- LOGIN
- MemberShip
- 2026-04-14 13:27:03
- Company
- Sales in the herpes zoster market have halved in 2 years
- by An, Kyung-Jin Jun 04, 2021 06:06am
- Sales in the domestic shingles prevention vaccine market, which had been on the mend, fell again. In December last year, sales of two vaccines to prevent shingles fell as the vaccination rate fell in the wake of the third pandemic of COVID-19. According to IQVIA, a pharmaceutical research institute, the size of the vaccine market for shingles prevention in the first quarter was ₩10.9 billion, down 10.8% from ₩12.2 billion a year earlier. It is down 44.5% from ₩19.7 billion. The first quarter of last year was a time when the economy stagnated sharply as COVID-19 pandemic began around the world. South Korea's two vaccines for shingles prevention were competing, but sales fell to the lowest level. This year's sales declined from the first quarter of last year, further slowing down. Two types of shingles prevention vaccines are being sold in Korea, including MSD's Zostavax and SK Bioscience's Sky Zoster. It was monopolized by Zostavax, but it continued to grow rapidly with the advent of Sky Zoster in late 2017. The successful shingles prevention vaccine market has worsened in the face of an unexpected infection crisis. Its fourth quarter sales increased to ₩27.9 billion and halved to ₩12.2 billion in the early stages of COVID-19 crisis. Although its second quarter sales recovered to ₩22.6 billion, but decreased again to ₩20.3 billion in third quarter and ₩17.3 billion in fourth quarter. Until the first quarter of this year, quarterly sales have fallen for three consecutive quarters, and have rarely recovered. The industry believes that the vaccine market for shingles prevention is more easily affected by factors such as the epidemic of infectious diseases than other drug markets prescribed for chronic diseases. Since it is a vaccine to prevent diseases, not treatments used in urgent situations, the inoculation rate will inevitably fall if patients avoid visits to medical institutions. The fact that the COVID-19 vaccination, developed by Pfizer and AstraZeneca since early this year, has also had some impact on the decrease in the number of other vaccinations. The market for adult vaccines is sluggish, with the exception of pneumococcal vaccines that benefited from COVID-19. Both Zostavax and Sky Zoster have drawn similar quarterly sales distributions since last year. Sales of Zostavax in the first quarter were ₩6.5 billion, down 10.9% from a year earlier. This is a 40.6% decrease from $10.9 billion (10.9 billion KRW) in previous quarter.Sky Zoster posted sales of ₩4.4 billion in the first quarter, down 10.6% from a year earlier. Compared to the previous quarter, it decreased by 30.6%. As sales of the two products showed similar ups and downs, market share was similar. Sky Zoster's share in the first quarter stood at 40.4%, no significant difference from 40.3% a year earlier. There is another variable in the domestic shingles prevention vaccine market. GSK reportedly applied to the MFDS for the approval of Shingrix earlier this year. Starting with FDA approval in 2017, Shingrix is a product that has been sold in major countries around the world. Demand was high enough to cause scarcity overseas. Market competition is expected to intensify if GSK starts selling Shingrix in Korea.
- Policy
- Humira's price cut 30% due to Adalloce Prefilled Pen listing
- by Kim, Jung-Ju Jun 04, 2021 06:06am
- Abbvie Korea’s lead product line Humira is facing an insurance price cut of 30%. This ex officio adjustment by the government is to be made due to the introduction of the two biosimilars earlier this year by Samsung Bioepis, including its Adalloce prefilled pen inj.. The Ministry of Health and Welfare (MOHW) is preparing to amend the 'drug benefit list and price ceiling schedule' to include such adjustments. Once the amendment is finalized, it will take effect from the 7th of this month. Humira is a biologic product approved for rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis, and Crohn’s disease, etc. Humira is facing price adjustments in Korea as Samsung Bioepis' biosimilar of this product, Adalloce Prefilled Syringe inj. 40mg and Adalloce Prefilled Pen inj. 40mg were listed in February. Under the Criteria for Decision or Adjustment on Drugs, the government may reduce the ceiling price of first-listed products, products with the same route of administration/ingredient/formulation, and those in the same class for mixed nutrient solutions to 53.55% of the original price when another company lists a drug with the same route of administration/ingredient/formulation. For narcotics and biologics, the price is adjusted to a 70% level. The MOHW ordered negotiations for Humira, under which the National Health Insurance Service (NHIS) and Abbvie Korea held negotiations from the 11th to 18th last month. However, the terms were not introduced or deliberated by the Health Insurance Policy Deliberation Committee as it missed the deliberation period. The price cuts will be at around 30% for each product in the Humira line. The MOHW is expected to make the final decision soon as the authorities believe that the price cuts are necessary for saving health insurance finances.
