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- 2026-05-20 15:26:59
- Policy
- Remdesivir's special import was decided
- by Lee, Tak-Sun Jun 05, 2020 06:10am
- RemdesivirThe special import of Gilead’s Remdesivir was decided. It will be used in severely hospitalized patients infected with the COVID-19. The MFDS (Minister Lee Eui-kyung) decided to import special cases for Remdesivir, which is being developed as a treatment for COVID-19, and accordingly, the KCDC (Director Eun-Kyung Jung), announced on the 3rd that it is planning to negotiate with the MFDS and Gilead science Korea as soon as possible In the special drug import system, the MFDS imports unlicensed drugs from the country through importers at the request of the relevant ministries in order to deal with the public health crisis, such as pandemic of infectious diseases. The KCDC requested the special import from the MFDS, as the 'Clinical Committee for Infectious Diseases' proposed the introduction of 'Remdesivir' as a treatment for COVID-19 in Korea. As a result, the MFDS announced that it had decided to import special cases after deliberation by the National Stabilization and Supply Council for Essential Drugs (Disease Management Subcommittee). The MFDS judged that the shortening of the treatment period in severe patients due to the use of Remdesivir was clinically meaningful and that it was necessary to secure additional therapeutic agents. In addition, the US, Japan, and the United Kingdom are also considering the fact that the use of Remdesivir in the COVID-19 Pandemic situation was also considered. The government announced that it will support as much as possible to ensure that the medicines are imported as soon as possible, along with domestic importer Gilead Sciences Korea. Remdesivir is used for COVID-19 confirmed patients through PCR tests, in case of ▲Patients who have 94% or less of oxygen saturation (SpO2) in room air ▲Patients who need supplemental oxygen treatment ▲Non-invasive or invasive machines. It is used for severely hospitalized patients, such as those requiring ventilation or extracorporeal membrane oxygen therapy (ECMO). The total administration period is within 10 days.
- Policy
- COVID-19 vaccine by Inovio was first approved in Korea
- by Lee, Tak-Sun Jun 05, 2020 06:09am
- COVID-19 vaccine is the first clinical trial approved in Korea. It is a vaccine candidate developed by Inovio of the United States and is conducted by theInternational Vaccine Institute (IVI). On the 2nd, the MFDS approved phase I/IIa of IN0-4800, a candidate for COVID-19 vaccine, applied by the IVI. In clinical trials, the safety, tolerability and immunogenicity of COVID-19 preventive vaccine INO-4800 using electroporation after intradermal inoculation in healthy adults will be evaluated. It will be administered to 160 healthy adults in Korea and will be administered at Seoul National University Hospital. Inovio began clinical trials of INO-4800, a candidate for COVID-19 vaccine, in 40 healthy adults since last April. It is expected that the results of Phase I clinical trial will be released soon, and antibodies have been successfully generated in animal studies. INO-4800 is a DNA vaccine that activates immune T cells in the body by inserting a part of COVID-19 gene into the plasmid and a 'transcription factor' to express it as an antigen. It is different from the existing fertilized egg or cell culture vaccine. Currently, the fastest clinical candidate for COVID-19 vaccine in Moderna, the United States, is also a DNA vaccine. The vaccine candidate developed by Genexine in Korea is also a DNA vaccine.
