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- 2026-04-17 19:19:01
- Policy
- Lupus drug 'BENLYSTA' opened rehabilitation path
- by Lee, Tak-Sun Nov 29, 2019 06:33am
- There is now a way to recover the lupus drug, Benlysta, which is at risk of withdrawal due to failure to meet postmarketing (PMS) criteria. The MFDS decided to use the drug as a RMP (Risk Management Plan) after long discussion of the Central Pharmaceutical Affairs Council and continue to use it for patients to monitor side effects. According to the MFDS on November 28, Benlysta, which PMS expired in June, will be designated as an RMP target and managed. The new drug should submit a monitored use report for more than 3000 patients for six years after marketing. Failure to comply will result in administrative disposition in three stages, and the final product license will be revoked. Although Benlysta is the only biologic formulations used in lupus disease, it has not met the PMS standards due to its high price as a non-reimbursement drug. Moreover, the possibility of failing to fill more than 3000 patients even during the three administrative disposition periods was strong, and in the end, the cancellation of the product license was prominent. However, as the drug is undergoing a reimbursement discussion recently and voiced that the license should be maintained at the request of the patient and the seller, the MFDS discussed it through the Central Pharmaceutical Affairs on the 4th. As a result of the discussion, it was recognized that Benlysta's necessity to maintain licenses was secured in order to secure patient treatment opportunities. Therefore, it was suggested that new measures for safety and effectiveness should be prepared. There were also opinions that it is practically difficult to report 3000 cases of use report through existing drug review. Kyu-han Chae, director of Biopharmaceutical Quality Control department in MFDS, said, "Benlysta is the only biologics of lupus treatment, and the experts have agreed with the necessity of maintaining the license because of its usefulness in patients who have not responded to existing treatment." The MFDS will continue to monitor post-marketing and maintain permits through RMP instead of PMS. RMP is a submission of a risk management plan throughout the life cycle of a drug product, which requires the reporting of evaluation results every six months up to two years after the product approval and once a year after two years. The director, Chae said, "We plan to evaluate the safety and efficacy of post-marketing products according to the characteristics of drugs." Mr. Chae added “ We ordered the company to make a risk management plan so that it could be actively marketed and used to treat patients”. Mr. Chae added that the action was decided to be patient-centered in order to secure patient treatment opportunities. However, Benlysta's initial disposal cannot be avoided. If the new drug fails to submit a usability survey necessary for re-evaluation, the first administrative disposition will suspend the sale of the item for three months. Meanwhile, lupus disease is a chronic autoimmune disease that occurs mainly in young age, including women of childbearing age, and is an inflammatory reaction in the whole body such as skin, joints, kidneys, lungs, and nerves. Over time, symptoms worsen and relieve over time, greatly reducing the quality of life of patients. It is reported that there are about 10,000 lupus patients in Korea.
- Company
- PPC signs MOU with Clinerion to shorten clinical period
- by Eo, Yun-Ho Nov 29, 2019 06:32am
- Asia-specific CRO PPC (Protech Pharmaservices Corporation) recently signed an MOU with Clinerion, Switzerland, to shorten the time for clinical institution selection and patient registration. Through this partnership, PPC expects to use Clinerion's Patient Network Explorer platform to accelerate enrollment of subjects in global clinical trials in Korea, China and Taiwan. PPC will encourage hospitals to participate in Clinerion's Patient Network Explorer platform for Real World Data / Real World Evidence (RWD / RWE), which will have more global research opportunities. PPC is a CRO providing services related to Phase 1-4 clinical trials in Asia. In order to develop new products for pharmaceutical companies, we provide all services related to clinical trials (Project Management, Regulatory Affairs, Clinical Monitoring, Biostatistics, Data Management, Medical Writing, and Pharmacovigilance) with high quality in line with global standards. Clinerion uses the Patient Network Explorer platform to connect patients in hospitals with global networks to clinical trials conducted by pharmaceutical companies or researchers conducting research. The system is based on electronic health record (EHR) data, in which the individual patient is not identified, and the individual patient is not identified, thereby protecting the patient's personal information. Clinerion is also working with the Hospital Information System (P-HIS) Development Group to internationalize the next generation of HIS terminology and code standards, share precision medical data and know-how, AI-based knowledge services and related technology exchanges. Michael Stibilj, CEO of PPC Group, said, “We are pleased to provide our customers with a globally integrated subject registration service through the Patient Network Explorer platform. "We will have more opportunities to get involved, and patients will have easier access to new potential therapies." "We expect that increasing access to patient information for clinical trial registration will eventually speed up the clinical trial process and help us develop innovative products."
