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- 2026-04-16 01:49:55
- Policy
- No.1 anticancer drug in Rx sales is Palonosetron & Tamoxifen
- by Lee, Hye-Kyung Nov 16, 2020 06:03am
- Based on the number of prescriptions, gastric cancer patients were prescribed 'Palonosetron' and breast cancer patients were prescribed 'Tamoxifen' the most. The HIRA released a retrospective study on preparing a platform for real-world evidence (RWE) for drug reimbursement management (Research Director Dr. Dongsuk Kim, Dr. Jihye Byun). This study explains the current status of medicines for gastric and breast cancer patients. According to the research report, the most frequent medicines for gastric cancer patients in 2018 were Palonosetron(20.3%), Oxaliplatin (20.1%), and Megestrol (18.5%), accounting for more than half of the prescription rate. .Also, from 1st to 3rd place were the same as in 2017 .Capecitabine, which was ranked 5th in 2017, ranked 4th, accounting for 17% of the prescription rate in 2018 .The fifth was Fluorouracil .The ranking changed when it was based on drug cost .In the case of gastric cancer high frequency drugs in 2018, Oxaliplatin accounted for ₩17.3 billion (22.6%) out of the total ₩76.4 billion .Ramucirumab (16%), Imatinib (14%), Tegafur (9.4%), and Trastuzumab (7.5%) were followed . Looking at the top 20 anticancer drugs used by breast cancer patients based on the number of prescriptions, Tamoxifen (23.9%) was the same as in 2016 and 2017, and Trastuzumab was 14.2% as the second highest in 2018 .Letrozole is the same as in 2017, but the prescription ratio is 13.1%, which has increased the number of claims compared to 2017 .Goserelin (9.6%) and Cyclophosphamide (9.1%) ranked 4th and 5th . In the case of drug costs for breast cancer treatment in 2018, there was a change in ranking except for Trastuzumab (25.3%), which ranked first .In August of that year, Trastuzumab emtansine was second with 9.9%, while Pertuzumab (9.7%) and Palbociclib (7.9%) ranked third and fourth .Letrozole, which was second in 2017, dropped to sixth with 6.7%, and Doxetaxel (7.8%), which was third, fell to fifth .ult of examining the drug costs by dividing the anticancer drugs into group 1 and group 2, Doxetaxel ranked first in the gastric cancer frequency in group 1 anticancer drugs in 2018, with a high drug cost with ₩831 million, followed by Leucovorin with ₩498 million .Fluorouracil and Cisplatin accounted for ₩260 million and ₩194 million respectively .In group 2 anticancer drugs, Oxaliplatin were most expensive, and Ramucirumab was second .In 2016 and 2017, TGO (tegafur+gimeracil+oteracil) and Trastuzumab, which were second and third, ranked third and fourth .The first to third anticancer drugs in the 1st group of frequent breast cancer were Goserelin, Tamoxifen, and Doxorubicn, which were the same from 2016 to 2018 .In group 2 anticancer drugs, Trastuzumab was ranked first, with 38.7% .In 2018, the total number of gastric cancer patients was 177,271, which is increasing every year, and the total number of breast cancer patients is 199,553, an increase of about 9% every year .Like the number of patients, the number of claims increased every year .In 2018, the cost of treatment was about ₩622 billion for gastric cancer and ₩962.2 billion for breast cancer, and ₩3.5 million for gastric cancer and ₩4.8 million for breast cancer were spent per patient .In terms of anticancer drug costs, gastric cancer in 2018 was ₩76.4 billion and breast cancer was ₩340 billion, up 11.5% and 30% respectively compared to 2017.
