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- 2026-04-17 03:16:38
- Opinion
- [Reporter’s View] What COVID-19 revealed in drug industry
- by Kim, Jin-Gu Apr 29, 2020 06:20am
- The humanity will ultimately overcome the COVID-19 pandemic. But the problem is what follows next. Scholars around the world talk about the Post-COVID-19. Each of them theorizes their own seemingly realistic ideas of “New Normal.” Among all of their hypotheses, ‘giving science back to the public’ speaks to the heart. At an online forum convened on Apr. 28 regarding the Post-COVID-19 and the new normal, Professor Park Sangook of Earth and Environmental Sciences Department at Seoul National University stated, “The science and technology should find their way back to the public in the future.” In fact, it was on the 100th day since the first reported case of COVID-19 in Korea. His diagnosis was unyieldingly honest. He said the science and technology in pharmaceutical and bio sector have advanced remarkably, but they are skewed to specific areas. It is as it is. Quoting his words, regardless of developed countries, global pharmaceutical giants or Korean pharmaceutical and bio industry, no one can deny the fact their R&D was fixated on “profitable sector.” Every one of them was into developing chronic disease treatment and “happy drugs.” The result is what we see today. According to Professor Park Sangook, the humanity is “in a dire situation, where we helplessly face a simple virus generated from the nature.” In their defense, the companies could claim their concentration on profitable business is obviously justifiable with their corporate nature. However, considering the pharmaceutical and bio industry put down their roots in public healthcare, they need to take a look back at themselves even shunning the ‘bare minimum.’ The government’s role is essential in turning the corporations around. To let the companies open their eyes on the public healthcare, the government should pay more attention and provide further support. Motivated by the pandemic, the Korean government seems to be making various promises to provide support for the pharmaceutical companies responding against the threat of the infectious disease. The government means to properly compensate the companies developing treatment and vaccines for the virus. These should not be empty promises for temporary purposes. Not just to spike their stock prices, but the government should show pharmaceutical companies that taking up a challenge for the public interest, despite the risk in failure and loss, would be compensated appropriately. Only when the government takes the right action, science and technology would find their way back to the public.
- Policy
- Issues to remain as restricting bioequivalence test scrapped
- by Lee, Tak-Sun Apr 29, 2020 06:19am
- The issues regarding highly saturated first generic market would likely to remain as the Regulatory Reform Committee has axed the Korea Ministry of Food and Drug Safety’s (MFDS) plan to restrict joint and cosigned bioequivalence test. Even if the government grants favorable pricing on generics with individual test data from July, the industry experts expect that many of pharmaceutical companies would still choose to run joint bioequivalence tests to not miss out on their market release timing. Accordingly, pharmaceutical companies can now save much on their R&D and production costs like on pharmaceutical research and bioequivalence test. But the issues of pharmacy and primary consumer’s difficulty in product dispensing and illegal rebate provision within the heated competition would remain the same in the saturated generic market. Moreover, the issue of multiple generic receiving preferential sales approvals, initially expected to be eliminated with the joint bioequivalence test restriction, would likely to continue causing inefficiency in the market. Nothing to cripple first generic market saturation On April 24, the Regulatory Reform Committee has disclosed its meeting minutes deliberating the MFDS’ revision on the Regulation on Pharmaceuticals Approval, Notification and Review that restricts joint and cosigned bioequivalence test, and recommended to abolish the plan. Sources report MFDS is reviewing on accepting the recommendation and issuing the regulation revision notice without the restriction on bioequivalence test. The Regulatory Reform Committee has recommended the ministry to abolish its plan to limit the number of generics with joint or cosigned bioequivalence test data as one (main tester) plus three (number of cosigned testers), which the restriction was supposed to be reevaluated after five years. The restriction on the joint bioequivalence test was temporarily imposed (one-plus-one) due to the 2006 joint test manipulation incident, but it was lifted in 2010 by the Regulatory Reform Committee’s demand. Currently, an unlimited number of cosigned testers can share the bioequivalence test results and use CMOs to manufacture generic product. Since the discovery of impurity in valsartan products, MFDS pointed out the quality control as a reason for the restriction on the joint bioequivalence test, but it actually targeted prevention of further saturation in the generic market. Moreover, the Ministry of Health and Welfare (MOHW) has also started restraining the generics market by pricing the products depending on the submission of individual bioequivalence test results and the use of DMF registered substances. The differentiated drug pricing by MOHW would be enforced from coming