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- 2026-04-15 11:06:07
- Policy
- The clean reporting center will be opened
- by Lee, Tak-Sun Apr 05, 2021 05:53am
- The MFDS opened the Clean Report Center for Drug Manufacturing and Quality Illegal Activities in order to revitalize public interest reporting after Binex drug manufacturing incident. The center operates anonymously to increase the reporting rate. The MFDS announced on the 1st that it has opened the Clean Report Center for Drug Manufacturing and Quality Illegal Activities in the representative website. The report center was opened by the MFDS to prevent recurrence when the fact of the voluntary manufacture of drugs was discovered at the Binex Busan Plant. In order to promote public interest reporting, it will be operated completely anonymously. The report center is established on the website of the MFDS and can be reported by phone (043-719-2699) or e-mail (cleancenter@korea.kr). In an official letter sent to each pharmaceutical organization, the MFDS said, "We have opened the Clean Report Center for Drug Manufacturing and Quality Unlawful Behavior to promote public interest reporting and raise awareness of intentional and illegal serious violations in relation to pharmaceutical GMP manufacturing establishments." The MFDS ordered, "Please publicize it so that all citizens can easily access and report intentional and illegal activities." Previously, the MFDS confirmed violations of the Pharmaceutical Affairs Act such as ▲Use of additives at will without permission to change ▲Double-write manufacturing records falsely ▲Without changing the manufacturing method ▲Randomly changing the amount of raw materials, etc. through administrative investigations on Binex and Vivozon. In the case of the two companies, especially in preparation for inspection by the MFDS, all processes from raw material weighing to completion of manufacturing were falsely written using a manufacturing record in the same format as the licensed matter, and the records used in actual manufacturing were found to have been discarded after manufacture. In addition, the MFDS uncovered the failure to conduct tests on finished products and raw materials at one site through additional inspections at 30 entrusted and entrusted manufacturing sites nationwide, and some of the product standards were not prepared. The MFDS plans to establish a special planning and inspection team for GMP to prevent recurrence of any manufacturing activity. This is the expansion of regular GMP surveys conducted every three years. It plans to operate a reporting center to activate public interest reporting, and cancel the GMP conformity determination for illegal acts such as intentionally changing manufacturing methods and creating false and double records.
- Opinion
- [Reporter’s Eye] MNC CEOs' response to ‘Korea passing'
- by Eo, Yun-Ho Apr 05, 2021 05:52am
- MNC CEOs’ response to the ‘Korea passing’ phenomenon “Have you ever received pressure from corporate headquarters to consider ‘Korea passing’?” This question was asked to every multinational pharmaceutical company CEO interviewed by the reporter. Although the answer differed for each company and CEO, all the answers shared one common sentiment – a sense of burden. With the idea that ‘new drugs come from multinational pharmaceutical companies’ yet firmly established in Korea, it would have been difficult for them to say that “the company will not sell drugs to Korea because Korea sets prices low.” Such a response would imply that the company disregards ‘patients' that are so integral to the system. In addition to the burden, a sense of ‘crisis’ was also ingrained in their responses. “Our company has never chosen ‘Korea passing’ as an option yet," said the CEOs. ”However, Korea’s influence on China, the U.S., and other countries may impact future decisions.” The seemingly simple proposition, ‘better drugs enable people to live longer,' has now become a complicated issue that the government, pharmaceutical companies, doctors, patients, and even the general public can hardly be free from. Even now, highly effective but costly drugs, the special ‘commodities’ that are directly related to human health that cost hundreds of millions of won are waiting in line to enter our society. Although Market Access is responsible for such drugs, the CEOs are the real point of contact when it comes to communicating with headquarters. Therefore, their thoughts and even their philosophy may affect access to new drugs in Korea. That Korea is a good country for reference with a small market is a dilemma that we must bear. Despite pressure from civic groups, it is encouraging that the government has taken the first steps to expand the Risk Sharing Agreement (RSA) system. However, more must be done to minimize the risk of ‘Korea passing.’ as the pressure adds on with the possibility that the U.S. may also consider using Korea’s drug price as a reference. Nevertheless, in the process of improving policies, as well as discussing and persuading headquarters to release the company’s drugs in Korea, those in charge should bear a sense of responsibility for the commodity - the drug itself. Responsibility is one value that ‘those who bring their company’s drugs to Korea’ should cherish at all times. The ‘Korea passing’ phenomenon should not be abused as a pretext for easier listing in Korea. Our eyes will be on those who manage the Korean subsidiaries of MNCs, to see which companies choose to sideline Korea after detecting the slightest unfavorable element and whether management is doing their part to persuade their headquarters while pushing for systemic improvement in Korea.
