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- 2025-12-24 07:46:24
- Policy
- Moon "Invest ₩2.2 trillion in 5 years for vaccines"
- by Lee, Tak-Sun Sep 14, 2021 05:55am
- President Moon Jae-in President Moon Jae-in announced that South Korea will “invest ₩2.2 trillion to increase its vaccine competency over the next 5 years.” On September 13th, President Moon expressed such plans in a recorded welcome address for the 'Global Bio Conference' that is being held at the Grand Intercontinental Parnas Hotel in Seoul. Moon said, "Korea aims to become one of the global vaccine production hubs that could lead the response to the rise of infectious diseases in the future. Moon added, “Biopharmaceuticals have provided new hope to mankind’s fight against COVID-19. The typical development period for vaccines, which used take more than 10 years, have now been reduced by 1/10, and pharma companies have successfully developed various vaccines and drugs.” Such achievement was only possible with close cooperation of global biopharma experts and businesses across borders, Moon reckoned. Moon also indicated that “The Korean government also is continuing its attempt to find different solutions to supply a steady flow of vaccines. Contract manufacturing and technology transfers have increased, and competing pharma companies have joined forces to co-produce vaccines. South Korea also has begun contract manufacturing of four vaccine products to aid the global vaccine supply." "Such collaborations between the industry, academia, and research organizations as well as emerging industries like artificial intelligence and big data, will be what brings the current biopharmaceutical industry to the next level. The minister of Food and Drug Safety Kang-rip Kim is giving a opening address The Minister of Food and Drug Safety (MFDS) Gang-Rip Kim, who gave the opening address, said that “This conference seeks to discuss new roles of the industry, the academia, and the government in the new normal, the 'With-COVID-19' era. During the pandemic, MFDS has not only served as a regulatory agency but also stepped up to become an active cooperator in the research, development, production, import and export, and international diplomacy of biopharmaceuticals." He added, “The conference will solidify MFDS’s new role in the ‘new normal,’ and be the opportunity to take the scope of regulatory science to the next level.” Meanwhile, the 7th GBC this year will be conducted for 3 days under the theme, ‘A New Normal: A Leap Towards Newly-Found Future of Biopharmaceuticals.’ Biopharmaceutical experts, pharmaceutical companies, and regulatory reviewers from companies had participated in the event.
- Policy
- Hanmi pushes for Champix follow-on despite hardships
- by Lee, Tak-Sun Sep 13, 2021 05:55am
- One pharmaceutical company is determined to develop a follow-on of the smoking cessation drug, ‘Champix’ (Pfizer, varenicline tartrate), and it is Hanmi Pharmaceuticals. Hanmi Pharmaceuticals had succeeded in the early release of its drug as a salt-modified drug, but had lost the patent challenge failed to enter the market. After the original's patent expiry, the company had attempted to set foot in the market again with a CMO product but faced hardships due to an impurity issue. On the 7th, the company voluntarily recalled its products due to an excess amount of N-nitroso-varenicline (NNV) impurities. With perseverance, Hanmi Pharmaceuticals attempted once more with a self-developed salt-modified drug. This is the company’s third attempt at a varenicline product. According to industry sources on the 9th, Hanmi Pharmaceuticals had recently applied for the approval of its smoking cessation treatment, ‘varenicline oxalate hydrate,’ to the Ministry of Food and Drug Safety. Industry experts observed that the product was prepared to replace the ‘Nokotine S tablet' that was partially recalled due to excess NNV detection. ▲ Smoking cessation treatment being sold by Hanmi Pharmaceuticals, Nokotine S is a Varenicline salicylate substance that is being produced on consignment by CTC Bio. The drug was released by Hanmi Pharmaceuticals after the original Champix’s substance patent was expired in July last year. Hanmi Pharmaceuticals had released a varenicline product before Nokotine S called ‘Nokotine,’ a varenicline oxalate hydrate that was originally developed by Hanmi Pharmaceuticals. However, the item was withdrawn after the company lost the patent challenge. Hanmi Pharmaceuticals had released Nokotine in November 2018 before the original's substance patent expiry, using the logic that the extended substance patent duration does not apply to salt-modified drugs. The claim, which was accepted by the Intellectual Property Trial