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- 2026-07-03 08:28:57
- Policy
- 76 generics for DM tx Jardiance Duo have been approved
- by Lee, Hye-Kyung Apr 06, 2022 06:06am
- Generics for Jardiance Duo, a diabetes treatment complex affiliated with SGLT-2 inhibition of Beringer Ingelheim, have been approved. On the 4th and 5th, the MFDS approved 76 items of Empagliflozin/Metformin HCl from 26 pharmaceutical companies. Generics for Jardiance Duo are commissioned by Dongkoo Bio. Empagliflozin/ Metformin for the original Jardiance Duo, which expired on March 11, 2025, but Chong Kun Dang succeeded in avoiding the patent by challenging the crystalline patent of Jardiance and Jardiance Duo, which ends on December 14, 2026. In January 2018, it was the first Korean company to request a passive judgment on the scope of rights, and the decision to establish some of them was confirmed in June 2019. Later in November last year, unlike Jardiance Duo, it was first licensed as CKD Empagliflozin Metformin, which combines Empagliflozin, Metformin HCl with L-Proline, a type of amino acid, and obtained generic for exclusivity. However, Chong Kun Dang's exclusive sale period is from August to December this year, and competition in the diabetes complex market is expected to intensify as 76 items that have been approved have also obtained generic for exclusivity. According to the drug market research firm UBIST, sales of Jardiance was 40.8 billion won last year, up 10% from 36.9 billion won in 2020, and Jardiance Duo also recorded 24.4 billion won, up 47% from 16.6 billion won a year earlier. The pharmaceutical companies that have been approved for Jardiance Duo's generics are Kookje, Hutecs , Shin Poong, Daehan Nupharm, Korea Medica, Guju, Theragen Etex, Aju, Samsung, Daewon, Dongkoo Bio, Jin Yang, SCD Pharm, Samik, Dongkwang, PharmGen Science, Myungmoon Pharm, Withus Pharmaceutical, Il Yang, Young Poong, Hana, JW Shinyak, Daewoong Bio, Dae Hwa, Daewoo, and Ahn-Gook.
- Opinion
- [Reporter’s View] Still no news on SGLT-2 combo reimb.
- by Eo, Yun-Ho Apr 06, 2022 06:06am
- Still no news nor progress has been made on the discussions regarding reimbursement of combination therapies using SGLT-2 inhibitors. After a long three years, the Health Insurance Review and Assessment Service called for a diabetes expert meeting to discuss expanding reimbursement of SGLTL-2 inhibitors in September last year. At the meeting, the experts saw consensus on integrating and accepting the ‘class effect’ of DPP-4 and SGLT-2 inhibitor combinations as well as three-drug combinations for reimbursement. Such results had sparked hope that the non-reimbursed combination drugs would also be finally listed for reimbursement. But that was the last spark of hope. The year has passed and April has come with no news on the reimbursement of SGLT-2 combos that is now subject to formal review by the Health Insurance Review and Assessment Service. Recognizing the expected efficacy of drugs with the same mechanism of action is an issue that requires consideration. However, with the interests of various experts and pharmaceutical companies clashing, and the opinions of the experts divided, the issue was dealt with case-by-case. However, consistency was the issue for the reimbursement deliberation of SGLT-2 inhibitors. The authorities recognized the class effect of some drugs are recognized regardless of their indication and applied the same reimbursement standard, while other cases of reimbursement for some classes differ by each drug. In 2013, the diabetes society played a leading role in discussing the reimbursement extension of DPP-4 inhibitors and TZD class combos and claimed the need and justification for the extension. The society emphasized the importance of clinical experience and expert judgment over fiscal impact, and the government accepted the expert’s decision based on disease characteristics and drug use experience. What has changed since then? The academic society changed its position on the reimbursement of SGLT-2 inhibitors in 2018 and pushed back the plans for the proposed improvement. Many drugs were expected to be affected by the plan, not only SGLT-2 inhibitors such as ‘Jardiance (empagliflozin),’ ‘Forxiga (empagliflozin),’ ‘Suglat (ipragliflozin),’ ‘Steglatro (ertugliflozin)’ but DPP-4 inhibitors such as ‘Januvia (sitagliptin),’ ‘Galvus (vildagliptin),’ ‘Trajenta (linagliptin),’ ‘Zemiblo (gemigliptin)’ were affected. However, the amendments that were made thereon were encouraging. The society had reached a consensus and submitted an opinion that reimbursement should be extended to combination therapies, which was accepted by the Ministry of Food and Drug Safety. The MFDS then announced it would ‘simplify’ the diabetes treatment indications in August of the same year, from listing the ingredients to ▲monotherapy or ▲combination therapy, adding momentum. The various movements made had borne fruit. And then the baton was handed over to the government. The SGLT-2 inhibitors are now also subject to PMS. Most of the drugs are required to submit their PMS results between 2023-2024. In other words, the companies only have around a year or two left. For the PMS study, hundreds to thousands of patients need to be recruited and registered. However, due to the characteristic of the diabetes market, it is hard to secure a stable proportion of prescriptions for a non-reimbursed drug. Unless the reimbursement issue is resolved, the companies will not be able to recruit the necessary amount of patients required by the MFDS. Now is the time to conclude this issue once and for all, and decide on extending reimbursement for SGLF-2 inhibitors.
