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- 2026-05-19 23:04:58
- 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.
- [Reporter's view]COVID-19 Vaccine Development in Asia
- by Jun 02, 2021 06:11am
- The development of COVID-19 vaccine in Asian countries is on track. Currently, about 6 companies in South Korea, 4 in Japan, 3 in Taiwan, 2 in Thailand and 1 in Singapore are developing their own COVID-19 vaccine. All have just entered clinical trials or are preparing for large-scale clinical trials. Chinese vaccines whose clinical data are unknown were excluded. Specifically, Daiichi Sankyo, Shionogi, KMB, AnGes MG in Japan, Medigen, United Biomedical , Adimmune in Taiwan took the lead. Chulalongkorn University and Mahidol University are developing in Thailand. In Singapore, Duke-Nus Medical School is also working with Biotech in the U.S. to conduct research and development. Korea is dominated by Genexine, SK Bioscience, EuBiologics, GeneOne, Cellid, and ST Pharm. They made full use of their specialized areas. Genexine and GeneOne Life Sciences, which are the core of DNA technology, will develop DNA vaccines, while ST Pharm, which is specialized for mRNA, will develop LNP-type mRNA vaccines for the first time in Korea. Japan's Daiichi Sankyo and AnGes MG are RNA and DNA-based, respectively, and Thailand's Chulalongkorn University also tests RNA-based vaccines. Although development is slower than Western countries such as the U.S., the U.K., and Germany, it is meaningful to make vaccines with its own technology. This is because even if there is a shortage of vaccines that are contracted for supply, it can be replaced with domestic vaccines. In Korea alone, the supply of COVID-19 vaccines is still unstable. Unexpected side effects may lead to a shortage of supplies. Domestic vaccines will be reliable in unexpected circumstances. In response, the government signed a contract to supply vaccines to its own country preemptively. The Taiwanese government has signed 5 million dose vaccine contracts with Medigen and United Biomedical respectively. There are already some places that are about to produce commercial vaccines. Of course, there are many steps to overcome before vaccines in Asian countries are commercialized. Some of them may not be able to confirm their efficacy and safety, and development may be suspended. Many of them have no actual drug development experience. Although development can be successful without experience in commercialization like Moderna, probability is not high. Nevertheless, it is meaningful in terms of industry development that there are many companies that develop vaccines. Based on this experience, it is an opportunity to develop various kinds of vaccines. This also leads to securing sovereignty over vaccines. Currently, only 16 (57%) of the 28 essential vaccines in Korea have domestic products. Although it has been pushing for projects to support localization for more than 10 years, its performance is slow. In the meantime, it is good to hear that many Korean companies are focusing their efforts on vaccine development. In Taiwan, vaccines from their own countries could first appear as early as July. United has applied for EUA with health authorities on the 27th of last month. In Korea, we also expect a vaccine developed by a Korean company.
- Policy
- The new rheumatoid oral drug Smyraf was revoked after a year
- by Lee, Tak-Sun Jun 02, 2021 06:10am
- Astellas' Smyraf, which has drawn attention as a treatment for rheumatoid arthritis, withdrew the license in a year. Smyraf is the third domestically licensed inhibitor of Januskinase (JAK) after Xeljanz (Tofacitinib, Pfizer) and Olumiant (Baricitinib, Lilly). However, it failed to complete the registration process and withdrew from the Korean market. The MFDS announced on the 31st that the permits of Smyraf 100mg and Smyraf 50mg from Astellas Korea have been revoked. Smyraf was licensed in January last year as a new drug for rheumatoid arthritis. In particular, although existing rheumatoid arthritis treatments had the disadvantage of injection type, this product was highly anticipated in that it could be taken oral. The oral JAK inhibitor was a third drug following Xeljanz and Olumiant. After the approval, it was reported that this product was negotiated with insurance authorities to register drug prices. JAK inhibitors have mechanisms that inhibit the Jak-STAT pathway involved in the production of cytokines that cause inflammation in the body. In particular, attention has been paid to whether Smyraf will be listed since the fourth JAK inhibitor "Rinvoq (Upadacitinib, AbbVie)" was released in November last year. However, there was no news of listing for Smyraf, and the withdrawal led to Smyraf leaving the Korean market. JAK inhibitors are steadily rising in the domestic market. In the case of Xeljanz, sales of prescription amount outside the market reached ₩12.6 billion last year. In this situation, the news of Smyraf's withdrawal is very disappointing.
