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- 2026-04-14 03:36:12
- Company
- 3 generics for Champix have been withdrawn in just one year
- by Lee, Tak-Sun Jul 28, 2021 05:54am
- Anti-smoking treatment Varenicline, a smoking cessation drug, is being withdrawn. It is believed that the impurity incident, which occurred last month, affected the cancer. According to the MFDS on the 26th, eight items of Varenicline have been withdrawn since June. On the 22nd of last month, the MFDS also began a safety survey after recovering Pfizer's Champix due to concerns over cancer-causing substances in countries such as Canada. As a result, pharmaceutical companies with Varenicline will have to conduct tests on impurities by August 31. The MFDS recommended that Varenicline are needed to use only the minimum amount for treatment and consider other treatments if possible until the results of the impurity test were published. It released a product developed in November 2018 with different salt from Champix, but later in December 2019 all sales were suspended due to the loss of patent litigation. It was released again after seven months. However, it has already lost trust due to the suspension of sales, and the sales performance of generics has fallen short of expectations. Currently, there are 62 generics for Champix. Only CTC Bio and Jeil are producing Varenicline. The rest of the pharmaceutical companies are supplied by two pharmaceutical companies. An official from related companies said, "We were originally going to clean up because it does not produce generic directly, and we have decided not to delay further because of the impurity incident." Other companies are similar. It is known that two additional items have been submitted to the MFDS. Including this, 30% of all licensed products will be canceled or dropped within a year of release. Eight of them were revoked on charges of selling them during the patent period.
- Policy
- The weighted average price may vary when charging Xarelto
- by Lee, Hye-Kyung Jul 28, 2021 05:54am
- When pharmacies claim Bayer Korea's Xarelto, they need to reconfirm the purchase price. This is because the weighted average price may change due to changes in drug prices due to lawsuits such as suspension of the execution of notification on drug price cuts. In particular, if a pharmacy claims a drug price change without checking it, it needs to be careful because it can be disposed of as a claim mismatch through "regular confirmation of the purchase price" in the future. The HIRA conducted a "Guidance on Xarelto's Suspension Claims" on Sunday. Following the Seoul High Court's decision to suspend the execution of the revised Xarelto (2.5/10/15/20 mg), the MOHW suspended the notice as of July 2. The existing upper limit price was reduced by 30% from June 8 to July 1, but returned on July 2, causing a change in the price of medicine. Since it is a period that is reflected in the calculation of the purchase price of medical treatment in August and October of this year, the medical institutions should check once more when they claim it. The purchase price will be calculated based on the "quarterly weighted average price" divided by the total purchase amount of the drug purchased quarterly. It will be the purchase price for the treatment that lasted from the beginning of the second month of next quarter to the third month. If Xarelto is charged from August 1 to October 31, the weighted average price will be the average of the purchase price in the second quarter of this year. It is accurate if checking the medical expenses claim → medication management → pre-weighted average price → weighted average price by medication on the website of the medical institution's task portal. The history of the purchase can be managed by registering the purchase details of the drug in → claim for medical treatment → medication management → purchase medicine calculation management in the pharmacy's task portal screen.
- Policy
- Moderna vaccine by Samsung Biologics is supplied worldwide
- by Kim, Jung-Ju Jul 27, 2021 05:36am
- Prime Minister Kim Bu-gyeom briefly mentioned in a radio media interview today (the 26th) when Samsung Biologics' moderna COVID vaccine will be released, and quarantine authorities said that hundreds of millions of doses of Samsung Biologics products will be supplied to the world except the U.S. next year. The KDCA made the announcement in a regular "COVID-19 briefing" this afternoon. Earlier, Prime Minister Kim Bu-gyeom appeared on radio media and said, "I know that Samsung BioLogics' Moderna vaccine will be released in late August or early September." Regarding the production schedule, the KDCA said, "We understand that Samsung Biologics is doing its best to produce this year, and will supply hundreds of millions of Doses to the world except for the U.S. by next year."
- Policy
- When will Phase 3 trials of K-COVID-19 vaccines begin?
