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- 2026-04-14 23:24:31
- Policy
- Moderna's COVID-19 vaccine has been applied for approval
- by Lee, Tak-Sun Apr 15, 2021 05:56am
- Moderna's COVID-19 vaccine has begun to be approved in Korea. If Moderna vaccine is approved, it will be the fourth vaccine after AstraZeneca, Pfizer and Janssen vaccines. The MFDS announced on the 12th that GC Pharma has applied for approval as an import item for COVID-19 vaccine from Moderna in the US. Moderna vaccine is one of the vaccines announced by the government and was developed in a two-doses (28 days apart). It is the same platform as Pfizer’s Comirnaty, which is approved in Korea as a 'mRNA vaccine' that induces an immune response by injecting the antigenic gene of COVID-19 in the form of mRNA to generate antigenic protein in the body. The government announced that it signed a supply contract for 20 million people with Moderna in January. The MFDS carefully reviews the submitted quality, non-clinical, clinical, and GMP data, and undergoes triple consultation from the COVID-19 vaccine safety and effectiveness verification advisory group, the Central Pharmaceutical Affairs Review Committee, and the final inspection committee to ensure the safety and effectiveness of the product. It said that it was going to check whether or not to grant permission. Meanwhile, Moderna vaccine has been Emergency Use Authorization in the United States and the United Kingdom, and CMA has been required to submit additional data after approval in the European Union (EU), Canada, and Switzerland. An official from the MFDS said, "We will do our best to ensure that safe and effective vaccines are quickly supplied to our people in the future."
- Opinion
- [Reporter's view] Expensive vaccine sovereignty
- by Apr 15, 2021 05:56am
- The cervical cancer vaccine is Gardasil 9, and the rotavirus vaccines RotaTeq and Rotarix. Vaccines that are considered essential vaccinations, but consumers are less accessible. Foreign pharmaceutical companies are raising prices all at once. Gardasil 9 and RotaTeq's supply prices rose by 15% and 17%, respectively, from this month. RotaTeq will also become about 12% more expensive from next month. As supply prices rise, consumer vaccination prices also rise. Already, some hospitals are demanding additional costs from consumers who have made a prepayment. Gadasil 9 is already a vaccine that was burdensome at ₩450,000~600,000. Since 2016, women and adolescents aged 12 have been vaccinated free of charge for cervical cancer, but men and women born before 2003 have to get the vaccine at their own expense. Parents who have to give their newborns the rotavirus vaccine are also feeling not good. Due to the increase in supply prices, most hospitals have increased their vaccination prices since April, resulting in an average increase of 50,000 to 60,000 won for parents. Rotavirus vaccine is considered an essential vaccine for newborns, but in Korea it is not included in the national vaccination (NIP) program, so it is unconditionally non-reimbursement benefit. It should be inoculated with. The price of cervical cancer and rotavirus vaccines are rising, which is causing consumer dissatisfaction. In the case of Gardasil 9, even a national petition against the price increase appeared. There is a growing recognition that the cervical cancer vaccine is a vaccine that men as well as women should get. MSD Korea, a manufacturer, also announced the need for male vaccination by using male comedians such as Jo Se-ho and Yoo Byung-jae as advertising models. It is unreasonable to pay more than ₩600,000 and hope that the male vaccination rate will increase. Unfortunately, there is no basis for restricting pharmaceutical companies from raising the price of non-paid items. However, from the perspective of public health, the nation can expand NIP and support localization of vaccines. The former is the most obvious way to directly reduce the cost of the public, but the fiscal burden is high. In addition, the former has a problem that it is not possible to make a virtuous cycle in domestic demand because the invested finances go only to foreign companies. There is also an indirect method of inducing price cuts by increasing supply by supporting commercialization of domestic vaccines. Of course, it is difficult to predict how much the price cut effect will be in the market, but when a domestic vaccine is released, supply and demand and management are more stable. This is the same opinion as the government that it will secure'vaccine sovereignty' by increasing the self-sufficiency rate of domestic vaccines. Currently, both cervical cancer vaccines and rotavirus vaccines are only products from multinational pharmaceutical companies, so there is no way to deal with them even if prices rise or sell out. It is necessary for the government to make active efforts so that a domestic vaccine can appear as soon as possible and help improve the health rights of the people.
