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- 2026-05-15 21:38:28
- Company
- Sales of Losartan are plummeting due to the impurity crisis
- by Chon, Seung-Hyun May 09, 2022 06:03am
- The prescription market for the hypertension drug "Losartan" has shrunk significantly. It is analyzed that a large number of prescription gaps occurred due to detection of excess impurities at the end of last year. According to UBIST, a pharmaceutical research agency, on the 2nd, the outpatient prescription amount of Losartan-containing drugs in the first quarter was 60 billion won, down 24.4% from the same period last year-on- The prescription market for Losartan drugs rose 20.7% in four years from 65.8 billion won in the first quarter of 2017 to 79.5 billion won in the first quarter of last year, showing a stable upward trend every year. In the third quarter of last year, it formed a market size of 81.2 billion won. However, it fell to 75.7 billion won in the fourth quarter of last year and fell for the second consecutive quarter. The recent sluggish prescription market for Losartan drugs is directly attributed to the impurity wave that erupted last year. The manufacturing numbers of 183 items of 73 items of Irbesartan 3 ingredients were recovered due to the detection of excess impurities. At the end of last year, impurity problems were exposed throughout Losartan products. In December last year, 295 items made by Losartan were voluntarily recovered from 98 companies that were detected in excess of the standard or feared to be detected in excess. As many as 96.4% of 306 items from 99 companies on the market were included in the recall list. At that time, 94 items from a total of 34 companies out of 295 Losartan products were virtually avoided by having available products. Since then, many Losartan drugs have solved the problem of impurities and returned to the market. It is observed that many of the impurities excess detection Losartan formulations have been changed to the same formulation without problems. However, there is a possibility that the prescription may have been changed to other drugs of the same angiotensin II receptor blocker (ARB) as the impurity problem was exposed throughout the Losartan formulation. In the first quarter of last year, the prescription performance of Losartan was 17.4 billion won, down 35.2% from the same period last year. The single Losartan showed a total of 26 billion won in prescriptions from the first quarter to the third quarter of last year. Following a drop of 24 billion won in the fourth quarter of last year, the decline has widened this year. Combination drugs including Losartan had a prescription amount of 42.7 billion won in the first quarter, down 18.9% from the previous year. The Losartan complex has been around 50 billion won since the second quarter of 2019, but it has fallen to 40 billion won in three years. Combination of Losartan+Amlodipine and Combination of Losartan+HCTZ were significantly sluggish. The combination, which combines Losartan and calcium channel blocker (CCB)-based hypertension drug Amlodipine, was 22.2 billion won in the first quarter, down 14.6% from the previous year. The compound of Losartan and diuretic HCTZ shrank 43.8% from 17 billion won in the first quarter of last year to 9.5 billion won in a year.
- Hunterase makes new record in overseas exports
- by Chon, Seung-Hyun May 06, 2022 05:46am
- The homegrown rare disease treatment ‘Hunterase’ made record-high performance in its exports. By expanding the number of countries in the global market, the company generated over four times its domestic sales overseas. According to GC Cross on the 5th, Hunterase recorded sales of ₩22.6 billion in Q1 this year. This is a 72.5%, ₩13.1 billion increase from the same period of the previous year. The company had raised around half of the ₩53.2 billion it had made with Hunterase last year in just one quarter this year. Hunterase, which was approved in 2012 in Korea, is the world’s second treatment for developed Hunter syndrome, which is also known as ‘Mucopolysaccharidosis type II (MPS II),’ is a rare disease that is known to occur in roughly 1 in 100,000 to 150,000 male live births. As a congenital, hereditary metabolic disorder, Hunter syndrome shows various unpredictable symptoms such as skeletal abnormalities and