- Policy
- Dantrolene designated as emergency drug at KRW 95K
- by Kim, Jung-Ju Nov 28, 2019 09:39pm
- 20 mg injection of Dantrolen, used for malignant hyperthermia and neuroleptic malignant syndrome (NMS), was designated as an emergency treatment and its insurance reimbursed price would be maintained at around 95,000 won. According to pharmaceutical industry source on Nov. 26, Ministry of Health and Welfare (MOHW) is planning to update the lists of reimbursed drugs and their upper limit price with the said changes. When the update is finalized, the revised list would be in effect from December 1. When Korea Orphan & Essential Drug Center (KOEDC) requests for a deliberation on a drug, government refers to imported price and list the drug for insurance reimbursement with pricing set by Drug Reimbursement Evaluation Committee. Dantrolene secured approval on indication for treating malignant hyperthermia and NMS. Healthcare institute stocks the injection vial and use it for an emergency use only. KOEDC received import approval in May and has been supplying it ever since. But since then, the center designated 20 mg of Datrium IV as an emergency treatment and listed the item on Nov. 1. Before the listing removal, Dantrolene was given grace period until Nov. 30, and the market was going to end up with a lot of unused stock. The issue was reimbursed price. The upper limit prices of two items showed a huge price gap with 20-mg Dantrium IV at 137,628 won and 20-mg Dantrolene injection at 95,709 won. As the government predicted the switch in items would bring up the National Health Insurance expenditure by about 30 million won, it designated Dantrolene injection as emergency treatment and decided to maintain its reimbursed price. The maintained price before listing removal is 95,709 won per vial, which is also the current reimbursed price.
- Company
- GLP-1 diabetes, Trulicity runs at a high speed
- by An, Kyung-Jin Nov 28, 2019 10:45am
- Trulicity Once-weekly diabetes treatment, Trulicity, overwhelms the GLP-1 analog market. The company's annual sales are over ₩30 billion, exceeding ₩27 billion in nine months. The market grew to more than 98% with a single item, increasing the overall market size. According to the drug market research agency IQVIA on the 28th, Trulicity (Dulaglutide), Lyxumia(Lixisenatide), Victoza(Liraglutide) and Bayetta(Exenatide) Sales of four GLP-1 analogs, totaled ₩10.2 billon. That's a 35.8% increase over the same period last year. GLP-1 analogues are drugs developed using the GLP-1 (Glucago-Like Peptide-1) hormone, which is involved in blood glucose control in the body. GLP-1 hormone stimulates insulin secretion right after meals to lower blood sugar, and when blood sugar drops below a certain level, it reduces insulin secretion to help prevent hypoglycemia. Lilly's Trulicity, launched in 2016, dominates the market and leads the market expansion. Trulicity's revenue in the third quarter was ₩10 billion, up 38.4% YoY. Cumulative sales for the third quarter of this year amounted to ₩27.3billion. Trulicity is the only long-lasting drug administered once a week among GLP-1 analogues in Korea. Since its launch in 2016, Lilly Korea and Boryung Pharmaceuticals jointly sell. Quarterly GLP-1 Analogs Revenue and True Share Market Trend (Unit: ₩ million ,%, Source: IQVIA) Since its launch, Trulicity has established a monopoly in the GLP-1 analogue market, changing its sales record every quarter. Trulicity's sales, which totaled ₩1.4 billion in the first year, exceeded the ₩12 billion mark in the following year. In 2018, revenue was ₩2.2 billion , up 2.2 times from the previous year. This year, the company achieved its sales record set for last year in three quarters. Trulicity accounts for 98.4% of the total sales of the four GLP-1 analogs. It also contributed to the expansion of the GLP-1 analogue market. Quarterly sales of the three GLP-1 analogues, such as 'Victoza', 'Byetta' and 'Lyxumia', amounted to ₩3 billion , but the overall market expanded rapidly after launching Trulicity. It is 23 times larger than the ₩4.4 billion in the first quarter in 2016, just before the launch of Trulicity. Unlike conventional GLP-1 analogues, which had to be injected once or twice daily as a fast-acting mechanism, it was evaluated that the convenience of patients was improved by increasing the interval between injections once a week. In addition, GLP-1 analogues have been revised up in domestic and foreign diabetes care guidelines, and the baseline