- by Lee, Tak-Sun Jul 27, 2021 05:35am
- Development of domestic COVID-19 vaccines has come to a standstill before entering the final stages - the phase 3 trials. Cellid, which had shown the fastest progress in development, is planning to reenter phase 1 trials with an improved version of its vaccine. Due to such changes, the industry has a negative outlook on the commercialization of domestic vaccines by the first half of next year. According to the Ministry of Food and Drug Safety on the 26th, there are currently 10 candidate COVID-19 vaccines in clinical trials in Korea. The Phase 1 clinical trial for HK Inno.N’s recombinant vaccine, ‘IN-B009,’ was approved on the 22nd to increase the count to ten. 5 are recombinant vaccines, 3 are DNA vaccines, 1 is a viral vector-based vaccine, and 1 is an RNA vaccine. 자료제공 : 식약처The only viral vector-based vaccine, Cellid’s 'AdCLD-CoV19,’ was approved for a new Phase 1 clinical trial on the 23rd. The trial will evaluate the candidate vaccine’s safety and immunogenicity on 40 healthy adults. Cellid’s candidate vaccine is no different from the vaccine that was approved for a clinical trial in December last year. However, the vaccine’s production yield was improved to allow mass production. Cellid plans to proceed with Phase 3 trials for its improved vaccine candidate immediately after completing the Phase 1 trial, as a Phase 2 trial for its previous vaccine candidate is already in progress. Clinical trials can be divided into 3 parts: Phase 1 trial that assesses the safety of a drug, Phase 2 that determines the dosage, and Phase 3 trial to confirm the drug’s effectiveness in a large number of patients. However, no domestic COVID-19 vaccines have been verified for their efficacy yet. Many trials have been approved since SK Bioscience received approval for the first clinical in November last year, but all are still in their early stages. However, SK Bioscience had submitted a Phase 3 clinical trial protocol for its recombinant vaccine ‘GBP510’ last month and is awaiting MFDS approval. The vaccine received support from the Bill and Melinda Gates Foundation and CEPI. SK Bioscience plans to start its Phase 3 trial for its candidate vaccine as early as August. The MFDS has approved companies to conduct Phare 3 trials in comparison with previously authorized vaccines to reduce the burden of the large-scale Phase 3 trials. As a result, the trial is expected to assess the candidate vaccine’s efficacy and immunogenicity using currently marketed vaccines as comparators such as Pfizer, Moderna, AZ, and Janssen vaccines in around 3,000 healthy adults. However still, as a Phase 3 trial takes a long time from participant recruitment to analysis, there are growing concerns about whether Korea will be able to produce a domestic vaccine soon. Even if the candidate vaccines enter Phase 3 trials in the second half of this year and completes it successfully, experts believe that it will be difficult to commercialize the vaccine in the first half of next year.
- Company
- 19% of valsartan Rxs disappear 3 years after impurity issue
- by An, Kyung-Jin Jul 27, 2021 05:35am
- Three years have passed since the valsartan impurity issue swept across the pharmaceutical industry, however, the valsartan market is still showing no signs of recovery. Prescriptions of products containing valsartan as monotherapy and combination therapy both decreased by nearly 20%. Analysts believe that distrust in valsartan after the impurity issue has led to switching prescriptions to similar drugs. According to the pharmaceutical research institution UBIST on the 26th, outpatient prescriptions for valsartan monotherapy products recorded ₩29.9 billion in the first half of this year, a 5.4% decrease from the same period of the previous year. This is the second consecutive year of decline since the 4.1% decrease to ₩31.6 billion last year. Compared to the ₩34.1 billion in 1H of 2018, prescription of valsartan monotherapy products decreased by 12.4% in three years. With losartan, valsartan used to occupy the largest share of the angiotensin II receptor blocker (ARBs) market for the treatment of hypertension. The valsartan market had contracted much since an N-Nitrosodimethylamine (NDMA) impurity was detected in the valsartan active ingredient from China's Zhejiang Huahai Pharamceutical, which led to unprecedented mass recalls and sales suspensions around the world. This incident had delivered a hard blow to the growing domestic prescription market for valsartan products. On July 8th, 2018, the Ministry of Food and Drug Safety had suspended the sale of 209 pharmaceutical products containing valsartan that were being distributed in Korea for using an active ingredient that was found with NDMA. Afterward, the authorities made remedies for products that did not use the active ingredient in question and additionally uncovered products that use NDMA containing active ingredients, resulting in a