- Company
- “The framework to list ultra-expensive new drugs exists"
- by Eo, Yun-Ho Apr 14, 2021 06:07am
- We are living in an era where a single injection may completely cure cancer. The catch is that the 'single dose' would cost 500 million won. Such ultra-expensive advanced new drugs are not an item of our dreams – it is already within our reach. In addition to the CAR-T (Chimeric Antigen Receptor T cells) therapy Kymriah (tisagenlecleucel) that was approved in Korea, dozens of other gene therapy and cell therapy candidate drugs are also under development, some of which are being developed by domestic biopharmaceutical companies. The regulatory authorities have also passed the ‘Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals’ in 2019 to reflect the changes in the new era. However, for these paradigm-shifting advanced medicines that overturn the existing concept of drug therapy to be used in real life, the lingering issue of their ultra-high ‘drug price’ needs to be resolved. How should the company that wants rightful compensation for the innovation, and the government that needs to take care of the public’s health with a limited budget, reach a consensus on the matter? Professor Hyung Ki Lee, SNUH In search of the answer, government and industry officials gathered at the 41st Pharmaceutical Industry Future Forum, "Finding the correct solution for the ultra-expensive drug listing system," held by Dailypharm at its Moonjeong-dong office. Dr. Hyung-Ki Lee, Professor of Clinical Pharmacology and Therapeutics at the Seoul National University Hospital, chaired the event. Various industry and government officials including Kyung-Ho Choi, Deputy Director of the Division of Pharmaceutical Benefits at the Ministry of Health and Welfare; Min-Young Kim, Director at Korean Research-based Pharma Industry Association (KRPIA); Hyeon-Seok Na, Senior Manager at JW Pharmaceutical Corp.; and Jae-Ho Jeong, Department Head at Novartis Korea participated as panelists for discussion. ◆ Now is the time to fully implement the Pre-listing Post-evaluation system = The key to pre-listing and post-evaluation is ‘speed.’ The system allows drugs to skip the deliberation on the appropriateness of reimbursement and be listed first, then decide whether to continue its reimbursement by evaluating the efficacy, use amount, etc. based on real-world data. The system would speed up the listing process, however, it may also cloud the transparency of the process. People are voicing concerns about whether the cancellation mechanism of already-listed drugs would definitely work, and whether the patients will be able to accept the reimbursement discontinuation of drugs they have been taking. There also lies the controversy over the method of accumulating RWD or RWE data and its and reliability. Officer Kyungho Choi, MOHW At the event, Deputy Director Choi said, “The ‘continuity of care’ issue of pre-listing post-evaluation drugs cannot be ignored from the government’s perspective. There are problems such as difficulties in adjusting drug prices when the pharmaceutical companies do not accept the evaluation results, as well as the issue of the system weakening the drug negotiation power of NHIS.” However, the industry had a strong aspiration to implement the system as a means to ‘introduce ultra-expensive drugs to Korea.’ Of the three industry panelists that participated in the forum, KRPIA director Min-Young Kim, and Novartis's Departement Head Jae-Ho Jeong pointed to the pre-listing post-evaluation system as the top priority solution. Kim explained, “The system can be well-managed. We already have had experienced similar cases like ‘Evoltra,’ the first therapy to be listed under the Risk Sharing Agreement (RSA). The government was unable to evaluate the cost-effectiveness of Evoltra at the time of its listing, and the drug was listed under conditional coverage with evidence development. After 4 years, the company underwent data collection and a re-evaluation process maintains its reimbursement.” “The pre-listing post-evaluation system needs to be accepted as a type of RSA. The industry has long conducted negotiations and signed agreements with HIRA and NHIS for the stable supply of its products," added Jeong. "The government should show some trust based on its accumulated experience with the companies. The potential risks and countermeasures can be discussed while conducting a pilot project.” Executive Director Minyoung Kim, KRPIA The government has consistently maintained a conservative attitude on implementing the pre-listing post-evaluation system. However, at the forum, MOHW did not rule out the possibility of implementing such a system. Deputy Director Choi said, “I agree that now is the time to seriously consider the implementation of such systems. If the industry proposes a detailed action plan, we will review the plan with HIRA and NHIS. However, one thing that I hope the industry also bears in mind is that the continuity of care is not an issue that impacts the listing or delisting of a single drug product; It is an issue that needs to be considered collectively for the sustainability of NHI finances.” ◆ Considerations on ‘cost-effectiveness,’ the first criteria considered in drug evaluations = Cost-effectiveness is central to Korea’s reimbursement listing system. Industry officials agree that is an essential criterion for the system while pointing out that too much stress is being laid solely on cost-effectiveness. In