insulin and combination therapy received reimbursement recognition in late 2017. In contrast, GLP-1 analogs, administered once daily, continue to show negative sales. Sanofi's Lyxumia received a momentum of sales shortly after the launch of Trulicity. In the same period, Novo Nordisk's 'Victoza' and AstraZeneca's 'Byetta' sales were only ₩153 million and ₩35 million , respectively. This is in contrast to Saxenda, an obesity drug that uses only the same ingredients as Victoza, and recorded cumulative sales of ₩32 billion until the third quarter of this year. GLP-1 analogue 'ozempic (semaglutide)' by Novo Nordisk was approved by the US Food and Drug Administration (FDA) at the end of 2017 for the release. In last September, FDA approved Rybelsus which converts ozempil to oral use. but both products are still before permission in Korea.
- Company
- BMS-Celgene Korea promotes Kim Jinyoung as new CEO
- by Eo, Yun-Ho Nov 28, 2019 10:19am
- 김진영 대표 The decision has been made and it was a promotion from within. Kim Jinyoung (43), a former acting CEO, was appointed as the CEO of merged BMS-Celgene Korea. Kim used to serve as a Head of Legal and Compliance in BMS Korea, but was appointed as an acting CEO after former President Park Hye-sun (49) left the office. Kim had been active as the acting CEO up until recently. With the appointment of a new CEO in merged Korean office, the company is to initiate the integration process with Celgene soon. Including the headquarters, BMS and Celgene are in process of appointing new CEOs in respective regional offices. And those offices with new CEOs are also to immediately kick off the reorganization process. The new CEO at BMS-Celgene Korea, Kim Jinyoung majored in French literature at Ewha Womans University, and passed the New York State bar exam after studying at the Ohio State University Moritz College of Law. Beginning her pharmaceutical industry career as Legal Counsel at Pfizer Korea in 2009, Kim continued her path as Legal and Compliance Lead in Korea, Taiwan and Southeast Asia BMS from August, 2012 to May, 2019. As for BMS, the global pharmaceutical company has decided to acquire a U.S.-based biotechnology company Celgene for USD 74 billion (about 86.40 trillion won) in January this year.
- Company
- Ildong great likelihood to sell strongly 'Otrivin' by GSK
- by Jung, Hye-Jin Nov 28, 2019 06:14am
- Ildong pharmaceuticals has the most potential of otc vendor for 10 GSK items. It is possible that A distributor, Zuellig Pharma Korea will be charge of selling Lamisil. According to the industry on the 26th, GSK, Ildong Pharmaceuticals and Zuellig Pharma Korea are in the last negotiations over the right to sell 10 generic drugs. A retailer said, "Since last September, Ildong Pharmaceuticals is going to distribute GSK products. The industry has already begun. The preparations are almost finished". "Zuellig Pharma Korea has recently been added as a distributor and is in charge of selling Lamisil" he said. GSK and Ildong Pharmaceuticals said, "There is no confirmation yet". However, retailers and pharmacies believe that Ildong Pharmaceuticals was determined to be the main seller of 10 items. The 10 items to be negotiated are Lamisil, Otrivin, Voltaren, Nicotine-L, Theraflu, Sensodyne, Breathe right, Zantac, Polident, and Driclor. Among them, Lamisil is expected to be sold by Zuellig Pharma Korea and Ildong Pharmaceuticals to sell the remaining nine items. However, as negotiations are still underway, each company's products may change. In addition to Lamisil, it is likely that Zuellig Pharma Korea will be responsible for selling more products. An official at GSK said, "We can't formalize anything until the agreement is signed. Nothing has been decided yet." . An official of Ildong Pharmaceuticals said, "We cannot confirm when the contract is finalized. We will announce it after all contracts are concluded". Dong-wha Pharmaceuticals has distributed 10 GSK generic drugs. Originally, the copyright contract was until 2020, but the merger of GSK and Pfizer Healthcare prevented the company from maintaining its existing contract. Dong-wha Pharmaceuticals recently announced that it will end its generic drug supply contract with GSK on Dec 31. Dong-wha Pharmaceuticals is in the process of returning GSK products at pharmacies, and GSK is said to have almost stopped sending out 10 products to which the copyright is transferred. Next year, a new dealer will settle inventory with Dong-wha Pharmaceuticals before supplying the product.
