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- 2026-04-13 01:42:36
- 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.”
- Company
- Heads of 4 MNCs were newly appointed last year… increase of
- by Eo, Yun-Ho Jan 07, 2022 06:06am
- (From the left) GMs Byungjae Yoo, Martin Corcoll, Cherry Huang, So Eun Kim Four multinational pharmaceutical companies have appointed new CEOs over the past year. According to Dailypharm’s update of CEOs in 32 major multinational pharmaceutical companies, including the Korean Research-based Pharmaceutical Industry Association, heads of 4 pharmaceutical companies were replaced or newly appointed last year. Most were regular personnel appointments mainly due to term of office expiry, with others due to CEO’s relocation or corporate spin-offs. ◆ Novartis·BI·Janssen’s appoints new head due to term expiry… New launch of Organon First, companies such as Novartis Korea, Boehringer Ingelheim, and Janssen Korea welcomed new heads to their office due to the expiration of the term of office of former CEOs or promotions. Novartis appointed Byungjae Yoo, former Managing Director of Johnson & Johnson Medical North Asia to succeed Joshi Venugopal who made a promotional transfer to Novartis headquarters. Boehringer Ingelheim Korea appointed Martín Coroll, former general manager of Boehringer Ingelheim Austria, to lead the office after Steven Walter’s term expiry. In Janssen’s case, Janssen Korea appointed Cherry Huang as the next CEO of Janssen Korea in June to take place after the former CEO Jenny Zhuang moved to head its Chinese subsidiary. Huang had previously served as the CFO of Janssen Asia Pacific. Just as Viatris Korea entered the industry in 2020, Organon Korea spun off from MSD Korea in 2021 and launched as a new and separate company. In line with its new establishment, the company appointed So Eun Kim as its first Managing Director. Since entering MSD Korea in 1998, Kim had served various roles in MSD Korea and abroad for 23 years. ◆17%, a record-high proportion of local CEOs…rate of women CEOs exceed 30% 2021 is also a significant year in that the proportion of women and Korean CEOs recorded the highest-ever within Korean subsidiaries of multinational pharmaceutical companies. In particular, this will be the second time since its establishment that a Korean subsidiary of Novartis will be managed by a local CEO. Since its establishment in 1997 and the first president Frans Hompe, the company had mostly appointed foreign heads to lead the Korean subsidiary. The only Korean national that had previously been appointed was Hak-sun Moon in 2015. In addition, Organon also appointed a Korean women head with its establishment. Moderna Korea, which entered the Korean market with the development of its COVID-19 vaccine, also added weight to the proportion of women CEOs by appointing Ji-Young Sohn as the new General Manager. Meanwhile, Sang Wook Kang, CEO of GSK Consumer Healthcare resigned. Due to Kang’s unexpected resignation, the company is currently being operated under an acting representative system.
- 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.
- Company
- Ahn to reduce generic price to counter Lee's hair loss reimb
- by Kim, Jin-Gu Jan 07, 2022 06:06am
- Cheol-Soo Ahn, the presidential candidate of the minor opposition People's Party, pledged to reduce the price of hair loss drug generics. Ahn prosed this as an alternative in concern over the worsening insurance finances that may be caused by Democratic Party Jae-Myung Lee’s mention of reimbursing hair loss treatments On the 5th, Ahn criticized Lee’s pledge of reimbursing hair loss drugs through his social media channel. “How will you manage the soon to be depleted NHI finances? It would only lead to a hike in insurance premiums.” He added, “Reimbursement is not the only solution. We can reduce the people’s price burden significantly without using NHI finances if we reduce the price of hair loss drug generics by 30-40%.” In the case of finasteride drugs that are used for hair loss, the original drug ‘Propecia’ costs around 1,800 to 2,000 won per tablet. Propecia's generic ‘Monad’ currently costs 1,500 won per tablet. Ahn claims that reducing the generic’s price to around 600-800 won per tablet can greatly reduce patient burden without spending NHI finances. Ahn said, “In the US, if there are 19 generics in market, a drug’s price may fall to 6% of the original drug's price at the lowest,” stressing the need to reduce the price of generics for all pharmaceuticals in general, including hair loss treatments. Ahn also promised to support the research and development of hair loss treatments. Ahn said, “The 56 trillion won global hair loss treatment market is growing over 4% every year. If we provide significant support for the R&D of new drugs for hair loss treatment, it would benefit industry development as well as contribute to providing a more economic option for those suffering from hair loss.”
- 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.
