- LOGIN
- MemberShip
- 2026-05-19 06:50:48
- Company
- AstraZeneca co-sells Qtern with Ildong Pharmaceutical
- by Eo, Yun-Ho Nov 01, 2021 05:56am
- According to related industries, AstraZeneca Korea and Ildong Pharmaceutical have decided to jointly promote Qtern, which combines DPP-4 inhibitor Onglyza (Saxagliptin) and SGLT-2 inhibitor Forxiga(Dapagliflozin), which will be released today (1st). Since March 2014, the two companies have already been conducting co-marketing on diabetes treatments such as Onglyza and Kombiglyze XR(Metformin·Saxagliptin). Qtern jointly conducts sales and marketing of the product at general hospitals and Ildong Pharmaceutical alone at clinics. With the official launch of Qtern, the market for diabetes combination drugs is expected to change. Currently, in addition to Qtern, combinations of DPP-4 inhibitors and SGLT-2 inhibitors are licensed in Korea, Beringer Ingelheim's Esglito(Linagliptin+Empagliflozin) and MSD's Stegluzan(Ertugliflozin+Sitagliptin). It has been confirmed that they are also preparing to launch along with resolving benefit issues. GC Pharma received approval from the MFDS on the 25th for the biological equivalence test plan of GC2123A. The active ingredient of this product candidate is known as Empaglipozin+Linaglipin. Meanwhile, Qtern was approved in Korea in March 2017, but its launch in Korea was delayed as the problem of combined diabetes insurance benefits was not resolved. However, a change in the market is expected as insurance authorities have recently discussed recognizing the combined benefits of SGLT-2 inhibitors. Not long ago, a meeting of diabetes experts convened by the HIRA is trying to integrate and recognize the combined use and three-drug benefits between DPP-4 inhibitors and SGLT-inhibitors.
- Policy
- Redundancies in CDRD and PBAC roles in continuous dispute
- by Lee, Hye-Kyung Nov 01, 2021 05:56am
- [News follow-up from a friendly reporter] The functional redundancies in the Cancer Disease Review Committee (CDRC) and Pharmaceutical Benefit Appraisal Committee (PBAC) arose as an issue at the NA Health and Welfare Committee audit recently. At the audit, the National Assembly Health and Welfare Committee member Sun-woo Kang of the Democratic Party of Korea had pointed out that a long-term delay has occurred in discussions on expanding reimbursement for a new anti-cancer drug due to the redundant functions of the two committees. The new anti-cancer drug that Kang referred to was MSD Korea’s ‘Keytruda (pembrolizumab).’ ‘Keytruda is an immuno-oncology drug that was first approved reimbursement for NSCLC patients with ‘Opdivo (nivolumab)’ on August 21st, 2017. The issue arose with the reimbursement for Keytruda in first-line in lung cancer delayed for 4 years. According to the data disclosed by Kang, MSD Korea applied to extend reimbursement of Keytruda to first-line NSCLC in September 2017, but the agenda finally passed the CDRC in July 2021. Why the delay? The CDRC had delayed making the decision for 4 years due to concern over its fiscal sharing plan despite having no disagreement over the drug’s clinical usefulness. New anti-cancer drugs require CDRC review for setting reimbursement standards, but the fiscal sharing discussions that should be discussed at the PBAC were also conducted at the CDRC level. The CDRC has less than half the personnel of PBAC, and remarks of Ministry of Health and Welfare officials at public hearings or debates indicate that they expect CDRC to make decisions based on objectivity rather than expertise. In other words, objective reimbursement standards are set at the CDRC level without input from the pharmaceutical company. But Keytruda’s review was put on hold for 4 years over its ‘fiscal sharing’ at CDRC, not its reimbursement standards. That was why the drug was mentioned as an example at the NA audit. What about HIRA? To what extent does the HIRA stipulate the scope of the work for CDRC? The scope of work for CDRC and PBAC are stipulated in the ‘Regulations on the Criteria for NHI Insurance Benefits.’ Article 5-2 of the regulation stipulates that ‘HIRA should organize a CDRC to deliberate the methods and standards for applying insurance benefit to medicines prescribed and administered to severe disease patients.’ The members of the committee should be comprised of 45 or fewer members with extensive experience and profound knowledge in the field of public health.’ In other words, under the regulations, the CDRC deliberates the standards and methods for drugs used for patients with rare, severe diseases or cancer. HIRA sees that the committee may assess a drug’s medical feasibility, alternative drugs and treatment cost, fiscal impact, etc. to deliberate its reimbursement standards. This was included in the written QA that was submitted after Kang’s NA audit, but the contents of the deliberation for setting the reimbursement standards could not be found. However, DREC’s role is clearly stated in the regulations. Article 11-2 of the regulation is the basis for DREC, and it reviews insurance benefits of drugs that applied for assessment under Article 10-2(3). DREC has subcommittees for drug benefit standards, economic evaluation, RSA, fiscal impact assessment, herbal medicine, post-marketing evaluation, etc. The manpower pool for DREC is 102, and the members evaluate whether new drugs are eligible for medical care insurance benefits, reimbursement standards, and the price cap for drugs based on calculation standards. The stipulated standards show that the functions of CDRC and DREC need not overlap. HIRA explained that a delay in deliberation had occurred at the CDRC level due to the fiscal burden that may arise in NHI finances due to the high price of new anticancer drugs. However, financial sharing is an agenda that needs to be reviewed by DREC or the NHI that has fiscal power, not the CDRC. Therefore the question that lies is whether the 45 non-expert members of the CDRC had the authority to neglect the patients’ 4 years’ worth of time over the fiscal sharing plan.
- Policy
- HIRA clarifies ‘Opdivo·Keytruda·Tecentriq’ eligibility
- by Lee, Hye-Kyung Nov 01, 2021 05:56am
- The 'Stage ⅢB or higher’ phrase was added to the subjects eligible for reimbursement of ‘Opdivo (nivolumab),’ ‘Keytruda (pembrolizumab),’ and ‘Tecentriq (atezolizumab)’ in NSCLC. The Health Insurance Review and Assessment Service announced that it will implement the ‘Amendment to the Notice on Drugs Prescribed and Administered to Cancer Patients' which will take effect from November 1. The amendment was made to address the confusion that arose regarding the eligibility of reimbursement after the cancer stage criteria were deleted in subjects for immunotherapy as second-line or subsequent lines of palliative therapy on May 1st. HIRA added the 'Stage ⅢB or higher’ to ‘patients who have previous platinum-based chemotherapy experience with positive PD-L1 expression (expression rate ≧ 10%)’ in the criteria for the administration of Opdivo, Keytruda, and Tecentriq as second-line or higher therapy in NSCLC. Also, the G-CSF injection, ‘Rolontis Pre-filled Syringe (eflapegrastim)’ was included in the announced amendment. Rolontis Pre-filled Syringe was approved to reduce the incidence of severe neutropenia in patients that receive cytotoxic chemotherapy for solid cancers and malignant lymphoma. After reviewing the reimbursement standards, HIRA decided that Rolontis was necessary for treatment and set a standard for the drug after the drug demonstrated non-inferiority to the currently reimbursed eflapegrastim in the mean duration of severe neutropenia through a Phase III clinical trial in cycle 1.
- Company
- Hanmi & Ahn-Gook finally won the Galvus patent dispute
- by Kim, Jin-Gu Nov 01, 2021 05:55am
- The Supreme Court sided with Generic companies in a patent dispute over Galvus (Vildagliptin), a DPP-4 inhibitor-based diabetes treatment. On the morning of the 28th, the Supreme Court dismissed Novartis' appeal against Ahn-Gook Pharmaceutical and Hanmi Pharmaceutical to invalidate the extension of the patent duration. There is a problem with the reason for the appeal claimed by Novartis. Generics succeeded in invalidating 55 days of the material patent duration. Ahn-Gook and Hanmi Pharmaceutical began early launch of generics for Galvus in accordance with the ruling. Generic is likely to be released early next year. The issue of this case is which period of the "extended duration" of the drug substance patent will be considered invalid. So far, there has never been a case in which generic has overcome the extended duration of drug substance patents against the original company. Ahn-Gook claimed that "187 days" out of the 1,068 days of Galvus' extended material patent duration was invalid. On top of that, Hanmi also requested an extension invalidation trial. Ahn-Gook won the first trial. Intellectual Property Trial and Appeal Board sided with Ahn-Gook and said 187 days were invalid. Ahn-Gook was qualified to release the generic 187 days earlier. Novartis won some of the second trials. The patent court ruled that only 55 days out of 187 days were invalid. Novartis once again objected and filed an appeal to the Supreme Court. Novartis argued that it could not be considered invalid.