- Company
- MA experts admit headquarters’ “Korea Passing” orders
- by Kim, Jin-Gu Nov 28, 2019 06:14am
- With one phenomenon, there are two interpretations. The government and pharmaceutical industry are showing polarizing views on the current situation and the cause of Korea Passing phenomenon. As if they are speaking in different languages, their prospective and proposed solutions are like parallel lines never crossing each other’s path. So what does pharmaceutical industry fear about in those two words of ‘Korea Passing’? Daily Pharm conducted a survey on 21 Market Access experts from respective affiliation to get a better look into what the industry is trying to convey. Korea Passing is not a myth, but a reality in global pharmaceutical companies First, the survey questionnaire asked if the experts have experienced Korea Passing either directly or indirectly. Except one response, 20 said they have experienced directly or have heard of it. For those have either experienced or heard of it, the survey questioned how many cases of Korea Passing they have come across with. Nine said one case, and other nine said two to three cases. Three answered five or more cases. The average was about 4.2 cases. Sorting by treatment type, chronic disease treatments faced Korea Passing the most with 12 cases (multiple responses allowed). Rare disease and anticancer treatments followed with ten and nine cases, respectively. Immune checkpoint inhibitor and infectious disease treatment each experienced once. So far, allergic asthma treatment Xolair, antidiabetic treatment Victoza, amyotrophic lateral sclerosis (ASL) treatment Radicut, and immunotherapy Obdivo have been mentioned the most when talking of Korea Passing. But the survey revealed more cases. It hinted that more Korea Passing phenomena are happening behind the scenes. "Headquarters ordered a withdrawal at pricing under certain point” The survey delved deeper into the phenomenon. Excluding indirect experience of the phenomenon from word of mouth, the questionnaire asked if they have received an order from global headquarters to drop application or negotiation with government body. 16 out of 21, or about 76 percent of the survey participants answered they have. 11 of them said there was one such case, and four said two or more cases. One did not answer. Apparently, the order was given for seven items before they applied for insurance reimbursement listing, eight during reimbursement feasibility evaluation, and four during drug pricing negotiation. On the details of the ‘order’ regarding Korea Passing, 13 answered the headquarters specifically mentioned the word “withdrawal” or “defer” during a meeting. One said their office was ordered to defer the Ministry of Food and Drug Safety (MFDS) approval application submission. Three items received an order to suspend reimbursement listing application submission, and other three got an order to postpone processing after applying for reimbursement listing Three answered they were given an order to pull out from negotiation when negotiating pricing went under certain price. Moreover, three said their headquarters ordered them to unilaterally withdraw from reimbursement listing. Not a specific order, but even six of the participants said they had to read between the headquarters’ message implying withdrawal or suspension during meetings. Taken at face value, there have been at least 16 cases where a global headquarters has given a direct order to either withdraw or suspend government processing. Multiple responses aside, the survey confirmed many of global headquarters are sensitive about pricing in Korea and also go as far as to directly give an order. All because of Korean government? Industry admits some of their contribution The participants suspected two major reasons were behind the Korea Passing phenomenon. 19 said drug pricing in different countries, and 16 said low reimbursed price in Korea, including multiple responses. Questionnaire asked once again to see if Korean government or pharmaceutical company played any part. None of them said pharmaceutical companies were either entirely or mostly responsible. However, six of them said it was entirely because of the Korean government. Majority of the participants, or ten of them said the Korean government is mostly responsible while pharmaceutical companies were also partially responsible. Five answered the companies and government were responsible 50/50. Majority of the participants, or 13 of them answered China played the biggest role in Korea Passing, as expected. Other regions like the Middle East, A7 countries and others were mentioned by ten, three and two participants, respectively. None of them