- Company
- Dispute over Eliquis patent will be closed in six years
- by Kim, Jin-Gu Apr 05, 2021 05:51am
- Eliquis The six-year-old Eliquis (Apixaban) substance patent lawsuit will be closed next week in the Supreme Court. If the Supreme Court overturns the judgment of the first and second trials and takes the side of the original company, BMS, an all-round lawsuit for damages against related generic companies is expected and attracts attention. The ruling is expected to affect Eliquis prices. It has not yet been lowered even after the generic launch, because BMS has filed a court request to suspend the drug price reduction until the final conclusion of substance patent lawsuit for Eliquis is concluded. According to the pharmaceutical industry on the 2nd, the Supreme Court announced on the 8th the date of the appeal decision on the patent registration invalidation lawsuit filed by BMS against Navipharm, Huons, Intro Bio Pharma, and Alvogen Korea. On March 20, 2015, the dispute over substance patents will be closed after more than six years after Navipharm et al. requested an invalidation trial against a substance patent of BMS. In the preceding 1st and 2nd trials, a generic company has won. In February 2018, the Patent Tribunal ruled that Eliquis' substance patent was invalid. Based on this trial decision, patent challengers tried to release generics for Eliquis early. Prior to this, the patent was also successfully overcome, so it was possible to release it early. However, when BMS applied for a temporary injunction to prohibit patent infringement at the Seoul Central District Court, the release of the generic was put on hold. The Seoul Central District Court accepted the application, and the generics companies had to postpone the release date of September of that year. In March 2019, the Patent Court ruled that substance patents were invalid, similar to the Intellectual Property Trial and Appeal Board. Generics for Eliquis were released one after another. After June 2019 ▲Chong Kun Dang's Liquisia ▲Yuhan's Yuhan Apixaban ▲Samjin's Elxaban ▲Hanmi's Apixban ▲Ajou's Apixaban ▲Yooyoung 's Yupix have been released. It is analyzed that the release of generics has had some effect on the decline in prescription performance of Eliquis. The outpatient prescriptions for the past five years have steadily increased from ₩19.5 billion in 2016 to ₩49 billion in 2019, but fell 3% to ₩47.7 billion last year. The total prescription amount of generics for Eliquis surged from ₩1.2 billion in 2019 to ₩8.3 billion last year. As of last year, Liquisia was ₩2.6 billion, Elxaban was ₩1.7 billion, and Yuhan Apixaban was ₩1.1 billion. Considering the rise in monthly prescription performance, it is expected to exceed ₩10 billion this year. If the Supreme Court approves Eliquis' substance patent, BMS' lawsuit against patent infringement and claims for damages are expected based on this ruling. The generic company is in a situation where it has to return the sales revenue it has earned so far in the event of a discontinuation of generic sales. The ruling is also expected to affect the lawsuit over Eliquis price cut. Earlier, the government announced that it would cut the upper limit by 30% in July 2019 based on the launch of generics. However, BMS applied for suspension of execution to the administrative court because the final result of the substance patent lawsuit did not come out. As a result, Eliquis price remains the same as before. If the Supreme Court takes side with BMS, Eliquis price is likely to remain as they are. If BMS loses, it will be cut from next month. An official in the pharmaceutical industry said, "Like the first and second trials, there is a high possibility of denying the progressiveness of the optional invention." “However, since the Seoul Central District Court has accepted the BMS' provisional injunction application, there is a possibility that a judgment different from the first and second trials may come out.”