- Product
- Tylenol's sales at convenience stores rose 125% year-on-year
- by Jun 04, 2021 06:06am
- Convenience stores are also benefiting from the shortage of outpatient pharmacies' Tylenol as vaccination begins in earnest.Tylenol sales at convenience stores designated as household medicine rose. Household medicine sold at convenience stores First of all, CU's Tylenol sales increased 125.5% year-on-year. According to sales from May 27 to May 31, when vaccinations for people aged 65 or older began in earnest, it increased 89.9% compared to the previous month (April 26 to 30), and it also increased 68.1% compared to the previous week (May 20 to 24). In the case of Seven-Eleven convenience stores, sales of Tylenol increased 23.3% compared to the previous month, especially sales from the 27th to 30th increased 99.6% from the same period last month. In the case of GS25 convenience stores, Tylenol sales rose 41.9% last month from a year ago and 38.8% compared to the previous month, the survey showed. In some convenience stores, Tylenol is in short supply like pharmacies. "The number of consumers visiting Tylenol has increased recently," said CU convenience store owner in Seoul. Both Tylenol 500mg and Tylenol160 mg are out of stock, he said. "We only have children's syrup in stock at the moment." Meanwhile, the Gyeonggi Pharmaceutical Association criticized the government and the vaccination center's inexperienced administration for causing Tylenol shortage on the 1st and insisted that Tylenol should not be sold at convenience stores for a while as it is time to manage side effects.
- Product
- Korean Tylenol is in stock
- by Jun 04, 2021 06:05am
- "It doesn't have to be original Tylenol." Pharmacists have launched a counterattack in connection with the Tylenol shortage. As Tylenol has been out of stock for months to respond to consumers due to recommendations from vaccination centers and health centers, pharmacists are trying to immediately inform them of fever and painkillers. They started to improve consumer awareness by spreading the message that It doesn't have to be original Tylenol through pharmacies and SNS. First of all, pharmacist Lee Jung-chul, the author of "Alssulshinyak" told by dispensing brothers, recently posted a message on blogs and YouTube saying, "You don't have to stick to Tylenol after the vaccine against COVID-19." The pharmacist recognizes that "the painkillers available after COVID-19 vaccine are Tylenol unconditionally, but there is no need to insist on Tylenol." Tylenol is just one of many drugs made of Acetaminophen, and said, "There are many drugs made of the same Acetaminophen even if they are not Tylenol." Since Tylenol has become an issue due to its high recognition of many drugs with Acetaminophen, there is no problem in taking Acetaminophen, the same active ingredient as Tylenol, in situations where Tylenol is not easy to obtain. "About 10 to 20 consumers a day visit and ask for Tylenol," said pharmacist Lee Jung-chul. "It doesn't matter if it's Acetaminophen, but if patients don't understand or if the media or hospitals nominate Tylenol, they often think they can't do other drugs," he said. "I'm filming a video out of frustration, and I hope the message will be shared widely." The pharmacist explained, "In fact, the number of cases where people accept and buy other products is increasing if they use the 'Ask a Pharmacist' card news produced by the Korean Pharmaceutical Association." Tylenol-related notice attached to the entrance of a pharmacy in Incheon A pharmacist in Incheon recently attached a sign that Tylenol is out of stock and there's a stock of same active ingredient to the entrance of a pharmacy and a consultation desk. Tylenol is Acetaminophen formulations made by Janssen, a foreign company, under the notice, "If you take fever and painkillers after the COVD-19 vaccine, take Acetaminophen-based medicine." There are 80 items such as Suspen, Tramol, Tacenol, Nasphen, and Setopen," a notice said. The pharmacist said, "When asked repeatedly by consumers if they had Tylenol in stock all day, the voices of working pharmacists were hoarse. "It was like the public mask crisis in the past," he said. "We changed our sales strategy because of the release of good domestic drugs." In addition, pharmacists who run SNS channels such as blogs, Instagram, and YouTube are also participating in "Knowing About Acetaminophen Right away," explaining the types of Acetaminophen, how to take it, and alternatives. The Korean Pharmaceutical Association and the MFDS urgently produced posters and distributed them to pharmacies about the ridiculous situation of trying to buy only Tylenol at pharmacies despite the presence of a number of Acetaminophenes. Posters distributed by the Korean Pharmaceutical Association & the MFDS The Korean Pharmaceutical Association and the MFDS posted a poster saying, 'Relax if some items are out of stock. There are about 70 Acetaminophen formulations approved by the MFDS. Talk to a pharmacist' in the message.