July, starting from newly approved items. For instance, a product using pharmaceutical ingredients registered on DMF but submitted data from a cosigned bioequivalence test would be priced at 45.52 percent of the original’s price. Whereas the ones with individual test data are priced at 53.55 percent of the original’s price as stipulated by the existing drug pricing formula. But many of the pharmaceutical industry claim the differentiated pricing would inevitably change the cosigned manufactured generic policy, regardless of the joint bioequivalence test policy. As a result, the industry also projects the effect of abolishing the joint bioequivalence test policy would be insignificant. As for the effort to prevent saturation of generics market, however, the number of generic products in the first generic market would unlikely to be affected, because the joint bioequivalence test policy is scrapped. There are several reasons as to why the industry experts expect the demand on cosigned manufactured generic would not be crippled any time soon. Many of the pharmaceutical companies without individual bioequivalence test result would highly likely to resort to CMOs to not miss out on timely market release. And the CMOs without strong sales power would call for clients to generate as much profit as possible. On Apr. 17, 16 of benign prostatic hyperplasia (BPH) treating generics, tamsulosin 0.4 mg, were approved by the Korean government. All of them are manufactured by a same CMO, Dongkoo Bio&Phama. And other various items manufactured by CMOs like Kolmar Korea, Dasan Pharmaceutical and others are seeking for approvals. If the joint bioequivalence test was limited to one-plus-three, Dongkoo Bio&Pharma would only get to manufacture four items, which would then reduce the number by 12. Despite the policy that prices CMO generics 8 percent less, the industry experts see that the small and medium companies’ demand on CMO generics in the first generic market would remain the same, as they can still save on R&D cost and make profit from early release in the market. Questionable benefit of preferential sales approval on multiple items As long as the preferential sales approval grants exclusivity in the generic market for nine months, the generic market would never seize to get even more saturated. A number of pharmaceutical companies competing against each other for the patent-challenged first generic market would turn to the CMOs once they lose out in the game, and share its bioequivalence test data to join the generic market early. And generic makers with an option to opt out on investing on drug development would eventually sign the CMO deals. CMOs that have developed generics for client deals would have nothing to fear with the abolishment of the joint bioequivalence test restriction. The pharmaceutical industry has been constantly reprimanding the existing preferential sales approval system distributing the benefit to multiple companies. Some expected the restriction on the joint bioequivalence test would also eliminate the preferential sales approval issues, but now it seems it would remain the same as the plan has been shut off. Due to the government’s action, now the industry may demand for the change more than before.
- Policy
- The MOHW, support for pharmaceuticals entering overseas
- by Lee, Jeong-Hwan Apr 29, 2020 06:19am
- The government will create a ₩100 billion fund to support domestic biohealth companies that have excellent technology but are having difficulty attracting external investment. The final goal of the fund is to enhance the international competitiveness of Korean bio-health companies and to expand into the global market due to the COVID-19 crisis. The government's plan is to recruit fund managers by June and form a fund within the year. The policy is to focus on investment in the domestic pharmaceutical, bio, and medical device industries and overseas support areas for medical institutions. On the 27th, the MOHW (Minister Park Neung-hoo) said, "We will create a new fund worth ₩100 billion to support overseas expansion of K-BIO." Since 2013, the MOHW has raised and invested ₩80 billion in funds to foster the domestic bio-health industry and support overseas expansion. The MOHW said that it has created a number of successful cases by actively investing by discovering companies that have technological skills but are having difficulties in attracting investment. The MOHW added that there is no bio-health fund that has yet to be liquidated by investing for 4 years and operating for 8 years, but it has been recovering investments of ₩51 billion. The fund to be newly raised is about ₩100 billion by recruiting private investors with initial investment of ₩15 billion of investment funds and ₩25 billion of the Export and Import Bank of Korea contributions. In addition, the MOHW plans to unify the five funds that have been created and operated as K-BIO new growth funds. The new fund will be named 'K-BIO New Growth Fund No. 6'. The MOHW will announce the selection of managers to manage the fund through Korea Venture Investment and Korea Export-Import Bank from 28th to 20th next month. It will plan to select fund managers in June and close the fund formation in September at the earliest and this year at the latest. The MOHW's Eul-ki Lim, . the Health Industry Development Division Officer, said that COVID-19 is a concern for the global economic downturn, but it will be an opportunity for the domestic bio-health industry, which is attracting attention all over the world.
