- LOGIN
- MemberShip
- 2026-04-09 09:45:01
- Policy
- Monterizine generics prepare for release in Oct
- by Lee, Tak-Sun Sep 13, 2023 05:28am
- Hanmi Pharm’s asthma and rhinitis combination drug Companies are preparing to release their generic versions of Hanmi Pharm’s Monterizine (Montelukast+Levocetirizin) in October at the earliest. The generic drugs that were approved in August obtained first generic exclusivity and were able to move up their reimbursement listing date. According to the industry sources on the 8th, the price calculation process for Monterizine generics has been completed and it is expected to be listed with reimbursement next month. HIRA is known to have been conducting pricing calculations for Monterizine generics that applied for reimbursement after being approved in August. The generics, which received generic exclusivity, are expected to be released in October. Unlike general drugs that take 3 months to reimbursement listing, it only takes 2 months for drugs that are granted generic exclusivity to reimbursement listing. 10 Monterizine generics that were granted generic exclusivity by HIRA are owned by Genupharma, Huons, Daehwa Pharmaceutical, DongKoo Bio&Pharma, Binex, Boryung Pharmaceutical, Daewon Pharmaceutical, Daewoong Pharmaceutical, Medica Korea, and Jeil Pharmaceutical. The difference between the generics and the original Monterizine Capsule is that the to-be-released generics are tablet formulations. The pharmaceutical companies succeeded in avoiding Monterizine’s formulation patents with that difference. The MFDS therefore granted them exclusive rights so other companies may not sell the same drug until May 2024. Monterizine is Hanmi’s incrementally modified drug that it received approval in May 2017. It is the world’s first combination of montelukast, which blocks the action of leukotriene that causes tightening of airway muscles, breathing difficulties, and runny nose, and levocetirizin hydrochloride, an antihistamine used to treat allergic rhinitis. Hanmi demonstrated its combination’s superior efficacy compared to a single agent in a Phase III trial targeting domestic patients. Monterizine exceeded the blockbuster drug threshold of KRW 10 billion for the first time last year. Based on UBIST, the amount of its outpatient prescriptions was KRW 11.5 billion last year, up 24% points from the KRW 9.3 billion it had posted in the previous year. Supported by its marketability, the generic companies are expected to make efforts to market their drugs early into their release. An official from a related company said, "Because it is effective in relieving allergic rhinitis symptoms in patients with asthma and perennial allergic rhinitis, we expect to achieve high performance if we focus on marketing our product to HCPs in Korea." The current insurance ceiling price of Monterizine Cap is KRW 886/capsule. Hanmi also owns a chewable tablet formulation of the same drug at the same price.
- Opinion
- [Reporter’s View] MFDS makes changes ahead PIC/S reeval
- by Lee, Hye-Kyung Sep 13, 2023 05:28am
- The Ministry of Food and Drug Safety will be amending the ‘Regulations for Good Manufacturing Practices for Medicinal Products’ as preannounced ahead of PIC/S re-evaluations. The main point of the amendment is to amend the GMP for sterile medicinal products to align with those of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S). This includes the establishment of a contamination control strategy through quality risk management and the establishment of management standards for the latest aseptic manufacturing equipment and technology. The main purpose of the amendment is for the MFDS to prepare for the PIC/S reevaluations that will be held next year. This is because member countries are obligated to implement the PIC/S’s GMP regulations to maintain their member status. PIC/S is the only organization worldwide that promotes the international harmonization of GMP and inspection procedures. Since its establishment in 1995, 56 regulatory agencies from 53 countries, including the US FDA, the UK, France, Germany, and Japan, have joined as members. Korea became the 42nd country to join in 2014 but will be subject to reevaluation of its PIC/S member state requirements starting in H2 of this year. As part of the reevaluation process, the PIC/S will visit Korea in H1 next year. In order to receive a good evaluation, the latest revisions to PIC/S GMP regulations must be reflected in Korea’s regulations as well. This is why the MFDS prepared ‘Regulations for Good Manufacturing Practices for Medicinal Products (Plan) that reflect the latest PIC/S GMP regulations that include improvements to the GMP for sterile medicinal products. PIC/S member countries can receive benefits such as the waiver of some procedures including on-site GMP inspections when exporting pharmaceutical products to other member countries. Therefore, the membership status can strengthen the competitiveness of domestic pharmaceutical companies seeking to export products to other countries. Therefore, the MFDS has been preparing to amend the regulations since 2021 ahead of the PIC/S reevaluations. The Ministry of Food and Drug Safety expects that there will be no difficulties in implementing the amended regulations, as it has set a sufficient grace period for its enforcement in consideration of industry opinion on their need for ample time to prepare for regulatory implementation. However, there are bound to be difficulties following the introduction of new systems, due to the addition of new personnel or new facilities such as lyophilizers and sterilization equipment. At the information session MFDS will be holding for managers of domestic sterile medicinal product manufacturing plants from the 19th to the 20th, the reporter hopes that the authorities will hold an ear out to the voices in the industry and make efforts to reflect the opinions into the system.