- Company
- New triple combo ‘Enerzair’ for asthma lands in 'Big 5'
- by Eo, Yun-Ho Jan 06, 2022 06:09am
- ‘Enerzair Breezhaler,’ a three-in-one triple combination therapy for asthma, can now be prescribed at general hospitals in Korea. According to industry sources, Novartis Korea’s triple combination drug ‘Enerzair Breezhaler (mometasone·indacaterol·glycopyrronium)’ that contains ICS (inhaled corticosteroids) · LABA (beta2-agonist) · LAMA (long-acting muscarinic antagonist) has passed the review of drug committees (DC) of ‘Big-5’ general hospitals including Samsung Medical Center (SMC), Seoul National University Hospital (SNUH), Seoul Asan Medical Center, and Severance Hospital. The company had sought rapid entry into the market after it was approved for insurance benefit in September last year. Enerzair was approved for reimbursement as maintenance treatment of asthma in adult patients (aged 18 or older) who are not adequately controlled with a maintenance combination of LABA and a high-dose ICS who experienced one or more asthma exacerbations in the past 12 months. As a first-in-class combination, Enerzair identified significant results in ▲lung function improvement ▲ exacerbation reduction ▲asthma control ▲quality of life improvement compared to existing two-drug therapy (ICS·LABA) and three-drug therapy (ICS·LABA·LAMA). The drug’s lung function improvement effect was identified in the pivotal IRIDIUM study that compared the efficacy and safety of Enerzair with high-dose ICS·LABA. (fluticasone·salmeterol, mometasone·indacaterol) in asthma patients. In the study, high-dose Enerzair improved the primary endpoint of trough FEV1 (volume of air that can be forced out in the first second of expiration approximately 24 hours post-administration of study drug) by 76mL and 65mL compared to high-dose Atectura Breezhaler (ICS·LABA). In the primary and secondary analysis, it showed a significant improvement in trough FEV1 (199mL) compared to high-dose fluticasone·salmeterol (FLU·SAL) that was administered twice-daily. The FEV1 improvement that was identified at week 26 lasted until week 52. Enerzair also significantly reduced asthma exacerbation rates by 36% (moderate or severe) and 42% (severe) versus high-dose FLU/SAL over 52 weeks. In asthma control, high-dose Enerzair also showed a statistically significant improvement in the rate of patients whose scores improved over the clinically significant difference of 0.5 points at week 4, week 12, and week 52 in the Asthma Control Questionnaire score. Meanwhile, Enerzair also demonstrated an improvement in quality of life even compared to a triple combination therapy that combines the ICS·LABA combo with LAMA. In the ARGON study that compared the improvement in quality of life in patients with uncontrolled asthma of twice-daily FLU/SAL to once-daily tiotropium (TIO), both the medium-dose and high-dose Enerzair demonstrated non-inferiority in the change of Asthma Quality of Life Questionnaire (AQLQ) score from baseline. Enerzair also met the primary endpoint, change in AQLQ from baseline at week 24, and demonstrated non-inferiority to its comparator. In the secondary analyses, medium-dose and high-dose Enerzair improved asthma control (ACQ-7 score, -0.124) and lung function (trough FEV1, 96 mL] compared to high-dose FLU·SAL·TIO.
- Product
- Lee’s pledge to reimburse hair loss drug creates buzz
- by Jung, Heung-Jun Jan 06, 2022 06:09am
- The news that presidential candidate Lee Jae-Myung's is considering reimbursement of hair loss treatments as his election pledge is drawing attention for days. However, as many unresolved issues including creating empathy on its need, budgetary projections, and review of beneficiaries remain, it is unclear whether this may be practically enforceable. Although most pharmacies are welcoming the pledge, the expectation is that some pharmacies that have been selling non-reimbursed hair loss drugs at a lower price will not be welcoming the reimbursement. Lee’s vow to review reimbursement of hair loss treatments has generated continuous buzz in online communities. Since the drugs cost over ₩30,000 every month and require continuous administration, their reimbursement is raising expectations of reducing the burden. However, the reimbursement of hair loss treatments may not benefit all those affected. Reimbursement will apply depending on the type of hair loss, cause, and degree of reimbursement. Therefore, unlike the rumors on social media, not all will be able to receive reimbursement. In Seok Oh, Pharmaceutical Benefit Director of the Korean Pharmaceutical Association, said, “Hair loss treatments are non-reimbursed, therefore their prices are set at a higher level. In general, patients pay over ₩30,000 every month for the drugs. If these drugs are reimbursed, a price ceiling will be set on the drugs, and a budgetary projection must be made. Also, reimbursing hair loss means that hair loss is recognized as a disease, thus specific classifications must also be made for this disease for insurance.” Oh added, “Also, not all people will be able to receive reimbursement, since the condition and type of hair loss vary greatly by person. Some may be due to stress, some due to skin irritation, and some may be at a stage where taking a drug may no longer be effective” If reimbursed, patients who had avoided treating their condition will also visit clinics and hospitals, increasing the number of patients. Consequently, pharmacies are also expected to see more hair loss patients. However, some local pharmacies that have attracted customers by selling hair loss drugs at a lower price may not welcome the change. Pharmacists A from Gyeonggi-do said, “It is good news for pharmacies that have not sold hair loss products before in the sense that their shares of the pie will increase. However, for pharmacies that specialize or sell many hair loss drugs that have attracted patients with a very low price, the harm may outweigh the benefits. Meanwhile, according to the market research institution IQVIA, the top-grossing hair loss treatments (finasteride, dutasteride) in Korea in 2020 were Propecia (₩41.3 billion), Avodart (₩38.4 billion), Monad (₩6.2 billion), Mypecia (₩ 5 billion), Damodat (₩3.3 billion), Finated (₩2.3 billion), Neodart (₩1.7 billion), Zygard (₩1.4 billion), Duted (₩1.2 billion) Jdart (₩1.3 billion).