- Company
- OB-GYNs fume over the price hike of HPV vaccines
- by Moon, sung-ho Apr 05, 2021 05:51am
- The medical community is in turmoil over the news that MSD Korea will raise the price of ‘Gardasil 9,’ its 9-valent HPV vaccine. Relevant doctors’ associations are determined to discuss countermeasures for the unilateral price increase carried out by the pharmaceutical company. The Korean company in charge of domestic sales of the vaccine also brace for the burden that it would need to bear due to the price hike. On the 30th, industry sources said that MSD Korea has recently sent a notice that it will increase the supply price of its human papillomavirus vaccine by 15% to front-line clinics and hospitals. MSD Korea's position was that the price hike was inevitable due to the inherent complexity of production, long production periods, and quality control processes required for the vaccine. Some clinics and hospitals have been using the news of the price increase in April as a marketing tool to encourage customers to vaccinate sooner than later. Gardasil 9 is indicated for the prevention of cervical cancer, vulvar cancer, vaginal cancer, anal cancer, and genital warts caused by 9 types of the HPV virus (HPV Types 6, 11, 16, 18, 31, 33, 45, 52, 58). However, as Gardasil 9 is not provided as part of the Korean National Immunization Program (NIP), it is currently administered without reimbursement in front-line clinics and hospitals. The average non-reimbursed price of Gardasil 9 in clinics and hospitals range from 107,928 won to 202,524 won. As Gardasil 9 is administered through a 3-dose schedule, at most, roughly 600,000 won will be required to complete the vaccination. Based on the non-reimbursed price disclosed by the Health insurance Review and Assessment Service (HIRA), a price hike of 15% from April will increase the price of a single dose of Gardasil 9 to range around 120,000 won to 240,000 won. “Clinics and hospitals cannot individually protest against the pharmaceutical company’s unilateral decision to increase the price,” said one gynecologist who owns a clinic in Seoul. “My pharmaceutical sales representative had told me about the rumors of the price increase earlier on this year, so I actually ordered more in advance.” Furthermore, the medical community is voicing complaints as they will not be able to directly charge the 15% price increase applied from April to their patients. “Some hospitals and clinics are encouraging people to vaccinate in advance; however, it is unlikely that the people will be able to receive all three doses of the vaccine in the limited time period," another ob-gyn explained, “We can’t charge or explain the price hike to the patients awaiting their last vaccination if they have already received the first and second dose before March.” Faced with such strong opposition, HK inno.N, the company that signed a joint sales agreement for 7 vaccines including Gardasil 9 with MSD Korea, is also positioned in a fix. HK inno.N had prepared a marketing team dedicated to the sale and marketing of the 7 vaccines this year and was moving to expand its sales capacity. However, HK inno.N’s position is that they have no say regarding vaccine prices. Despite the burden they will have to bear selling the more expensive vaccines to hospitals and clinics, the company has to follow MSD Korea’s decision regarding the price increase. As a result, the Korean Association of Obstetricians and Gynecologists (KAOG) decided to hold a meeting to gather opinions on the matter. The association plans to hold an internal meeting first and discuss countermeasures. ”It may already be late, but we plan to discuss the issue and garner opinions at the association’s level.” said Lee Gi-Chul, vice president of insurance at KAOG. “The problem was in the unilateral notice. We will have to discuss the price hike with the pharmaceutical company and then notify our members.” “Up until now, pharmaceutical companies used to consult relevant expert associations before carrying out measures like price increases for vaccines, etc. However, the system seems to have changed now." Lee continued, "We will discuss ways and create a system so that relevant medical groups and pharmaceutical companies can discuss their options in advance when similar issues arise.”