addition to cost-effectiveness, the Principles on Determining Eligibility of Long-term Care Benefits list factors such as medical significance (clinical utility) and social benefits as factors for consideration. However, industry officials say that these other factors are not sufficiently reflected during reimbursement evaluations. At the forum, Director Hyeon-seok Na from JW Pharmaceutical Corp. said, “The industry does feel that the government is too focused on cost-effectiveness. Such focus on cost-effectiveness would lead so many drugs to be not approved for reimbursement listing. We hope that the weight of other factors such as social benefit should be increased” Senor Manager Hyeon-seok Na, JW Pharm. Professor Hyung-Ki Lee who chaired the event added, “This reminds me of a paper published by HIRA. It was a 2006 study that tracked the standards used by HIRA in deciding reimbursement for drugs. Results showed that drugs that had lower prices were listed and at a faster rate than those with high clinical utility.” Cost-effectiveness is a staple topic in the discussion of improving the domestic drug reimbursement system. The difficulty in demonstrating cost-effectiveness leads to requests for improving the ICER threshold and the exemption of PE assessment. On this, the government’s response is that considerations of cost-effectiveness are just a matter of order. “The government does not solely focus on cost-effectiveness in the reimbursement decision-making process. For a drug to receive reimbursement, it first needs to prove its clinical utility,” said Choi. ”Only drugs that are determined to be clinically effective are then evaluated for their cost-effectiveness. The strict evaluation criteria may be worth discussing; however, it does not mean that we have had made no efforts to resolve the issue.”
- Company
- Generic for Eliquis, stop selling after supreme court loss
- by Kim, Jin-Gu Apr 14, 2021 06:07am
- Eliquis (Apixaban)’s generic companies stop selling one after another. This is a strategy after the Supreme Court ruled in favor of the original company BMS in the Eliquis patent dispute. This is a measure to reduce the risk even a little in preparation for future lawsuits for claiming damages. According to the pharmaceutical industry on the 13th, Chong Kun Dang, Yuhan Corporation, Samjin Pharm, and Hanmi Pharm, which are selling Eliquis generics, have either stopped or stopped selling the product. An official from a company selling generics said, "We have already stopped selling them." An official from another pharmaceutical company also said, "We are actively considering a plan to stop the sale." Another pharmaceutical company official, whose sales performance of generics is not large, said, "We will follow the choices of other companies." The reason they stop selling is because of the burden of a lawsuit for damages in the future. Claims for damages are proportional to product sales. This is because the more sales, the more compensation. In preparation for this, the sale is stopped in an effort to reduce the amount of compensation even a penny. BMS officially announced a claim for damages immediately after the Supreme Court ruling. Korea BMS Pharmaceutical CEO Kim Jin-young said, "As the validity of the Eliquis patent has been confirmed, we will take all possible legal actions, including claims for damages, for any act that infringes on the patent." ◆"The amount of damages will be less than the actual sales. Fierce legal disputes expected" In the pharmaceutical industry and the legal community, damage compensation is expected to be calculated less than the actual sales of generic products. According to the drug market research institute UBIST, the cumulative combined prescription amount of generic items is a little less than 10 billion won as of the end of last year. Since its launch in July 2019, it has been prescribed 1.2 billion won that year and 8.3 billion won last year. By item, Chong Kun Dang Liquisia 3 billion won, Samjin Pharmaceutical Elxaban 1.8 billion won, Yuhan Apixaban 1.3 billion won, etc. Typically, the amount of damages due to patent infringement is determined from operating profits, not from sales of the generics. This is because the'profit' obtained as a result of patent infringement is calculated as the amount of compensation. However, it goes through a very complicated calculation process as to how much the actual profit will be viewed. For example, raw material prices are generally excluded from damages. If the generic had not been released, the raw material would not have been bought, so it is subtracted from the damages. An official in the legal profession said, "Other items are added or subtracted from the calculation of damages," and "Another legal dispute between BMS trying to receive even a penny more in relation to the calculation of damages and a generic company trying to reduce even a little will develop very fiercely." . Generic companies are also preparing for destruction and repatriation along with the suspension of sales. This is because the legal battle has not yet ended. Earlier, the Supreme Court remanded the case to the Patent Court while making a decision on the side of BMS. In general, the remand of revocation is based on the judgment of the superior judge. However, if a new allegation is raised at the remand of revocation trial, the opposite decision may be made. Accordingly, generic companies are looking for new logic to deny Eliquis' material patent.