decreased intelligence and even premature death around the age of 15 in severe cases. Only 70-80 patients with Hunter syndrome exist in Korea. Recently, Hunterase has been showing more prominence in the overseas markets. Sales of Hunterase in Q1 this year recorded ₩18.3 billion and expanded over twofold compared to the same period in the previous year. Its Q1 exports have risen to record the highest since Hunterase's release. The company had raised 4 times more sales in overseas exports than in domestic sales. The exports account for 81.0% of Hunterase’s total sales. With the number of patients in Korea being limited, there is inevitably a limit to the growth of its sales in Korea. This is why GC Cross had been boosting Hunterase's growth by entering new overseas markets. Hunterase is currently being sold in Russia, Egypt, Turkey, and Brazil. With a little number of its competitors in the market, high price, and lifelong administration required due to the characteristic of the rare disease, the drug has been recording continued growth in the global market. Before Hunterase, the only treatment for Hunter syndrome was ‘Elaprase.’ Recently, the drug started generating sales in the Japanese market. GC Cross received marketing approval for its 'Hunterase ICV' that is administered directly to the cerebral ventricles from the Japanese Ministry of Health, Labor, and Welfare early last year. Hunterase ICV comes in a new formulation that is inserted as a device in the head, through which a drug is directly administered into a patient’s cerebral ventricle. It overcomes the limitations of existing IV-type formulations that were unable to penetrate the blood-brain barrier (BBB) and reach the cerebral parenchyma. Also, the company is preparing to enter the Chinese market. GC Cross had obtained marketing approval from the National Medical Products Administration in China. With no other treatment for Hunter syndrome approved in China, if Hunterase completes the local drug listing process and is released in the Chinese market, it may further expand exports of the drug in the global market.
- Company
- Breast cancer supplement Nerlynx is available in hospitals
- by Eo, Yun-Ho May 06, 2022 05:46am
- Breast cancer supplement Nerlynx has become available in hospitals. According to related industries, Tyrosine kinase inhibitor Nerlynx (Neratinib), which inhibits Bixink's HER2 protein, passed the Drug Committee (DC) of medical institutions such as Seoul National University Hospital. However, as it is still non-reimubrsement, it is expected to take time until Rx is activated. It was submitted to the HIRA's Cancer Disease Review Committee in February, but the standard was not set. Bixink plans to submit an application again in the second half of this year. HER2-positive early breast cancer has a 1.89 times higher risk of epilepsy than HER2-negative breast cancer. The high incidence of brain metastasis is interpreted as having a direct effect on the survival rate. Comparing the 5-year survival rate of metastatic breast cancer in Korea, the 5-year survival rate of patients with epilepsy is only 10.7%, which is a clear difference compared to the 34% 5-year survival rate of patients who have metastasized to other areas. Compared to the past, a number of HER2-positive early breast cancer target treatments have been developed, diversifying treatment options for patients and gradually improving survival rates. However, in the case of current standard therapy treatments, drugs that prevent epilepsy or prove therapeutic effects are still insufficient. In a five-year long-term follow-up study, Nerlynx reduced the risk of recurrence or death in women with HER2-positive early breast cancer by 42% and reduced the risk of developing or death of epilepsy by more than 59%. Nerlynx was originally a drug developed by Puma Biotechnology in the U.S., and was first approved by the U.S. FDA in July 2017 as an extension aid for early HER2 positive breast cancer patients. In February 2020,it was expanded to treat metastatic HER2 positive breast cancer. Bixink introduced Nerlynx in Korea in October last year, and the current indication is "extension therapy for patients with early breast cancer who are positive for HER2 and hormone receptor within one year of completion of Herceptin-based treatment after surgery."