total of 175 products being suspended from sales. The valsartan combination prescription market, which had a larger market than the monotherapy market, was also unable to escape the aftermath of the impurity crisis. In the first half of this year, the prescription volume for valsartan in combination with a calcium channel blocker (CCB) class amlodipine amounted to ₩98.1 billion. This was a 19.0% decline from the ₩121.1 billion in the first half of 2018, just before the impurity was detected. The market had somewhat recovered – by 6.6% - compared to the first half of 2019 when the valsartan issue just hit the industry. The combination of valsartan and the diuretic hydrochlorothiazide sold ₩19.3 billion in prescriptions in the first half of this year. From the ₩25.5 billion that was recorded in 2018 to ₩21.5 billion in 2019, and to ₩21.1 billion in 2020, the record has continued to fall. Compared to 3 years ago, prescriptions of the valsartan and hydrochlorothiazide combination fell 24.5%. Combined, the monotherapy and combination therapy market for products containing valsartan recorded ₩147.3 billion in the first half of this year. This was an 18.5% decrease from the ₩180.8 billion recorded in 2018. Until the first half of 2018 before the impurity issue broke, the monthly prescription of valsartan monotherapy and combination therapy products exceeded ₩30 billion per month. The monotherapy market by itself had recorded ₩6 billion in prescriptions every month. However, the prescription of valsartan monotherapy and combination therapies that reached ₩30.5 billion in July of 2018, fell immediately after the impurity issue, falling sharply to ₩25.8 billion in August, and ₩22 billion in September. And for three years since then, the monthly prescription has never exceeded ₩30 billion. As of June this year, the prescription for valsartan monotherapy and combination therapy combined recorded ₩24.3 billion. In other words, one-fifth of the prescriptions for valsartan disappeared after the impurity issue. Analysts believe that the distrust built in valsartan after the impurity issue has led to an avoidance of prescriptions containing valsartan. It is highly likely that some of the existing valsartan prescriptions have been switched to similar drugs. In fact, the ARB-based anti-hypertensive drug market itself did not contract after the valsartan impurity issue. The prescription for ARB-class monotherapies in the first half of this year amounted to ₩188.2 billion. As the pharmaceutical market had contracted in general due to the prolonged COVID-19 pandemic, the ARB market had also seen a decrease of 5.1% compared to the same period of the previous year but had increased by 2.9% compared to the ₩182.8 billion in 2018. The dual combination therapy market for the ARB+CCB class of antihypertensive ingredients had grown even more steeply. The accumulated prescription amount for the ARB+CCB combination in the first half of this year was ₩399.5 billion. This was an 0.2% increase from the same period last year and an overwhelming 19.1% increase from the ₩335.5 billion in the first half of 2018.
- Company
- Sales in the SGLT-2 diabetes drug market rose by 10%
- by Kim, Jin-Gu Jul 27, 2021 05:35am
- Xigduo·Jardiance Duo Prescription performance of compound drugs has increased significantly in the market for diabetic drugs in the SGLT-2 inhibitors. Outpatient Rx increased by 23% in the second quarter of the year. The single formulation only increased by 4% during the same period, showing slowing down. According to UBIST, a pharmaceutical market research agency on the 23rd, the total amount of outpatient prescriptions for diabetes treatments related to SGLT-2 inhibitors in the second quarter is estimated at ₩32.2 billion. Compared to ₩29.2 billion in the second quarter of last year, it increased by 10%. Market growth was led by combination formulations. The combined prescriptions for Xigduo (Metformin HCl+ Dapagliflozin Propanediol Hydrate) and Jardiance Duo (Empagliflozin +Metformin HCl) increased from ₩10.6 billion in the second quarter of last year to ₩13 billion in the first quarter of this year. Sales of Jardiance Duo rose 42% from ₩3.7 billion to ₩5.2 billion. Xigduo rose 13% from ₩6.9 billion to ₩7.8 billion. Boehringer Ingelheim launched the product a year later than AstraZeneca. The total amount of prescriptions for AstraZeneca's Forxiga and Boehringer Ingelheim's Jardiance, Astellas' Suglat and MSD’s Steglatro rose from ₩18.7 billion to ₩19.3 billion in the second quarter. By item, Forxiga increased 4% from ₩8.8 billion in the second quarter of last year to ₩9.2 billion in the second quarter of this year. Jardiance increased 5% from ₩8.5 billion to ₩8.9 billion over the same period. Suglat posted a prescription record of ₩800 million in the second quarter of this year, following the second quarter of last year. Steglatro fell 27% from ₩600 million to ₩400 million during the same period.