- Policy
- NHIS and choline alfoscerate makers fail to reach agreement
- by Kim, Jung-Ju Apr 14, 2021 06:06am
- Negotiations on the retrieval of health insurance benefits paid for 60 choline alfoscerate products have all fell through despite the series of extensions made on its negotiation period. The key cause of the negotiation breakddown was that the payer, National Health Insurance Service (NHIS), and the pharmaceutical companies were unable to reach an agreement on the collection rate. As a result, the government is now at a crossroads. It may either order deletion of the 60 products from the benefits list or order renegotiations. According to industry officials on the 12th, NHIS reported to the Ministry of Health and Welfare that the negotiation between NHIS and relevant pharmaceutical companies on the retrieval of insurance benefits paid for the 60 drug products ended in a breakdown, The three main items for negotiation were: ▲recollection amount ▲recollection period ▲recollection rate. NHIS and the companies had reached some level of consensus on the first two items, as they agreed to cover the claims including the patient's copayment amount and to pay back the benefits received in the clinical re-evaluation period. Therefore, the key issue that could make or break the negotiation was the recollection rate. NHIS had originally set the rate at 100%. However, to close the gap in the negotiation process, NHIS had reduced the rate by half to 50% as an acceptable rate. However, the rate proposed by companies was around 10%, in the 6%-10% range. As the gap between the two rates was too large to close in the limited time period, the industry predominantly expected the negotiation to fall through. It is now up to the government to make the final decision. The government, which has extended the negotiation period and awaited its results, may now decide to the products from the benefits list or order renegotiations. At this point, the only hope left for the companies is to count on the renegotiation order that is generally made by the government for negotiations on drug prices.
- Policy
- MFDS to support domestic vaccine for COVID-19
- by Lee, Tak-Sun Apr 14, 2021 06:06am
- The MFDS has announced that it will establish a new indicator that eases the phase 3 clinical criteria for the existing COVID-19. Through this, the plan is to support the rapid commercialization of domestically developed vaccines. Director Kang-rip Kim made such a statement at a briefing at the special quarantine inspection meeting in response to COVID-19 on the 12th. Director Kim said, "We will promote the rapid establishment of immune surrogate indicators that enable clinical trials at low cost and with a smaller number of subjects compared to the existing phase 3 clinical trials," and "guide for vaccine development using immune surrogate indicators. We will cooperate with international organizations such as WHO as well as presenting the line in detail and securing basic data by analyzing the immunogenicity of the vaccinated person." In addition, he added, "We will also promote technical support for production and quality control, such as establishing production technology and test methods for each platform of vaccine for most domestic vaccine developers without mass production experience." Phase 3 clinical trials of COVID-19 vaccine are administered together with placebo to compare the number of confirmed cases, which requires tens of thousands of subjects, which is expensive and time consuming, and the speed varies depending on the environment of COVID-19 occurrence. Accordingly, the industry is demanding the establishment of an immune proxy to replace this, which is being reviewed positively by the MFDS. The MFDS is also planning to expand the scope of clinical trials for Regkirona, a domestic antibody treatment. "The domestic antibody therapy Regkirona is limited to the use of the elderly, cardiovascular, respiratory, diabetes, and hypertensive patients due to the lack of clinical evidence due to short-term development." "We will support the expansion to patients with reduced immunity and obesity such as heart disease and cancer." He emphasized, "If we approve treatment purposes for emergency patients, we will support timely treatment of corona patients, such as shortening administrative procedures." Lastly, the MFDS promised to support the rapid introduction of self-test kits. Therefore, it is an explanation that we will cooperate with related ministries to shorten the development period, which normally takes 8 months, to less than two months.