- Opinion
- [Reporter’s View] Now is the time for drug reclassification
- by Lee, Tak-Sun May 06, 2022 05:46am
- 10 years have already passed since the heated discussion arose on the drug reclassification and sale of over-the-counter drugs in non-pharmacy venues. As the Korean saying goes, even nature can change in one decade. In that not-so-long but also an epoch of a period in terms of change, many drugs have established safety profiles and await better patient access. In other words, the time has now come for discussions on drug reclassifications, just as we have done in 2012 a decade ago. Above all, we need to make an opportunity to discuss reclassifications because no system that regularly reclassifies drugs exist in Korea. The Ministry of Food and Drug Safety announced that it would establish a regular system at the time of the reclassification in 2012, but the switchings based on overseas and safety data are not being performed smoothly. There are cases where the reclassification process itself is at a standstill despite rising social demand, such as in the case of the morning-after pill. This is mainly due to the absence of an applicant, but this doesn’t mean that the government should just let go of the matter. The government should actively come up with a plan and have applicants such as pharmaceutical companies, medical/pharmaceutical associations, and consumer groups fill out application forms. The environment and timing are also set for reclassifications, as 10 years have passed since the full reclassification and the people who led the reclassification at the time have returned with the administration change. Of course, opposition from medical and pharmaceutical groups such as the Korea Medical Association and the Korean Pharmaceutical Association is expected. KMA is opposed to the reclassification plan, and the KPA is also passive in reclassification to avoid increasing the number of over-the-counter drugs. Also, civic groups are much less interested in enabling reclassification than a decade ago. The pharmaceutical companies that rely on insurance prices are less likely to request reclassification on their part. However, it is negligence on the government's part to let go of the drug classification issue due to fear of conflict. The authorities must do what is needed despite the expected turmoil. Update the overseas cases and collect the new safety data to reform the outdated system. Just firmly withhold the set principles during the reform. Allow easier access for drugs with verified safety, if not, tighten access. Stop walking on eggshells in fear of the medical and pharmaceutical groups and gather the experts who are aware of the gravity of the situation and hear their opinions.
- Policy
- Only 40% of asthma pts undergo Pulmonary function testing
- by Lee, Tak-Sun May 06, 2022 05:46am
- Although it is recommended to take pulmonary function test at least once a year to manage diseases in asthma patients, only less than half of all patients are tested. The HIRA announced on the 3rd that it will analyze and disclose the results of the 2020 (8th) asthma adequacy evaluation to mark World Asthma Day. As a result of the evaluation, the rate of Pulmonary function test was steadily increasing, but only 42.4% of the patients subject to evaluation were tested, which was still low. For early detection of asthma exacerbation and management of diseases such as drug control, Pulmonary function tests should be performed at least once a year. (Guidelines for Asthma Treatment, Korean Academy of Tuberculosis and Respiratory Diseases 2020) By age, the pulmonary function test rate in their 70s was the highest at 48.5%, and those in their 90s and older were the lowest at 27.6%. By gender, 40.9% of women and 44.2% of men showed a lower rate of pulmonary function tests for women of all ages than men. The ratio of ICS prescription patients was also low at 55.9%, showing low results for both tests and prescription indicators. Inhalation steroids are the most effective preventive drugs for maintaining asthma control and should be used in all possible asthma patients. (Guidelines for Asthma Care, Korean Academy of Tuberculosis and Respiratory Diseases 2020) Institutions with pulmonary function test equipment showed better results in all evaluation indicators than institutions without. Asthma is a chronic respiratory disease that can prevent the deterioration of the disease and hospitalization if it is treated effectively in an outpatient clinic. In 2019, the prevalence of asthma over the age of 19 in Korea was 3.2% and 5.0% over the age of 65, and the asthma hospitalization rate was 65 per 100,000 people, higher than the OECD average of 34.4. Since the number of patients receiving treatment is less than the prevalence of asthma estimated by the national health statistics, it is more important to conduct lung function tests for early diagnosis of asthma. Kim Yang-joong, a member of the HIRA, said, "There are some types of respiratory tests that can be easily taken," and explained, "Not only suspected asthma patients but also patients undergoing treatment are encouraged to take respiratory tests at least once a year." The HIRA is unveiling a hospital with good results in the adequacy evaluation of asthma so that it can be continuously managed at a nearby local hospital.
