How will biosimilar drugs impact the future of diabetes?

Release date: 2019-12-27 Views: 0

Source: E Medicine Manager  

As CDE begins to solicit opinions on the guidelines for clinical trials of liraglutide biosimilars, the race for this breed will begin. East China Pharmaceutical, Tonghua Dongbao, Shenzhen Hanyu, Zhengda Tianqing, Dongyangguang, etc. all hope to get a slice of NO.1 drugs in the field of diabetes. However, it is worth noting that the recent policy has disturbed the price of drugs in the field of diabetes. In the future, what will the market for liraglutide and the GLP-1, SGLT-2, DPP-4 behind it be?

Yesterday, CDE publicly solicited opinions on the "Guiding Principles for the Design of Clinical Trials of Lilarutide Injection for Biosimilars". This opinion draft elaborates the general requirements for the development of liraglutide biosimilars from three aspects: overview, clinical development requirements, and clinical trial design points.

Liraglutide (brand name: Novotel) was developed by Novo Nordisk, Denmark, and went on sale in the United States in 2010 and entered the Chinese market in 2011.

After being marketed, liraglutide became the best-selling GLP-1 receptor agonist, with global sales of US $ 3.85 billion in 2018, ranking first in all global hypoglycemic agents. In China, the volume was rapidly increased after the medical insurance negotiations in 2017.

But looking at the diabetes drug market in 2019, the situation is getting more and more complicated: the State Council requires that outpatient medications within the scope of the medical insurance catalogue for urban and rural residents to be included in medical insurance payments, and the reimbursement rate be increased to more than 50%; Traditional medicines such as carbohydrate and insulin are included in the volume purchase; more GLP-1 and SGLT-2 innovative medicines are lowered into medical insurance; a large number of biosimilar drugs and generic drugs are coming to the city.

01. Liraglutide is the only one, can health care negotiations be disrupted?

According to relevant statistics, the global diabetes market size has reached 45 billion U.S. dollars in 2018, a decrease of 1.5% compared with the previous year. This situation is mainly due to the expiration of three generations of insulin patents, and competition for biosimilars leading to the entire insulin sales. Amount of downward trend. But at the same time, the GLP-1 receptor agonist market is expanding rapidly, reaching a scale of USD 9.3 billion in 2018, with an average annual compound growth rate of 35.7%, which has become the main driving force for the entire diabetes market.

In the future, the diabetes drug market may be impacted by GLP-1 biosimilars.

At present, no liraglutide biosimilars have been marketed globally. However, dullatide, which is also a GLP-1 receptor agonist, sold nearly $ 3.2 billion in 2018, followed closely behind, and is currently Lilly's largest product.

Although liraglutide has been the best-selling hypoglycemic agent in the world, it has not been able to open the Chinese market because of its price. Six years after entering China, it was included in the National Medical Insurance Catalogue through negotiation in 2017. Only liraglutide has a significant volume in the Chinese market. In 2018, sales revenue increased by 73% to 521 million Danish kroner (about 82.5 million US dollars). , Already accounted for 87% of the entire GLP-1 drug market in China, but only 1.3% of the entire diabetes drug market.

The data shows that the mainstream medications in domestic public hospitals are still oral hypoglycemic agents represented by insulin and metformin. Pharmaceutical Cube reported that among diabetes drugs in 2017, the total sales of innovative drugs such as DPP-4 inhibitors, GLP-1 receptor agonists and SGLT-2 inhibitors in China were 1.8 billion yuan, accounting for only 3.4 of the market share In the same period, the total sales of these three drugs in the United States were 14.7 billion U.S. dollars, accounting for 42.6% of the total market share. They have become the three major drugs for diabetes following insulin.

It can be seen that in the diabetes market in China, the proportion of GLP-1 is extremely low, which is far from the global pattern. But its future growth rate and space are evident. This is why it attracts many biosimilar drugs.

In January 2018, the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China" prepared by the Chinese Medical Association Diabetes Society (CDS) upgraded GLP-1 to one of the two treatment options, that is, patients who cannot be controlled by metformin monotherapy, can Early combined treatment with GLP-1, DPP-4, SGLT-2 or insulin. In addition, if the glycemic control of the dual therapy is still not up to standard, three different mechanisms of hypoglycemic drugs can be used in combination. To a certain extent, this has raised GLP-1's status in the treatment of diabetes.

In the global GLP-1 market, liraglutide, doxylose, and Novo Nordisk's latest somalutide account for about 90% of the market. In China, the Insight database shows that there are currently seven GLP-1 receptor agonists approved in China, namely the short-acting formulations exenatide (AstraZeneca) and benarutin (Renhui) , Liraglutide (Novo Nordisk) and lisinatide (Sanofi); long-acting inhibitor losenadide (Haussen), exenatide microspheres (Sansei Pharmaceutical), duranose Peptide (Lilly).