- Policy
- Amendment to cascading drug price revision proceeds as it is
- by Kim, Jung-Ju Apr 29, 2020 06:19am
- If the co-biological equivalence test 1 + 3 system is discarded by the Regulatory Reform Committee among the 'Regulation on Pharmaceuticals Approval, Notification and Review', what will happen to the 'cascading drug price revision' of ‘a partial revision of the Criteria for Decision or Adjustment on Drugs’? The MOHW plans to carry out the so-called 'the cascading drug price system' to be implemented in July. According to the government, the Regulatory Reform Committee previously recommended to withdraw the 1+3 system, that is, the MFDS' amendment, which restricts the number of items that are exempt from bioequivalence test submissions when drug approval is granted. The reason for this is that it is difficult to achieve the goal of improving the generic quality even if the exemption of co-biological equivalence test is limited based on this system. However, it was because the effectiveness of the regulation introduction was difficult, and there were large negative opinions within the regulatory framework, such as the problem of restrictions on market entry, lack of direct effect on quality and safety, and lack of effect on promoting R & D. The issue is insurance price. When the generic price revision was originally announced, the government said that it would grant the drug price by calculating the 'drug approval and price linkage system' based on the content of differentiating the generic insurance price depending on whether or not it has its own bioequivalence test. However, the MOHW plans to carry out the cascading drug price system, in July, in a scheduled order without change. According to the government, the core of the standard of drug price addition is ▲ self-biological equivalence test and ▲the use of DMF registration, the method of granting the drug price (53.55% of the original) by preferentially treating its own biological equivalence product is separate from the withdrawal of this 1+3 system. In addition, the reorganization of drug prices is a major source of stabilization for health insurance finance, and self-biological equivalence testing and the preferential treatment of DMF registration in cascading reorganization is different from the effectiveness of the system that the Regulatory Reform Committee made as a justification. However, even if the government pursues drug price revision, there is a concern that the reorganization of the 'drug approval and price linkage system' will be changed to a regulation pattern in a direction different from the original goal, even if the drug price lawsuits surrounding generics are still being pursued. This means that it could spread to another lawsuit issue between the government and the industry. For this reason, the company's position is expected to be divided according to the revision of the MFDS’ amendment (deletion of the new provision of the 1 + 3 system for co-biological equivalence test) and the realization of the MOHW's generic cascading drug price revision.
- Opinion
- [Reporter’s view] Pharmacist's role to meet post COVID-19
- by Kim, Min-Gun Apr 29, 2020 04:59am
- COVID-19 is changing our lives and culture itself with more powerful infectious power than any other epidemic. Telecommuting and video conferencing, represented by social distance, began in earnest, and online shopping malls are booming. It is a daily routine of non-facing contact. Hong Nam-ki, Deputy Prime Minister and Minister of Economy and Finance also pointed to non-face-to-face meetings such as teleconference and video conferencing for economic policy since COVID-19 outbreak. In order to prevent the spread of infection in medical institutions, the government even allowed non-face-to-face treatment for people with chronic diseases and the elderly. The U.S. FDA also issued a deregulation guideline that lowered the barrier to entry into telemedicine during the COVID-19 epidemic in March. This is to activate telemedicine to prevent infection between face-to-face contacts. Non-face-to-face treatment is an issue directly related to the delivery of prescription medicines. The Korean Pharmaceutical Association is concerned about this. The government reassured that there was no expansion of telemedicine beyond the current law, saying that non-face-to-face care is needed to protect medical institutions and patients from COVID-19, a highly contagious infection. However, it is a sign that non-face-to-face counseling, such as telemedicine, will become necessary in the future in response to infectious diseases. However, the current social distance is accompanied by economic losses. There are also a lot of people who are tired of restraining outside activities. Accordingly, the government is considering the future health care system. There will be active discussions regarding non-face-to-face contact policies. The government is preparing to switch to a non-face-to-face, life-prevention system. It becomes social distance campaign in life. The most important countermeasures against the epidemic have been proved that quarantine measures through rapid inspection and confirmation, and that essential quarantine supplies should be supplied in a timely manner. This means that the diagnosis