- Company
- Amgen-CKD ink co-promotion deal on Evenity
- by Nov 16, 2020 06:03am
- CEO Kim Young-joo of Chong Kun Dang (left) and General Manager Noh Sang-kyung of Amgen Korea are photographed after signing an agreement On Nov. 12, Amgen Korea (General Manager Noh Sang-kyung) and Chong Kun Dang (CEO Kim Young-joo) announced they signed a co-promotion agreement on a novel osteoporosis drug Evenity (romososumab) on Nov. 11. The two companies also renewed the Prolia (denosumab) co-promotion deal as well. According to the agreement, Amgen Korea would focus on the Prolia and Evenity sales and marketing in general hospital accounts, whereas Chong Kun Dang would center semi hospital. Their partnership is expected to consolidate the synergy effect between Amgen Korea’s all bone disease related treatment and Chong Kun Dang’s resources within the treatment area. Launched in November in the South Korean market, Prolia is an osteoporosis drug that inhibits bone absorption by targeting receptor activator of nuclear factor-κB ligand (RANKL), which is a key to survival and formation of osteoclasts. Prolia, administered once every six month, has confirmed its efficacy in reducing the risk of vertebral, non-vertebral and hip fracture. And also the drug demonstrated the effect of increasing bone density and bone fracture reduction with extensive clinical data of 10 years, unprecedentedly long for an osteoporosis drug. Evenity is an osteoporosis drug targeting the protein sclerostin that hinders bone formation, and it can be used on patients with high risk in bone fracture. The drug was released in December 2019 in the South Korean market as a first and the only treatment option with a dual effect that increases bone formation and to a lesser extent reduces bone resorption. General Manager Noh Sang-kyung of Amgen Korea stated, “We are exhilarated to extend our partnership with Chong Kun Dang for Amgen’s novel osteoporosis treatment portfolio including Prolia and Evenity to provide the treatment options to patients in South Korea.” CEO Kim Young-joo of Chong Kun Dang commented, “Chong Kun Dang would do its best to benefit even more patients with the innovative treatments by utilizing the company’s excellent sales force and the market presence.”
- Policy
- Detailed review for COVID-19 tx budget are insufficient
- by Lee, Jeong-Hwan Nov 16, 2020 06:02am
- The National Assembly's Health and Welfare Committee was found to have insufficient details of the detailed review of the new budget of ₩965 billion, which accounted for the largest volume of the COVID-19-related budget, before the resolution of the budget under its jurisdiction next year. Although it accounts for the highest budget among health budgets, not welfare, the specific direction of how to spend ₩965 billion on securing COVID-19 treatments and vaccines in the future has not been reviewed, so it may be mistaken as a poor review. As a result of reviewing the budget bill decided by the Special Committee on Budget and Accounts of the Welfare Committee on the 10th, the 'COVID-19 Treatment and Vaccine Acquisition' project in the General Account of the Korea Disease Control and Prevention Agency's Medical Safety and Prevention Bureau is planned to use a detailed budget. The need for the budget was pointed out by Kiyoon Kang, a member of People Power Party. He requested a new formation of ₩965 billionn in the budget for securing treatments and vaccines. The Korea Disease Control and Prevention Agency expressed its position of 'partial acceptance', saying that advanced review is necessary in consideration of the COVID-19 outbreak situation, and the preliminary subcommittee recognized the necessity in the screening and decided to organize a new program of ₩965 billion. The budget will be reviewed by the Special Committee on Budget and Accounts after going through the plenary session of the welfare committee. The problem is that although it occupies the largest portion of the health budget for next year, the specific direction of how and where to spend the future budget has not been examined. In the future, it is impossible to know the direction of the detailed budget at all, whether the budget is to be used for free vaccination by investing a budget of ₩965 billion for the national vaccination project for COVID-19 treatment and vaccines, or to support domestic and foreign pharmaceutical companies that are needed for domestic supply and demand of treatments and vaccines. In this case, even if it is judged by the Special Committee on Budget and Accounts, there is a greater possibility that the Strategy & Finance Committee will refuse to reflect the budget because it does not recognize the validity. This is because there is a low justification for accommodating the budget of around ₩1 trillion without a specific reason. A member of the Welfare Committee's Special Committee on Budget and Accounts said, "There is no way to confirm the details of the relevant budget review and future directions," adding to the question. The noticeable budget is an advanced flu vaccine cold chain system that has revealed problems in the process of preventing COVID-19 Twindemic. Democratic Party of Korea Rep. Seo Young-suk insisted on an increase of ₩300 million in the new budget for advanced cold chain systems in the MFDS budget. Since it is necessary to introduce a temperature change system for each stage of distribution and storage after exposure to the vaccine at room temperature, the opinion is to increase the 'Intelligent Cold Chain System Introduction Research Service Budget' by ₩300 million. The MFDS also announced its acceptance of the budget and has been voted for. Democratic Party of Korea, Hyun-young Shin also requested an increase of ₩100 million from the national