However, since only Laraglutide entered the medical insurance before, the heavy volume effect was obvious and occupied most of the market.

But in this year's medical insurance negotiations, AstraZeneca (Sansei Pharmaceutical) 's Exenatide and Sanofi's Risenatide successfully negotiated and became spoilers. It is difficult to say how the pattern will change under the data and the future entry of Somaglutide.

02. Biological similar drugs may impact

According to Insight data, at least 11 companies have applied for liraglutide, including Tonghua Dongbao, East China Pharmaceutical, Federal Pharmaceuticals, Zhengda Tianqing, Shenzhen Hanyu, Shengnuo Pharmaceutical, and Guangdong Dongguang.

Data from China's drug clinical trial registration and information disclosure platform show that Tonghua Dongbao is conducting a phase III clinical trial compared with Novo Nordisk's liraglutide. Phase III clinical trials of East China Medicine have also been fully launched in the first quarter of this year. It is expected that It will be completed by the end of the year and be declared for listing early next year.

In addition, Shenzhen Hanyu Pharmaceutical Co., Ltd. has made progress faster. On November 20, its product application for listing was approved by the Drug Review Center. This time, it was listed in accordance with the new 4 generic drugs.

In addition, Dongyang Sunshine said last month that it plans to acquire pyroglutamate and liraglutide for 2.057 billion yuan, of which the national Class 1 new drug pyroglutamate ringglucin (SGLT-2) is currently being prepared for launch. In phase III clinical trials, the biological agent liraglutide is preparing to carry out phase I and phase III clinical trials simultaneously.

It is foreseeable that in the next two years, biosimilars will be launched on the market, and it is not only liraglutide that encounters generic drugs. There are also chasers for innovative hypoglycemic agents such as SGLT-2 and DPP-4.

But everyone needs to be alert that the diabetes field has experienced multiple policy impacts in 2019. The first is at the beginning of the year. In this year's "Government Work Report", the Prime Minister proposed to prevent and cure common chronic diseases, and include outpatient drugs such as hypertension and diabetes into medical insurance reimbursement. Subsequently, the State Council proposed that more than 300 million hypertensive and diabetic patients participating in the basic medical insurance for urban and rural residents should be included in the medical insurance payment for outpatient drugs within the scope of the national basic medical insurance drug catalog, and the reimbursement rate was increased to more than 50%. policy.

One of the more notable is Hebei, where the province has centralized purchases of hypertensive and diabetic outpatient drugs for urban and rural residents. This purchase involves 6 diabetes medications, such as metformin, glibenclamide, glipizide, acarbose, and Xiaoke Pills, etc., of which, the price of metformin tablets of Shiyi Ouyi is 0.043 yuan / piece, a decrease of up to At 94.7%, the "Glimepiride Tablets" of Beilu Pharmaceutical decreased by 79.5%, and the Acarbose tablets of East China Pharmaceutical decreased by 59.3%.

Immediately afterwards, insulin, the main medication for diabetes, also encountered epidemics. Insulin was included in Wuhan's strip purchases announced in December. Data from the Minnet Network shows that in 2018, the scale of the market for chemical drugs and diabetes drugs in key provincial and municipal public hospitals rose to 6.77 billion yuan. As the main therapeutic drug, insulin and similar drugs have a market share of more than 37%. In 2018, the sales in public hospital terminals in key provinces and cities exceeded 2.5 billion yuan. In 2018, the total market share of the top 10 brands of chemical drugs insulin and similar drugs in public hospitals in key provinces and cities remained at about 95%. Among the Top 10 brands, foreign companies accounted for 7 seats.

It is foreseeable that the insulin price system will also be disturbed, and the trend of domestic substitution may accelerate.

With the launch of domestic GLP-1 and its analogs, will liraglutide experience the same situation? However, at least for the moment, domestic GLP-1 has not caused much threat, and Novo Nordisk's long-acting GLP-1 somaglutide not only has better clinical performance, but also may be available in oral dosage forms in the future.

However, in this year's medical insurance negotiations, Daglenet, which suffered a bargain from the soul, eventually cut its price significantly, and its first copy or will settle in Lukang, and its listing application was submitted mid-year.

On the one hand, the continuous improvement of medical insurance, the original research of liraglutide and daglipem have entered the medical insurance, but at the same time, with the follow-up of a large number of biosimilar drugs and generic drugs, will this chronic disease area be included in centralized procurement in the future It's hard to say yet again when prices are touched. But at least from the perspective of the structure of foreign drugs, the domestic market of GLP-1 is far from being developed.

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