- Company
- Roche Korea conducts the voluntary retirement program
- by Jun 03, 2021 05:56pm
- Roche Korea conducts the Early Retirement Program (ERP). In the first half of this year alone, many multinational pharmaceutical companies, including Viatris, Astellas, and GSK, started reducing the number of people. According to pharmaceutical industry on the 3rd, Roche Korea is currently conducting ERP for reorganization. The first target is the sales department. At the end of last year, Roche reportedly conducted ERP for some manager-level employees in the sales department. It is heard that specific size and conditions of ERP are under discussion. Industries estimate that it will be about 20% of 60-70 employees in sales department. It is heard that ERP will be carried out for desk job departments in second half of this year. In the first half of this year alone, five to six multinational companies conducted ERP to reorganize or sell their business units, including Viatris, Astellas, GSK, Zuellig Pharma, Jansen, and Roche. Viatris, which split from Pfizer and merged with Mylan, operated ERP as part of its global headquarters' massive restructuring plan. In the process, several managers appear to have resigned. GSK also conducted ERP to some sales and marketing executives while reorganizing its business structure. In particular, as telecommuting and non-face-to-face marketing have increased due to COVID-19 outbreak, and the reporting system has changed, management executives are mainly on the ERP list. The reason for the implementation of Astellas Pharma and Zuellig Pharma's ERP is the deterioration of management. In order to overcome the situation in which patents of major items expire or are damaged in the long term, restructuring has begun. Astellas said its goal is to reduce its total staff by 40%. Zuellig announced it would restructure about 80% of its 100 sales staff. It posted operating losses for the third consecutive year last year, with a debt ratio of 30,000%. Janssen is different from other companies. Janssen, which sold its Hyangnam plant to Whanin, added ERP as an option in the process of redeploying its employees. Employees who want to stay will be transferred to the Songdo plant in Incheon. Retention of employment is a fundamental principle. Employees who do not want this can choose the ERP. Meanwhile, Sanofi and Lilly also conducted ERP late last year due to the COVID-19 crisis.
- Company
- Amgen speeds up commercialization of its KRAS drug
- by Eo, Yun-Ho Jun 03, 2021 06:12am
- Amgen is rapidly working to commercialize its KRAS targeted anticancer therapy in Korea. Industry sources have said that Amgen Korea has submitted an application for the marketing authorization of the first-ever KRAS-targeted anticancer therapy, ‘Lumakras (sotorasib),' on the 28th to the Korean Ministry of Food and Drug Safety (MFDS) immediately after receiving accelerated approval from the U.S. FDA. Amgen's actions seem to be an attempt to solidify Lumakras's position as a first-in-class treatment. As the drug had already received orphan drug designation from the Korean Ministry of Food and Drug Safety in March, the approval process is expected to go smoothly unless there is a special reason for its disqualification. Lumakras is the first-ever drug to be introduced since the KRAS gene was discovered about 40 years ago. Its indication is for non-small cell lung cancer (NSCLC), and patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have received at least one prior systemic therapy may use Lumakras. The KRAS gene was first discovered in a lung tumor in 1982. About 25% of Western patients and 10-15% of Asian patients with lung adenocarcinomas are found to have the KRAS mutation. In Korea, 5-8% of patients have the KRAS mutation. As there had been no suitable targeted therapy for the KRAS mutation, taxane-based chemotherapy was used for its treatment. But Amgen’s CodeBreak 100 trial results showed that the 124 KRAS G12C-mutated NSCLC patients who received Lumakras 960mg had an ORR of 36%, and their median duration of response was 10 months. Despite continuous efforts to develop a KRAS targeted therapy, none had shown promising results in clinical trials. The discovery of the signaling pathway of KRAS afterward led to the development of more specific targeted therapies for various subtypes of KRAS such as G12C, G12D, G12F, etc. Among these, Sotorasib targets the KRAS G12C mutation, which is known to be the most common mutation in lung cancer. Multinational pharmaceutical companies including Amgen, Mirati Therapeutics, and Boehringer Ingelheim have been attempting to develop therapies targeting KRAS, among which Amgen became the first to produce tangible results.