- Policy
- Janssen vaccine was confirmed to maintain an immune response
- by Lee, Tak-Sun Apr 05, 2021 05:50am
- The COVID-19 vaccine license verification advisory group composed of external experts recognized the preventive effect of Janssen's COVID-19 vaccine. Janssen vaccine was confirmed that the immune response was maintained for up to 12 weeks with only one administration. The COVID-19 vaccine safety and effectiveness verification advisory group held a meeting on the 28th and made such a conclusion about the clinical trial results of Janssen's COVID-19 vaccine. Six people including infectious medicine specialists, vaccine specialists and clinical statistics specialists attended the conference. In the data submitted on the preventive effect of the vaccine, the advisory group confirmed the effect 14 days and 28 days after one dose of 18 years of age or older, and the immune response (conjugated antibody and neutralizing antibody) is maintained for up to 12 weeks. It was judged that the preventive effect was acceptable. The advisory group determined that the safety profile in the clinical trial was acceptable in relation to the abnormal case that occurred in the clinical trial, and additionally observed the abnormal cases that appeared during the clinical trial through the 'risk management plan' after approval. They expressed the opinion that it is reasonable to collect and evaluate information. Clinical trial data submitted to the MFDS include 1 clinical trial conducted in the United States and Belgium (Phase 1 and 2), 1 case in Japan (Phase 1), 1 case in multi-country such as Germany (Phase 2), and 8 countries including the United States ( Phase 3) was conducted in a total of 4 cases, including one multinational clinical trial, and safety and effectiveness were evaluated through a phase 3 clinical trial conducted in the United States. As a result of the efficacy evaluation, after 14 days of vaccine administration, 116 people in the vaccine group and 348 people in the control group showed a preventive effect of about 66.9%, and after 28 days, 66 people in the vaccine group and 193 people in the control group showed about 66.1. % Of the preventive effect was shown. After 14 days of vaccine administration, there was a prophylactic effect of more than 60% regardless of age and underlying disease. In addition, about 76.7% of the vaccine group 14 people and 60 control people after 14 days of vaccine administration, about 85.4% of the vaccine group after 28 days of vaccine administration, and 34 control people. In the case of the binding antibody that binds to COVID-19 antigen, the serum conversion rate was 95% or more, in which the antibody value increased by more than 4 times from 4 weeks after the vaccine was administered compared to before administration. In the case of neutralizing antibody, which can induce a preventive effect by binding to the surface of virus particles and neutralizing the infectivity of the virus, the serum conversion rate after one vaccine administration was more than 90%. Of all 43,783 subjects enrolled in the clinical trial, significant adverse events were reported in 0.4% (83) of the vaccine group and 0.4% (96 people) of the control group, and significant adverse drug reactions that cannot be excluded from being related to vaccine administration were brachial neuromyositis, Guillain-Barre syndrome, pericarditis, brachial neuromyositis, post-inoculation syndrome, hypersensitivity reaction in 1 each, and facial paralysis in 2 cases. However it was recovering at the time of submission of clinical trial data. The MFDS is planning to conduct another expert review by holding the Central Pharmaceutical Affairs Review Committee, a legal advisory body, on April 1, combining the results of this review. The results will be released in the afternoon of the day.
- Company
- Novartis' Xolair self-administration prescribed at GHs
- by Eo, Yun-Ho Apr 02, 2021 06:06am
- The self-administration formulation of the asthma treatment ‘Xolair’ can now be prescribed at general hospitals. According to industry sources, Novartis Korea’s Xolair (omalizumab) prefilled syringe 75mg solution has passed the review of drug committees (DCs) in 8 general hospitals nationwide, including the Seoul National University Hospital, Seoul Asan Medical Center, and Cheonnam National University Hospital. On December 20th, 2018, Novartis had abruptly withdrawn Xolair's application amid negotiations with the National Health Insurance Service (NHIS) after receiving the nod on its reimbursement feasibility. The reason for the sudden withdrawal was the company's concern over its impact on the Chinese market, as the drug price set in Korea may negatively affect the drug price in China as well. The incident made an exemplary case of the ‘Korea Passing’ phenomenon. After launching Xolair in China in 2019, Novartis reconducted the pharmacoeconomic evaluation procedure to apply for reimbursement listing in Korea. As a result, the Xolair injection was first listed in July last year. The maximum reimbursed price for the Xolair injection and the Xolair prefilled syringe injection in 150mg is 271,700 won, and 143,000 won for the Xolair prefilled syringe injection in 75mg. However, due to Novartis’s internal supply issues, the Xolair prefilled syringe 75mg solution started reimbursement in January of this year. The prefilled syringe 150mg solution will be reimbursed from October. Novartis's plan is to quickly proceed with the landing process in general hospitals as soon as the supply of pre-field syringe solutions begins. Various trials on Xolair including the ASTERIA, GLACIAL, OPTIMA, XTEND-CIU, and X-ACT have demonstrated that Xolair ▲rapidly improves symptoms and quality of life of chronic idiopathic urticaria patients; ▲alleviates symptoms of patients who do not respond to antihistamine treatment or leukotriene receptor antagonists; ▲is safe and continuously effective for long-term use; ▲can manage symptoms when used for retreatment after discontinuation. The clinical effect of Xolair in treating allergic asthma has been confirmed through the INNOVATE study conducted on 419 patients from 108 centers in 14 countries. The rate of clinically significant asthma exacerbations, the primary efficacy endpoint in the INNOVATE trial, was 0.68 for the Xolair group and 0.91 for the placebo group, demonstrating a significant difference between the two groups. Response of patients evaluated using the Global Evaluation of Treatment Effectiveness (GETE) showed that 64.3% of the patients responded favorably to Xolair, as reflected by a GETE rating of “excellent” or “good."