vaccination budget for the investigation of the cold chain of vaccine distribution in the budget of the Korea Disease Control and Prevention Agency. The Korea Disease Control and Prevention Agency also plans to accept the budget to investigate the distribution and storage of vaccines that are important to the NIP. In the MOHW's budget, a new budget of ₩2.5 billion was accepted to support the development of new drugs targeting COVID-19, solve the problem of discontinued research, and support linkage to follow-up projects. The details are the ₩1.5 billion for new drug development and ₩1 billion for the drug recycling budget using the drug repositioning strategy. Ho-young Joo, Seo Jeong-sook and Paik Jong-heon , members of People Power Party requested. Democratic Party of Korea, Seong-ju Kim and Lee In-geun were voted for an increase of ₩2 billion in the budget for establishing a clinical trial support system to support rapid development of infectious disease treatments and vaccines. Seong-ju Kim, Lee In-geun, and Nam In-soon also requested an increase of ₩1.5 billion in the budget to establish the basis for advancement of clinical trials, and the detailed budget plan is to establish a clinical platform for infectious diseases, foster clinical experts, and introduce a clinical trial center. Nam In-soon also requested an increase of ₩500 million in the clinical research budget for oriental medicine standard guidelines for the creation of an oriental medicine basis and ₩500 million for the support of the establishment of a clinical infrastructure for oriental medicine from the budget for developing oriental medicine leading technology. In The MFDS budget, Democratic Party of Korea Kang Byungwon, Ko Young-in, Kim Seong-ju, Kim Won-i, Nam In-soon, Shin Hyun-young, Seo Young-suk, and People Power Party Lee Jong-seong requested an increase in the budget for strengthening clinical trial safety standards by ₩5,316 million. The budget is based on a joint review committee for integrated review of multi-center clinical trial plans, a customized clinical helper center for patients, and DSUR data evaluation management. Democratic Party of Korea Choi Hye-young and People Power Party Lee Jong-seong also requested an increase of ₩4.2 billion in budget for approval and approval from the MFDS. It is a business that operates audit personnel by using the licensing fee as an income replacement expense. Details include ₩3,040 million for expansion of the audit personnel, ₩100 million for office rental, ₩265 million for examination-related goods, and ₩795 million for examination advisory expenses. .Democratic Party of Korea Choi Hye-young requested a new budget of ₩1.45 billion to improve accessibility for people with disabilities in drug safety information .The budget is based on the development of labeling methods and standards such as Braille on pharmaceutical packaging, research on labeling systems, education and public relations, survey and evaluation, and labor costs for six personnel at the KIDS .People Power Party Bong-min Jeon asked for ₩1 billion increase in the budget to expand the promotion of the drug side effects damage relief system .It is based on the expansion of publicity such as terrestrial advertisements, radio advertisements, and outdoor media .The Korea Disease Control and Prevention Agency's budget is the largest increase in the national vaccination budget for the prevention of COVID-19 Twindemic, along with the new budget of ₩965 billion for COVID-19 treatment and vaccine acquisition .Specifically, People Power Party Kiyoon Kang, Miae Kim, Jongheon Baek, and Hoyoung Joo requested an increase in the national expansion budget for flu vaccination by ₩274.6 billion, and the Korea Disease Control and Prevention Agency made some acceptance positions .Democratic Party of Korea Kang Byungwon, Kim Seong-ju, Kim Won-i, Nam In-soon, Shin Hyun-young, Heo Jong-sik, Ko Young-in, and Lee Yong-ho ( nonpartisan representative) requested an increase of ₩80.7 billion to expand flu vaccinations for those aged 14-18 and 62-64 .Democratic Party of Korea Yeong-Seok Seo also proposed an increase in flu vaccination budget for the ages 14-18 and 62-64 to increase by ₩41.4 billion, and Chung Chun-suk by ₩17.2 billion for 14-18 years old .People Power Party Kang Ki-yoon, Kim Mi-ae, and Paik Jong-heon called for an increase of ₩246.4 billion in the budget to add 23-valent polysaccharide vaccines and 13-valent protein-conjugated vaccines to the scope of support for the pneumococcal vaccination project over the age of 65 .Democratic Party of Korea Seo Young-seok and Choi Hye-young also proposed an increase in budget of ₩7.2 billion to support 13-valent protein-coupled pneumococcal vaccine for high-risk groups among the elderly over 65 .Democratic Party of Korea Choi Hye-young and Seo Young-suk demanded an increase of ₩100.9 billion in budget for the expansion of the human papillomavirus (HPV) vaccination program for 12-year-old girls .In addition to cervical cancer, the HPV vaccine is effective for men as it has the effect of preventing anal cancer and penile cancer, and it is pointed out that men also need vaccination to prevent men from passing the virus to women .The Korea Disease Control and Prevention Agency was in a difficult position to accept because of the cost-effectiveness of expanding boys, the effect of preventing infectious diseases, and reviewing public health priorities .The Welfare Committee is expected to hold a plenary meeting on the 17th and decide on a budget under the jurisdiction for next year, which has been preliminary reviewed by the Special Committee on Budget and Accounts .The budget proposal is finalized when it passes the plenary session after the preliminary committee's review.
