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- 2025-12-23 05:26:10
- Policy
- Chong Kun Dang applied for combination of Januvia+Forxiga
- by Lee, Tak-Sun Jan 10, 2022 11:40am
- Chungjeong-ro Headquarters of Chong Kun DangA combination of diabetes treatments Januvia (Sitagliptin) and Forxiga (Dapagliflozin) is gaining popularity among domestic pharmaceutical companies. Although it can only be released after September next year due to patent rights issues, many domestic pharmaceutical companies are developing products. According to the pharmaceutical industry on the 6th, Chong Kun Dang recently applied for permission from the MFDS for a combination of Sitagliptin+Dapagliflozin. Combination of Sitagliptin+Dapagliflozin succeeded in commercialization for the first time in Korea on the 21st of last month when Dapacombi of Daewon Pharmaceutical obtained permission. Two days later, Dongkoo Bio's Sitaflozin, the same ingredient as Dapacombi, was approved. On the 4th, 22 items from other pharmaceutical companies entrusted by Dongkoo Bio were approved and the number of related items increased to 24. Pharmaceutical companies that started developing products for the purpose of product approval include Alvogen Korea, GL Pharm Tech, SK Chemical, and Theagen Etex. Alvogen was approved by the MFDS in October 2020, GL Pharm Tech in March last year, SK Chemical in September last year, and Theagen Etex in December last year. Chong Kun Dang seems to have applied for permission by completing the development ahead of them. However, even if commercialization is successful, it is expected to be after September 2023, when Januvia's material patent ends. The reason why many domestic companies are developing products is that commercial expectations are high. This is because the two components are the flagship items of SGLT-2 and DPP-4 inhibitors, which are currently leading the diabetes treatment market, and the proportion of prescriptions using both drugs in combination at the treatment site is high. Based on UBIST, Januvia's outpatient prescription amount in the first half of last year was 21.2 billion won, and Forxiga's outpatient prescription amount was 18.3 billion won, ranking at the top of the market. Combination of Januvia+Forxiga is the first product introduced by a domestic pharmaceutical company without an overseas original product, so expectations are high for market creation by domestic pharmaceutical company sales. However, more than 20 pharmaceutical companies have already been approved, so it is difficult for any one company to be exclusive, which is considered a limitation in generating profits. There are no overseas products with the same ingredients, but there are three overseas original products of the same category (DPP-4+SGLT-2) combination, so if they are reimbursed, there will be little market preoccupation effect. In the industry, it is highly observed that top companies with large-scale customers such as Chong Kun Dang will eventually take the lead over other companies in terms of market share.
- Policy
- Will companies be able to apply for EUA for COVID-19 tx?
- by Lee, Tak-Sun Jan 10, 2022 05:55am
- PfizerThe development of COVID-19 treatments is actively progressing at home and abroad. Pfizer's oral treatment Paxlovid received EUA from the MFDS in December last year and is expected to be used in Korea soon. Currently, pharmaceutical companies that develop COVID-19 treatments are in a position to introduce them quickly in Korea through EUA like Paxlovid. By the way, is EUA possible only with the will of pharmaceutical companies? Companies can apply for the EUA. However, the MFDS must first announce the scope of medical products subject to emergency. The EUA is a system introduced under the "Special Act for Promotion of Development and Emergency Supply of Medical Products Responding to Public Health Crisis" enacted in March last year. The EUA refers to the urgent introduction of drugs that have not been approved for domestic items. Even before this law, it was possible to introduce unlicensed imported items in Korea through special import system. In February last year, it was decided to introduce the Pfizer COVID-19 vaccine through special import. However, special import was only possible if the head of related organizations, such as the head of the KDCA, requested special cases. In other words, as a special import procedure, the developer could not request approval for the item. The newly established EUA system can introduce drugs not only at the request of the heads of related agencies, but also when the MFDS deems it necessary to adequately cope with public health crises. At this time, the MFDS must announce ▲ the scope of medical products subject to EUA, and ▲other matters determined by the Minister of Food and Drug Safety as necessary, such as EUA requirements and approval period, etc. Based on this announcement, pharmaceutical companies can apply for the EUA. The application documents include data that can prove the safety and effectiveness of medical products. Evidence such as▲ Clinical trial results of medical products studied until the date of announcement, ▲ current status of domestic and foreign permits, etc., ▲reason for applying for the EUA, ▲ the instructions for the medical product, ▲ Quality inspection results of overseas manufacturing plants, etc. should be submitted. The MFDS is in a position that at least a clinical second-phase report that can prove its validity should be secured. Under this EUA system, pharmaceutical companies that develop COVID-19 treatments have completed phase 2 clinical trials and quickly introduced products into Korea. However, It does not mean that the EUA system can be used according to the will of pharmaceutical companies. Only when the MFDS announces it first can it be applied to pharmaceutical companies. In the current COVID-19 situation, it is not easy for the MFDS to announce alone because the state oversees the purchase of vaccines and treatments. Therefore, like the existing special import system, it is highly likely that the MFDS will review EUA products by applying for KDCA. Pfizer's Paxlovid is also a case in which the EUA was decided by KDCA application. An official from the MFDS explained, "If EUA is needed, corporate applications can be received, but since COVID-19 tx and vaccines are purchased and managed under state control, it will be difficult to do EUA without KDCA applications." The recent plan that pharmaceutical companies that develop COVID-19 treatments will apply for EUA to the MFDS cannot be considered feasible. This is because the state must purchase the treatment.