and Appeal Board, was then rejected at the Patent Court. Due to the ruling, the product was taken off the market. To make matters worse, the Ministry of Food and Drug Safety revoked the license of ‘Nokotine’ with the reason of its sale before patent expiry. This was why the company had released the CMO product ‘Nokotine S,’ as an alternative. But the impurity issue put a hold on Hanmi’s path. Excess amounts of N-nitroso-varenicline were detected in products produced by Hanmi’s CMO, CTC Bio. The company recalled 16 lots of Nokotine S that was produced by CTC Bio. The fact that Hanmi Pharmaceuticals, whose credibility had suffered due to the impurity issue, was preparing a new product was found last month. The company filed an application to revive the canceled license for the varenicline oxalate hydrate product. In fact, many pharmaceutical companies have been wrapping up their Champix’s follow-on business due to the downtrend of the smoking cessation treatment market. Based on IQVIA, Champix sold ₩8.8 billion and NoKotine sold ₩715 million in the second half of last year. However still, Hanmi Pharmaceuticals is still intent on making it in the market. The company had entered the smoking cessation treatment market with ‘Nicopion,’ which was rare using bupropion products., and also lead the patent challenge against Champix after the development of its salt-modified drug. The company had filed for an invalidation trial of a patent after its appeal had failed. The company also runs a smoking cessation program involving all of its employees every time it launched a new product. Will the company be able to reap the rewards for its sincere efforts some day? Whether Hanmi Pharmaceuticals’ new smoking cessation treatment market will be able to break the sole lead held by Pfizer is gaining attention.
- Policy
- Voluntary recovery of 73 drugs with excess impurities
- by Lee, Tak-Sun Sep 13, 2021 05:55am
- 73 items from about 36 companies with blood pressure exceeding impurities will be recovered. Patients can also be exchanged for normal products at pharmacies. However, the MFDS explained that concerns about human harm are very low, and that it is not a situation to stop taking them arbitrarily. It announced on the 9th that some of the drugs containing Sartans, which are treatments for hypertension, have exceeded the daily intake allowance of AZBT (1.5//day) (1.51 to 7.67//day). AZBT (5-(4'-(azidomethyl)-[1,1'-biphenyl]-2yl)-1H-tetrazole) is a substance with mutant properties (genetic mutations). The MFDS explained that the pharmaceutical company is voluntarily collecting 183 Sartan drugs from 73 items from 36 companies that exceeded the daily intake allowance among the items subject to safety investigation. It also added that only sartan drugs with AZBT less than the daily intake allowance have been shipped since September. The MFDS ordered the AZBT test results for 819 items from 125 companies with production and import records to be submitted by the end of August and received test results for 751 items from 117 companies. The MFDS said that patients taking the drug should not stop taking it, but should decide whether to continue taking it after consulting with a pharmacist, but can exchange it for a lot number below the standard if necessary. It explained that it consulted the Central Pharmaceutical Review Committee to set the daily intake capacity of AZBT, and that it was set at 1.5㎍/day by applying the ICHM7. ICHM7 sets a daily intake allowance of mutagenic impurities that do not have data such as toxicity values as 1.5//day, which is a "negligible level" when consumed daily for life (70 years). This means that the possibility of additional cancer is less than 1 in 100,000 people. The MFDS evaluated the health effects of most patients who took Sartan drugs with excessive daily intake of AZBT, and found that the possibility of additional cancer was very low. The human impact assessment of patients taking Sartan drugs with excess detection of AZBT was conducted in accordance with ICHM7, considering the results of the daily maximum dose of Sartan drugs in circulation in Korea. As a result, the possibility of additional cancer is 0.008 to 0.224 out of 100,000 "Losartan containing drugs", 0.010 to 0.298 out of 100,000 "Valsartan-containing drugs", " It is explained that 0.004 to 0.804 out of 100,000 Irbesartan-containing drugs were very low, which was "negligible" according to the ICHM7 standard. The MFDS said that it will announce additional final results after completing the ongoing AZBT test and review of the results as soon as possible, and that it will strictly manage AZBT to supply and distribute only Sartan drugs that are less than permitted to consume on the market.