- Policy
- RWD is useful for shortening new drug's approval period
- by Lee, Hye-Kyung Nov 16, 2020 06:02am
- (From left) Professor Hyungki Lee & Ph.D student Yoomin JeonOpinion was raised that the use of RWD (Real Word Data) owned by The HIRA could accelerate and improve domestic drug development and new drug approval. Prof. Hyung-ki Lee and Ph.D student Yoo-min Jeon published their contributions in the HIRA Big Data Brief on the subject of 'The possibility of utilizing HIRA big data for efficient design, simulation, and pre-prediction of clinical trials.' The research team said that deriving meaningful RWE (Real Word Evidence) from high-quality RWD through appropriate analysis 1 method shortens the process of drug development as well as new drug approval, but the HIRA's RWD can be usefully used. As a result of reproducing the CAROLINA clinical trial, which compared cardiovascular safety for diabetes treatments, Professor Patorno of the UK said that the group receiving 'Linagliptin' had more cardiovascular system than the group receiving 'Glimepiride'. The risk was reduced by 9%. While it took six weeks to analyze this data, it took a pharmaceutical company eight years to obtain the results of the Carolina clinical trial, and even including the four years it took to accumulate billing data, RWE is effectively used to reduce research costs and time. It is the opinion of the research team that it can be done. In particular, the HIRA's RWD has recently been emphasized in the epidemiological evaluation of the COVID-19 disease and monitoring the efficacy and safety of drugs. The research team said, "The HIRA has released clinical data in a large-scale open source format for the first time in order to analyze COVID-19 test and medical bill data using a common data model (CDM)." It will be the basis for linking the hospital billing data with the HIRA, and by connecting the RWD possessed by the HIRA to the EMR that contains specific clinical information and test results of individual patients, the scope of domestic RWD use can be further expanded." However, in order to actually introduce the HIRA's RWD into domestic drug development and new drug approval, it suggested the need to approach short-term, mid-term, and long-term utilization plans. First of all, it provides the basis for prescription and approval of over-licensed (off-label) drugs in therapeutic orphan groups such as children, the elderly, and pregnant women with RWD previously held as a short-term plan. And they asked for help in the development process for rare disease treatments. Lastly, the HIRA's RWD is used as a prototype of a national research cohort for the implementation of precision medicine, and a long-term use plan is needed to accelerate the process of developing innovative new drugs for new targets. The research team said, "The HIRA has already revealed that it is a domestic leader in the field of RWD and RWE through the healthcare big date platform." And the research team then emphasized that "It is necessary to establish an action plan by driving the momentum of success in the initial stage, and to pursue it strategically after consulting external experts." Developed countries have been preparing guidelines and legislation to actively use RWE in regulatory decision-making for many years. The US is focusing on securing RWD and RWE after the emphasis on developing patient-specific medicines through the '21st Century Remedial Act' in 2016 and the'Regulatory Science Strategy for 2025' in the UK this year. As 'Data 3 Act' (Personal Information Protection Act, Credit Information Act, and Information and Communication Network Act) was implemented in Korea, the HIRA, the NHIS, the Korea Disease Control and Prevention Agency, and the National Cancer Center integrated health care big data. It is now possible to use pseudonymized data.