and prevention of infectious diseases is not the only role of medical institutions. Through the 5-day rotation mask distribution system, it was recognized that the pharmacy's role in the daily life prevention system is important. As the interest in the role of the pharmacist's skill that has been overlooked has been refocused, the pharmacist society should not be left behind by the post-COVID-19 era that will change in the future rather than clinging to telemedicine issues. The role of the pharmacist's function in the era of infectious diseases and the future are even more important. Masks, hand sanitizers, and disinfectants can also be bought at marts, but an expert who can explain the exact range of use and how to do it can be done by a pharmacist at the pharmacy. The role of the pharmacist in the daily life prevention system is inevitable. The pharmacist should conduct specialized training to cope with infectious diseases, and the trained pharmacist should be more professional in the prevention of life. In addition, specialized pharmacists in the prevention of infectious diseases should be fostered in accordance with the legislation of the specialized pharmacist system. If the pharmacist's skill is specialized, the opinion that pharmacists should be included in the health care providers will be more supported. In this case, expansion of the pharmacist's competency may also be considered. It can be considered that if the patient's care and prescription are stopped in response to an infectious disease that occurs simultaneously in a specific local medical institution, it is considered to be in accordance with the exhibition situation. If patient care and prescriptions are stopped in response to infectious diseases that occur simultaneously in certain local medical institutions, it will be like wartime situation. Before separation of prescribing and dispensing drugs, the pharmacy directly diagnosed the patient and took the role of prescribing and dispensing. In order to prevent the collapse of the health care system in the epidemic area, Measures for prescribing medicines temporarily by local pharmacies may be considered. Systematic protection measures should be prepared, such as storing personal protective equipment (PPE) for each pharmacist society and distributing it to member pharmacies when an epidemic occurs.
- Policy
- CSL, Australian company, licensed for business in Korea
- by Lee, Tak-Sun Apr 28, 2020 06:24am
- CSL, an Australian global pharmaceutical company, conducts full-scale marketing in Korea. It was the first time in the domestic pharmaceutical industry to acquire a business license and an item license. CSL Behring Korea, a subsidiary of CSL, received a drug import license from the MFDS on the 16th. General manager, Ji-Young Sohn, who has served as the marketing and strategy planner of Korea Pfizer Pharmaceuticals and the head of the department of anti-cancer drugs at Roche Korea. Sohn is a pharmaceutical management expert who graduated from the College of Pharmacy at Ewha Womans University and Korea University (MBA) Along with the business license, CSL Behring Korea also brought permission to approve ‘Afstyla’, a type A hemophilia treatment. This product, which was licensed in January, was the first subsidiary of Zuellig Pharma Korea Ltd. to be registered as a license holder. This is because CSL Behring Korea did not obtain a business license, so Zanovex Korea acted as an item license. However, recently, Afstyla's license for item approval has been changed to CSL Behring Korea. Afstyla is now owned by CSL because it is generally assumed that the licensed company holds the copyright. However, Afstyla will be sold by SK Plasma. Unfortunately, Afstyla is a product developed by SK Chemicals, a subsidiary of SK Plasma, to preclinical and technically exported to CSL. In March, it was approved for the marketing of the type B hemophilia treatment drug 'Idelvion'. Janovex Korea is also registered as a license holder. Idelvion will also be transferred to CSL Behring Korea in the near future. CSL Behring is a global pharmaceutical company with hemophilia treatment and rare disease treatment, and is a subsidiary of the Australian CSL Group. It has expanded into 60 countries worldwide and is headquartered in Pennsylvania, USA. Afstyla and Idelvion, which have been licensed this time, are evaluated as drugs with a significantly improved half-life than conventional hemophilia drugs. However, it is unlikely that the domestic market will be settled. The size of the domestic hemophilia treatment market is about ₩180 billion, of which Type A treatment accounts for 80%, and the Green Cross is dominated. In the case of Shire's highest-selling Adbate, Green Cross sells, and the second-largest product, 'Greengene F', is a product of Green Cross. Pfizer's Benefix has the largest share of type B drugs. In the case of hemophilia treatment, the Koham has great influence, so pharmaceutical companies with high contribution are currently leading the market. In this situation, it is unclear whether CSL, a latecomer, will settle into the domestic market with only upgraded products. This is because SK Plasma, a sales agent, is not a very influential pharmaceutical company in the domestic hemophilia treatment market.