- Company
- Hospitals Busy Introducing Kymriah
- by Moon, sung-ho May 06, 2022 05:45am
- The full-fledged administration of Kymriah, a Korean Novartis CAR-T treatment called an "ultra-high-priced anticancer drug," has begun. Hospitals have also become busy as the administration of treatments at four large hospitals in Korea has begun in earnest. At the beginning of last year's domestic approval, it was a wait-and-see attitude, but as the number of inquiries from patients increased at the same time as the benefit increased, it is eager to complete the facility. According to the medical community, starting with Asan Medical Center in Seoul, Kyungpook National University Hospital, Chonnam National University Hospital, and Pusan National University Hospital are currently undergoing preliminary work for Kymriah administration, focusing on the metropolitan area and national and public university hospitals. At the same time as health insurance was applied in April, there are currently four hospitals that have completed the certification process conducted by the MFDS and Novartis on their own. Specifically, they include Seoul St. Mary's Hospital, SMC, Seoul National University Hospital, and Severance Hospital. Some professors from local university hospitals raised complaints about Novartis' first certification work at only four places, but the controversy subsided as public opinion prevailed that the introduction should not be delayed anymore. The situation has changed since April when Kymriah's benefit was applied. "After Kymriah's domestic approval last year, Novartis first certified four large hospitals, raising equity issues at local university hospitals," said a professor of blood medicine at Seoul National University Hospital, who asked not to be identified. He supported public opinion, saying, "Some professors publicly raised problems by saying that they would introduce CAR-T treatments for other global pharmaceutical companies to be introduced after Kymriah." According to the MOHW, the number of non-Hodgkin lymphoma patients, including DLBCL, in 2017, is counted as 1904 per year. "Last year, the process of collecting patient cells and sending them to Novartis in the United States was not established," said a professor of blood medicine at another local university hospital. It is true that there were complaints as pharmaceutical companies pushed for it from Seoul's mega hospital. We are currently pushing for the introduction of Kymriah, and the full-scale discussion began last November. While full-scale discussions have been underway since this year, we have been in a hurry as we have been reimbursed," he explained. A professor at a local national university hospital, who is promoting the introduction, said, "Since we have certified Kymriah from Seoul's super-large hospital, local hospitals are somewhat late. However, in the second half of the year, more than 13 university hospitals will be able to administer Kymriah, he said. "Novartis also has know-how while signing contracts with hospitals, so it will proceed quickly in the future." "What's worrisome is that CAR-T treatments are being developed in Korea in addition to Kymriah," he said. "The same facility standards should be applied to them, but the evaluation process for the GMP standards of the MFDS is needed." Novartis explained that the university hospital that first introduced Kymriah was comprehensively considered such as the GMP certification situation of the MFDS. An official from Novartis explained, "The hospital approved as a CAR-T center (Kymriah treatment available) is Samsung Medical Center, Seoul National University Hospital, Severance Hospital, and Seoul St. Mary's Hospital, and Asan Medical Center will soon open." He emphasized, "CAR-T treatment is a one-person customized treatment that requires completely new procedures, and various facilities, manpower, and technical aspects should be equipped for approval of the MFDS' management business, including human cells." He added, "The certification process of the four hospitals has been completed and opened as a Kymriah center first, and soon, the center certification will be completed at Asan Medical Center in Seoul with permission for management such as human cells."
- Company
- Risk of Impurities in Treatment of Schizophrenia
- by Chon, Seung-Hyun May 04, 2022 06:04am
- The health authorities have started to check for impurities on Quetiapine-based drugs used as schizophrenia treatments. It is a new type of nitrosamines impurity that has not appeared before. The number of drugs that have raised the risk of impurities in Korea has increased to 10. According to the industry on the 3rd, the MFDS recently ordered pharmaceutical companies to submit data for reviewing impurities N-Nitroso-Aryl Piperazine of Quetiapine-containing drugs. This is a proactive measure based on safety information that NNAP has been detected in Quetiapine recently. The MFDS ordered pharmaceutical companies to submit test results for representative manufacturing numbers among commercially available Quetiapine finished products by July 28. Representative lot numbers refer to more than three units of manufacture that are nearing their use date every year. If three lot numbers or less are produced each year, the test results of all lot numbers shall be submitted. Quetiapine is a drug used to treat schizophrenia, and the original product is Alvogen Korea's Seroquel. Currently, more than 30 domestic pharmaceutical companies are selling generic products. The size of the domestic prescription market is about 30 billion won per year. This is the first time that a risk of impurities has been raised in Quetiapine formulations. NNAP is a nitrosamines impurity that has not been exposed to risks in existing drugs. Since 2018, two types of Nitrosamines impurities, NDMA and NDEA, have been detected in Valsartan, Ranitidine, and Nizatidine. Recently, the MFDS launched an inspection according to safety information that another nitrosamines impurity NDPA was detected in Montelukast, a treatment for asthma and allergic rhinitis. In March, NMOR exceeded the daily intake allowance of drugs containing the vascular reinforcement Flavonoid Fraction ingredient, and voluntary recovery was carried out. Last year, two types of Azido-based impurities were found in Sartan products. As a result, drug impurities triggered by the first NDMA expanded to seven species in four years. Valsartan, Ranitidine, Losartan, Nizatidine, Metformin, following Varenicline, Irbesartan, Montelukast, and Flavonoid, the number of drugs exposed to the risk of impurities increased to nine. Among them, Valsartan, Losartan, Nizatidine, Metformin, Varenicline, and Irbesartan were suspended and recovered from sales of some products, and Ranitidine was expelled. Montelukast has not yet recovered any products due to the detection of excess impurities.