- Policy
- Are there less than 20 licensed generic drugs?
- by Lee, Tak-Sun Apr 02, 2021 06:05am
- The pharmaceutical industry is looking for generics with less than 20 identical ingredients/same content due to the effect of stepped drug prices. This is because there is a large difference in drug price depending on whether there are more than 20 or less than 20 outsourced generics permitted to use bioequivalence test data. The recent increase in 1mg of generic for Livalo has the same effect. According to the MFDS on the 1st, generics for Livalo (Pitavastatin), a hyperlipidemia drug, are increasing recently. Livalo is a blockbuster product approved by JW Pharma in 2005. As of last year's UBIST, outpatient prescription sales amounted to ₩73.4 billion, ranking in the top ranks among single drugs for hyperlipidemia. There are 1mg, 2mg and 4mg by dose. Generic for Livalo was first approved in 2011. So far, about 90 items have been approved, mainly at a dose of 2mg. However, generics for Livalo 1mg are increasing recently. Generic for Livalo 1mg has been approved for the first time by Arlico in May of last year, and 8 generics have been approved this year. Most of them are consignment products. Genuonesciences manufactures seven, including its own, and Arlico produces four. The reason generic for Livalo 1mg was licensed late is that the government's cascading drug prices, which have been in force since July last year, are affecting. For stepped drug prices, if 20 generics with the same dose of the same ingredient are listed, then the next listed generic is determined at 85% of the existing lowest price. Therefore, it is advantageous to register when there are less than 20. Since the number of generics for Livalo 1mg has not yet exceeded 20, subcontractors and consignees are less likely to lose drug prices. A total of 11 generics for Daewoong Zoledronic Acid were launched in 2011. Six generics were approved, all of which are drugs produced by Penmix. The industry expects this kind of entrusted generics to become popular in the future as there are not many new generics. However, since many of the licensed items existed in the market, it is expected that it will not be easy to be competitive in the market even if there is no loss in the drug price.
- Policy
- Levitra was withdrawn from the Korean market after 20 years
- by Lee, Tak-Sun Apr 02, 2021 06:05am
- Levitra, which Bayer launched on the Korean market for erectile dysfunction drugs, withdrew completely on the 1st. It was withdrawn due to expiration of the validity period because Bayer Korea did not renew the license. Only Kyongbo Vardenafil HCl of Kyongbo, a subsidiary of Chong Kun Dang, remains in the active ingredient containing Vardenafil HCl. According to the MFDS on the 1st, it was withdrawn due to the expiration of all four items of Bayer Korea's erectile dysfunction treatment Levitra. In January, Bayer has informed distributors of the suspension of supply. It is explained that supply was inevitably stopped due to unstable supply and reduced demand due to the modernization of the plant in Leverkusen, German. It seems that the decline in demand rather than supply was attributable to it. According to IQVIA, Levitra remained at about ₩300 million in 2018, about ₩200 million in 2019, and about ₩100 million in 2020.It is explained that the market competitiveness was completely lost due to the introduction of the original drugs Viagra and Cialis, and the release of generics after 2012. Chong Kun Dang, who conducted initial co-marketing with Levitra, re-launched Yailla (Vardenafil) in 2018, but it was also withdrawn. This is because it was sold before the expiration of Levitra's patent in July of last year. However, Kyongbo, a subsidiary of Chong Kun Dang, was approved for two items of Kyongbo Vardenafil HCl in April of the same year.