- Company
- General hospitals ready to prescribe Verzenio
- by Eo, Yun-Ho Apr 28, 2020 06:24am
- The general hospitals in Korea have started entering the anticancer treatment Verzenio’s prescription code. According to pharmaceutical industry sources, drug committees at major general hospitals like Seoul National University Hospital, National Cancer Center, Ajou University Hospital and Chonnam National University Hwasun Hospital have recently cleared Lilly’s Verzenio (abemaciclib). When the company successfully completes the pricing negotiation with National Health Insurance Service (NHIS), Verzenio would be prescribed more consistently with the insurance reimbursement. The medication is in process of settling a risk sharing agreement (RSA) to receive reimbursement to treat patients with HER2- advanced breast cancer in combination with AstraZeneca’s Faslodex (fulvestrant). Cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor Verzenio can be prescribed to perimenopausal women with HR+/HER2- advanced or metastatic breast cancer either for first-line endocrine therapy combined with an aromatase inhibitor, or for combination therapy with Faslodex after receiving endocrine therapy. The first-in-class CDK4/6 inhibitor Ibrance by Pfizer requires seven days of off treatment after 21 consecutive days of once-daily 125 mg administration, whereas Verzenio can be administered every day. Ibrance is also negating with the government over the pricing, at the moment. Ibrance’ efficacy of significantly improving progression-free survival (PFS) as a second-line therapy has been confirmed during PALOMA-3 study. Besides patients with early stage breast cancer, the CDK4/6 inhibitor showed consistent effect on patients with stage 4 metastatic breast cancer that affected their lungs and bones. Verzenio has recently attracted the industry’s interest, when it completed MONARCH2 study as it not only improved PFS, but also improved overall survival (OS). The achievement was unprecedented for a CDK4/6 inhibitor. As a part of secondary endpoints, the OS of both pre and postmenopausal women was observed.
- Company
- Boryung records new quarterly operating profit
- by Chon, Seung-Hyun Apr 28, 2020 06:23am
- Boryung showed good results in the first quarter. Despite COVID-19, operating profit was the largest ever. Sales also rose from last year. The self-developed drug 'Kanarb Family' led the improvement. Boryung announced on the 24th that its operating profit in the first quarter increased by 42.1% year-on-year to ₩13.4 billion. During the same period, sales increased by 13.0% year-on-year to ₩134.2 billion, and net profit decreased 6.1% to ₩8.3 billion. 1Q operating profit is the largest ever. It surpassed ₩11.9 billion recorded in the third quarter of last year. After the spread of COVID-19, patients' concerns about sluggish sales due to a decrease in visits to medical institutions were dispelled. Kanarb Family led the rise in earnings. According to pharmaceutical research firm UBIST, Kanarb recorded an outpatient prescription amount of ₩12.3 billion in the first quarter. It increased 5.8% from the same period last year. Kanarb (Fimasartan), is an ARB (Angiotensin II receptor blocker) type hypertension treatment developed by Boryung. The growth trend of combination drugs using Kanarb was remarkable. 'Dukarb', a combination of Kanarb and calcium channel blocker (CCB) drug 'Amlodipine', was prescribed in the first quarter of ₩8.4 billion, an increase of 26.2% from the same period last year. 'Tuvero', which combines Kanarb with 'Rosuvastatin', an ingredient for hyperlipidemia treatment, was prescribed amount of ₩1 billion. The four combination drugs including Kanarb, such as Dukaro (₩200 million) combination of “Fimasartan, Amlodipine, and Rosuvastatin” released in February, jointly totaled ₩21.9 billion in the first quarter alone. The anti-ulcer drug “Stogar” also contributed to the increase in earnings. Stogar's prescription performance in the first quarter was ₩5.1 billion, up 64.5% from the previous year. Stogar is the same H2 receptor antagonist that was discontinued last year due to excessive detection of impurities, and prescriptions surged due to reflex benefits from Ranitidine withdrawal. The growth trend of new drug products, which have been licensed by multinational pharmaceutical companies, also contributed to the expansion. 'Trulicity', a diabetes treatment drug introduced and sold by Boryung from Lily, recorded an outpatient prescription amount of ₩8.3 billion, up 19.4% YoY in 1Q. The company explained that the spread of COVID-19 contributed to improved profitability. The decrease in sales management expenses due to the contraction of operating activities contributed to the increase in operating profit.