- Policy
- Concerns about the introduction of the Reference Price
- by Kim, Jung-Ju Nov 01, 2021 05:55am
- The government expressed concern over the National Assembly's proposal to review the introduction of the Reference Pricing System. Although they sympathize with the need for rational drug price management, side effects such as an increase in the patient's economic burden are predicted from the reference price system itself. Regarding price policies, such as proposals for mandatory general administration, it said that the pros and cons of the pharmaceutical industry and conflicts will be reviewed through collecting various opinions because social consensus is important. The MOHW recently submitted a written response to such issues related to drug price policies proposed and inquired by the Health and Welfare Committee during the last parliamentary audit. Through written inquiries, lawmakers belonging to the Welfare Committee asked about generic drug price policies such as discussing the reference price system to normalize the generic drug market and reduce health insurance finances. The MOHW agreed on the need for drug price management to reasonably manage health insurance drug costs and create a cost-effective generic use environment. In fact, after the Valsartan crisis in 2018, the government has implemented a generic drug price reorganization since July last year to prevent competition for generic turmoil. However, the government was virtually negative regarding the Reference Pricing System. The MOHW explained, "The Reference Pricing System can contribute to reducing health insurance finances, but it is likely to bring about significant changes in the current drug price system and increase the economic burden on patients." The government said, "It is necessary to refer to overseas cases and carefully review them through collecting social opinions." In the case of generic substitution, social consensus is needed in consideration of the principle of division of medicine established in 2000. Currently, one out of every two benefit drugs is given incentives for items that can be generalized, but it is negative in the medical community. The MOHW replied, "We will review it by collecting opinions from related ministries, related organizations, and experts." The Welfare Committee also inquired about the necessity of establishing an expensive drug to prevent it from being recklessly prescribed. In response, the government explained, for example, that in the case of Spinraza, the HIRA is operating a pre-approval system to prevent disputes, and said, "We will consider various drug management measures considering individual drug characteristics of individual drugs."
- Policy
- 'Symbenda' withdraws from Korean market 3 years after reimb.
- by Lee, Tak-Sun Oct 29, 2021 05:54am
- A blood cancer drug that took 7 years from approval to reimbursement is being removed from the market only 3 years since starting its sale in earnest. The company that sells the product has pointed to the termination of their agreement as to the cause of its market withdrawal, however, the analysis is that profitability has declined due to drug price cuts following the introduction of generic drugs earlier this year. According to the Ministry of Food and Drug Safety, Eisai Korea withdrew its license for ‘Symbenda inj. (bendamustine hcl.)’ on the 27th. The withdrawal comes after 10 years since its approval in May 2011. The drug is used to treat blood cancers such as lymphoma and chronic lymphatic leukemia. The drug, which was approved 10 years ago, has only been sold in the market for around 3 years. Symbenda was finally approved for reimbursement 7 years after its approval in September 2018, as combination therapy with rituximab. With the reimbursement, a price cap of 283,793 won per 100mg vial was set for the drug. According to IQVIA, the drug sold 2.5 billion won and 2.2 billion won in 2019 and 2020, respectively. Analysts have said that Symbenda’s performance as a new anticancer drug that finally received reimbursement after 7 years was below than expected. Moreover, the drug’s price has been cut in April this year by 30% with the introduction of its generics and set at 198,655 won per 100mg vial. After Boryung Pharmaceutical received the first approval for Symbenda’s generic in November last year, Samyang Holdings and Handok Teva followed into the market with their Symbenda generics. Boryung Pharmaceutical has started selling its first Symbenda generic with reimbursement in April. Eisai Korea, the seller of Symbenda in Korea, notified the MFDS that it would discontinue the supply of Symbenda in April, a month before Handok Teva received the approval for Symbenda’s third generic in May. At the time, Eisai explained, “With the expiry of the partnership agreement that was made between Eisai and the original developer of Symbenda due in October 2021, the company had made the necessary decision to discontinue supply Symbenda in Korea.” The company expected that the 100mg dose will be discontinued in July and the 25mg dose in August. The company added that “Many drugs with the same ingredient that was approved for the same indications are being sold in the market and are available as a replacement for Symbenda. Therefore, the discontinuation of Symbenda’s supply will not affect patients’ treatments. The industry believes that the lower-than-expected performance and the decline in profitability due to the introduction of its generics were what made it difficult for the company to continue on the business in Korea, rather than the two companies'' agreement expiry. With the original’s withdrawal from the Korean market, competition between the three bendamustine generics that are left in the markets and is expected to intensify to compete in filling the original's gap.