- Company
- Immunotherapy Keytruda faces Cancer Committee once again
- by Eo, Yun-Ho Jun 05, 2020 06:09am
- An immunotherapy Keytruda would be standing before the Cancer Deliberation Committee once again. On June 3, Keytruda (pembrolizumab) would be deliberated by Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee again, although the committee deferred the decision in a meeting finally held on Apr. 29 after COVID-19 postponing the schedule twice. The Cancer Deliberation Committee reviewed granting reimbursement on Keytruda’s five indications, including as a first-line treatment (monotherapy and combination therapy) for non-small cell lung cancer (NSCLC), monotherapy for second or later-line treatment in bladder cancer, and monotherapy for third or later-line treatment in or refractory classical Hodgkin lymphoma. In March 2017, Keytruda monotherapy has been approved as a first-line treatment in patients with NSCLC. And the MSD Korea has submitted an application for reimbursement approval on the monotherapy indication to be used as a first-line treatment in September 2017, and continued the talk with the government for over two years. Regardless of the effort, the talks fell through in September last year. Considering the health authority’s decision, MSD showed its commitment by submitting unasked-for economic evaluation data on the first-line treatment in NSCLC to seek for the reimbursement expansion. But the Cancer Deliberation Committee rather demanded additional data on reducing the cost and deferred the decision. Accordingly, MSD has revised the financial impact resolution plan once again for technically the last negotiation. If Keytruda fails to pass the Cancer Committee this time, the coverage extension discussion on the immunotherapy would highly likely to get pushed aside indefinitely. Keytruda was listed for the first time in August 2017 through a combination of refund and expenditure cap type risk sharing agreement (RSA) based on the PD-L1 expression rate as a standard. The drug is even trying to replace existing first-line chemotherapy option with the immunotherapy as a monotherapy. This holds a significant meaning. If the coverage expansion is granted, then a patient diagnosed with stage IV lung cancer, not subject for targeted therapy with EGFR mutation, could be prescribed with Keytruda.
- Policy
- Permission is increasing prior to the end of PMS
- by Lee, Tak-Sun Jun 04, 2020 10:41pm
- Hanmi's RosuzetEven before the end of PMS (Post marketing surveillance), a lot of new items have been approved through a contract production contract with the original company. Since PMS system in Korea is also provided with the data protection function of the original drug, it is possible to apply for a license for the same ingredient after PMS expires. However, as more and more original companies share item data in order to expand commissioned production, market competition is intensifying even before PMS. According to the industry on the 3rd, 18 new drugs (6 companies) were approved for the hyperlipidemic complex (Rosuvastatin and Ezetimibe) on the 29th of last month. New products have been released in about 3 years since December 2017. The first licensed item for this formulation is Hanmi's Rosuzet. Rosuzet was approved in June 2015. Subsequently, by December 2017, 84 additional drugs with the same ingredients were approved. All of these items, including Rosuzet, are drug for data-based re-evaluation, and were granted PMS until June 7, 2021, in recognition of the new combination of the two ingredients. During this period, the vendor of the item should conduct a post-marketing investigation on a certain patient. If post-marketing investigation is mandatory, data protection rights are also granted to prevent the generic drug of the same ingredient from applying for permission during the PMS period. As expected, until June 7, 2021, the same ingredient generic cannot apply for permission. However, 18 items that received this new license were commissioned and produced by the original PMS-granted original company and shared data, making it possible to enter the market. In 2016, it was approved through Ajou Pharm, which has been approved for Cretrol. Imported original companies do not increase their competitors. However, these days, domestic companies often share it with competitors even though it is a drug that has been granted exclusive rights. As for the sustained-release tablet of the indigestive drug, Mosapride citrate, PMS expires on June 29th, but 50 items of the same ingredient have already been approved. The original company, Daewoong Pharmaceutical, was granted permission to share data and produce it in consignment. Telmisartan, Amlodipine besylate The hypertensive complex Telmisartan-Amlodipine besylate complex also ends PMS on October 30th, but only 30 items have been approved this year. This is because Ildong Pharmaceutical, one of the original companies, is a consigned product. This trend is accelerating in recent years as the calculation of consignments aimed at rapidly entering the market and pharmaceutical companies seeking to increase profits by expanding commissioned production. However, pharmaceutical companies that maintain the No. 1 market share are not happy with the addition of competitors. These are Hanmi Pharm, which owns Rosuzet, and Yuhan, which has a dominant share of Duowell (Telmisartan-Amlodipine besylate) and Gastin CR (Mosapride citrate sustained release tablet). Industry officials said, "This is a result of a combination of Korean development situations driven by lucrative items."