- Company
- Flu drug prescription plummets by 21% due to COVID-19
- by Kim, Jin-Gu Apr 28, 2020 06:23am
- The general prescription volume of influenza medications treatment has gone down drastically. Compared to the previous season, this season’s volume has plummeted by 21.0 percent. The flu treatment prescription seems to have been affected by the COVID-19 outbreak. The threat of the virus has particularly raised the awareness of personal hygiene nationwide, which ironically ended the flu season earlier than expected. ◆Lowest prescription volume in last six seasons, generics got impacted worse than the original According to the data released by pharmaceutical market research firm UBIST on Apr. 23, total 15.3 billion won was generated from prescribed flu medications in Korea from November 2019 to March 2020. Compared to 19.4 billion won made in the previous flu season (November 2018 to March 2019), the volume fell significantly by 21.0 percent. Since the 2014-2015 season six years ago, the prescription volume has hit the lowest point. (Left) Prescription volume of Tamiflu and generic in last six influenza season (Unit: KRW 100 million) Source: UBIST. (Right) Number of influenza patients in last six seasons* (Unit: 10,000 people) Source: Health Insurance Review and Assessment Service. *Accurate number of patients has not been reported, yet, for the 2019-2000 season. Most of the 38 medications in Korea took the steep fall. Even the prescription volume of Roche’s Tamiflu, the original oseltamivir, was decreased by 18.3 percent from 6.2 billion won to 5.0 billion won. The 37 oseltamivir generics had even steeper fall of 22.5 percent and the volume plunged from 13.2 billion won in the previous season to 10.3 billion won this season. Major generic products like Hanmi Pharmaceutical’s Hanmi Flu prescription volume had a 31.0 percent dip from 4.7 billion won to 3.2 billion won, while the volumes of Kolon Pharmaceutical’s Comyflu, Yuhan’s Yuhan N Flu and Jeil Pharm’s Flu-one were loweredl by 8.4 percent (from 1.3 billion won to 1.2 billion won), 25.7 percent (from 1.1 billion won to 800 million won) and 16.8 percent (from 600 million won to 500 million won), respectively. In this season, on the contrary, the prescription volumes of Arlico Pharm’s Tamipro (30.8 percent), CTC Bio’s Easy Flu (16.9 percent) and Boryung Biopharma’s Boryung Flu (1.8 percent) have surged, regardless of the decrease in general patient size. Comparing prescription volume of major flu treatment in 2018-2019 season and 2019-2020 season (Unit: KRW 1 million) Source: UBIST ◆Flu season ends 84 days shorter, “Infection was well-controlled due to COVID-19”” The flu medication prescription volume is heavily affected by the severity and patient size of the respective flu season. In the 2017-2018 flu season that reach the highest flu treatment prescription volume at 30.7 billion won, the flu patient size also reached the highest at 2.24 million. And this season has ended earlier than usual with far less patient size. The Korea Centers for Disease Control and Prevention (KCDC) has lifted the influenza alert on Mar. 27, after 134 days. Considering the 2018-2019 flu season lasted for 218 days, the last season lasted 84 days shorter. Apparently, the severity of the influenza was not so potent. Only average of 5.9 out of 1,000 people was infected by the flu, which is the lowest figure in the latest six seasons. In the previous season, the average rate was at 6.3 out of 1,000 people. Duration of flu seasons and average patient number in 1,000 people. Source: KCDC The pharmaceutical industry experts claim the COVID-19 outbreak has ironically help the flu season to end faster. As the novel coronavirus spread through the country, majority of the people in Korea stayed at home and paid an extreme attention to their own personal hygiene, which prevented severe spread of the influenza. A pharmacist with a pharmacy in the metropolitan area commented, “Even in last January, three or five Tamiflus were sold a day, but since the COVID-19 outbreak the number dropped to zero. As so many people are avoiding outdoor activity and paying a close attention to personal hygiene, the number of patients with influenza and common colds has gone down significantly.”