- Company
- Qtern will be released in Korea after 4 years of approval
- by Eo, Yun-Ho Oct 29, 2021 05:53am
- The DPP-4 inhibitor and SGLT-2 inhibitor diabetes complex Qtern will be released four years after approval in Korea. According to related industries, AstraZeneca Korea will start promotional activities for Qtern, a product that combines Onglyza and Forxiga, on the 1st of next month (November). Qtern was approved in Korea in March 2017, but its launch in Korea was delayed as the problem of insurance benefits for diabetes combined therapy was not resolved. However, a change in the market is expected as insurance authorities have recently discussed recognizing the combined benefits of SGLT-2 inhibitors. A meeting of diabetes experts convened by the HIRA integrated the benefits of a combination of DPP-4 inhibitors and SGLT-inhibitors. The reason for the decision to release Qtern is also believed to have reflected this. Currently, in addition to Qtern, combinations of DPP-4 inhibitors and SGLT-2 inhibitors are licensed in Korea, Beringer Ingelheim's Esglito and MSD's Sitagliptin+Ertugliflozin. It has been confirmed that they are also preparing to launch as the benefit issue has been resolved. On the 25th, GC Pharma's GC2123A received approval from the MFDS for a biological equivalence test plan. The active ingredient of this product candidate is known as the same ingredient drug Empagliflozin+Linagliptin. In addition, Dongkoo Bio applied for permission for a combination drug of Januvia (Sitagliptin) and Forxiga in March. LG Chem is conducting commercialization clinical trials for Zemiglo and SGLT-2 inhibitors, while Aju is conducting commercialization clinical trials for a combination drug of Jardiance and Forxiga. Meanwhile, the PMS period of the DPP-4 inhibitor and SGLT-2 inhibitor combination is now less than two years away. The PMS period ends in March 2023. Since March 2023, news of generic development has continued as it is possible to apply for a generic license.
- Policy
- KDCA “will monitor development of oral COVID-19 treatments"
- by Lee, Hye-Kyung Oct 29, 2021 05:53am
- The government expressed its determination to introduce a safe treatment with verified efficacy by continuously monitoring the COVID-19 treatment trends, including the US Merck & Co. (MDS)'s oral COVID-19 treatment, 'molnupiravir .' That was the KDCA's response to when NA member Young-seuk Seo of the Democratic Party of Korea asked in via a written inquiry about verifying the efficacy of molnupiravir after the NA audit that was held by the Health and Welfare Committee. Seo asked,” The published results show patients who took placebo or molnupiravir until Day 5 and had no virus detection. Authorities need to consider whether a drug this potent is necessary to increase relief among the public and as well as for disease containment." Regarding Seo’s inquiry, the KDCA said, “We have been reviewing the indications and clinical trial results from various countries." For the approval of an oral COVID-19 treatment the government plans to purchase, the authorities have been comprehensively reviewing various clinical trial results with various measures including the virus detection results, improvement in clinical symptoms, safety assessment, and the drug's approval status in advanced countries such as the United States.” In addition to the publsihed paper, Merck also announced the interim results of its clinical trial on mild-to-moderate patients at high-risk on October 1st. Results showed that 28/385 of the patients who received molnupiravir were hospitalized or died within 29 days of administration compared to the 53/377 in the placebo group. Deaths were reported in 0 patients that were administered molnupiravir and in 8 patients in the placebo group. Also, the drug showed a consistent effect in all mutations, including the gamma, delta, and Mu variants. Based on such results, the company has applied for the Emergency Use Authorization after discussions with the US FDA. KDCA said, “we will continue to monitor COVID-19 treatments and endeavor to introduce safe and verified treatments to Korea."