- Company
- Aldactone, which was frequently sold out, is resupplied
- by Apr 02, 2021 06:05am
- Pfizer Korea's diuretic drug Aldactone, which was often sold out, is scheduled to resume supply. According to the distribution industry on the 27th, the supply of Aldactone (Spironolactone) 25mg is expected to resume from the 29th. It was earlier than the April 8th, the resupply date originally expected by the company. Aldactone is often sold out due to continued supply disruption. Last year, there were five reports of production, import, and supply interruptions and shortages to the MFDS. In December of last year, Pfizer expected to resume supply around February, but it was postponed for another two months. This is because it has not been able to resolve the supply and demand of drug substance. Aldactone was available from April. Pfizer Korea said, "We apologize for the inconvenience caused by the sold-out of Aldactone, and we will do our best to stabilize supply." Sanofi Aventis' amyotrophic lateral sclerosis drug Rilutek, which has been out of stock for nearly two years, is also scheduled to be supplied at the end of April. Sanofi Aventis explained, "We expect Rilutek to resume supply from the fourth week of April. Based on the shipping date to the wholesaler, there may be 1-2 days difference by region. There are no product codes, insurance, and benefit related changes," Sanofi explained. Rilutek has not resumed supply since it temporarily sold out in October 2019. This is due to a shortage of main ingredient raw materials in overseas manufacturers. It was expected to resume in February 2020, but the company delayed the schedule until January this year. Finally, supply started at the end of April. Sanofi Aventis said, "We apologize once again for any inconvenience caused by supply instability. We will do our best to supply the product smoothly with patient health as our top priority."
- Company
- Only hope for pancreatic cancer Onivyde seeking for coverage
- by Eo, Yun-Ho Apr 01, 2021 06:08am
- The pancreatic cancer with highly unmet medical needs may welcome a newly listed drug. The pharmaceutical industry sources reported Servier Korea’s Onivyde (Irinotecan Hydrochloride) would be deliberated by the Health Insurance Review and Assessment Service (HIRA) Drug Reimbursement Evaluation Committee (DREC). Requested for the National Health Insurance (NHI) reimbursement last July, the drug is finally starting the practical discussion on the listing after about six months. Onivyde has requested for reimbursement on an indication to treat patients, who have failed a first-line gemcitabine-based treatment, as second-line 5-FU/LV combination therapy. But Onivyde faces an unexpected challenge. The South Korean government has recently decided to significantly reform the anticancer treatment reimbursement standard used for pancreatic cancer. As a result, HIRA is to enforce the revised notification of drugs prescribed and administered to cancer patients reflecting the details from Apr. 1. According to the change, the division between the first and second tier anticancer treatments has been removed, and the first tier anticancer therapies (10 items including cisplatin monotherapy) were delisted, while gemcitabine plus paclitaxel combination, previously categorized as a second tier anticancer treatment for first-line palliative therapy with reimbursement, can be now also prescribed for second-line therapy. As patients with pancreatic cancer had extremely limited option for a first-line therapy so far, the patients would greatly appreciate the government’s new reimbursement expansion decision. But the latest change can be burdening for Onivyde. As many of anticancer treatments initially not listed for reimbursement as second-line or later therapy are now listed, the government’s standard on reviewing the reimbursement feasibility, such as ICER, could get tougher. Medical experts complain the government should have included Onivyde, when discussing about the reimbursement listing reform. Professor Yoo Chang-hoon of Oncology Department at Asan Medical Center noted, “To this date, we talk about the second and third-line treatment with a lot of pancreatic patients. Because they do not get coverage, we also check on their private medical expense insurance. It is regrettable that Onivyde has not gotten reimbursement, yet, even it has global Phase III trial and Asian subset analysis data and Korean RWE.” The global multicenter Phase III trial NAPOLI-1 study has confirmed Onivyde, in combination with a standard second-line treatment option '5-FU/LV,' significantly improved the treatment outcome on patients, who did not respond to first-line gemcitabine-based treatment. The drug raised awareness of the importance of sequential combination strategy in treating metastatic pancreatic cancer. It is the only treatment recommended as a Category 1 by NCCN guideline when second-line gemcitabine-based anticancer therapy is used to treat patients with metastatic pancreatic cancer.