- Company
- Insurance benefit for Vemlidy expanded in Korea
- by May 04, 2022 06:03am
- Pic of Vemlidy tabThe health authorities have extended the insurance benefit of Gilead Science’s chronic hepatitis B treatment ‘Vemlidy (tenofovir ala fenamide)’ to liver cirrhosis and hepatocellular carcinoma, accelerating the generation shift of HBV drugs in Korea. According to the Ministry of Health and Welfare on the 3rd, Vemlidy’s reimbursement standards have been extended starting May 1st for the initial treatment of decompensated cirrhosis and hepatocellular carcinoma patients. In the past, insurance benefit was only provided for patients who had been using Vemlidy for HBV and progressed to liver cirrhosis or hepatocellular carcinoma. With the expansion of the reimbursement benefit, the phrase ‘reimbursement of oral tenofovir ala fenamide is not recognized for decompensated cirrhosis and hepatocellular carcinoma’ in the detailed recognition criteria for oral chronic HBV treatments has been deleted. However, in patients with decompensated cirrhosis, reimbursement is only allowed when the patient has reduced kidney function or osteoporosis. Quarterly prescriptions of Viread, Baraclude, Vemlidy (Unit: ₩100million, Source:UBIST) Vemlidy is a next-generation HBV treatment that Gilead released as a follow-up treatment of ‘Viread (tenofovir).’ The company had improved safety and convenience in intake while maintaining the efficacy of its existing blockbuster HBV treatment Viread. Vemlidy is a novel, targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to and at a dose less than one-tenth that of Viread. Also, Vemlidy has improved toxicity issues such as the potential risk of nephrotoxicity that arose with the long-term use of Viread. Gilead succeeded in expanding the indication of Vemlidy to liver cirrhosis and end-stage renal disease last year and then succeeded in expanding the scope of reimbursement for the drug this year. By securing the scope of indications for which Viread and Baraclude were previously prescribed, the company was able to seek complete generation change. Also, Vemlidy's share and position in the chronic hepatitis B treatment market continue to grow. According to the market research institution UBIST, prescriptions of Vemlidy rapidly increased from ₩200 million in the first year of its release to ₩7.4 billion in the following year, then to ₩18.9 billion in 2019, and ₩29.7 billion in 2020. Last year, prescriptions of Vemlidy rose 34% from the previous year to reach ₩39.8 billion. Vemlidy is the only product that saw an increase in prescriptions among original hepatitis B drugs last year compared to the previous year. Also, Vemlidy recorded ₩10.5 billion in Q1 this year, up 20% from the same period of the previous year. However still, Viread and BMS’s Baraclude (entecavir) still tops the market as the No.1 and No.2 products, although the gap has narrowed significantly with Vemlidy’s sales continuing to grow while sales of Viread and Baraclude continue to fall. Viread, which had an annual prescription of ₩184.3 billion in 2017, decreased to ₩170.3 billion in 2018 and ₩115.9 billion in 2019 due to the introduction of Vemlidy. Last year, the drug recorded ₩951 billion. Baraclude recorded prescriptions of around ₩77 billion in the same period. One obstacle Vemlidy must overcome to achieve rapid generation change lies in the strict prescription switching standards for HBV drugs in Korea. Unlike other chronic diseases, the standards for switching drugs in HBV are quite strict. Patients should show tolerance or insufficient and non-response to treatment, justifiable decreased adherence, and objectively documented serious adverse reactions to switching their drugs. Serious adverse reactions here include muscle enzyme elevation and neutropenia. Switching drugs without justifiable cause will result in reimbursement cuts, and this is why Viread and Baraclude are maintaining their ₩170 billion prescriptions in the market.