- Company
- Rx amount for Ezetimibe·Statin increased 5 times in 4 years
- by Chon, Seung-Hyun Apr 28, 2020 06:23am
- The combination of Statin and Ezetimibe in the hyperlipidemic drug market is rapidly increasing. Over the past four years, outpatient prescription amount has increased five times. It was prescribed more than ₩100 billion in the first quarter. The prescription scale of the combination of 'Rosuvastatin·Ezetimibe' such as Hanmi's 'Rosuzet', MSD's 'Atozet', and Yuhan's 'Rosuvamibe' has expanded rapidly. According to UBIST, a pharmaceutical research institute on the 23rd, the outpatient prescription scale of the combination of Ezetimibe and Statin in the first quarter was ₩109.1 billion, an increase of 23.3% from the previous year's ₩885 billion. The combinations of Statin·Ezetimibe have become increasingly popular in recent years. In the first quarter of 2016, the prescription amount of Statin·Ezetimibe was only ₩23.8 billion, but it expanded 4.6 times in four years. Quarterly Statin·Ezetimibe outpatient Rx amount (Unit: ₩100 million, Source: UBIST) The combinations of Statin·Ezetimibe have an excellent effect on lowering low-density low-protein cholesterol (LDL-C), and it is not expensive, so it seems to have a high preference. In recent years, it is analyzed that the market size has expanded as domestic pharmaceutical companies have competitively released combination drugs combining Rosuvastatin and Ezetimibe. In Korea, a combination of Ezetimibe and Statins such as Simvastatin, Rosuvastatin or Atorvastatin is on the market. The growth of 'Rosuvastatin and Ezetimibe' combinations has been outstanding. In the first quarter, the prescription size of 'Rosuvastatin and Ezetimibe' combinations amounted to ₩80.9 billion, accounting for 74.1% of the prescription amount of 'Statin and Ezetimibe' combinations. At the end of 2015, Hanmi’s Rosuzet, the combination of 'Rosuvastatin and Ezetimibe' first released on the market. The combination of 'Rosuvastatin and Ezetimibe' continued to rise sharply after exceeding ₩10 billion in prescriptions in the second quarter of 2016. In the first quarter of 2017, it soared from ₩27.4 billion to three times in three years. Currently, the competition is fierce, with 29 pharmaceutical companies offering 'Rosuvastatin·Ezetimibe' combinations. Rosuzet's 1Q prescription amount was ₩22.8 billion, up 27.4% from the previous year. After recording the prescription amount of ₩80 billion last year, this year is expected to exceed ₩100 billion. Outpatient Rx amount of Statin·Ezetimibe by month (Unit: ₩1 million, Source: UBIST) Hanmi secured the right to use Ezetimibe from patent holder MSD, and the strategy that entered the market before competitors was effective. Since October last year, Rosuzet has continued its monthly prescription amount of ₩7 billion and recorded ₩8 billion last month. Among the combinations of 'Rosuvastatin·Ezetimibe', Yuhan's Rosuvamibie recorded a prescription amount of ₩13.3 billion in the first quarter. It has risen 27.9% YoY and has established itself as the company's flagship product. HK inno.N's 'Robazet' was prescribed by ₩5.3 billion in the first quarter, up 21.5% from the same period of the previous year, leading the rise in the combination of 'Rosuvastatin·Ezetimibe'. The rise in the combination of Atorvastatin·Ezetimibe is also noteworthy. The MSD's Atozet, combination of Atorvastatin·Ezetimibe, which was ₩10.8 billion in the first quarter, up 20.8% from the previous year. Atozet is being sold jointly by MSD and Chong Kun Dang. On the other hand, the prescription amount of Simvastatin·Ezetimibe was somewhat low. In the first quarter, the prescription amount of Simvastatin·Ezetimibe was ₩10.3 billion, a 3.9% decrease from the same period last year. The combination of Simvastatin·Ezetimibe released first among the combination of statin·ezetimibe, but its share was the lowest. The original product MSD's 'Vytorin' prescription amount in the first quarter was ₩5.3 billion, down 19.8% from the previous year. Vytorin is analyzed to have significantly lowered its market share due to advances such as Rosuvastatin· Ezetimibe combinations.