- Policy
- Remdesivir has been officially granted over the age of 12
- by Lee, Tak-Sun Jan 10, 2022 05:55am
- The MFDS has approved the change to use Remdesivir, which was first approved as a treatment for COVID-19, only for those aged 12 or older. However, the EUA was decided for this age group to prevent gaps in pediatric treatment under the age of 12. This is the same as when the U.S. FDA officially approved Remdesivir in October 2020. The MFDS announced on the 7th that it has allowed administration range of Veklury, a treatment for COVID-19, to be changed to "inpatients with severe or pneumonia who are adults and 12 years old and need adjuvant oxygen treatment for children over 40kg." In July 2020, Veklury was conditionally approved to use the results of phase 3 clinical trials on the market for "severe inpatients who need 3.5kg or more of auxiliary oxygen treatment confirmed with COVID-19." As Gilead submitted the results of the global phase 3 clinical trial to implement the permit conditions this time, the results report was reviewed and the scope of administration was allowed to be changed. The MFDS decided to use Veklury for "inpatients with severe or pneumonia who need adjuvant oxygen treatment under the age of 12 or under 40kg (3.5kg or more) considering that there is no COVID-19 treatment available in Korea. Pfizer's oral treatment Paxlovid, which will be introduced soon, is also used only for those aged 12 or older. This measure reflects a comprehensive review of domestic and foreign cases for children and overseas approval cases such as the United States and Japan. When officially approved in October 2020, the United States took the same measures as in Korea, fearing a gap in pediatric treatment. In Japan, it has been used for children since approval. The EUA is a system that allows manufacturers and importers to manufacture and import medicines that have not been licensed in Korea or to supply them with different uses and capacities than those that have already been licensed.
- Policy
- PAGs request expedited new drug listing system to candidates
- by Kim, Jung-Ju Jan 10, 2022 05:55am
- With the presidential election two months ahead, patient groups have asked the presidential candidates to introduce an expedited listing system in the National Health Insurance for new drugs directly related to life. On the 7th, the Korea Alliance of Patients' Organizations had set out to propose and deliver ‘4 key patient policies’ for patients in the healthcare industry to the presidential candidates of each party. The 4 key patient policies that were delivered to the candidates were: ▲ Introduction of an expedited NHI listing system for new drugs that are directly related to life ▲Establishment of an integrated patient support platform ▲ Severe disease and patient-focused innovation to the integrated nursing care system ▲Enactment of a basic law for patients Among these, the introduction of an expedited NHI listing system on new drugs that are directly related to life is an agenda being frequently discussed with the advent of 'one-shot treatments’ that can cure a disease with a single dose, on to what extent society may cover such ultra-expensive new drugs. The new drug paradigm has shifted from the era of chemotherapy that had large side effects but less effect to the era of targeted therapies/immunotherapies/ and CAR-T therapies that are groundbreaking in terms of effectiveness and side effects. In line with such a trend, enhancing coverage of the ‘one-shot treatments’ has emerged as a key agenda. KAPO pointed to “the fact that the new drugs are extremely expensive and that it takes over a year for drugs that are directly related to life to be reimbursed after gaining approval due to the ‘pricing tug-of-war’ between the government and pharmaceutical companies” as a key issue, and reminded that these delays are life-threatening issue to those affected. Economically wealthy patients or patients with private insurance can purchase these new drugs to extend their lives, but low-income patients with less economic affordability or those who do not have private insurance are dying because they are unable to receive the benefits of these new drugs. Therefore, KAPO believes that Korea’s universal health insurance should address this life-related issue. For this, KAPO proposed to the candidates that an expedited NHI listing system should be established for new drugs that are used in life-threatening diseases. The expedited system allows rapid reimbursement of new drugs by allowing the company to concurrently apply for the marketing authorization and reimbursement listing to the MFDS (authorization) and HIRA (reimbursement listing) and concurrently review both applications. KAPO said, “The authorities can set a tentative drug price when a new drug is first sold in the market after MFDS approval so that patients could be saved using NHI finances. The difference between it and the final price should be settled after the reimbursement procedures are completed - going through the CDDC and DREC’s reimbursement procedure, pricing negotiations between the company and NHIS, and deliberation by the HIPDC. This way, the government could guarantee patients’ right to promptly access new drugs as stipulated in the Constitution.” However, on how to define and set the scope for ‘new drugs directly related to life,’ KAPO proposed that a ‘social consultative body’ should be established with participation by the government, experts, pharmaceutical companies, public, consumer, and patient groups. KAPO said, “We need to reinforce the patient-focused health insurance system by ensuring low-income patients’ access to new drugs to allow everyone who is ill to be treated and increase public and patient trust in health insurance to reduce dependence on private insurance. Also, the system enables the government to ensure access to new drugs that are directly related to life for all patients – the tax-paying public - regardless of their economic ability.”