- Company
- Janssen revs up 2 new global trials on lazertinib
- by An, Kyung-Jin Jun 04, 2020 06:14am
- Janssen’s novel anticancer treatment lazertinib licensed out from Yuhan is initiating a new global clinical trial. Prior to a global phase 2 trial, the multinational company is accelerating the investigational drug’s commercialization process with other phase 1 trials. According to a clinical trial registration website ‘clinicaltrials.gov’ by the U.S. National Institutes of Health (NIH) on June 2, Janssen has registered two global phase 1 trials attached to lazertinib. One is an open-label study to investigate absorption, metabolism and excretion of administered 14C-lazertinib and another is assessing effects of CYP450 3A4 inhibitor itraconazole or CYP450 3A4 inducer rifampin on lazertinib. Both trials are testing the drug in healthy adults. Lazertinib, in development as a non-small cell lung cancer (NSCLC) treatment, aims to evaluate its tolerance, safety and pharmacokinetics. The two trials are scheduled to conclude in coming November, but they have not started calling for participants. In 2018, Yuhan licensed out a third generation epidermal growth factor receptor (EGFR) targeted therapy lazertinib to Janssen Biotech. The novel drug is evaluated to have potency to be a second-line treatment in NSCLC patient who developed T790M mutation after taking existing EGFR targeted therapy or a first-line treatment in NSCLC patient who has EGFR mutation. Janssen is currently focused on investigating the potency of combining lazertinib and a bispecific antibody targeted therapy amivantamab that the company started developing after licensing in lazertinib. A large-scale global clinical trial evaluating the amivantamab plus lazertinib combination therapy has started by calling for participants from September last year. By early this year, the trial participant size increased from 400 to 460 and moved up the end point to June 2022. The trial would proceed to next stage when the recommended phase 2 dose (RP2D) is decided. Johnson & Johnson (J&J) has appointed amivantamab and lazertinib as a promising pipeline of the pharmaceutical sector and drew up a blueprint to complete the U.S. Food and Drug Administration (FDA) New Drug Application (NDA) by 2023. The latest registration of the clinical trials could be interpreted as the company consolidating their commitment to commercialize lazertinib. Yuhan, on the other hand, could receive massive milestone payment again within this year with the combination therapy’s phase 2 trial in full motion. In November 2018, Yuhan has signed lazertinib license-out deal with Janssen Biotech and received an upfront payment of USD 50 million (approximately 55 billion won). The Korean company recently received milestone payment of 35 million dollars for the amivantamab combination therapy phase 2 trial. 18 months into the deal, the company generated 85 million dollars. When lazertinib is successfully commercialized, the Korean company would receive up to 1.25 billion dollars for achieving milestones.
- Policy
- Labeling will be promoted on product packaging
- by Lee, Tak-Sun Jun 04, 2020 06:14am
- In the future, it is expected that pharmaceutical companies carrying out bioequivalence tests will be separately labeled on generic drug packaging. In addition, policy initiatives are being undertaken to strengthen the global competitiveness of generic drugs, such as finding ways to disclose generic companies on a manufactory basis. The MFDS announced on the 1st that it is planning to draw the final plan through the public-private consultative body to strengthen the international competitiveness of generic drugs by this month. The public-private consultative body, which strengthens the international competitiveness of generic drugs, has been in operation since April, consisting of about 50 people from the pharmaceutical industry, academia, medical experts, patients, and consumer groups. The tasks for which the public-private consultative body came up with the final plan are: ▲ Conduct bioequivalence test, strengthen drug labeling and information disclosure ▲ Develop bioequivalence test evaluation indicators and disclose evaluation results ▲ Establish a generic drug database for each ingredient. First, among generic drugs, the number of bundled products that are entrusted and manufactured by companies that have not already conducted a bioequivalence test directly is increasing. Therefore, it is necessary to promote a method of labeling the product, such as the name of the pharmaceutical company that actually conducted the bioequivalence test. In particular, the MFDS explained that it is also considering ways to bundle generic drugs with the same bioequivalence test as a factory standard, and to disclose the information through the MFDS website and prescription preparation system. It means that bioequivalence tests are conducted on generic drugs, and products that are manufactured directly and products that have been granted product approval through consignment manufacturing are released together. The MFDS will also develop bioequivalence quality assessment indicators and disclose the evaluation results. It is a plan to increase the quality level and reliability of generic drugs by preparing quality evaluation indicators and transparently disclosing the evaluation results so that they can evaluate the quality level of generic drugs. The MFDS said that the analysis of the effect of the actual use stage after marketing, the MFDS in the bioequivalence test results indicates the ratio (The closer to 1 means the same) of the generic drug (test drug) to the original drug (control drug), the frequency of side effects after the generic drug is marketed may be an example for the quality evaluation index. In addition, the generic drug, which is manufactured by entrusting the entire process, will also clarify the responsible relationship between trustees, such as entrusting quality control obligations to consigned companies and strictly managing quality management of consigned companies. In addition, the establishment of a generic drug database for each ingredient will be promoted. In response, the MFDS will explain the current status of generics by ingredient in English so that overseas buyers and distributors can identify them to support the global advancement of generic drugs, and will also provide them to international organizations such as the World Health Organization (WHO). An official from the MFDS said, "We plan to prepare a plan to improve the specific system so that the contents under the agreement can be carried out normally in the public-private consultative body, and to prepare and announce a detailed action plan for the improvement method by the end of June."