- Policy
- Financial savings should be given for new domestic drugs
- by Lee, Jeong-Hwan Sep 10, 2021 05:58am
- The domestic pharmaceutical industry argued that new domestic development drugs, which contributed to improving the financial soundness of health insurance through steady R&D investment, should be excluded from the list of "The Price-Volume Agreement (PVA)" or introduced a system that limits the number of applications. Even after the registration of new domestic drugs, additional clinical trials to enter overseas markets, and improve drug convenience have dampened the willingness to innovate management due to drug prices under the PVA system. According to the pharmaceutical industry on the 9th, multiple pharmaceutical companies that succeeded in developing new drugs in Korea plan to point out the irrationality of the drug price follow-up management system centered on the PVA system and urge policy improvement. Pharmaceutical companies that have succeeded in developing new domestic drugs or are preparing for development are demanding that domestic new drugs that contributed to health insurance finances be excluded from PVA. The reason why domestic pharmaceutical companies are making such demands is due to the specificity and PVA of domestic new drugs. In particular, domestic companies pointed out the problem of Type Da of PVA. Type Da of PVA calculation drugs are subject to negotiation from the fourth year after the registration. Drugs with an increase of more than 60% this year or an increase of more than 5 billion won compared to last year and an increase of more than 10% are subject to negotiations. Domestic companies explain that the clause is pushing ahead with a collective reduction in drug prices between domestic and global new drugs. Specifically, in the case of global new pharmaceutical companies that enter the domestic market, it is common to release them after fully equipped with treatment indications and full contents at the time of domestic marketing approval. Even after its launch on the market, R&D expenses will continue to be spent to allow overseas marketing, add indications, develop complex drugs, increase convenience in taking them, and reduce drug prices even though sales will rise in earnest from the fourth year. The drug price negotiation guidelines say that domestic R&D investment costs are considered when negotiating, but it is not known whether R&D costs are also considered in PVA negotiations. Domestic companies said that exceptions to the PVA system for new domestic drugs, which contributed to the effect of reducing health insurance finances, are also needed. Domestic companies are taking the lead in developing complexes based on new domestic drugs in line with the characteristics of chronic diseases such as general diabetes, high blood pressure, and hyperlipidemia,, and in the case of these complexes, they are asked to be excluded from PVA negotiations or limit the PVA negotiations. An official from a domestic pharmaceutical company A said, "The PVA system is applied repeatedly only to new domestic drugs that continue to invest in R&D to expand indications or add complex drugs. Drugs that are burdensome to health insurance finances should be selected as targets for PVA negotiations." He said, "The more drugs are used in the market, the more positive they are for drug spending. These drugs need to be excluded from PVA or limited the number of applications."
- Policy
- The evaluation criteria's determination for reimbursed drugs
- by Lee, Hye-Kyung Sep 10, 2021 05:58am
- If the administration cost is lower than that of alternative drugs, it is possible to apply for adjustment to raise the upper limit of the drug. However, it should be the case where the number of companies in the formulation with the same administration route or component is one. The HIRA recently guided the pharmaceutical industry to answer questions and comparison tables before and after the change of evaluation criteria containing "change of evaluation criteria for adjusting the upper limit amount of drugs." The evaluation criteria for this mediation application were deliberated and resolved through the Drug Reimbursement evaluation committee on the 2nd, and will be applied from September 1st. Items for adjustment application may be applied if the upper limit amount of drugs announced pursuant to Article 3 (1) 1 of the Drug Decision and Adjustment Standards is deemed remarkably unreasonable. Previously, it was possible to apply for an increase in the upper limit of drugs only if there was no replaceable drug or if there was a drug that was essential for treatment. However, due to the change in the evaluation criteria, if the number of companies in the drug with the same route or component is one, it is possible to apply for adjustment to raise the upper limit of the drug if the drug is cheaper than the alternative drug. If there is no record of production, import, or claim over the past two years, it shall be excluded when determining the number of replaceable drugs or companies. However, it falls under one of the three requirements, but excludes drugs that have been fined for violating Article 47(2) of the Pharmaceutical Affairs Act in accordance with regulations related to the National Health Insurance Act. It refers to all drugs that have been disposed of in relation to rebates. It is impossible to apply for mediation by including all rebate dispositions under the relevant regulations regardless of the period. Compared to the previous one, additional documents to be submitted have been specified, and submission documents must be submitted according to the cost calculation method of shortage-preventive drugs.