- Policy
- Dong-A ST applied for Forxiga's Prodrug license
- by Lee, Tak-Sun Jan 07, 2022 06:06am
- Jegi-dong office building of Dong-A ST It was found that Dong-A ST applied for permission to the MFDS for Forxiga (Dapagliflozin Propanediol Hydrate, AZ), which has been devoted to development. Dong-A ST succeeded in avoiding material patents (scheduled to expire on April 7, 2023) through prodrug for Forxiga, so there is a possibility that it will dominate the generic market when commercialization is completed. According to the pharmaceutical industry on the 6th, Dong-A ST recently applied for permission to the MFDS for prodrug for Forxiga. Prodrug improves it slightly differently from the original substance. Prodrug differs from simple salt changes because the chemical structure is partially changed. Dong-A ST focused on avoiding Forxiga's material patents through the development of Produg. As a result, on June 23, 2020, it was the first domestic company to win a passive trial to confirm the scope of rights filed for Forxiga's first material patent. Currently, the case has been appealed by AZ, which objected to the results. As a result of the patent trial, Dong-A ST can be sold to the market after completing the product license and payment process. Other domestic generics cannot be sold until April 7, 2023, when Forxiga's material license is terminated even with product approval. Dong-A ST has been conducting phase 1 clinical trials to confirm equivalence with Forxiga 10mg since two years ago. Based on this, the plan was to apply for permission. There are cases where product approval was obtained after confirming the equivalence in phase 1 clinical trial with Prodrug. Developed by CTC Bio in 2013, Olmesartan Cilextil is a product that changed Prodrug Olmetec's isomer and was approved only for phase 1 clinical trials. Dong-A ST's Prodrug is expected to have a greater effect on preoccupying the market as soon as the item is approved. Analysts say that at least three months before the late-release market opens in April next year, it will have a proper preemptive effect. Dong-A ST has its own DPP-4 diabetes drug Suganon, which is expected to create considerable synergy in the diabetes treatment market if it secures SGLT-2 drugs with Forxiga's Prodrug. Sugaron has grown into a large drug worth 30 billion won per year. Forxiga is also leading the diabetes treatment market, which recorded 36.1 billion won in outpatient prescriptions (based on UBIST) as of 2020.
- Policy
- An additional purchase contract of pfizer tx has been signed
- by Kim, Jung-Ju Jan 07, 2022 06:06am
- The government said it has signed an additional purchase contract for oral treatments (Paxlovid) with Pfizer Korea. According to the KDCA, a total of 1,004,000 oral treatments were pre-purchased through the contract, including 762,000 with Pfizer and 242,000 with MSD Korea. Pfizer's oral treatment (Paxlovid) will be introduced in Korea in mid-January as scheduled. It is in the final stage of finalizing details with pharmaceutical companies, and plans to guide the public on how to introduce and utilize oral treatments next week. With the introduction of oral treatments, the government expects that they will greatly help treat home patients, while also contributing to quarantine and medical responses against Omicron mutations. The government will continue to review plans and purchases of treatments by synthesizing quarantine situations, medical response situations, domestic and foreign treatment development status, and clinical results of treatments.
- Policy
- Is the KRAS gene-targeted drug also released in Korea?