- Policy
- BT public-private council will soon resume operations
- by Lee, Jeong-Hwan Sep 13, 2023 05:28am
- The Ministry of Health and Welfare is expected to soon resume the operation of the 'BT (breakthrough therapy) Public-Private Council', a pharmaceutical industry discussion body necessary for establishing and implementing BT price preference policies. The Ministry of Health and Welfare is expected to establish standards for preferential drug prices based on the results of discussions at the BT public-private consultative body held from February to April, and then finalize them after gathering opinions from the pharmaceutical industry at the public-private consultative body, which is scheduled to resume as early as this month. In the case of the public-private consultative body to reform the generic drug price system, there has been no concrete movement yet, and as the Ministry of Health and Welfare has begun research on the form of private contracts, the atmosphere is waiting until the research is completed and the analysis of the results is completed. According to the pharmaceutical industry on the 11th, the Ministry of Health and Welfare recently met with three pharmaceutical organizations along with NHIS and HIRA and held a public-private consultative body to discuss pending issues of reforming the drug price system. At this meeting, the Ministry of Health and Welfare reportedly announced plans to resume the public-private consultative body in the near future and confirm the BT preferential treatment standards in response to inquiries from the three pharmaceutical organizations regarding the BT preferential drug price policy. It has been reported that the Ministry of Health and Welfare's position is to partially accept the demands of the three pharmaceutical groups not to announce preferential policies without prior discussion or to immediately submit them to the Health Insurance Policy Deliberation Committee agenda. Pharmaceutical industry officials are observing that the Ministry of Health and Welfare has already reached the stage of completing the internal establishment of BT preferential standards and measures. It is explained that the Innovative New Drug Public-Private Consultative Body, which will be launched in September at the earliest or early October at the latest, will decide on what criteria and how to give preferential treatment to the prices of drugs made by innovative pharmaceutical companies. The Ministry of Health and Welfare and NHIS have announced plans to announce BT preferential measures within September at a National Assembly debate and press conference. The public-private consultative body that will discuss the generic drug price system, including comprehensive generic drug price cuts, is showing no significant movement. Previously, in July, the Ministry of Health and Welfare signed a private contract with Professor Kim Dong-sook of Kongju University's research team for a research project to 'prepare a plan to improve the generic drug price system', so the pharmaceutical industry predicts that the implementation of the system related to generic drug price reduction will be delayed until the study is completed and the results are analyzed. This is the consensus of experts. Last April, under the direction of Second Vice Minister Park Min-soo, the Generic Drug Price System TFT was formed and the reform of the drug price system was initiated. Compared to the time when the pharmaceutical industry expressed concern that the government might immediately move to reduce generic drug prices in batches, some portion of the system has not been implemented. It has been delayed. An official in the domestic pharmaceutical industry explained, “We requested the Ministry of Health and Welfare to publicly announce the drug price preferential treatment plan after going through the BT public-private consultative body and go through a sound review process, and they responded that they would accept it.” He explained, “Research on the generic drug price system reform plan, including generic drug price cuts, is scheduled to be studied until this year, and discussions are expected to begin only after next year.” This official said, “Fear or backlash over the wholesale price cut for generics has been delayed until the end of the study, but just reevaluating the comparison of overseas drug prices right now is a significant burden on pharmaceutical companies.” He added, “I hope that the Ministry of Health and Welfare will create the system together rather than unilaterally establish the system and then go through a formal opinion-gathering process.”