- Policy
- Will it be possible to expand the benefit of Prolia?
- by Lee, Jeong-Hwan Sep 10, 2021 05:58am
- Attention is focusing on whether the criticism that biopharmaceuticals that treat osteoporosis by preventing bone absorption or activating bone formation are not fully enjoyed due to restrictions on Korea's benefit standards can be resolved. This is directly related to Amgen's Prolia (Denosumab) and Evenity (Romosumab) access to patients, as experts argued the need every year and the National Assembly also agreed, the government said it would consider reflecting it after collecting opinions. On the 7th, the MOHW promised to improve the benefit standards reflecting the latest treatment guidelines at the "policy discussion on improving the treatment environment for osteoporosis" hosted by Rep. Lee Jong-sung of the People Power Party (YouTube). Although the MOHW has made some prospective opinions on the benefit criteria for osteoporosis drugs, it remains to be seen whether it will actually lead to an improvement in the actual standards. There are two reasons why critics say that domestic benefit standards are holding back biopharmaceuticals that treat osteoporosis. First, if the osteoporosis drug benefit period exceeds the bone density level of T-Score -2.5, it is recognized only for one year. The standard is applied to biopharmaceuticals, Prolia, including synthetic drugs such as bisphosphonate drugs, SERM drugs, and Zoledronic acid, and specialists are demanding improvement. Another critical factor is that the "ultra-risk group for osteoporosis" drug benefit standard can only be used when fractures using bone absorption inhibitors occur for more than a year. This is the standard applied to Evenity, a biopharmaceutical that promotes bone formation, and it is pointed out that evenness benefits are recognized only after bone absorption inhibitors are administered. Specifically, Prolia obtained the first treatment benefit as of April 1, 2019. If the bone density level (T-Score) is -2.5 or less, it will be applied twice a year, and if osteoporosis fractures are confirmed on radiography, it will be applied six times a year. Despite the acquisition of primary benefits, experts are calling for an improvement in the benefit standard for osteoporosis treatments such as Prolia because of the current standard for suddenly converting the benefit drug to non-reimbursement a year later if the bone density level exceeds -2.5. This is because patients' access to medicines is blocked by suspending their benefit if the drug is partially effective, even though fractures can be prevented by continuous administration of treatments. Evenity is receiving the second treatment benefit as of December 1, 2020. It is recognized only when additional conditions are satisfied based on the criteria that at least one of the existing bisphosphonate formulations is ineffective or unavailable. An additional condition for Evenness Secondary benefit is ▲ postmenopausal women aged 65 or older,▲ Bone density test results measured by Dual-Energy X-ray Absorptiometry (DEXA) in the central bone (excluding lumbar spine and femur)] showed that the bone density test was less than T-score -2.5 SD, ▲When two or more osteoporosis fractures occur (data on osteoporosis fractures must be attached for fractures that have occurred in the past). The administration period is recognized only up to 12 times every one month in a lifetime. Professor Lee Yoo-mi of Endocrinology at Severance Hospital, who attended a policy debate hosted by Rep. Lee Jong-sung, stressed that it should be improved and expanded to middle-aged people. In fact, international guidelines recommend Evenity, a bone formation promoter, as the primary drug in the ultra-high risk group. Ultra-high-risk groups, such as the elderly who have already experienced fractures, first use bone formation promoters to increase bone mass, and then prevent bone density and fracture by preventing absorption of increased bone mass with bone absorption inhibitors. This means that Korea's benefit standards are the opposite of international guidelines. At a policy debate hosted by Rep. Lee Jong-sung, both irrationalities of the domestic osteoporosis benefit standard were a hot topic. Experts pointed out all the problems of the innovation of bio-new drugs and domestic salary standards from disease risks and social costs caused by osteoporosis. The MOHW, which attended the debate, plans to collect expert criticism and review international guidelines to improve and expand the standards. Choi Kyung-ho, secretary of the insurance drug department, explained, "I agree with the pain of elderly patients due to osteoporosis and fractures and the burden of social and economic costs." He said, "We will try to improve access to new drugs so that the standards meet the latest medical guidelines, but we will also carefully review the soundness of sustainable health insurance finances."