- by Lee, Tak-Sun Jan 06, 2022 06:09am
- The first KRAS gene-targeted anticancer drug approved by the U.S. Food and Drug Administration (FDA) in May last year is expected to be approved soon in Korea. It is Amgen's Lumakras (Sotorasib), which is expected to provide new treatment opportunities to KRAS mutant patients in about 5% to 8% of non-small cell lung cancer patients in Korea. According to the pharmaceutical industry on the 5th, the MFDS recently ended the safety and effectiveness screening of Lumakras. Analysts say that as the safety and effectiveness screening has ended, there is a high possibility of obtaining permission soon if there are no other variables. The drug drew attention when it was approved by the FDA in May last year. This is because it was the first KRAS gene-targeted anticancer drug. Lumakras demonstrated the efficacy of ORR at 36% in a clinical trial (CodeBreaK 100) in 124 patients with KRAS G12C mutation-positive non-small cell lung cancer. The median reaction duration was 10 months. The KRAS gene was the first mutant gene discovered in lung cancer in 1982, but unlike the EGFR and ALK genes, no targeted treatment was available. The KRAS gene itself has many types of mutations and is due to its structural characteristics that are difficult to develop target substances. Lumakras also targets the G12C gene among KRAS gene mutations. In Korea, it is known that KRAS mutation patients account for about 5-8% of all non-small cell lung cancer patients. The patients have been using Taxane therapy because they do not have other targeted treatments, and it is said that immuno-cancer drugs are also being used recently. Amgen reportedly applied for permission to the MFDS immediately after Lumakras received FDA approval. Currently, not only Amgen but also several pharmaceutical companies are focusing on developing new drugs for KRAS mutation. Seven pharmaceutical companies entered clinical trials related to KRAS last year. These include multinational pharmaceutical companies such as Novartis, Roche, Beringer Ingelheim, MSD, and Lilly. Clinical research is also underway to see if Lumakras can be applied not only to non-small cell lung cancer but also to direct bowel cancer. This is because 3-5% of patients with direct bowel cancer are caused by KRAS mutations.
- Policy
- There were no applications for Ultomiris·Soliris benefits
- by Lee, Hye-Kyung Jan 06, 2022 06:09am
- In November last year, it was confirmed that there was no pre-application for Ultomiris and Soliris benefits for new patients with paroxysmal night hemoglobin (PNH). There were only two applications for pre-approval of Soliris and one application for re-examination approval for new patients with atypical hemolytic uremic syndrome (aHUS), all of which were rejected. In the case of Spinraza, a treatment for Spinal Muscular Atrophy (SMA), two applications for new patient benefits have been approved. The HIRA conducted deliberation on 11 items, including ventricular adjuvant therapy (VAD), short-term hospitalization (2–4 days) with neuroblocking treatment, including Soliris and Ultomiris, short-term hospitalization with percutaneous epidural ganglion neoplasty (2–4 days), short-term hospitalization (2–4 days) with neuroblocking treatment, short-term hospitalization due to trauma (2-5 days), short-term hospitalization for pain control (2–4 days), mid- to long-term hospitalization (13 days), long-term hospitalization (27th~40th), Spinraza, and hematopoietic stem cell transplantation. Soliris costs 5,132,364 won per vial (30 ml), and if three vials are administered every other week, the drug price alone reaches 400 million won per year. Ultomiris was listed at 5,598,942 won per bottle on June 7, and should be administered once every eight weeks after the initial dose per patient is administered. Soliris and Ultomiris are ultra-high-priced new drugs, so they implement a pre-approval system to determine whether they are eligible for medical care benefits, and the agency must administer Soliris or Ultomiris within 60 days from the date of notification of the results of the pre-approval application. If it is intended to be administered after 60 days, it must be re-applied. Medical institutions approved for medical care benefits by Soliris or Ulromiris must submit monitoring reports every 6 months, and in the case of aHUS, additional initial monitoring reports must be submitted at 2 months after treatment commencement. Spinraza is an ultra-high-priced new drug with 92.35 million won per bottle of 5ml, and medical institutions that want to take it must apply for pre-approval and submit a monitoring report every four months after approval of benefits. Details of the deliberation can be found on the website of the HIRA (biz.hira.or.kr) or the medical institution's business portal (biz.hira.or.kr>examination criteria>standard>examination criteria>public deliberation cases).