- Policy
- Suspension extended due to prolonged lawsuit of Betmiga
- by Kim, Jung-Ju Jun 03, 2021 06:12am
- The price will be temporarily extended again as Astellas Korea, which had been expected to plunge last year due to the government's adjustment to insurance prices, has prolonged its refusal to lower the price of Betmiga PR. The 14th administration of the Seoul Administrative Court has decided to extend the suspension until the 30th day of the ruling on Betmiga PR-related litigation among the "pharmaceutical reimbursed list and upper limit price table" announced by the MOHW on June 23 last year. Suspension means suspending the government's price reduction measures until the lawsuit is closed. Last year, the MOHW included the drug in the list of items that cut the government's authority adjustment, signaling a sharp decline. The government is lowering the upper limit of the first registered generic and products with the same administration path, ingredient, and formulation. Originally, the price would have been lowered due to the adjustment of authority on July 1 last year. According to the suspension, the price will be temporarily maintained at ₩673 per Betmiga PR 50mg and ₩449 per Betmiga PR 25mg. The MOHW will further guide if there is any change later.
- Company
- Awareness of multiple sclerosis should increase
- by Jun 03, 2021 06:12am
- Today (26th) is World MS Day. Although the treatment environment has improved significantly with the release of more new drugs for multiple sclerosis compared to the past, early diagnosis is not easy due to the low awareness of the disease. The same is true of overseas situations. In response, the International Association for Multiple Sclerosis (MSIF) has designated the last Wednesday of May every year to raise awareness of the disease. This year's theme is 'Connection'. The goal is to challenge the social obstacles and isolation experienced by multiple sclerosis patients and establish relationships for patients' better lives. Multiple sclerosis is a chronic disease in the central nervous system, including the brain, spinal cord, and optic nerve, and an autoimmune disease caused by the immune system attacking healthy cells and tissues. If myelin, which surrounds and protects nerve fibers in the central nervous system, is damaged, unregulated inflammatory reactions cause wounds in various areas such as the brain and spinal cord, leading to diseases that interfere with nerve transmission. Multiple sclerosis has a wide variety of conditions and symptoms depending on where it occurs. Sensory abnormalities, visual impairment, fatigue, motor impairment, balance abnormalities, bowel and bladder problems, sexual dysfunction, and pain are combined, which are characterized by repeated recurrence and remission. In the early stages of the outbreak, it improves without a disorder after a recurrence, but it is also a rare incurable disease that does not fully improve over time and remains disabled as the recurrence repeats. The incidence of women is more than 50% higher than that of men, and it often occurs in young people aged 20 to 40 who are actively engaged in social activities. The number of patients in the country is about 2,500. Rare diseases have low awareness, making it difficult for patients to suspect multiple sclerosis. Difficulties in diagnosis also make early diagnosis difficult. This is because there is no specific test method to confirm multiple sclerosis so far. The doctor should observe various symptoms, medical history, and image findings that the patient appeals to and then determine the disease clinically. It usually applies McDonald standards. Progressive multiple sclerosis is classified as primary and secondary progressive. Primary progression is slow to manifest, while secondary to continuous recurrence and recovery continue to deteriorate over a long period of time. In general, about 50% of patients with recurrent palliative multiple sclerosis progresses to secondary progression within 10 years, and 90% of patients switch to secondary progression after more than 25 years. There is no cure for multiple sclerosis, but treatment options have increased. In the early 1990s, when there was no cure at all, the prognosis of patients was poor, but in 1993, the first multiple sclerosis drug appeared, and the prognosis of patients began to improve. In addition, the half-life of the injection has been extended significantly. Currently, multiple sclerosis treatment relieves the disease with steroids during the acute period, and in the long run, the disease is managed with interferon-like injections and oral drugs (DMT). It is important to curb recurrence so that it does not develop into a permanent disability. Reimbursement standards are also improving. As a representative example, the reimbursement clause of Aubagio, an oral primary treatment drug, has been expanded since February this year, allowing oral formulation to be used from the beginning of treatment. Aubagio is the first oral drug to be launched in Korea, and has more than 16 years of long-term safety data to date, along with features that inhibit recurrence and maintain immune action. As there are more options to choose from depending on the patient's life pattern and condition and the benefit is improving, it is important to find and manage medications that can be conveniently treated by the patient themselves. However, there are still diagnostic and therapeutic limitations that arise from unclear causes of the outbreak. Experts say that improving awareness of the disease is urgently needed to elicit early diagnosis. Multiple sclerosis should be suspected if sensory disorders and muscle weakness occur over several days in situations where symptoms of multiple sclerosis are nonspecific, but there is no pain in the neck or back. In particular, if vision disorders accompanied by sudden eye pain are accompanied by young people aged 20 to 50, optic neuritis and spinal cord, which can be seen as before multiple sclerosis, can be suspected. "Multiple sclerosis is possible to slow down the progress of the disease and maintain daily life without disability when appropriate treatment is started in the early stages of the outbreak," said Kim Byung-joon, chairman of the Korean Society of Neuroimmunology. Early diagnosis by professional neurologists is a very important disease, and medical and social understanding and interest in multiple sclerosis need to be improved to maintain continuous treatment by selecting appropriate treatments.