- Opinion
- [Reporter's view] What is the solution
- by Eo, Yun-Ho Sep 13, 2023 05:28am
- A drug is so effective that it is difficult to discuss listing it for insurance benefits. Although it has proven a very large improvement in survival rate compared to existing drugs, this actually increases uncertainty in health insurance, making it difficult to estimate cost-effectiveness. Since no patients die in clinical trials, costs increase. The important point is effect estimation. OS can only be counted when the patient dies, but since no one dies, calculating OS becomes difficult. Paradoxically, if the effect of the drug is too good, the cost will definitely increase, but the problem of not knowing how much the effect will increase arises. However, the clinical results are excellent. Drugs that are truly the best of all time are emerging right now. So what is the solution to these drugs? Currently, the government is requesting a financial sharing plan, but this is not a regular regulation. I think it is time to consider establishing a fundamental evaluation system for the value of social requirements themselves. Decisions related to healthcare are a process of compromise between many complex and conflicting factors. Multiple-criteria decision analysis (MCDA) is a type of decision analysis designed to transparently integrate multiple considerations in decision-making situations where multiple criteria act simultaneously. Using such a structured and explicit approach can improve the quality of decision-making, and its application in the medical field has recently been increasing. There is an increasing discussion on the introduction of MCDA as a decision-making support tool related to pharmaceutical reimbursement in countries other than these countries. In Spain, MCDA is referred to as a method of systematic evaluation procedure that helps consistent decision-making and ensures equity in access to medicines when evaluating early access to medicines and indications before approval and reimbursement. MCDA faced opposition domestically. However, on the other hand, it is already being used domestically. In accordance with the National Health Insurance Comprehensive Plan, the Ministry of Health and Welfare is conducting a reevaluation of drug coverage adequacy every year, starting with Choline alfoscerate, a brain function improvement drug, in 2020. At this time, clinical usefulness, cost-effectiveness, and social needs are used as criteria to evaluate the adequacy of benefits. Comprehensive evaluations such as MCDA may have interpretation difficulties depending on the weights and methodology, but the reality is that the current new drug registration method relies too much on cost-effectiveness and does not reflect the characteristics of each drug. Now is the time to take action.
- Policy
- Will Enhertu pass PE evaluations for reimb in KOR?
- by Lee, Tak-Sun Sep 13, 2023 05:28am
- Due to delays in the review of the economic feasibility of the anticancer drug Enhertu (trastuzumab deruxtecan), the industry is seeing delays in its reimbursement agenda being submitted for deliberation to the Drug Reimbursement Evaluation Committee. The agenda had previously passed the Cancer Disease Deliberation Committee review after redeliberation in May. The company expects to receive positive results at the Pharmacoeconomic Evaluation Subcommittee meeting in October. According to industry sources on the 12th, Daiichi Sankyo recently submitted supplementary pharmacoeconomic evaluation data to HIRA for its Enhertu and expects to pass HIRA deliberations in October. Enhertu passed the CDDC review after redeliberations in May. The committee determined Entertu reimbursable for the treatment of ▲unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens (third-line or higher treatment), and ▲locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received two or more prior therapies including an anti-HER2-based regimen (third-line or higher treatment) As a result, the agenda was supposed to be submitted for deliberation by the Drug Reimbursement Evaluation Committee. However, it seems that the company and the government are having difficulty reaching a consensus in the pharmacoeconomic evaluation process. Daiichi Sankyo submitted the PE evaluation data in July, but was unable to reach an agreement with HIRA. The industry analysis is that Enhertu's superior effect is hindering economic evaluations. Currently, the Pharmacoeconomic Evaluation Subcommittee is evaluating the cost-effectiveness of Enhertu compared to Kadcyla. However, as Enhertu demonstrated an extension in progression-free survival (mPFS) by more than 22 months compared to existing drugs, and the increase in the administration period that followed, there have been limitations in proving the cost-effectiveness of the drug using the current