- Policy
- COVID-19 vaccine likely to be approved w/o clinical trials
- by Lee, Tak-Sun Nov 16, 2020 06:02am
- The COVID-19 vaccine candidate material, which is showing a rapid pace in commercialization, is expected to undergo bridging study after the market because clinical trials are difficult in Korea. The clinical trial is difficult because, ironically, there are few COVID-19 confirmed cases in Korea. On the 10th, Pfizer USA and BioNTech, Germany are developing a vaccine candidate for COVID-19, showing an effect of preventing viral infection in about 90% of subjects as a result of the interim clinical trial. Pfizer is undergoing phase III clinical trials with 43,538 people. This interim result is based on data that about 90% of cases occurred in the placebo group as a result of analyzing 94 confirmed cases of COVID-19 in the group receiving the COVID-19 vaccine and the group receiving the placebo. In other words, only 10% were confirmed in the COVID-19 vaccine group. The Korean quarantine authorities plan to promote domestic introduction by looking at the final clinical results while being cautious about the intermediate clinical results. However, in Korea, clinical trials prior to domestic approval seem to be practically difficult. This is because the efficacy of the vaccine can be confirmed only when the target number of confirmed patients is reached. The clinical trial of Pfizer's vaccine will also continue until 164 confirmed cases of COVID-19 are reached. It is pointed out that in Korea, where there are few confirmed cases, it is virtually difficult to proceed with a clinical trial waiting for a confirmed case to occur in the test group. Accordingly, it is known that there is a high possibility of verifying whether the vaccine is effective in Koreans through a bridging study after marketing after approval of the vaccine based on multinational clinical trials. A bridging study refers to a test conducted for Koreans when it is difficult to apply foreign clinical data due to racial differences. To date, there has been no case of an overseas vaccine for COVID-19 applied for permission to the MFDS. However, the MFDS believes that the COVID-19 vaccine jointly developed by AstraZeneca and Oxford University will apply for approval soon, and is undergoing preliminary evaluation. Preliminary screening is conducted by the MFDS’ exclusive review team 90 days before the expected date of application for products that are expected to apply for permission. The Pfizer vaccine is also expected to undergo preliminary screening and approval early.
- Product
- A professor reserves thoughts on “90% effective vaccine"
- by Kim, Min-Gun Nov 16, 2020 06:02am
- Professor Seol Dai Wu at Chung-Ang University A U.S. pharmaceutical company Pfizer has attracted a global attention as it announced a COVID-19 vaccine in development has demonstrated an efficacy rate above 90 percent in early results from a Phase 3 trial. One of vaccine experts in South Korea, Professor Seol Dai Wu at Chung-Ang University College of Pharmacy spoke on Nov. 11 at an interview by YTN and said, “Although I look forward to the positive results, experts would need to see more transparent information to properly assess the vaccine.” Professor Seol carefully commented, “The final result of the Phase 3 study on Pfizer vaccine is expected to be out on Dec. 11, 2022. The announcement was based on 94 early test participants. The company is running the Phase 3 study with 50,000 participants, and it is almost impossible to fathom the final result from an early analysis on 94 people out of 44,000 people, who have been administered with the vaccine. Also the claim of ’90-percent effective’ could be controversial, so we need wait to see further results.” “The early test result is from a comparison between the vaccine-administered group and placebo-administered group, where most of the COVID-19 positive cases were found from the placebo group. And the number of infected cases among the vaccine group was so low that the early result was claimed to have shown efficacy of 90 percent,” the professor added. Professor Seol does not see high possibility of adverse reaction breaking out from the Pfizer vaccine, but the vaccine’s level of efficacy is still unknown. He said, “Based on the vaccine’s technology, the adverse reaction is less likely to be observed, but a basic efficacy is extremely crucial for a vaccine. An outstanding vaccine has an effect of immediately killing off virus that infiltrated a body to completely block the proliferation, but underperforming vaccine could actually let the virus to spread inside the human body. We have all our attention fixed on Pfizer’s vaccine to evaluate how effective the vaccine really is.” If the result of the vaccine’s Phase 3 clinical trial is good, Pfizer would apply for the U.S. Food and Drug Administration’s (FDA) emergency approval to provide the vaccine to the mass. However, the professor stated he would reserve his opinion on using the vaccine for now, regardless of the efficacy, it would be challenging to distribute it via cold chain in South Korea. Professor Seol elaborated, “Pfizer’s vaccine is instructed to be delivered and stored at a temperature under negative 70 degrees Celsius and to be used within five hours from the point of production. The mRNA used in the vaccine is exceptionally insecure, which can falter the vaccine to lose the effect if it is not properly kept in cold chain.” “Although South Korea has good cold chain facilities that maintain the temperature at negative 2 to 8 degrees Celsius, a cold chain system for negative 70 degrees is not prepared. If South Korea were to use Pfizer’s vaccine, a significant amount of investments should be made as well,” he noted.