- Company
- Geo-Young is interested in distributing botulinum products
- by Nho, Byung Chul Apr 14, 2021 06:06am
- Geo-Young and Zuellig entered the competition for the storage and distribution of Xeomin of Multz, Germany, which is the best importer of botulinum toxin products. According to the pharmaceutical industry on the 9th, Multz is conducting a competitive bidding ahead of the expiration of the contract with Zuellig, an existing Xeomin storage and distribution company, in December of this year. Xeomin's bidding is highly likely to serve as a business expansion for Geo-Young and Zuellig. Zuellig has been in charge of botulinum toxin formulations, a multinational pharmaceutical company. Geo-Young also has experience in supplying small quantities of botulinum toxins to general hospitals, but the maintenance of various systems according to the expansion of the nationwide network is a task that cannot be overlooked. This is the reason Geo-Young is making great efforts in this bid because it is highly likely to have a significant impact on the expansion of distribution rights for vaccines and biological products, including other botulinum toxin products, depending on how high the rating is received in the construction of the Xeomin storage and delivery system. An industry insider said, "Zuellig has an edge in terms of botulinum toxin distribution know-how, experience and network. However, Multz has the potential to give additional points to Geo-Young, which has a lower distribution cost compared to competitors." The storage temperature of the botulinum toxin formulation is between 2 and 8 °C, so it is important to secure a cold chain from manufacturing to distribution warehouse, hospital delivery, and final treatment stage. There are five distribution warehouses with Geo-Young's refrigeration system: Incheon Logistics Center, Gimpo West Logistics Center, Uijeongbu North Center, Seoul Gangbuk Center, and Gyeonggi Gunpo Center. Geo-Young plans to establish a new vaccine business headquarters in August, which will be in charge of marketing of biological products such as botulinum toxin, vaccine and biopharmaceuticals. The estimated number of personnel in the organization is about 30 to 40 people. Geo-Young official said, "It has not been confirmed whether Xeomin products will only be in charge of refrigeration or distribution. Zuellig has also participated in this bidding. The final contract will be decided in a month. In addition, the establishment of the vaccine division is also in the review stage, and it is not a final issue.” The earnings of Xeomin and Xeomin 50 in 2018 and 2019 are totaled at 4 billion, 600 million, and 5.6 billion and 100 million, respectively. Xeomin is the first product to remove complex proteins, and since its launch in Germany in 2005, it has been approved for safety through US FDA approval, EMA, and the MFDS, and is used in 65 countries around the world. In 2009, Han Wha signed a contract with Multz and made plans to enter the'Botox' market, such as working on an agency to acquire Xeomin's domestic license, but it is known that with the establishment of Multz Korea in 2011, it is known that when Multz Korea was established in 2011, it is known that the license rights have been renounced. Meanwhile, imported finished botulinum toxin items include Allergan's 50 units of Botox, Botox, and Ipsen's Dysport.