- Policy
- A bill to revise some of the Jeju Special Law
- by Lee, Jeong-Hwan Sep 09, 2021 05:55am
- The bill banning the opening of for-profit hospitals and pharmacies in Jeju is aimed at preventing controversy over the Greenland International Medical Center by deleting special provisions on the opening of foreign medical institutions and foreign-only pharmacies. The plan aims to eliminate controversy that could cause confusion in the domestic medical system by abolishing a conditional permit system that allows the opening of foreign medical institutions and foreign-only pharmacies with permission from the Jeju Governor based on the Foreign Investment Promotion Act. Representative Wi Sung-gon of the Democratic Party of Korea submitted a bill to the National Assembly to revise some of the Jeju Special Law as of the 7th. The most important contents of the amendment are to delete Article 307 of the current Jeju Special Act, "Special Cases concerning the Opening of Medical Institutions" and Article 308 "Special Cases concerning the Opening of Foreign-only Pharmacies." Article 307 of the current law allows corporations established by foreigners to open foreign medical institutions through the approval process of the governor of Jeju Island. When permitting the establishment of a foreign medical institution, the Policy Delivery Committee for Health and Medical Service must be reviewed, and the provincial governor also included a clause approved by the MOHW. Foreign medical institutions are stipulated not to be included in medical institutions under the National Health Insurance Act and medical institutions under the Medical Benefit Act. This is the part of the provision that allows for profit-seeking medical practice. Article 308 allows foreign-only pharmacies that are not allowed by the Pharmaceutical Affairs Act to be opened after the Foreign Investment Promotion Act and the registration of the provincial governor's opening. Pharmacists engaged in foreign-only pharmacies cannot dispense and sell medicines to Koreans. However, foreign pharmacies can also be prepared and sold to Koreans in the prescription issuance group at foreign medical institutions. Foreign-only pharmacies are also not included in medical institutions under the Health Insurance Act. Article 310 allows foreign license holders to work at foreign medical institutions and foreign-only pharmacies. It also includes a clause that mandates foreign-only pharmacies to clearly indicate that they are foreign-only pharmacies inside and outside the pharmacy so that Koreans can know they are foreign-only pharmacies. A foreign license holder engaged in a foreign medical institution or foreign-only pharmacy in violation of the amendment shall be punished by imprisonment for up to five years or a fine of up to KRW 50 million. Even if foreign-only pharmacies are not properly marked, they will be sentenced to up to one year in prison or fined up to 10 million won. Rep. Wi Sung-gon abolished the special cases of foreign medical institutions (Article 307) and foreign-only pharmacies (Article 308), while carefully pointing out all provisions related to foreign medical institutions and foreign-only pharmacies. This is expected to block the possibility of opening for-profit hospitals and pharmacies regardless of the Foreign Investment Promotion Act, while eliminating the concept of foreign medical institutions and foreign-only pharmacies itself. Rep. Wi added a clause to promote the reinforcement of the publicity of health care in Jeju. Article 306 added reinforcement of publicity and development, while newly establishing matters related to major health care business plans, financing, and management. The health impact assessment of residents on climate change and other matters deemed necessary for strengthening and developing health care publicity were also added to the health care development plan. The above bill should be implemented from the date of promulgation of the enforcement date of the revised law in the supplementary provisions, and those who obtained permission to open foreign medical institutions or foreign-only pharmacies according to the previous regulations at the time of enforcement of the law can open and operate. Controversy over the legality surrounding the cancellation of the Greenland International Medical Center's permission to open remains. Jeju Island submitted an appeal to the Supreme Court against the judgment of the appeal trial on "a lawsuit to cancel the cancellation of the permission to open a foreign medical institution."