- Company
- Improved reg. allow price succession of transfer products
- by Chon, Seung-Hyun Jun 02, 2021 06:10am
- Drug price succession in transferred pharmaceutical products has been increasing. As the stepped pricing system is no longer applied to drugs that are relisted due to change of licensees, companies have been actively engaged in the transfer of their products. Some products have seen a twofold increase in their price compared to when the stepped pricing system was applied. According to the Ministry of Health and Welfare (MOHW) on the 30th, Organon Korea’s ‘Ezetrol tab.’ will be listed at a ceiling price of 744 won. Ezetrol (ezetimibe) originally used to be owned by MSD Korea. As the license holder was changed to Organon Korea, a new spin-off of MSD Korea, the drug had to be newly listed on the health insurance benefit list. MSD Korea’s Ezetrol will be removed from the reimbursement list from next month and its license will be transferred to Organon Korea. In January this year, a drug price succession regulation for transferred products was newly added, which allowed Ezetrol to maintain its previous maximum ceiling price of 744 won. In July last year, the drug pricing system was revised to add a stepped-pricing system that reduces the price of drugs that are listed late. The key point of the system was to reduce the price of later entrant generics by 15% when the number of products exceeds 20. In other words, if there are more than 20 drugs listed of the same ingredient, the drug price is set at ‘85% of the drug price of products that does not satisfy the two qualifications’ or ‘85% of the lowest price among the previously listed drugs,’ whichever is lower. Under the system, an unexpected issue arose as the drug products transferred between businesses were being listed at the lowest price among all products in the same category due to the application of the stepped pricing system. In transfers where the license of a pharmaceutical product is handed over to another company, the product needs to undergo a removal and relisting process. Even products that were previously listed are regarded a newly listed product after removal from the benefits list and is inevitably applied the stepped pricing system. The industry had pointed out that it was unreasonable to list transferred products the same as newly listed products, and the MOHW agreed to improve the system. From January, MOHW had made a partial amendment to the ‘Criteria for Decision or Adjustment on Drugs,’ so that in cases ▲where the manufacturer’s position was succeeded; ▲ where the same company switches its license from manufacturing and marketing to import authorization; or ▲ where the company withdraws its license due to business conversion, etc. and receives relicensing for the same product; the product’s price will be calculated at the same ceiling price that was previously set for the removed product. The regulation allows for the succession of the previous drug price in process of removal and relisting the same products in product transfers, etc. 42 ezetimibe products are currently listed in the reimbursement list, and their prices range from 480 won to 746 won. If Organon Korea’s Ezetrol was to be regarded as a newly listed product, its price may not have exceeded 408 won, which is 85% of the lowest listed price of 480 won. However, with the amendment, the company was able to maintain Ezetrol’s price at its previous listing price of 744 won. Recently, the drug price succession is actively being carried out among transferred drug products. In only this month, 4 products succeeded their previous drug price and were newly listed on the reimbursement benefits list. Daewoong Bio’s amlodipine and Valsartan combination ‘V-Forge Tab 10/160mg’ was newly listed at a ceiling price of 1,128 won on the 1st of this month. 1,128 won is the highest price among all products in its category and dose, and is a price 60% higher than the lowest price, which is 699 won. 81 products of the 10/160mg dose Amlodipine and Valsartan combination are currently listed in Korea. Under the stepped pricing system, newly listed products may not exceed a price of 594 won, which is 85% of the lowest price of 699 won among the same products. However, V-Forge Tab 10/160mg was a transferred product from Cosmax Pharma. By entering the market through a transfer, Daewoong Bio was able to be listed at a price that was twice higher than that of newly authorized products. Alvogen Korea’s ‘Maxgrel-A,’ which was newly listed from this month, received a ceiling price of 1,209 won. This is the highest price among the same products. With 35 Maxgrel-A products already listed, the price of a newly listed product in the same class would have had received a price discount through the stepped pricing system. However, Maxgrel-A was able to maintain its highest price by being newly listed through a transfer. If Maxgrel-A was a newly licensed product, its price would not have been able to exceed 732 won, which is 61.4% of the highest listed price. Celltrion Pharm’s ‘Celltrion Neopa,’ and Albogen Korea’s ‘Lutsnal Cap. 0.4mg’ would also have been applied the stepped drug pricing system, receiving a price that is ‘85% of the lowest price’ or ’61.4% of the highest price.’ However, the drugs were able to maintain their previous price as a transfer product.
- Opinion
- [Reporter's view] Tylenol is out of stock
- by Jun 02, 2021 06:10am
- As vaccinations began in earnest, the Tylenol crisis broke out in pharmacies. The Tylenol crisis has become inevitable as vaccinations for people aged 75 or older and those aged 65-74 have been implemented following preferential vaccinations for essential social workers. The government and the media are instructing people to take Tylenol if they have a fever after the inoculation. If pharmacists order Tylenol through wholesale, only the quota amount is supplied, so there are always times when the stock is tight or out. "Do you have Tylenol in stock?" "No, but we have the same active ingredient as Tylenol." "Oh, never mind." "Do you have any masks in stock?" "There are no more masks any more" This situation is similar to the mask crisis of the past. Pharmacies with relatively stable supply and demand through Jansen direct transactions do not mean that the situation is better. It is exhausting to guide dozens of consumers to take "after vaccination." Pharmacies are innocent, but it's as if they've become sinners. The pharmacy said this. "The moment I took out Tacenol, the patients looked different. That's exactly where I am going to do business. I don't know why I have to be a merchant, not a pharmacist, with a same pill." The Korean Pharmaceutical Association also urged the government to take Tylenol. The reason why patients only look for Tylenol at a time when many APAP are in sufficient stock is that health authorities have mentioned Tylenol directly since the beginning of the vaccine, causing confusion in their choice of fever reducer. Through the KCDA, the Korean Pharmaceutical Association asked each district health center to guide them to take APAP such as Suspen, Bukwang's Tacenol, and Penzal when fever symptoms occur after inoculation. The government, which authorizes the people to "Tylenol," should correct this issue. The situation has already deteriorated to persuade patients that pharmacies have the same ingredients and that other pharmacies do not have Tylenol. The MFDS has unveiled 70 items that have the same efficacy and effect as acetaminophen preparations, but pharmacists question their effectiveness. Since Tylenol has already been so deeply established in the public's perception, it is necessary to come up with effective measures, saying that the release of 70 products will not be much help unless campaigns and advertisements are combined. The target will also be expanded sequentially. Pharmacies say there will be a bigger problem in the future than it is now. It seems necessary to come up with measures quickly before vaccinations for the entire country are implemented in earnest.