economic evaluation method. Even so, Daiichi Sankyo has accepted most of the deliberation results from the last Pharmacoeconomic Evaluation Subcommittee’s deliberation in order to quickly receive reimbursement. The company had requested redeliberation on some aspects that are difficult to accept. Daiichi Sankyo recently submitted the supplementary materials and is expecting positive results at the Pharmacoeconomic Evaluation Subcommittee meeting that will be held in October. In the paper, ‘Analysis of Socioeconomic Indirect Cost of Premature Death in Patients with HER2-positive Metastatic Breast Cancer (MBC) using Nationwide Claims Data’ that was recently published on Yakhak Hoeji on August 31, research teams of Sungkyunkwan University’s School of Pharmacy and Samsung Medical Center showed that socioeconomic benefits were greater with the administration of Enhertu. The research teams identified the claims data of 2,212 patients with HER2-positive MBC who were prescribed trastuzumab-emtansine as a second-or-higher-line of treatment from January 2007 to May 2021 using nationwide insurance claims data to estimate the progression-free survival (mPFS) and the resulting socioeconomic benefits. As a result, the mPFS of trastuzumab-emtansine ranged from 7.1 months (age 65 or older) to 12.5 months (age 30s), and the mPFS of trastuzumab-deruxtecan (Enhertu) was more than three times longer for all ages, ranging from 23.4 months (age 65 or older) to a maximum of 41.1 months (age 30). Accordingly, the socioeconomic benefits brought about by the extended PFS with the use of trastuzumab-deruxtecan (Enhertu) compared to existing drugs were estimated to amount to KRW 261.4 billion, which is averages to KRW 118 million per patient. An official from Daiichi Sankyo Korea said, "We hope that the authorities will review Enhertu’s reimbursement more flexibly, in consideration of the various aspects such as social losses of breast cancer and the extension of patients' lives that can be expected through Enhertu treatment under the framework of Korea’s current pharmacoeconomic evaluation system.
- Company
- Obesity is a chronic disease
- by Kim, Jin-Gu Sep 12, 2023 05:37am
- “Currently, only obesity metabolic surgery is covered. The scope needs to be expanded to include obesity treatments, etc.” “Obesity is a chronic disease like high blood pressure and diabetes. We need to apply health insurance benefits from a treatment perspective, not from a beauty perspective.” Gyeong-gon Kim, Vice President of the Korean Obesity Society (Department of Family Medicine, Gachon University College of Medicine) Kim Gyeong-gon, vice president of the Korean Society of Obesity (Department of Family Medicine, Gachon University School of Medicine), made this claim at the policy symposium of the Korean Society of Obesity academic conference held at the Conrad Hotel in Seoul on the 7th. Vice Chairman Kim said that the number of obese patients in Korea has been increasing at a very rapid rate recently. Vice Chairman Kim said, "Severe obesity, especially among young people, is increasing rapidly. Just 10 years ago, severe obesity with a body mass index (BMI) of 30 or more was less than 3%, but recently, especially among men in their 20s and 30s, it accounts for 3% of the total." “More than 10% of people are severely obese,” he warned. Vice Chairman Kim emphasized that obesity should be recognized as a chronic disease like high blood pressure or diabetes. For example, in the case of high blood pressure, a systolic blood pressure of 150 mmHg does not immediately cause serious problems, but because we know that it can cause various problems, such as cardiovascular disease, in the future, we are prescribing various medications through health insurance coverage, he explains. Obesity does not cause any symptoms right away, but it causes a variety of conditions such as high blood pressure, diabetes, cardiovascular disease, stroke, osteoarthritis, and obstructive sleep apnea, so it is argued that it should be managed in advance through compensation. Vice Chairman Kim said, “In Korea, there are quite a few patients with stage 2 and 3 obesity with serious complications,” and added, “They must be provided with appropriate treatment.” Vice Chairman Kim said, "Fortunately, we have recently secured many diverse and effective tools for obesity treatment, such as obesity metabolic surgery and next-generation obesity treatment drugs," and added, "Patient treatment, examination, education, and drug treatment are still non-reimbursed." “Policies are needed to improve access to effective treatments for weight loss and improving complications,” he emphasized. Vice Chairman Kim added, "A change in perception is necessary. Obesity should not be viewed only from the perspective of beauty. Obesity must be recognized as a major chronic disease."