- Policy
- Proposal of a bill to abolish special cases for Jeju
- by Lee, Jeong-Hwan Sep 08, 2021 06:05am
- A bill has been proposed by the National Assembly to abolish special cases for the opening of Jeju for-profit hospitals. The move is aimed at resolving the controversy over the establishment of for-profit hospitals by deleting special cases for opening foreign medical institutions. On the 7th, Representative Wi Sung-gon of Democratic Party of Korea (Seoguipo City) proposed an amendment to the Special Act on the Establishment of Jeju Special Self-Governing Province and the Creation of Jeju Free International City. The amendment is to abolish the special cases for the establishment of medical institutions stipulated in Articles 307 and 308 of the Special Act. With the permission of the provincial governor, the provisions for opening medical institutions established by foreigners will be abolished. The abolition of the provisions for opening foreign-only pharmacies and the abolition of special telemedicine for medical personnel working in foreign medical institutions were also included in the bill. Measures to strengthen the public health of Jeju Free International City were included in the bill. This is to strengthen the publicity of medical care, which is supposed to be established under Article 306 of the Special Act. It is mandatory to add projects linked to the Framework Act on National Health and Medical Service, major health and medical project plans and financing and management matters, and evaluation of the impact of residents' health on climate change. Rep. Wi Sung-gon explained, "We abolished the provisions for the establishment of Jeju for-profit Hospital, which had been in great social conflict due to controversy over the damage to the public nature of medical care, and started to improve the system on ways to expand public health at the local level." He said, "As the importance of public health care has grown even more in the COVID-19 era, we will do our best to ensure that this amendment is passed by the National Assembly."
- Policy
- 3 companies voluntarily recall varenicline products
- by Lee, Jeong-Hwan Sep 08, 2021 06:05am
- Results of the safety investigation conducted by the Ministry of Food and Drug Safety on the N-nitroso-varenicline (NNV) impurity that was found in the smoking-cessation aid varenicline showed that the impurity’s risk of harming the human body was very low. However, all drugs that contain over ‘733ng (nanograms)/day’ of NNV will be voluntarily recalled by the companies in line with the standards set by the U.S regulators, Varenicline products that will be voluntarily recalled include those manufactured (consigned products included) by CTC Bio, and consists of 2 lots of Zerocotine tab. from Vivozone, 2 lots of Nicobreak tab. from CTC Bio, and 15 lot of Nokotine S from Hanmi Pharmaceutical. The MFDS announced the results of the NNV safety investigation on the 7th. With NNV detected in all products currently distributed in Korea, the Ministry plans to conduct phased safety management measured to assess its effect on administered patients, set standards on the acceptable level of NNV intake, prepare measures for each amount of NNVs detected, and issue guidelines for HCPs and patients. According to the MFDS, the NNV detected in varenicline products distributed in Korea was very low (16.70~1849ng/day). More specifically, NNV detected in varenicline products that were sold in Korea were: 16.70~1849ng/day for Jeil Pharmaceuticals’ products, 151~632ng/day for Pfizer Korea’s, and 812~1859ng/day for CTC Bio’s products. Products from Jeil Pharmaceuticals and CTC Bio were manufactured in Korea (including consigned products), and Pfizer’s was imported. Assessment of NNV’s effect on the human body also showed a very low level of concern. The safety investigation results were conducted according to the ICH(International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) standards, in consideration of the daily maximum dose of intake, NNV test results, the actual period of administration for patients who participated in the NHIS’s smoking cessation treatment support project. Assessment of NNV’s effect on the human body showed that the NNV brought further cancer risk to 0.194-0.391 out of 100,000 people. The ICH guideline defines the risk to be at a 'negligible level' if the probability is less