- Company
- MNC employees earn ₩91 million on average
- by An, Kyung-Jin Apr 13, 2021 05:19pm
- GSK Consumer Healthcare Korea employees received on average a salary of 150 million won last year. Employees at GSK Korea, Boehringer Ingelheim Korea, Sanofi Pasteur, Viatris Korea, Kyowa Kirin Korea, Galderma Korea, Pfizer Korea, and Abbvie Korea also received an average salary of over 100 million won. According to the Financial Supervisory Service on the 13th, employees and executives working at 24 Korean subsidiaries of multinational pharmaceutical companies had earned 91 million won on average last year. The amount is based on the salary of 471,742 executives and employees at 24 Korean subsidiaries of multinational pharmaceutical companies that submitted audit reports to the Financial Supervisory Service by April 12th. The average salary per person was calculated by dividing the total salary paid by the number of employees and executives listed in the audit report. Only the salary item in the selling and administrative expenses (SG&A) of the audit report was counted, and other items including the welfare benefits, bonuses, performance-related pay, and retirement allowances were excluded from the calculation. However, the amount may differ somewhat from the actual net pay received by employees depending on the description method of labor cost in each company. GSK Consumer Healthcare Korea paid a total of 12.861 billion won in employee wages last year. The number of executives and employees working at GSK Consumer Healthcare Korea as of last year was 87. As the number of executives and employees stayed the same while the total salary increased by 30.7% from the previous year, the average salary per employee rose by nearly 35 million won. GSK Consumer Healthcare Korea also paid nearly 20 billion won to its retired employees last year. Among the SG&A items, expenses listed as retirement allowance were 1.59 billion won, and 17.31 billion won was retirement bonuses. However, as the number of employees was the same as the previous year, it is difficult to determine the specific number of resignations. GSK Korea, which had kept its position as the top-paid multinational pharmaceutical company based on annual salary until 2019, ranked second place this year by a narrow margin. GSK paid 61.64 billion won in salaries last year, a 3.1% increase from the previous year. The number of executives and employees working at GSK as of last year was 434. With 7 less employees than the year before, the average salary of its people rose by 4.6%. However, as the increase rate fell short of the rate of GSK Consumer Healthcare Korea’s, GSK Korea’s rank fell one level. Boehringer Ingelheim Korea’s average salary rose by 27.4% per employee, which was the second-highest rate of increase after GSK Consumer Health Korea. Boehringer Ingelheim Korea paid 21.26 billion won in salaries last year. The company ranked 3rd place with an average salary of 133 million won, a 28 million won increase from the previous year. Sanofi Pasteur executives and employees received 129 million won on average as annual salary last year. As its number of employees decreased from 61 in 2019 to 53 at the end of 2020 while its total salary increased by 11.1%, the average salary per person rose 27.9% from the previous year. Also, companies including Viatris Korea (126 million won), Kyowa Kirin Korea (118 million won), Galderma Korea (103 million won), Pfizer Korea (102 million won), and Abbvie Korea (100 million won) also had an annual salary that exceeds 100 million won. Among the 24 companies surveyed, 9 companies had an average salary of over 100 million won, and 17 companies had an average salary of over 80 million won. The net pay that the executives and employees actually received may be higher depending on their individual performance. In the audit report, Sanofi-Aventis Korea had stated that it had paid bonuses and wages (2.8 billion won) and performance-based pay (3.3 billion won) in addition to the 47.8 billion won as labor costs. Sanofi Pasteur also listed bonuses and wages (0.4 billion won) and performance-based pay (0.8 billion won) separately from salaries. Amgen Korea had also paid 3.2 billion won as bonuses apart from the 13.8 billion won paid as salaries. In companies that have local manufacturing facilities such as Korea Otsuka Pharmaceutical and Janssen Korea, the actual net pay received by employees was found to be much different from the average salary listed in the audit. As these companies list wages of factory employees as production cost and the salary of clinical team employees and R&D cost., the method dividing the salary listed on SG&A by the number of employees could not accurately reflect the net pay received by their employees. As of last year, the average pay received by executives and employees of multinational pharmaceutical companies far exceeded the amount received by those at listed companies in Korea. Last year, the average salary of 30 KOSPI and KOSDAQ-listed biopharmaceutical companies were 70.4 million won. The amount is an average of the total salary of 2.43 trillion won that was paid to 34,323 employees and internal directors in the 30 companies. Simply calculated without considering the continuous years of service or position of the employees, the average salary per person in domestic pharmaceutical companies is lower by 20 million won. 24 companies - GSK Consumer Healthcare Korea, GlaxoSmithKline, Boehringer Ingelheim Korea, Sanofi Pasteur, Viatris Korea, Kyowa Kirin Korea, Galderma Korea, Pfizer Korea, AbbVie Korea, Lundbeck Korea, Sanofi-Aventis Korea, Amgen Korea, UCB Korea, Bayer Korea, Servier Korea, Lilly Korea, AstraZeneca Korea, Baxter Korea, Guerbet Korea, Novo Nordisk, Menarini Korea, Teva-Handok, Korea Otsuka Pharmaceutical, Janssen Korea - were included in the survey. Among the 25 Korean subsidiaries of multinational pharmaceutical companies that submitted an audit report by April 12th, Janssen Vaccine was excluded as it had minimized its operation of production facilities as well as operating personnel until the production line around its anticancer drugs and next-generation vaccines is reorganized.