- Company
- Celltrion’s Remsima celebrates 10th year of export
- by Chon, Seung-Hyun Sep 12, 2023 05:37am
- Celltrion’s first biosimilar, ‘Remsima’, has marked its 10th anniversary in entering the overseas market. Together with its subcutaneous injection formulation Remsima SC, Remsima successfully settled in the European market and recorded total exports that exceeded KRW 6 trillion over the past 10 years. Celltrion Healthcare announced on the 11th that it will launch various campaigns throughout the world to celebrate the 10th anniversary of Remsima's approval in Europe. Celltrion Healthcare is Celltrion's affilate that receives antibody biosimilar products from Celltrion and sells them to global distributors. Celltrion Healthcare plans to hold global lecture tours and symposiums around the globe from year to the second half of next year, starting with the United European Gastroenterology Week. During the campaign, the company will reexamine Remsima's achievements over the past 10 years and identify how the biosimilar industry, which was born with Remsima's success, has been impacting the field. Celltrion received marketing authorization for Remsima in Europe in August 2013 and received the title, ‘the world’s first antibody biosimilar.’ Remsima is a biosimilar of Remicade. Annual exports of Remsima and Remsima SC (Unit: KRW 1 million, Data: FSS) According to Celltrion Healthcare, Remsima's export volume has gradually increased since it generated exports of KRW 145.3 billion in 2013. Remsima recorded exports of KRW 402.3 billion in 2014, then exceeded KRW 700 billion in 2016. The growth of Remsima's exports slowed somewhat thereafter, recording exports of KRW 506.9 billion and KRW 401.4 billion in 2017 and 2018, respectively. However, its exports rebounded and exceeded KRW 500 billion for the first time in 2 years in 2019, then continued to grow to exceed KRW 800 billion in 2021 and last year, setting a new record for two consecutive years. By the first half of this year, Remsima recorded exports of KRW 477.3 billion. Remsima's cumulative exports over the past 10 years amounted to KRW 5.6314 trillion. Remsima SC has also started to produce export results in 2020. Celltrion received approval for Remsima SC, a subcutaneous injection formulation of Remicade, in Europe in November 2019 and began targeting the market in earnest. Remsima SC first generated exports of KRW 34.8 billion in 2020, and then posted KRW 236.9 billion last year, exceeding KRW 1 trillion in exports together with Remsima. Remsima SC recorded exports of KRW 146.6 billion in the first half of this year, exceeding KRW 500 billion in cumulative exports. The cumulative exports of Remsima and Remsima SC together over the past 10 years were calculated to be KRW 6.1394 trillion. Remsima is recording the highest sales performance among finished products sold overseas by domestic pharmaceutical companies. Celltrion Healthcare explained, “Remsima has steadily maintained its top spot in infliximab prescriptions since surpassing the market share of its original in 2017.” According to the market research institute IQVIA, Remsima recorded a market share of 56% in Europe, including 83% in the UK and 61% in France, in Q1 this year. An official from Celltrion Healthcare said, “Remsima was able to succeed and maintain its lead in the market for a long time by preoccupying the market after implementing a customized strategy for each country based on proven data on treatment efficacy and safety in the highly competitive biosimilar industry.”