said Australia. In fact, the industry has growing concern over the “China Risk” since last year. The Chinese government has been completely reforming its pharmaceutical insurance benefit policy for last two years. In the process, the government has decided to include Korea as one of their international reference pricing countries. Previously, the country has been referencing drug prices in Korea unofficially. But when China made it official was the tipping point for the global headquarters to make more drastic decisions. The point in time matches with right around when Korea Passing has become a social issue. Korean pharmaceutical industry is concerned of multinational drug maker headquarters making decisions to postpone or withdraw reimbursement listing application due to Chinese market. Besides China, the Middle East was also played a crucial role in Korea Passing. Among the Middle Eastern countries, Saudi Arabia is reportedly referencing Korean drug pricing. “The notion of Korea Passing is not that new. When Saudi government started referencing Korean pricing, the phenomenon occurred time to time. But it became as big of an issue, because the impact it bring is comparatively more detrimental than before”, an industry insider explained. “Especially after China officially added Korea as one of external reference pricing countries, the industry’s concern on Korea Passing has grown exponentially. Figures may not yet show the impact, but the influence has been substantial”, they added. All agree “Worried about future releases in Korea” All of the survey participants had a same answer for one part. They all agreed they currently have at least one item in risk of Korea Passing. Eight or the majority of them said there are two items. And it was followed by five answering one item, four saying three items, and one saying four, and three saying five to ten items. None of them said ten or more. Then what’s next for Korea Passing? Questioning about their views on the current administration capable of solving the issue, 14 of them answered negatively. Clearly, they are afraid of Korea Passing setting in over the time. But, six said the otherwise. Still some are positive the issue would get resolved, despite their serious concern about Korea Passing. They are hopeful the phenomenon is a temporary occurrence, and the Korean government and pharmaceutical industry would find a solution.
- Company
- Inflximab injection ‘Remsima SC’ good to go in EU
- by Lee, Seok-Jun Nov 27, 2019 11:06pm
- 사진은 램시마 정맥주사형. On Nov. 26, Celltrion announced its hypodermic injection Remsima SC got the green light from European authority. The injection was approved on indication of rheumatoid arthritis in 120 mg dose. Remsima SC is the first subcutaneous formulation of inflximab to have passed by the European regulator. Remsima SC would be available in 31 European countries for sales with the approval. Celltrion plans to extend its indication in the future for treating Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis. Celltrion Healthcare, in charge of overseas marketing and distribution of Celltrion product, would be introducing Remsima SC across European markets.
- Policy
- Gazyva applied Moon Care policy’s selective health benefits
- by Lee, Hye-Kyung Nov 27, 2019 11:06pm
- Roche's Gazyva(Obinutuzumab), a non-Hodgkin's lymphoma treatment, will be converted into a selective reimbursement benefit in accordance with Moon Jae-in Care's ‘Non-benefit’ policy. The implementation date is December 15. The Korea Health Insurance Review and Assessment Service announced that it would revise the details of the criteria and methods for applying medical care benefits to drugs prescribed and administered to cancer patients, and will hold an opinion inquiry by 28th. On the 26th, the amendment was made ▲ Gazyva(30/100) +Bendamustine(30/100) combination therapy (2nd or higher) and copayment for non-Hodgkin's lymphoma ▲Gazyva(30/100) Establishment of monotherapy (maintenance therapy) and self deduction rate ▲ Excludes the case where the primary site is the posterior intestine. Gazyva is approved as a monotherapy for maintenance therapy after coadministration with Bendamustine, or when does not respond to Rituximab monotherapy or combination therapy with Rituximab. On May 30 2018, the cancer disease review committee decided that the patient would pay the full amount of the drug within the scope of the permit for reasons such as lack of clinical efficacy and cost effectiveness, but the HIRA reviewed whether the benefits would be extended in accordance with the non-reimbursement benefit policy. After reviewing textbooks, guidelines, and clinical papers, no new additions have been made to