than 1 in 100,000 people. In consideration of the toxicity value set for NTHP, another nitrosamine-class substance with a very similar structure to NNV, the MFDS set the acceptable amount of daily intake of NNV to 37ng/day. This is the same as the level set by regulation institutions abroad and was determined after consultation with the Central Pharmaceutical Affairs Council. The acceptable amount of daily intake is the amount that increases the probability of developing cancer by 1/100000 when a substance is taken for a lifetime (70 years), apart from the naturally occurring cancer. The MFDS decided to allow the lot release of varenicline products that contain NNV of 185ng/day or less for the time being. This is the same level of standards as the one that was temporarily set by the U.S. The MFDS decision was affected by the fact that the NNV detected in varenicline was at almost no health risk as found from the NNV human impact assessment, and that it is difficult to immediately reduce the NNV amount to less than the acceptable amount of daily intake (37ng/day). The MFDS comprehensively reviewed the US's temporary approval of the lot release at 185ng/day, accessibility to smoking cessation drugs for patients, and advice from the Central Pharmaceutical Affairs Council. In particular, all drugs that are currently in the market whose NNV content exceeds 733ng/day will be voluntarily recalled by the companies. This is in line with the decision made by the U.S. to distribute drugs that contain 733ng/day or less without recall. Accordingly, all lots of the 6 varenicline products from 3 companies that were manufactured by CTC Bio will be voluntarily recalled. The MFDS plans to continue working with the pharmaceutical industry so that the amount of NNV detected can be reduced below the acceptable amount of daily intake as quickly as possible, and will announce the results after the reductions are complete. In addition, the MFDS recommended that patients who have already been prescribed the said products (lot numbers) should not arbitrarily discontinue the use of the drug but consult with his/her doctor or pharmacist on continuing taking the drug or switching to a different medication. If a patient needs to switch to an alternative drug after consultation with his/her doctor or pharmacist, the patient will need to receive a prescription for the alternative smoking cessation treatment from a medical institution participating in the National Health Insurance Service’s smoking cessation treatment support project.
- Policy
- GSK's Shingrix has been granted
- by Lee, Tak-Sun Sep 08, 2021 06:05am
- GSK's shingles virus vaccine has been approved in Korea. As a result, competition between MSD and SK Bioscience is expected to take place for the lead in the market. The MFDS approved GSK's gene recombinant shingles vaccine Shingrix on the 6th. This product is a vaccine used to prevent shingles in adults over the age of 50 and those who are expected to have high risk of shingles due to disease or treatment or immunosuppressants. It is a product that injects 0.5ml IM once and twice every two months. Shingrix was approved by the U.S. FDA in October 2017. In the United States, it is recognized for its product power by beating its competitors and ranking first in market share within a year of its launch. The strong defense effect shown in clinical trials is emerging as market competitiveness. Shingrix demonstrated an ERA of 97.2% in a 3.2-year follow-up in clinical trials (ZOE-50) in adults over 50 years of age, and 89.8% in 3.7-year follow-up in 70 years of age (ZOE-70). Compared to the fact that MSD's Zostavax had a 51% ERA in patients over 50 years of age and 41% in patients over 70 years of age, Shingrix is very superior. Sky Zoster, developed by SK Bioscience, is a product that proves non-inferiority compared to Zostavax. With the launch of Shingrix, the domestic shingles vaccine market, divided by Zostavax and Sky Zoster, will inevitably be reorganized. As of last year's IQVIA, sales of Zostavax and Sky Zoster were 43.2 billion won and 29.1 billion won, respectively. However, sales of shingles vaccines are on the decline this year due to COVID-19 vaccination. When COVID-19 subsides, sales are expected to rebound again. The MFDS classified Shingrix as a new drug and designated it as a drug subject to reexamination (PMS) by September 5, 2027.