- Company
- Ultomiris can be prescribed in general hospitals
- by Eo, Yun-Ho Jul 26, 2021 05:51am
- According to related industries, Ultomiris (Ravulizumab), a treatment drug for paroxysmal nocturnal hemoglobinuria (PNH) supplied by Alexion to the domestic market, recently passed the D.C. of Seoul National University Hospital. It will be quickly prescribed after obtaining approval from the MFDS in May last year and being listed on the insurance benefit list on April 7. Solaris (30ml), at ₩5,132,364, so if three vials are administered bi-weekly per patient, ₩400 million is needed per year alone. Ultomiris was listed at ₩5,598,942 per bottle, and Ultomiris can be administered once every eight weeks from two weeks after initial dose administration, which is expected to lower the annual dose per patient compared to Soliris. However, like Solaris, a pre-approval system is introduced, and health authorities inspect monitoring before and after administration. PHN disease is one of the rare life-threatening blood diseases characterized by the destruction of red blood cells by the body, which is part of the immune system. In particular, it is a serious disease in which four out of 10 people die within five years if they are not treated after diagnosis. It is known that there are about 200 patients in Korea. Soliris (Eculizumab), which was released in Korea in 2012, is the only treatment of PHN, and patients treated with soliris improved their 5-year survival rate by 95.5%. Ultomiris demonstrated its validity through two studies conducted on PNH patients ( study 301, study 302). In the studies, Ultomiris demonstrated non-equality of treatment results compared to conventional Eculizumab in primary evaluation metrics such as transfusion avoidance, LDH normalization, LDH rate of change, FACIT-Fatigue score change. In addition, 93% of patients preferred Ultomiris in a preference evaluation study conducted on patients with seizures night haemoglobinosis who had received treatment with both Solaris and Ultomiris as an extended treatment study in the study 302.
- Policy
- Onivyde listed at ₩672,320 as RSA refund type
- by Kim, Jung-Ju Jul 26, 2021 05:50am
- Servier Korea’s 'Onivyde injection(irinotecan liposome),’ which is used in second-line or higher treatment of pancreatic cancer, will be available with insurance benefits at ₩672,320 per vial starting next month. The Ministry of Health and Welfare announced today(23rd) that the Health Insurance Policy Deliberative Committee deliberated and passed the ‘amendment to the drug benefit list and the maximum ceiling price table’ containing the amendment mentioned above. The drug was approved by the Ministry of Food and Drug Safety as a ‘second-line treatment for metastatic pancreatic cancer,’ on August 29th, 2017. In the same year, the company applied for its reimbursement to HIRA, on October 31st. Although HIRA had held a Review Committee for Cancer Disease meeting to review its reimbursement on January 24th, 2018, the company withdrew its application in June, putting a stop to all discussions. On July 24th, 2020, the company reapplied for the insurance benefit listing. On April 8th of this year, HIRA held a Review Committee for Cancer Disease meeting and ruled that the drug is appropriate for reimbursement. At the time, the committee recognized that the clinical practice guidelines then had recommended Onivyde in combination with fluorouracil and leucovorin for patients whose disease had progressed after first-line cancer therapy and that Onivyde had an improved clinical benefit compared to the control group in clinical studies. Academic societies had also suggested compared to existing second-line treatments for pancreatic cancer that lacked evidence on their clinical usefulness, Onivyde had demonstrated its benefit through clinical studies and is being recommended as a preferred option in clinical practice guidelines for pancreatic cancer. Afterward, the government ordered pricing negotiations to NHIS, and the NHIS made negotiations with the company from April 23rd to June 21st. Among the A7 countries, the drug is currently listed in four countries - Japan, Germany, the United Kingdom, and the United States, and the A7 adjusted average price of Onivyde is ₩1,562,643. Based on the price, the company and the NHIS had drug negotiations with the company to reimburse Onivyde as a refund type under the RSA scheme. The refund type is a type of RSA agreement where the company refunds a certain proportion of the claimed drug cost. In consideration of the fiscal impact and the foreign drug price, the NHIS and the company agreed to set Onivyde’s price at ₩672,320 per vial starting next month. Through the reimbursement, approximately ₩12.1 billion of NHI finances is expected to be spent on Onivyde. Additional finances spent due to the nonavailability of an alternative drug are estimated to be approximately ₩9.6 billion.