- Company
- Entresto’s 2nd patent suit ruling postponed to November
- by Kim, Jin-Gu Sep 12, 2023 05:37am
- The rulings for the 2nd trial surrounding the chronic heart failure treatment ‘Entresto (sacubitril/valsartan)’ have been postponed to November 9. The drug has been posting annual prescriptions of more than KRW 40 billion annually. According to industry sources on the 11th, the Patent Court of Korea 1st Division recently postponed the decision date for the 2nd trial on Entresto’s crystalline patent to November 9. With the argument now concluded, the court originally planned to pronounce judgment on the 14th of this month but decided to postpone the decision for two more months. The exact reason why the judgment was postponed remains unknown. As a result, the outline of the second trial of the Entresto patent dispute is expected to come out after the end of this year. Three Entresto patent disputes are currently being tried at the Patent Court. In addition to the crystalline patent (10-1432821), whose judgment has been postponed, disputes over the composition/use patent (10-0984939) and the salt/hydrate patent (10-1549318) have not yet been resolved. The ruling surrounding the crystalline patent is expected to come first, followed by the other 2 rulings. Entresto is protected by 6 patents: ▲salt and hydrate patent that expires in November 2026, ▲use patent that expires in July 2027, ▲crystalline patent set to expire in September 2027, ▲composition patent set to expire in November 2028 (10-1700062), ▲another composition patent set to expire in January 2029 (10-1589317), and ▲a use patent set to expire in 2033 (10-2159601). Among the 6 patents, generic companies have succeeded in nullifying or avoiding 2 patents. The results of the two were finalized after the generic companies won the first trial and Novartis did not file an appeal. In the case of the use patent that expires in 2033, the patent was listed after generic companies applied for marketing authorization of their generics. The generic companies have also succeeded in winning against Novartis in the first trial for the other 3 patents as well. However, Novartis chose to appeal and proceed to the Patent Court of Korea for all 3 cases. The generic companies that challenged the 3 patents plan to succeed in overcoming the remaining patents and qualify for early release. Entresto's PMS already expired in April, so the companies may release their generic versions early as long as they overcome the remaining patents. However, if generic companies lose or win the second trial but Novartis appeals to the Supreme Court, the release of their generic will be further delayed. There is the possibility that the Entresto patent dispute will be prolonged for more than four years. Since 2021, generic companies have been filing trials against Entresto's patents. Starting with Elyson Pharm, about 10 companies including Hanmi Pharm, Chong Kun Dang, and Daewoong Pharmaceutical jumped into the dispute. According to the market research institute UBIST, Entresto's outpatient prescriptions amounted to KRW 42.5 billion last year. Entresto has shown rapid growth in the market, increasing prescription sales by nearly KRW 10 billion every year. Its prescription performance, which recorded KRW 5.5 billion in 2018, increased to KRW 14.3 billion in 2019, KRW 22.4 billion in 2020, then to KRW 32.4 billion in 2021. By the first half of this year, its cumulative sales reached KRW 27.2 billion, heralding annual sales of KRW 50 billion this year. The sales have surged after its indication was extended from heart failure with reduced ejection fraction (HFrEF) to heart failure with preserved ejection fraction (HFpEF) Entresto is a first-in-class angiotensin receptor-neprilysin inhibitor (ARNI) that combines the angiotensin receptor blocker (ARB) valsartan and neprilysin inhibitor sacubitril. The drug may be used as an alternative to an angiotensin receptor blocker (ARB) or an angiotensin-converting enzyme (ACE) inhibitor in patients with left ventricular (LV) dysfunction in combination with other heart failure treatments.