- Opinion
- [Reporter’s View] Use of maintenance and adjuvant therapies
- by Eo, Yun-Ho May 04, 2022 06:03am
- Continuous administration of a drug for ‘prevention.' This is not a new concept. Patients have been taking drugs to ‘manage’ their chronic condition for a long time, and drugs such as anticoagulants exist for the purpose of prevention. This only became an issue after the concept of maintenance and adjuvant therapies were introduced in cancer treatment. The introduction has been less welcomed undoubtedly because of its high price. Everyone fears the risk of recurrence after being cured of cancer. Depending on the type of cancer, some cancers have a recurrence rate of up to 80%. But in the era of high-priced drugs, prescribing the industry-leading high-priced anticancer drugs for preventive purposes, and providing insurance benefits for such can come as a burden for the health authorities. On the other hand, the introduction of such therapies has become the trend in the pharmaceutical industry. Existing therapies have been continuously adding maintenance and adjuvant therapy indications, and new anticancer drugs with their initial indication approved as adjuvant therapy are also being introduced into the field. This shows for sure that we now need to seriously consider the use of maintenance and adjuvant therapies. It is time for the authorities carefully examine the necessity of administering anticancer drugs as a preventive measure by each drug and consider the practicality rather than the indefinite ‘burden' they may bring. Paying out drug costs for the relapsed patients may be less cost-effective than reimbursing maintenance and adjuvant therapies. Recurrence and metastasis are fatal factors that increase the mortality rate of cancer. We now need to weigh the pros and cons of the drugs as the accumulating adjuvant and maintenance therapy drugs cannot be left unattended anymore, fully recognizing that there is no right answer. The drugs have to be considered not only by their profit and loss but also by the specificity of each drug and patient situation. All the interested parties including the health authorities and the pharmaceutical industry must make an effort to reach an agreement that takes into account Korea's health insurance system and the pharmaceutical industry’s ecosystem.
- Company
- Boryung challenges patent for leukemia drug Tasigna
- by Kim, Jin-Gu May 04, 2022 06:03am
- Boryung has challenged Novartis' patent for its leukemia treatment Tasigna (Nilotinib). If the patent avoidance challenge is successful, Boryung is expected to be able to aim for synergy with the previously released Glivec (Imatinib mesilate) generic. According to the pharmaceutical industry on the 3rd, Boryung recently requested a passive confirmation of the scope of rights in all directions on four patents of Tasigna. Tasigna is protected by a total of five patents. These include use patents that expire in November 2030, formulations patents that expire in 2027, crystalline and salt patents that expire in July 2026, and material patents that expire in August 2023. Among them, material patents have been challenged by domestic companies once. In 2015, nine companies, including Navipharm, filed invalid judgments during the extended duration of material patent of Tasigna, but failed to overcome it. Boryung has come up with a strategy to avoid patents other than material patents. If Boryung succeeds in the all-round patent avoidance challenge, generic releases will be possible after August next year when the material patent expires. Tasigna is a Philadelphia chromosomal-positive chronic myeloid leukemia treatment. It is a follow-up to Novartis's other leukemia drug, Glivec. It can be administered to patients who do not show efficacy in Glivec. According to drug market research firm IQVIA, Tasigna's sales were 40.8 billion won last year. Boryung already has Glima, Glivec's generic. Earlier, Boryung won a six-year patent lawsuit against Glivec. The Glivec patent lawsuit, which began in 2013, finally won the Supreme Court in 2019. Boryung released Glima in 2017. Glima has sales of 1 billion won every year. Sales of Glima are the largest among the generics for Glivec. The pharmaceutical industry predicts that synergy between the two drugs will be possible if Boryung secures the second drug, generic for Tasigna, following generic for Glivec.
