products.

Picture source: Reference materials 1

In addition to the total conservation, the report also emphasizes the importance of decline in prices related to the approval of generic drugs. In most cases, within one year after the first generic drug approval, the price decreased by more than 75%compared to the brand price. For example, in May 2012, Pfizer's patent in South Korea expired, and the next day there were 28 generic drugs listed. The price was only one -third of the former. The price was also greatly lowered. In other cases, for some of the products that serve smaller patients, the total savings are not large. However, for patients relying on these drugs, the reduction of these prices is meaningful and can increase their opportunities to get important drugs.

About 20%of these saved contributions come from India. In the 2021 global generic drug giant TOP10 list released by Fiere Pharma, 4 companies came from India. In the 1970s, India's "Iron Lady" Ingla Gandhi promulgated the Patent Law: medicines around the world do not have patent protection in India, and the company can imitate it at will. As a result, India has opened the history of generic drugs for nearly 20 years. During this period, a large number of Indian pharmaceutical companies emerged, bringing cheap generic drugs to patients including India, Europe and the United States, and even the world. Until now, India's generic drugs meet more than 50%of the world's various vaccines, 40%of the need for generic drugs in the United States, and 25%of British drug demand. China's generic drug market geometry?

Now that the FDA report is realized through data, it gives the first batch of generic drug approval. So, what is my country's generic drug market? From the perspective of the pharmaceutical market structure, most of the pharmaceutical companies in my country are still mainly generic drugs. According to the "Blue Book of China Physical Medicine" released by the China Pharmaceutical Industry Information Center in August 2021, the size of the Chinese generic drug market in 2019 was about 970.7 billion yuan, and the overall market size of the generic drug in 2020 was affected by 808.7 billion yuan. The proportion of generic drugs is as high as 63%, and the market proportion of generic drugs continues to increase. Judging from this data, my country's generic drug market is really "rolled".

Picture source: Reference materials 2

This state comes from the beginning of the 21st century. After the reform and opening up, the pharmaceutical factory's permission was decentralized. For a time, the number of pharmaceutical companies fascinated from 1320 to 6,357 at the end of the century. There is market demand, but there is no research and development capabilities, so I have to do it with it. At that time, the pharmaceutical market was mixed with fishmarks and the medicines. Under false prosperity, the lack of effective market supervision, and the price is also very chaotic. Extinction of the scandal of medicine and medicine, sickness is already a disaster, but it has to take up the gray of the times.

So medical reform came into being: the two -vote/one -vote policy, consistency evaluation policy, and collection policies. The two -vote/one -vote policy has compressed the intermediate sales expenses, limited the profit space with the highest retail price, and reduced the cost of drug circulation. The consistency evaluation policy avoids the status quo of rotten internal rolls, and compares the comparison of comparison of generic drugs and the original drug to improve the quality of generic drugs. Based on the consistency evaluation of the collection policy, the price of drugs is greatly reduced by centralized procurement.

Such a combination of fisting, the era of huge profits of domestic generic drugs is gone. At the same time, the new imitation drug pattern has also been reshaped, and the production of generic drugs tends to be commercialized and standardized.

In 2020, in 2020, a total of 915 acceptance numbers hosted by generic drug consistency evaluation, and 591 acceptance numbers passed. In 2021, the number of domestic innovative drugs was approved to enter the explosion period, and the number of generic drugs also increased significantly. NMPA approved a total of 983 chemicals (including 3/4/6 of the imitation 3/4/6), involving 341 varieties. According to the State Drug Administration's "Notice on the Release of the Catalog of the Impropvic Drug Reference Preparation (Fifty Batch)" (2022 No. 2), the most popular generic drug TOP10 in 2021 is ranked according to the number of enterprises: he Dala non -tablet, pomochexolinophenol, norofovir tablets, germazole injection, levofolin tablets, Prorbarin capsules, phosphates, viavada, non -quaste tablet Elert with amurate hydrochloride, Agatquan injection. Interestingly, 7 of the 10 drugs just mentioned according to the number of acceptance numbers are listed. It can be seen that once the hot -selling medicine still has a market that is worthy of reminiscent of the market.

Troop

Imitation drugs are still used as an important channel for the government to protect the people and improve the well -being of the people. It still has a broad market. The gradual and standardized market is the hotbed to promote benign competition. Whenever, cheap and easy -to -use medicine will always be welcomed by the market.

Reference materials:

1.fda, "ESTIMATINGIS from New Generic Drug Approvals in 2018, 2019, and 2020"

2. "China Physical Medicine Blue Book"

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