- Opinion
- [Reporter’s view] Pharmacists are tired of impurities
- by Kim JiEun Jun 04, 2020 06:13am
- Another task has recently been added to the pharmacy. From Valsartan, Ranitidine to Metformin. This is because pharmacies have to clean up with repeated impurities situation. The Metformin situation was stopped by the sale of some items, so there was not much confusion than the previous Valsartan or Ranitidine events. However, due to the past two cases, alternative medicines showed a shortage shortly after the announcement of discontinuation. In particular, some of the drugs that have been discontinued this time have fewer drugs to replace, and alternative drugs were sold out of major online drug stores less than an hour after the announcement of discontinuation. It had a hard time for pharmacists who couldn't order medicine quickly to get out of stock. Again, pharmacists who have come into contact with the media are in chaos. They had to clear the stock of drugs that had been discontinued since the morning, and they were busy going into and out of an online mall to order a replacement drug and inquiring about the drug at a wholesale dealer. The pharmacy dispensary was filled with new medicines that were ordered immediately after the announcement of the suspension. If the demand is unpredictable and they don't know when it will be out of stock, it is best to stock up on the new drugs. Even in the case of Valsartan and Ranitidine, pharmacies with many prescription preparations had to give up pharmacy space for drugs that had been ordered in advance for several months. This is not all. The pharmacy had to respond to patient inquiries that followed immediately after the announcement. Like any pharmacist who said, "We are not wrong, we must explain and persuade the pharmacy to be wrong every time." Even in this situation, pharmacists had to explain why the drug they were taking was discontinued and how to deal with it. It is not only a problem that will end with Valsartan, Ranitidine, and Metformin in an era when impurities have emerged as a new era of drug safety management. Although the original responsibility and management of impurity medicines ultimately belongs to the pharmaceutical industry and regulatory authorities, there is an unfair aspect in the current situation where pharmacies must stand at the center of the situation whenever it happens. Of course, it is a top priority to prevent the current situation from being repeated with clear standards and strict regulations. However, as impurities have emerged as a new paradigm for drug safety management, it seems that the government will not be able to ignore the introduction of the international common name and furthermore, the introduction of ingredient names. The fact that this year is the 20th anniversary of separation of prescribing and dispensing drugs will also be a part of empowering discussions on these systems.