- Policy
- Companies obtain generic for exclusivity in proportion
- by Lee, Tak-Sun Jan 06, 2022 06:08am
- Among pharmaceutical companies that use generic for exclusive in the licensed patent linkage system that took effect in 2015, it was found that companies with large sales are more likely to obtain generic for exclusivity. As a result, it was suggested that small and medium-sized pharmaceutical companies need more support such as consulting. Sungkyunkwan University's Industry-Academic Cooperation Group made the remarks in the "2021 Pharmaceutical Patent-approval linkage system Impact Assessment Research Service Result Report". The result report was released by the MFDS on the 29th of last month. This study is conducted annually to establish a stable patent-approval linkage system and minimize side effects, which has been fully implemented since March 2015, as a revision of the Pharmaceutical Affairs Act to implement follow-up measures to the FTA. Through research, the relevant status and status are identified, and the impact of the implementation of the system is analyzed and evaluated annually. The basis for the impact assessment is specified in Article 50-11 of the Pharmaceutical Affairs Act. As of 2020, the analysis targets the current status of obtaining generic for exclusivity of 171 domestic pharmaceutical companies with finished products. As a result of the evaluation, when other variables were controlled, companies with large sales were more likely to obtain generic for exclusivity. As of 2019, 20 pharmaceutical companies with annual sales of more than 300 billion won applied for generic for exclusivity (28.7%), 31 pharmaceutical companies with sales of more than 100 billion won (40.2%), 22 pharmaceutical companies with sales of more than 50 billion won to less than 100 billion won (17.1%), and 31 pharmaceutical companies with less than 50 billion won (14.0%). If the sales of the applied pharmaceutical company are more than 300 billion won, the average number of applications is 11.0, and the average number of applications tends to increase as sales increase. There was a high probability that a company with a large number of items would obtain generic for exclusivity. Through this, the researchers analyzed that companies with large sales and a large number of items are more likely to obtain generic for exclusivity. In response, the researchers said, "As large-scale pharmaceutical companies tend to gain generic for exclusivity, it is required to strengthen SMEs' capabilities in first-generation development. Consulting support for SMEs is needed to encourage SMEs to obtain patent challenges and approval." The researchers also analyzed the impact of generic for exclusivity on generics before and after the introduction of the parent-approval linkage system (March 14, 2015) in terms of market share. As a result of the evaluation, the number of items significantly decreased due to the introduction of the system. However, there was no significant change in the duration of generics' entry into the market. However, it was found that the period of entry into the market was shortened in the case of generic for exclusivity. The researchers said, "Unlike concerns at the time of introduction, stable operation continues, and it is evaluated to have a slight positive effect on health policies and employment in the pharmaceutical industry."
- Policy
- Request for non-reimbursed use of Pahtension in Loop's pts
- by Lee, Hye-Kyung Jan 06, 2022 06:08am
- Application for Pahtension 20mg was rejected for non-reimbursed patients with systemic erythema lupus accompanied by immunosuppressants, vasculitis that does not improve even with antibiotics, and peripheral ulcers. The HIRA is receiving applications in advance for use exceeding the MFDS' permission to prevent the use of drugs that lack medical evidence or are concerned about safety. According to the details recently released by the HIRA, a total of 237 cumulative cases were rejected due to insufficient medical evidence for the submitted data, including Pahtension. Cases added this time include Previmis 240mg tab, Previmis 480mg tab, and Previmis inj, which will be non-reimbursed to pediatric and adolescent patients receiving hematopoietic stem cell transplantation. The request to prescribe My-Rept 250mg to Sjogren's syndrome patient with steroid dependence that recur during steroid loss after diagnosis of MCD and renal syndrome was also rejected. After hematopoietic stem cell transplantation, prescriptions of R-A 10mg and R-A 20mg were also rejected for patients with BK virus-related hemorrhagic cystitis who did not respond to existing antiviral drugs or could not be used as side effects of existing antiviral drugs. All attempts to prescribe Premina 0.625mg and Premina 3mg to patients with hemorrhagic cystitis who do not respond to existing treatment after hematopoietic stem cell transplantation or after high-dose cyclophosphamide treatment have not been approved. Among patients with circular hair loss, frontal hair loss, or systemic hair loss aged 8 years or older, it was also rejected to prescribe Xeljanz to patients with severe intractable skin lesions or interstitial pneumonia who do not respond to SALT score changes of less than 25% or high dose glucocorticoid and at least two immunomodulatory treatment. Approval to prescribe Previmis 240mg and Previmis 480mg was also rejected if there was no improvement in the use of other antiviral drugs for more than two weeks due to giant cell virus infection and peripheral organ disease after hematopoietic stem cell transplantation. Among children with persistent tachycardia after heart transplantation, approval to prescribe Procoralan 5mg was also rejected to patients with tachycardia persistent tachycardia despite the use of drugs such as beta blockers.