- Policy
- Oral COVID-19 drugs prescribed to 1 in 100 patients
- by Lee, Jeong-Hwan Apr 06, 2022 06:06am
- One out of every 100 confirmed COVID-19 patients were found to have been prescribed oral COVID-19 treatments (Paxlovid·Lagevrio). According to the data NA’s Health and Welfare Committee member Hyun-Young Shin of the Democratic Party of Korea received from the Korea Disease Control Prevention and Control Agency on the 5th, a total of 124,571 patients were administered oral treatments from January 14th to March 26th of this year. A total of 39,747 patients were reported to have been administered the drug at medical institutions. 87.8% of the patients were over the age of 60. Specifically, 35.8% were in their 60s, 24.1% were in their 70s, and 27.9% were 80 years old or older. In particular, one in every 100 confirmed COVID-19 patients was prescribed oral COVID-19 treatments, and the prescription rate for the treatments was higher in non-metropolitan areas than in metropolitan areas. Among non-metropolitan regions, the Gyeongbuk region (1.83%), Honam region (1.55%), and Gangwon region (1.54%) received the most amount of prescriptions with Jeju (0.75%) recording the lowest. NA member Shin said, “We were able to confirm that securing a medical system that allows prescriptions in addition to procuring the treatments is important in Korea. It is necessary to ensure that the processes from prescription, dispensing, to drug delivery are provided in a quick and safe manner while allowing the establishment of clinical data for infectious diseases so that the prescription data can be properly collected and analyzed." Shin added, “To improve Korea’s medical system for the complete recovery of the nation from COVID-19, we need to start addressing the unfinished tasks in this era of infectious diseases now. With 220,000 more courses of COVID-19 treatments soon to arrive, we need to analyze the need for expanding subjects eligible for the use of oral treatments and their effect in more detail to increase the effectiveness of Korea’s COVID-19 response.”
- Policy
- It will not be easy to reflect generic positive list system
- by Lee, Tak-Sun Apr 06, 2022 06:05am
- The NHIS has completed a study of external services that only provides a positive list of excellent generics, but it is not expected to be easy to reflect the policy. This is because the research was promoted by the current government and it is still unreasonable to lead to policies. On the 31st of last month, the NHIS registered a "research report on the positive list system plan for excellent drugs" in the management information disclosure system of public institutions. However, the research results are set to be private, so it is not known what conclusions are contained. This study was conducted by Professor Bae Eun-young of Kyungsang National University College of Pharmacy. The list of published research results ▲ Current status and problems of the drug market after patent expiration, ▲ Review of foreign drug screening systems, ▲ Results of interviews with stakeholders on drug screening standards and methods, ▲ Drug screening model after patent expiration. Inferring the results through this, it is interpreted that a generic drug screening model suitable for the reality of Korea was proposed. Some foreign countries discriminate against generic drugs by dividing them into grades. In the case of Vietnam, only high-grade generic drugs are eligible for bidding. Regarding the non-disclosure of the study, Jeong Hae-min, head of the NHIS Pharmaceutical Management Office, said, "This study is a basic study focusing on foreign cases related to the generic drug screening model, and there are still things to be reviewed." The study was reportedly conducted under the direction of Kim Yong-ik, former chairman of The NHIS, who is progressive. Therefore, there is a possibility that the next conservative government will postpone the promotion. Moreover, since strong opposition from the domestic pharmaceutical industry, which has a high proportion of generic drugs, is expected, it is also expected to be cautious about reviewing policy reflection.