- Company
- 3 out of 10 executives, worries about poor performance
- by Chon, Seung-Hyun Jun 03, 2020 06:40am
- The executives working at the pharmaceutical company pointed out the poor performance after COVID-19 outbreak. Most people pointed out that the company should reduce its performance targets to minimize damage to COVID-19. On the 21st anniversary of its founding, Dailypharm conducted a survey of “Post COVID-19 Crisis Response Strategy” by 725 executives from pharmaceutical companies. Pharmaceutical executives responded to the question of what was the biggest inconvenience after the COVID-19 incident, with 228 respondents (31.4%) responding to poor performance due to face-to-face reduction. As patients are reluctant to visit medical institutions after the COVID-19 crisis, there is growing concern over the decline in prescription drug sales in pharmaceutical companies. In addition, pharmaceutical companies have expanded telecommuting since the spread of COVID-19, but concern about poor performance due to negligent account management has emerged as the biggest concern. 25% of respondents (181 people) pointed out anxiety about job cut. This means that there are many executives who are concerned about the reduction of manpower due to the restructuring due to changes in the way they work, such as expanding non-face-to-face work. Many respondents pointed out that the inefficiency of work due to telecommuting (17.9%), the strengthening of the company's surveillance and distrust of the boss (13.0%), and the deterioration of work and life balance (12.7%) due to the disappearance of the boundary between work and privacy were uncomfortable. Regarding the cost reduction plan to minimize the damage to COVID-19, 65.1% (472 people) of the pharmaceutical executives answered that they adjusted their sales amount such as lowering their targets. In COVID-19 crisis, it is the view that, in a situation where the economic recession is realizing, the crisis must be overcome by adjusting the company-wide goals. 8% (203) answered that they should cut costs by reducing operating expenses such as salary or marketing expenses. Over 10% of respondents said that they should consider reducing manpower (13.8%) and reducing investment (11.2%). Pharmaceutical executives agreed with COVID-19 to break away from traditional business methods. Regarding the direction of reorganization of sales and marketing strategies in the post-corona era, 40.3% (292 employees) of pharmaceutical companies said that they should strengthen online sales and marketing. As a result of the COVID-19 crisis, it is recognized that shrinking face-to-face sales and activating non-face-to-face sales are required, and strengthening IT-based face-to-face sales strategies is essential. 29.8% (216 people) said that it is necessary to find marketable products. Pharmaceuticals executives recognized that post-corona era workforce restructuring is expected. 61.1% (443) responded to the question that asked about opinions on the decline in jobs in the pharmaceutical industry after the COVID-19 crisis. In fact, 14.6% of executives predicted that the jobs in the pharmaceutical industry would drop significantly. 57% (413 people) said that the number of sales jobs would decrease the most. Also, 28.7% of respondents predicted that jobs would be reduced in office work such as personnel and management, which is expected to shrink due to the activation of non-face-to-face work. In the post-corona era, 40.1% of the respondents said that jobs in online IT-based jobs would increase. Also, 22.6% of respondents pointed to the expansion of marketing jobs. Pharmaceuticals executives also expressed negative views on the reorganization of the business method in the post-corona era. When asked whether to reduce face-to-face operations after COVID-19, more than half, 54.5% (395) said they could do as before. Although socially reluctant to face-to-face business, there are many conservative views that meeting with a doctor or pharmacist and conducting sales activities is more helpful for performance. According to the survey, 38.8% of respondents said that face-to-face sales should be reduced. About half of the executives (50.9%) predicted that the pharmaceutical industry would settle for telecommuting or flexible work. In the post-corona era, the reorganization of the way of working is a demand of the times. The employees of pharmaceutical companies expected that telecommuting or flexible work would increase work efficiency. 44.1% of respondents said that telecommuting or flexible work would improve work efficiency. This data is the result of a survey conducted by Dailypharm on 725 executives of pharmaceutical companies.