- Policy
- The government needs to create a sovereign wealth fund
- by Lee, Jeong-Hwan Oct 29, 2021 05:53am
- The National Assembly's Health and Welfare Committee urged both ruling and opposition parties to create tens to hundreds of trillion won worth of sovereign wealth funds to develop blockbuster vaccines and new drugs. As COVID-19 Pandemic has confirmed high demand in the global market for pharmaceutical and bio sectors such as vaccines and new drugs, Korea is also aiming to properly foster global big pharma like Pfizer. On the 27th, Rep. Seo Jung-sook of the People Power Party and Rep. Kang Byeongwon, affiliated with the Welfare Committee, strongly appealed to the MOHW that it is necessary to create a mega-level sovereign wealth fund to foster bio and pharmaceuticals in Korea. According to data submitted by the MOHW to the National Assembly, Korea's national R&D industry budget (2011-2021) totaled 173.7 trillion won, with an annual average of 17.3 trillion won. Among them, the investment budget in the pharmaceutical and bio sectors is 3.2 trillion won, which is being invested in 20,000 projects. In other words, the allocated budget per project is around 160 million won. Korea's budget for supporting the development of COVID-19 vaccines and treatments totaled 120.3 billion won, investing 40.2 billion won in vaccines and 80.1 billion won in treatments. The problem is that Korea's R&D budget in pharmaceutical and bio sectors is far short compared to global cases such as the United States. The United States is investing a total of 8.6 trillion won in vaccines alone. Compared to Korea, it is 70 times higher. The U.S. invested 2.182 trillion won only in Pfizer, a developer of the mRNA coronavirus vaccine and the world's No. 1 Big Pharma. The CEPI is investing 45.4 billion won in SK Bioscience. Lawmakers from the ruling and opposition parties of the Welfare Committee pointed out that it is urgent to create a "developmental sovereign wealth fund" to continue long-term investment while ensuring autonomy in the pharmaceutical and bio sectors. Rep. Seo Jung-sook said, "Korea should foster big pharma like Pfizer." Rep. Seo Jung-sook of the People Power Party pointed out that the government's investment in R&D in the pharmaceutical and bio sectors is too small. It is pointed out that in order to foster pharmaceutical companies that manufacture blockbuster vaccines or treatments that the global market finds first, efforts to innovate Korea's pharmaceutical and bio national budget by actively analyzing overseas cases are needed. In particular, Rep. Seo said that if it is difficult for the government to generate pharmaceutical and bio budgets alone, it should create a sovereign wealth fund in which the government and the private sector work together to have investment power of hundreds of trillion won to hundreds of trillion won. In Korea, the government and the private sector should actively cooperate to create a global big pharma like Pfizer. Representative Seo said, "Pfizer, which developed the COVID-19 vaccine, succeeded in producing PCN itself and secured capital power as it was used in large quantities in World War II and grew into a global pharmaceutical company." She said, "Pharmaceutical and bio cannot grow into a large company like Pfizer without a special opportunity. This is why fostering at the government level is essential, she explained. Rep. Seo said, "The current government is different from blockbuster-class with a distributed investment of 160 million won per project. The U.S. provided KRW 2.182 trillion to Pfizer alone for the COVID-19 vaccine, and the total investment in pharmaceuticals and bio exceeded KRW 8.6 trillion. It is more than 70 times that of 120.3 billion won in Korea, she added. "Domestic vaccines and new drugs are not being developed due to institutional problems." The government is controlled annually and cannot provide large-scale support by using budgets and funds for pharmaceutical and bio investments, it said. "In order to invest large-scale funds in pharmaceutical companies in the long run, we need to actively consider creating development-type sovereign wealth funds." Kang Byungwon said, "Mega funds are urgently needed in Korea" Following the last parliamentary audit, Kang also said it should support phase 3 clinical trials of domestic pharmaceutical companies that started developing blockbuster vaccines and new drugs with "10 trillion megafunds." In particular, Kang said, "Korean pharmaceutical bio companies' technology exports are at the top of the world with 11.6 trillion won, and it is regrettable that they cannot lead to final commercialization." Currently, government-private joint mega funds are essential to overcome the reality that the Korean government only supports R&D support in the pharmaceutical and bio sectors up to Phase 1 and Phase 2 clinical trials. Furthermore, Kang said the government should also take the lead in linking the technology of bio-ventures with the experience of large companies. Rep. Kang said, "The government should actively support the good ideas of pharmaceutical and bio venture companies to lead to the development of final new drugs somehow. The key to the development of new drugs depends on the success of late clinical trials, he said. "We need to create a mega fund in cooperation with the private sector so that the government can support up to phase 3 beyond phase 1 and 2 clinical trials to avoid WTO trade friction." Representative Kang said, "One way is to match and commercialize technology and capital power between bio ventures and large companies, and to support phase 3 clinical trials only for the development of new drugs for public interest purposes." He said, "In order to develop pharmaceutical and bio industries into new industries in the future, now is the most appropriate time when the world is paying attention to vaccines and new drugs due to COVID-19."