- Policy
- Bill to strengthen fines on rebates pass NA plenary session
- by Lee, Jeong-Hwan Jun 03, 2021 06:11am
- A bill to increase the upper limit of the penalty surcharge imposed on drugs caught doing illegal rebates, and allowing the use of the surcharge as a resource for catastrophic health projects passed the plenary session of the National Assembly on the 21st. In the session, the NA passed the bill for the partial amendment of the National Health Insurance Act that was proposed by Yongho Lee as the representative, and the altered bill for the partial amendment to the Catastrophic Health Expenditure Support Act that was submitted as an alternative by the Legislation and Judiciary Committee. Thus, following the government’s promulgation of the laws, the upper limit of the penalty surcharge imposed with the administrative disposition of a ‘reimbursement suspension’ on drugs that have paid illegal rebates will be raised. At the same time, the surcharge can be used for catastrophic health expenditure support projects. The amendment of the National Health Insurance Act that passed the plenary session allows companies to substitute the administrative ‘reimbursement suspension’ disposition to a penalty surcharge. Also, the amendment specified the reasons for substituting the disposition with a penalty surcharge and significantly increased the upper limit of the surcharge compared to before. Under the amended Act, drugs that paid illegal rebates may substitute its suspension disposition with a penalty surcharge up to 200% of the total medical care benefit paid for the drug in cases when the suspension ‘is expected to interfere with public welfare by causing inconvenience in patient care, etc.’ When the surcharge is imposed again for the same drug for rebates within 5 years, the upper limit is increased up to 350%. For the standard that had already existed - ‘special cases when the disposition is expected to cause a serious risk to public health' - the penalty surcharge was set up to 60% of the total medical care benefit paid for the drug. For repeated cases within 5 years, the upper limit is raised to 100%. The amendment to the National Health Insurance Act that passed the plenary session will take effect 6 months after the government’s promulgation. The amendment to the penalty surcharge will start to be applied to rebate cases that were found after the Act goes into effect.
- Company
- Tecentriq attempts reimbursement after Keytruda fails
- by Eo, Yun-Ho Jun 02, 2021 06:11am
- ‘Tecentriq’ is attempting what ‘Keytruda’ had failed. Industry sources have said that Roche Korea had submitted an application for the reimbursement of its ‘Tecentriq (atezolizumab),’ as monotherapy in the first-line setting for non-small cell lung cancer (NSCLC) patients whose tumors have a programmed death ligand-1 (PD-L1) expression on at least 50% of tumor cells (TC), or tumor-infiltrating immune cells covering at least 10% of the tumor area. The company received approval for this indication this April. The agenda will be put up for deliberation by the Cancer Drugs Benefit Appraisal Committee of the Health Insurance Review & Assessment Service in July. Accordingly, the possibility is rising for Tecentriq's reimbursement to be discussed together with MSD Korea’s PD-1 inhibitor ‘Keytruda,' which failed to be approved for the 8th time at the meeting held on the 26th last month, at the next Cancer Drugs Benefit Appraisal Committee meeting. The authorities may induce competition among pharmaceutical companies to reduce fiscal spending, however, this would lead to a delay in reimbursement listing. This irony often occurs in the process of listing expensive new drugs or expanding reimbursement in Korea. As drugs are expensive, if pricing competition arises between pharmaceutical companies, the government can take advantage of the net function of the market. Fiscal savings under the National Health Insurance system saved from such competition can create additional opportunities for coverage expansion. However, the issue at hand is its timing. It would be optimal if drugs of the same class are approved at a similar period so that they can apply for reimbursement listing at a similar timeframe, but this is not likely in reality. In general, the period of each company's reimbursement listing application varies by 6 months to even over a year. Of course, factors other than the physical 'application' date also do play a role in the reimbursement delay, but this difference is important because there are patients awaiting the approval. Moreover, most of the drugs in issue are anticancer drugs. Attention is on what the results would be for the 2 anticancer immunotherapies that walked very different journeys that are attempting the long-delayed reimbursement in first-line lung cancer. The NSCLC reimbursement expansion for Keytruda had been discussed since September 2017, and it has already been nearly 4 years. Among the many barriers, the biggest issue was the ‘pharmaceutical company taking the burden of the initial 3 cycles’ worth of administration cost’ requested by the government to companies with immunotherapy agents. Roche, which owned the then-latecomer Tecentriq was the only company to accept the government’s proposal, and 2 types of PD-1 inhibitors – Keytruda and ‘Opdivo (nivolumab)’ were unable to accept the offer.