the excluded countries' reimbursement standards, but in the additionally analyzed phase 3 study (GADOLIN 2018), the median progression-free survival (25.3 months vs. 14.0 months) compared to the control period until the next treatment (33.6 months vs. 18.0 months). However, there is a lack of evidence to determine the clinical efficacy of maintenance therapy, as further analysis does not provide a numerical value of the median overall survival of Gazyva’s maintenance therapy. In case of non-compliance, there was not enough alternative therapies, so they decided to pay 30% co-payment. Ipsen Korea's 120 mg of Somatuline autogel is approved for the treatment of non-resectable, highly differentiated or moderately differentiated local or metastatic gastric, intestinal and pancreatic neuroendocrine tumors. After reviewing textbooks, guidelines, and clinical papers on the elimination of primary site limitations, the NCCN guidelines recommends the drug as category 2A for gastrointestinal neuroendocrine tumors, and additional clinical studies on clearance studies (CLARINET). The progression-free survival for the posterior ulcer was reported to be 31.0 months in the lanleotide group and 24.4 months in the treatment conversion group. The Health Insurance Review and Assessment Service said, “The number of patients included in the study related to the licensed clinical literature and domestic research has a limitation that it is difficult to prove statistical significance. Given the limited need for medical care, we have decided to remove exclusions if the primary part is the posterior part of the current imbursement standards”.
- Company
- Handok has domestic copyright of Exelon & Trileptal
- by An, Kyung-Jin Nov 27, 2019 06:42am
- Exelon capsules Novartis Korea handed over copyrights of two neurology products including dementia medicine 'Exelon' to Handok pharmaceuticals. The intention is to organize copyrights for four medicines that were in charge of the department of neurology and concentrate sales marketing activities on the company's flagship products, including new products. According to the industry on Nov 26, Novartis Korea signed a domestic sales agreement for Alzheimer's dementia drug, 'Exelon' and anti-intermittent drug, 'Trepttal' with Handok pharmaceuticals. Handok will be in charge of sales activities next year, including the promotion of two products to medical staff and sales operational labor management. It is a condition that Novartis Korea continues to supply products while maintaining the license copyrights. The contract was made in accordance with the company's policy to clean up some of the drugs sold by the CNS department, including treatments for dementia, epilepsy and Parkinson's disease. The intention is to reduce the concentration of relatively unprofitable products and to focus sales marketing activities on the company's flagship products. It is said that the company will focus on promotion of SMA gene therapy drug named 'Zolgensma' and a follow-up product of Gilenia, 'ofatumumab' for relapsing multiple sclerosis. The CNS department in Novartis Korea's Specialty Pharmaceuticals Division, which was in charge of related products, was dissolved. Sales department employees in the department are in the process of transitioning to other departments. The anti-intervention drug 'Tegretol', except for two products signed by the copyright sale contract, will not be pushed forward. Novartis Korea has decided to continue supplying 'Tegretol' but will not deploy any promotion or sales marketing personnel. Parkinson's treatment drugs Stalevo and Comtan will continue to be available for the duration of the existing contract, as Novartis is not the original copyright holder, and will not renew the contract next year. An Novartis official said, “In the process of optimizing our product portfolio strategy, we decided to sell domestic sales marketing rights for some older products to Handok. It is the headquarters decision to increase the concentration of new drugs such as Zolgensma". "We're investigating departments wants to go for CNS staff and we're transitioning. Exelon and Trileptal have recorded prescription sales worth ₩10 billion as of last year. According to drug market researcher UBIST, In 2018, sales of outpatient prescriptions for `` Exelon '' and `` Trileptal '' are estimated at ₩1.7 billion and ₩8.2 billion, respectively. Both products received a six-month suspension from insurance payments for Aug 24 2017 ~ Feb 23 2018 due to illegal rebates for health care workers, which drastically reduced the size of prescriptions. In 2016, before the suspension of wages, the Exelon prescription dropped by 86.7% and 27.3%, respectively.