- Product
- PO treatment for COVID-19 "Molnupiravir" will be released
- by Whang, byung-woo Oct 29, 2021 05:53am
- The emergence of Molnupiravir of MSD, known as the first oral treatment for COVID-19, is drawing attention to how it will affect the war against COVID-19. While it is compared to Tamiflu and is evaluated as a game changer, there are mixed views on the other side that its role may be limited due to price limitations. According to the interim results of phase 3 clinical trials of MOVe-OUT, which evaluated the efficacy of the oral corona treatment Molnupiravir by MSD on the 1st, 775 patients with mild and moderate symptoms had reduced hospitalization and mortality by about 50%, satisfying the primary evaluation index. At this time, the dose of Molnupiravir was taken twice a day, 10 times for 5 days, and as a result, 7.3% of patients worsened to severe and there were no deaths. 14.1% of patients taking placebo worsened to severe and 8 died. Based on these clinical results, MSD terminated the clinical trial early without the registration of additional clinical patients originally planned and submitted an application for emergency use approval to the FDA. Considering the trend so far, Molnupiravir, which has been effective in clinical trials, is cheaper than conventional injections, so it will not be too much to win the title of the first oral treatment for COVID-19. The FDA will closely review safety and effectiveness data to determine whether to approve or not, and a final conclusion is expected within a few weeks. "The reason for getting a vaccine is to prevent it from going from mild to severe, that is, how severe it is even if it is a breakthrough infection," said Kang Jinhan, head of the Vaccine Bio Research Institute at Catholic University. "In the case of flu, the prevention rate is only about 50%, but the oral treatment of COVID-19 will be meaningful in that way." Director Kang said, "There is a need for oral treatments as a strategy to go to the so-called With Corona like the flu," adding, "I think it will be a concept that prevents medical confusion by administering it early so that mild patients do not get serious." Can Molnupiravir, which has been proven effective, be like Tamiflu? One question here is whether Molnupiravir can play the same role as Tamiflu or Xofluza, a flu treatment, at a time when many experts predict that COVID-19 will become endemic like the flu in the future. According to the most recently developed CAPSTONE-1 clinical study by Xofluza, the median time required for the Xofluza administration group to relieve symptoms after administration was about 2.3 days (Tamiflu 3.3 days). In addition, the median time it took to fever was about 1 day (Tamiflu 1.8), and the effect of reducing virus levels was reduced by half in about 1 day (Xofluza about 4 days). Choi Young-joon (pediatric infection), a professor at Korea University Anam Hospital, said, "I remember that Tamiflu was first introduced as an endpoint and gradually expanded to shorten the duration of symptoms," adding, "Molnupiravir aims to treat death and severe infections in public health and may expand the scope of treatment in the future." In fact, according to the MOVe-OUT clinical evaluation index that evaluated the efficacy of Molnupiravir, the primary evaluation index is the rate of hospitalization, death, and side effects, but the second evaluation index is the decomposition or improvement time of the coronavirus, so the possibility remains. Another variable is that the expected price of Molnupiravir is set at about 830,000 won ($700). As a result, the current market for oral treatments for COVID-19 is expected to form from about 7 trillion won (6 billion dollars) to about 8 trillion won (7 billion won).