- Policy
- New PBAC members to make big reimbursmeent decisions in 2H
- by Lee, Hye-Kyung Jul 26, 2021 05:50am
- From September, new members of the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service will be conducting evaluations on the adequacy of pharmaceutical reimbursements. PBAC members that will start committee activity from the second half of this year, will carry out major deliberations and tasks from whether the ultra-high-priced new drug ' Kymriah' is eligible for reimbursement to the coverage expansion of 'Keytruda' that has recently passed the Review Committee for Cancer Disease deliberations. HIRA received recommendations from relevant organizations to pool around 100 experts from relevant fields for the committee until the 23rd of last month. The 8th PBAC members are appointed among a double pool of candidates who are recommended from relevant organizations, who undergo qualification review. The number of recommendations requested by HIRA requested to relevant organizations was 192, including 112 from the Korean Academy of Medical Sciences (4 or more per society, 28 societies); 18 from The Pharmaceutical Society of Korea (6 or more per society, 3 societies); 10 from medical and pharmaceutical associations (6 or more per society, 3 societies); and 24 from civic and consumer groups (2 or more per group, 12 groups). Among the recommendations, HIRA will select 96 members in consideration of each member's professionalism, diversity, and connectivity to agendas. ▲Those performing pharmacoeconomic evaluation-related services for pharmaceutical companies; ▲executives, private practitioners, or private pharmacists in the recommended medical and pharmaceutical organizations; ▲those who are judged unfit to perform fair work during pre-diagnosis of work ethics ▲those subject to administrative disposition or punishment under the Medical Service Act, Pharmaceutical Affairs Act, National Health Insurance Act or Medical Care Assistance Act within the last 5 years; ▲ those who have served as a member of the PBAC for two or more consecutive terms, were excluded from recommendations. In the case of ‘two or more consecutive term’ standard' that was prepared to limit long-term appointment and duplicate appointments, reappointment is possible for members who have served as an advisory member or who are in specialized fields in consideration of their unique circumstances In case of data submitted for PE evaluations. the characteristics of each drug and disease are difficult to regularize or standardize due to various assumptions, methodologies, and models involved. To address this, appointment standards have been slightly relaxed to ensure continuous participation of certain committee members, which is necessary for maintaining consistency in PBAC review. The 8th PBAC will consist of 102 members. In addition to the 96 recommended members, HIRA plans to add one member from the Ministry of Health and Welfare, one from the Ministry of Food and Drug Safety, the Department head of the HIRA Pharmaceutical Benefit Department, and 3 panels from the Healthcare Review and Assessment Committee to compose the 8th PBAC. The PBAC meetings will be held by 3 fixed members from MoHW, MDFS, and HIRA, and 17 other members (19 for agendas related to oriental medicine) from the 120 members.
- Opinion
- [Reporter's view] The MFDS shouldn't selectively explain
- by Lee, Tak-Sun Jul 26, 2021 05:50am
- In a recent series of incidents, the MFDS did not properly explain, causing confusion. It wasn't a big issue, but it's not something to skip. The issue of whether the RNA-based QTP104, which was approved for phase 1 clinical trial on the 20th, was initially marked as "domestic development" on a site where approval status can be checked, but it was changed to "foreign development." A reporter raised a question through an article, and this time it was changed to "domestic development." As a result, there was confusion among reporters. The vaccine could not be clearly processed because it was not distinguished whether it was the first RNA-based or overseas vaccine. As of 4 p.m. on the 22nd, it is marked as "domestic development," so it seems to be a domestic development vaccine, but there is no clear answer from the MFDS. It is the government's long-cherished project to localize the RNA vaccine that Pfizer and Moderna monopolized. As there is also a great interest in the public, it was important to understand the reality of phase 1 clinical approval of QTP104. However, the MFDS has changed its mark from "domestic development" to "foreign development" again, making it difficult to identify the reality. I also asked the MFDS. Even now, the MFDS should quickly answer whether QTP104 is a vaccine developed in Korea. It seems necessary to explain the use and capacity change of the 31st new drug "Leclaza" developed by Yuhan. The MFDS said it was legally changed at the request of the company, but the usage and capacity were changed a day before the benefit confirmation this month. .Moreover, it is necessary to clarify why the dosage and indications have been changed because the diagnosis method is different compared to Leclaza's competitive drug Tagrisso .The MFDS should not just announce on its website the cancellation of the item license of Daewoong's Albis D, but explain it more actively .Previously, the Fair Trade Commission and the Korea Intellectual Property Office detected data manipulation during the patent registration process of this product .The cancellation of item permits is the strongest disposition that the MFDS can make .It should be explained whether the disposition is an extension of the disposition of the Fair Trade Commission and the Korean Intellectual Property Office, or is part of the GMP investigation .Watching this series of events, I suspect that the MFDS is deciding what to explain .It also seems that there is no problem with procedural justification or neglects explanation if it does not become an issue .Even though the method of storing the Pfizer vaccine was changed last time, journalists of daily and economic newspapers raised questions because they did not notify it .Since the MFDS has not explained each and every change in permission, the reporter thought it would not be a big issue .However, As the MFDS' lack of objectiveness continues, it may not have been recognized as a public communication problem.