- Company
- Cancer Committee to review 3 signature drugs by BMS-Celgene
- by Eo, Yun-Ho Jun 03, 2020 06:25am
- On June 3, the Cancer Deliberation Committee is to review granting coverage on key products by the combined company of Bristol Myers Squibb (BMS) and Celgene. Celgene’s multiple myeloma pipelines—Revlimid (lenalidomide) and Pomalyst (Pomalidomide)—and BMS’ immunotherapy Opdivo (nivolumab) plus Yervoy (ipilimumab) combination are on today’s agenda. Revlimid and Pomalyst each targeting different goals Revlimid, despite the Cancer Committee deferring the drug in last September, is trying the committee again with coverage extension as a maintenance therapy to prevent relapse in patients who had stem cell transplantation. Unlike last time, Celgene has apparently prepared more accommodating financial solution to offer. From a financial standpoint, Revlimid’s maintenance therapy does not strain NHI so much. Research data claims a patient who did not receive maintenance therapy after the transplantation comes to initiate the second-line therapy quicker than the patients who have. And the following second-line therapy uses at least two drugs combined, but the U.S. National Comprehensive Cancer Network (NCCN) guideline and European Society for Medical Oncology (ESMO) recommend triple therapy including Revlimid. The recommended triple therapy is a combination of comparatively high-cost drugs like Revlimid, Kyprolis (carfilzomib), Empliciti (elotuzumab), Ninlaro (ixazomib) and Darzalex (daratumumab). Technically, using a single therapy for maintenance to delay the relapse would ultimately delay the high-cost triple therapy. Moreover, the already-reduced pricing of off-patent Revlimid would be additionally reduced when the reimbursement is extended to cover the maintenance therapy. Pomalyist, on the other hand, has applied for coverage review as a second-line therapy, in addition to its coverage on third-line therapy. The committee would review the combination therapy consisting of Pomalyst, Velcade (bortezomib) and dexamethasone for patients with multiple myeloma, who have previously received one or more treatment including Revlimid. Opdivo and Yervoy combination therapy tries renal cell carcinoma treatment Opdivo is focusing on a combination therapy with Yervoy. During the April Cancer Committee meeting, the reimbursement on Opdivo has been cleared for a second-line therapy for relapsed or metastatic head and neck squamous cell carcinoma (HNSCC) and a second-line therapy for classical Hodgkin lymphoma (CHL), but indication on second-line renal cell carcinoma therapy and third-line stomach cancer therapy have failed. But the committee would review Opdivo as a first-line therapy for renal cell carcinoma. Ono Pharmaceutical and Opdivo have technically given up on reimbursement on the non-small cell lung cancer indication after having a preliminary meeting with the government in May last year. But now the company has shifted its focus to different indications. At the moment, Sutene (sunitinib), Nexavar (sorafenib) Torisel (temsirolimus), Votrient (pazopanib) and Avastin (bevacizumab) are available for first-line treatment in patients with renal cell carcinoma, but the reimbursement is granted when choosing one among all options except for Avastin. The CheckMate-214 study has confirmed the Opdivo plus Yervoy combination therapy significantly improving the overall survival of the participating patients regardless of PD-L1 expression against the sunitinib group.
- Policy
- The MFDS designated Mobocertinib as an orphan drug
- by Lee, Tak-Sun Jun 03, 2020 06:25am
- The MFDS (Minister Eui-kyung Lee) announced that Mobocertinib was newly designated as an orphan drug, and it announced on June 1 that target diseases were added for three types, such as Ipilimumab, designated as an orphan drug. An orphan drug is a drug that is used for the purpose of diagnosing or treating a rare disease, a drug that has no or no substitute drug, or is significantly improved in safety or effectiveness than a substitute drug, and has been designated by the MFDS. In order to support the development of treatments for rare and incurable diseases, the MFDS firstly authorizes orphan drugs and operates 'Orphan drug designation system' so that it can separately set data, standards, and conditions for approval according to the nature of the disease. The main announcement of this orphan drug designation was that Mobocertinib was designated for the treatment of patients with non-small cell lung cancer with epidermal growth factor receptor mutation, and Ipilimumab has been further designated for use in recurrent metastatic colorectal cancer in adult patients with DNA mismatch repair defects, etc. Also, Ixazomib was added to maintenance therapy of patients with multiple myeloma who received autologous hematopoietic stem cell transplantation, and Ravulizumab was added as a treatment for patients with atypical hemolytic uremic syndrome. Atypical Hemolytic Uremic Syndrome (aHUS) is a disease that occurs in blood clots in blood vessels, interferes with blood flow, destroys red blood cells, and causes hemolytic anemia. An official from the MFDS said, "The orphan drug designation is expected to help in the development of treatments for people with rare and intractable diseases., and will continue to develop policies to ensure patient care opportunities in the future."