- Company
- Dong-A ST introduces SHR-1701 in China
- by Chon, Seung-Hyun Nov 16, 2020 06:02am
- Dong-A ST announced on the 11th that it has signed a contract with Jiangsu Hengrui Medicine to introduce the next-generation immune anticancer drug 'SHR-1701' in Korea. With this contract, Dong-A ST has secured the exclusive domestic development and sales rights of fusion protein, which is undergoing phase I and II clinical trials in China by Jiangsu Hengrui Medicine. The down payment is $2.29 million (about ₩2.5 billion). The technical fee (milestone) according to the stage of development is $8.46 million (about ₩9.5 billion). Jiangsu Hengrui Medicine will supply the finished drug to Dong-A ST. Dong-A ST headquartersAccording to the company, SHR-1701 is a fusion protein that suppresses both PD-L1 and TGF-βRII at the same time, and is expected to show anticancer efficacy against various carcinomas. It suppresses immune evasion and metastasis of cancer cells, and suppresses fibrosis of cancer cells in the tumor microenvironment, thereby removing the physical barrier that protects cancer cells from immune cells and therapeutic agents. Currently, TGF-β is known as one of the causes of the low response rate, which is the disadvantage of immuno-anticancer drugs in the mechanism of inhibition of PD-(L)1. Therefore, researches that increase the effectiveness of immuno-anticancer drugs by simultaneously inhibiting PD-(L)1 and TGF-β at home and abroad have been conducted. It is actively in progress. The company said, “SHR-1701 is expected to have improved anti-cancer effect compared to single-dose therapy and combination therapy of PD-L1 inhibitor or TGF-β inhibitor, and it is possible to reduce development cost and secure pharmaceutical price competitiveness compared to combination therapy with one single substance. That's an advantage.” SHR-1701 is currently undergoing phase I and II clinical trials in China for solid cancers such as non-small cell lung cancer, pancreatic cancer, biliary tract cancer, and cervical cancer. Jiangsu Hengrui Medicine, established in 1970, is a Chinese longevity pharmaceutical company with strengths in anticancer drugs, anesthesia, and pain relievers. Last year, it achieved ₩3.9 trillion in sales, and invested ₩620 billion, 16% of its sales, as R&D expenses. An official from Dong-A ST explained, "Through the introduction of this next-generation anti-cancer drug, we have secured competitiveness in the anti-cancer drug pipeline and the domestic anti-cancer drug market at the same time." He said, "Based on close cooperation with Jiangsu Hengrui Medicine, we will strive to help patients suffering from cancer through successful domestic development."
- Policy
- The introduction of vaccine will be discussed after results
- by Lee, Tak-Sun Nov 12, 2020 06:28am
- The MFDS said it would discuss the final clinical results of Pfizer's COVID-19 vaccine, which showed the potential for clinical success, for introduction. Seo Kyung-won, the head of the drug review department at the MFDS, made such a statement at a briefing on the approval status of vaccines for the treatment of COVID-19 held on the 10th. She said, “According to Pfizer's announcement, the interim results of a phase III vaccine trial resulted in 94 infected patients with 38,599 vaccines twice on the 8th.” She also reported that the vaccinated group had more than 90% of the preventive effect when compared to the non-vaccinated group. "Intermediate results seem positive, and phase III trials are currently in progress in six countries including the US and Brazil," she added. The phase III clinical trial ends when 164 confirmed cases are found. She said, “We will comprehensively judge the final clinical results and determine whether it is effective or not, such as safety, duration of immunity, and effects on the elderly.” “We have been continuously monitoring the test results, but we will continue to closely monitor the test results, and we plan to discuss the introduction at the government level.”