- Policy
- Hanmi’s Rosuzet with annual sales of ₩99.1 billion
- by Lee, Tak-Sun Apr 13, 2021 05:46am
- Rosuzet (Hanmi, Rosuvastatin-Ezetimibe), a blockbuster drug with annual prescriptions of ₩99.1 billion, expects to add a new dose. Rosuzet is currently licensed for three doses, and the new dose is known to contain unlicensed doses in Korea. According to industry sources on the 12th, Hanmi recently applied for a new dose of Rosuzet to the MFDS. Rosuzet is a combination drug that combines Rosuvastatin and Ezetimibe, an ingredient for treating hyperlipidemia, containing Ezetimibe 10 mg and three different doses of Rosuvastatin. Specifically, there are 3 items including Ezetimibe-Rosuvastatin 10/10mg, 10/20mg, and 10/5mg. Currently, Rosuvastatin 5mg, 10mg, and 20mg are approved in Korea. However, it is known that the product applied for approval this time contains 2.5mg of Rosuvastatin. Overseas, there are also 2.5mg and 40mg in addition to the currently approved 10mg, 20mg and 5mg in Korea. In particular, Ministry of Health, Labor and Welfare of Japan recommends an initial dose of 2.5mg considering the size of Asians, which are smaller than Westerners. The effect is improved as Rosuvastatin increases, but it is said that side effects also increase. Accordingly, customized prescriptions are also being made in the medical field. Rosuzet's earnings are expected to improve if the number of products by dose increases, taking this into account. In particular, Rosuvastatin 2.5mg and 40mg do not exist in Korea, so the choice of prescription is expected to improve. Rosuzet was a blockbuster drug with sales of ₩99.1 billion (based on UBIST) in outpatient prescriptions last year. However, it is difficult for Rosuzet to maintain its market share, as products such as generics for Atozet have recently been poured into the Statin-Ezetimibe combination market. Therefore, it is noteworthy whether new dose products will lead to growth.
- Policy
- Sanofi withdraws 'EVE QUICK' from domestic market
- by Lee, Tak-Sun Apr 13, 2021 05:46am
- Imported pain relievers that entered the Korean market late are not faring well in Korea's market. This is because brand products like Tylenol, Geborin, and EZN have already settled in the market, and the fierce competition ongoing between multiple companies has left no room for late entrants. As a result, Sanofi has withdrawn its license for ‘EVE Quick tablet’ on the 8th. The 'EVE QUICK tablet' was first introduced to Korea in 2011 by Boehringer Ingelheim. Based on a non-steroidal anti-inflammatory pain killer, ibuprofen, its formula contains magnesium oxide and allyl isopropyl acetyl urea. Like its name, the product was focused on treating pain experienced by women, such as menstrual pain. The drug, which was produced by Boehringer Ingelheim Japan, was often introduced as a must-buy item for travelers to Japan. Sanofi has been selling EVE QUICK since 2017 after acquiring Boehringer Ingelheim's OTC division. In the early days of its release, full-scale efforts were made for the sale of EVE QUICK, including a marketing partnership with Yuhan Corporation. However, its sales revenue did not live up to the company's expectations. In addition, competition became more intense with various pain relievers for women entering the market in the 2010s. No results were found on the performance of EVE QUICK for the past three years on IQVIA, an institution that researches the drug market. In the pain reliever market for women, KyongDong Pharm's 'GNAL-N,' Janssen Korea's 'Women's Tylenol,' and Samjin Pharm’s 'Geworin soft capsule' are waging fierce competition. In 2019, Sanofi also decided to not renew its license for its ‘EVE-A tablet,' leaving it to expire. With the withdrawal of EVE QUICK, Sanofi will have completely withdrawn from the domestic pain reliever market. Other late entrants are also not living up to their company’s expectations. GSK Consumer Healthcare’s ‘Advil' is one example. Although Advil is one of the most commonly sold pain relievers with Tylenol, since its launch in 2013, it has failed to produce significant results in Korea. Based on IQVIA data, Advil’s sales only amounted to 1.6 billion won in 2020. In 2018, Oxy Reckitt Benckiser also withdrew the marketing license for its 3 types of Nurofen pain relievers.