- Policy
- Forxiga's generics, advertised for off-label indications
- by Lee, Hye-Kyung Sep 12, 2023 05:37am
- Forxiga's generic development companies that promoted 'chronic heart failure, chronic kidney disease' in their drug advertisements were subject to administrative sanctions. On August 18th and 22nd, the Ministry of Food and Drug Safety suspended Boryung and Aju Pharmaceuticals from advertising for products containing Dapagliflozin for three months, respectively. The objects of disposal are three items, including Boryung's Trudapa 10 mg (Dapagliflozin Bis L-proline), Trudapa M SR 10/500 mg (Dapagliflozin, Metformin), and Trudapa M SR 10/1000 mg (Dapagliflozin, metformin). and Aju Pharmaceutical's Daparil 5 mg (Dapagliflozin Propanediol Hydrate), Daparil 10 mg (Dapagliflozin Propanediol Hydrate), Daparil Duo SR 10/500 mg, Daparil Duo SR 10/1000 mg, etc. There are 4 items. They were subject to administrative action after it was discovered that they used pamphlets targeting doctors and advertised content other than the approved efficacy and effects. The original, AstraZeneca Korea's Forxiga, has three indications, including type 2 diabetes, chronic heart failure, and chronic kidney disease, but the generic developed by domestic pharmaceutical companies only has type 2 diabetes as an indication. In this situation, Forxiga's generic companies became subject to administrative action by producing and distributing promotional materials containing claims that the drug was effective against chronic heart failure and chronic kidney disease, which are unauthorized indications. The only companies to which the Ministry of Food and Drug Safety has issued administrative measures are Boryung and Aju Pharmaceuticals, but as the number of domestically approved products for Dapagliflozin reaches 222, the likelihood that other pharmaceutical companies will also be subject to administrative measures if they advertise for indications other than those approved has increased. The efficacy or performance of pharmaceuticals cannot be advertised unless permission or modification is granted in accordance with Article 68 of the Pharmaceutical Affairs Act. In the case of a first violation according to the standards for administrative disposition in Table 8 of the Rules on the Safety of Medicines, etc., the advertising business for the product concerned will be suspended for 3 months. As it became known that generic drug developers were promoting non-approved indications, AstraZeneca Korea sent a certificate of contents to the companies in question, leading to an inspection by the Ministry of Food and Drug Safety. Meanwhile, after Forxiga's substance patent expired last April, a total of 90 pharmaceutical companies entered the market with 105 single-drug products and 64 combination products approved. According to UBIST, a pharmaceutical market research firm, the outpatient prescription performance of Dapagliflozin single and combination drugs in May was 11 billion won. The sales of the original Forxiga were 4.7 billion won, and those of Xigduo were 4.1 billion won, accounting for about 80%. The remaining 2.2 billion won was accounted for by generics Forxiga and Xigduo. As of May, 60 pharmaceutical companies recorded a total of 1.436 billion won in prescriptions for single drugs, and 31 pharmaceutical companies recorded a total of 772 million won in prescriptions for combination drugs.
- Company
- Dinutuximab beta was designated as an orphan drug
- by Eo, Yun-Ho Sep 12, 2023 05:37am
- Dinutuximab beta, an immunotherapy drug administered to neuroblastoma patients, has been designated as an orphan drug. Dinutuximab is a drug from EUSA Pharma, a domestic corporation launched last year, and is currently undergoing formal approval procedures. EUSA Pharma was absorbed and merged into Recordati in 2021. This drug is a chimeric antibody that targets a specific antigen called 'GD2' expressed on neuroblastoma cells. Dinutuximab beta is indicated for patients who previously received myelosuppression and hematopoietic stem cell transplantation and showed a partial response after receiving induction chemotherapy, and for patients with a history of relapsed or refractory neuroblastoma regardless of residual disease. United Therapeutics' Unituxin, which has a similar mechanism, was approved by the FDA in 2015, but production is insufficient. Accordingly, it remains to be seen whether the domestic supply of Dinutuximab beta, a major treatment option for high-risk neuroblastoma patients, can be smoothly achieved. Neuroblastoma refers to a tumor that appears in the adrenal medulla and sympathetic ganglia. Most occur in the abdominal cavity, but about half originate in the adrenal medulla. The rest are known to appear in the sympathetic ganglia around the spinal cord and also in the skeleton surrounding the neck, pelvis, and chest where the sympathetic nerves pass. It usually occurs in children under 5 years of age, and symptoms vary. It is often felt in the form of a lump in the stomach and can cause coughing or difficulty breathing. If the tumor spreads to the cerebellum, symptoms such as rapid movement of the eyes, arms, and legs may appear, and if the tumor spreads to the pelvis, symptoms such as frequent need to urinate or difficulty urinating may appear.