- Policy
- Boryung introduced Symbenda's first generic in Korea
- by Lee, Tak-Sun Nov 12, 2020 06:19am
- #Boryung introduces a generic drug which was reimbursed in 2 years ago. Boryung's Bendamustine HCl is the first generic for Symbenda. The MFDS approved Boryung's Bendamustine HCl on the 11th. It is a generic for Symbenda which was approved by Ezai Korea in 2011, and is the first generic in Korea. Symbenda was approved in 2011, but it took seven years to be reimbursed. It has been listed in September 2018. BR (Bendamustine/Mabthera (Rituximab)) therapy was successfully applied in Follicular Lymphoma (FL) with no previous treatment experience, raising expectations. BR therapy is recommended as a first-line treatment for follicular lymphoma patients in the United States and Europe. Follicular Lymphoma accounts for about 3% of all non-Hodgkin lymphomas, an average of 150 patients a year, and most of them are 55-60 years old. BR therapy demonstrated the efficacy of improving overall health status and improving quality of life in terms of cognitive, emotional, and social function in a phase III study compared with standard therapy R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin HCl, Vincristine Sulfate, and Prednisolone). .The safety aspect is improved compared to the existing Mabthera-based chemotherapy combination therapy .Last year, Symbenda recorded sales of ₩2.5 billion (IQVIA) in Korea .Symbenda's re-examination (PMS) expired on June 16th .As there are no patents listed on the MFDS’ Green List, there are no restrictions for generics to enter .Boryung, which has established a strong sales network among domestic companies in the anticancer drug market, preoccupied the first generics .Boryung is also developing 'BR2002', a new drug for treating non-Hodgkin's lymphoma .BR2002 was approved for phase I clinical trial by the US FDA last year .It has 4 licensed lymphoma treatment systems .Boryung's 'Bendamustine HCl', which was approved this time, is an imported finished drug by Boryung .
- Opinion
- [Reporter’s View] ERP should be kept ‘voluntary-basis’
- by Nov 12, 2020 06:19am
- The pharmaceutical industry is bracing themselves as winter is coming with the management offering early retirement program (ERP). Lilly Korea, a South Korean branch of the U.S.-based Eli Lilly’, has presented the ERP plan to reduce a quarter of its sales force. It is its first ERP after three years since 2017. Only Lilly Korea has officially announced the ERP plan, but the industry sources hint many more multinational pharmaceutical companies are preparing for the program as well. But what should be highlighted is that these multinational companies’ ERP is not local specific, but rather a part of reorganization trend apparent throughout the world. The global pharmaceutical companies are unfolding the strategy of focusing on selected key resources. Pfizer split off the off-patent drug business as a whole, while MSD is also planning to spin off female healthcare and off-patent products. Sanofi has announced its major downsizing plan to vastly shrink the antidiabetic and other chronic disease treatment business. Instead, the company is focusing on autoimmune disease and anticancer therapies. The wave of reorganization occurring outside of South Korea is now impacting the Korean branches as well. There is no reason for the executives to keep the employees under the departments to be closed. In the process of reorganization in Europe, Sanofi has notified its plan to lay off about over 400 employees under the chronic disease department. Moreover, the novel coronavirus (COVID-19) has been worsening the situation. As the sales and marketing activities have turned noncontact-focused online events, the company has a justifiable reason to downsize the sales force. The real motivation of ERP, the voluntary-basis retirement, seems to be out of reach for the employees in the multinational companies. The management claims they are only accepting voluntary applicants. However, the employees, especially the ones in the targeted department, would feel immensely insecure. They predict the management would eventually pressure the specific departments’ employees, when the management does not see a satisfying number of volunteers. This is why the labor unions in the multinational companies are constantly demanding the management to disclose transparent ERP procedure and to promise to provide the program without pressure. Reorganization and downsizing could be inevitable for a company to survive and relentlessly seek for changes. But a company is an organization that a board of executives cannot take a full control over the employees. If the employees are not taking the ERP offer as expected, than the management should follow legal procedure and offer more favorable options or change the objectives accordingly. Hopefully the approaching winter would not be so harsh, so the ‘voluntary retirement’ does not turn into a ‘pressured retirement.’