- Company
- Sales of AZ COVID vaccine increased 32% to 655.3 billion won
- by Apr 06, 2022 06:05am
- AstraZeneca Korea surpassed 600 billion won in sales last year by supplying the COVID-19 vaccine. According to an audit report by AstraZeneca Korea, the company recorded 655.3 billion won in sales last year. The figure is up 31.6 percent from the previous year's 498.1 billion won. Operating profit was 26 billion won, up 7.5% from 24.2 billion won a year earlier. It is analyzed that the increase in operating profit was relatively small because there was little difference between the purchase amount and domestic sales amount purchased globally. AstraZeneca Korea, which has improved its performance with anticancer drug Tagrisso, saw its performance jump significantly last year when it supplied the COVID-19 vaccine AZD1222 in Korea. After gradually increasing sales to 383.1 billion won in 2018, 438.9 billion won in 2019, and 498.1 billion won in 2020, sales jumped more than 100 billion won last year when the COVID-19 vaccine was introduced in earnest. AstraZeneca started researching vaccines with a research team at Oxford University in the UK as COVID-19 spread around the world. In particular, it received attention by signing a contract with SK Bioscience, a Korean company, to produce the COVID-19 vaccine on consignment. Last year, SK Bioscience commissioned the production of AstraZeneca vaccine extract and the complement and supplied them to the global and domestic markets. The Korean government signed a purchase contract with AstraZeneca early last year and introduced the vaccine in earnest. At the beginning of the inoculation, when the supply and demand of the Pfizer vaccine were not smooth, AstraZeneca supplied most of the supplies. Although it received the EUA around the same time as Pfizer, the increase in AstraZeneca sales is relatively small. In the case of Pfizer Pharmaceutical Korea, which supplied the COVID-19 vaccine, sales reached a record high of 1.69 trillion won last year. The figure increased by 332.3% from 391.9 billion won in the previous year. Pfizer Pharmaceutical Korea generated about 1.3 trillion won worth of vaccine sales. The difference in vaccine supply had a significant impact on the performance of the two companies. This is because the use of the Astrazeneca vaccine has gradually declined as the number of vaccinations in Korea has been limited due to rare side effects, and the volume of modern and Pfizer vaccines has increased. According to the Korea Centers for Disease Control and Prevention, the total amount of Astrazeneca vaccinations over the first to third rounds is 20.32 million doses, which is one-third of Pfizer's 74.23 million doses. In the first inoculation, about 25% of the total were vaccinated against Astrazeneca, but in the third inoculation, only 4% were vaccinated against Astrazeneca. Vaccine prices have also led to differences in sales. According to the company's stance that it will not make profits from the COVID-19 vaccine, the price of the AstraZeneca vaccine was set at $4 per dose, the cheapest. It is only one-sixth the price of a Pfizer vaccine ($24).
- Company
- Sales of MSD in Korea exceeded 500 billion won
- by Apr 05, 2022 09:32am
- MSD Korea surpassed 500 billion won in sales last year. Keytruda's effect increased 1% year-on-year. Analysts say that it will be able to quickly recover its past sales of 800 billion won before Organon's spin-off. According to MSD audit report, the company recorded 541.9 billion won in sales last year. The figure is up 11.8% from the previous year's 486.8 billion won. During the same period, operating profit shifted from a deficit of 5.8 billion won to a surplus of 58 billion won. Sales of Keytruda, an immuno-cancer drug of MSD Korea, are evaluated to have been good. Keytruda's sales were not specified, but according to pharmaceutical research firm IQVIA, Keytruda surpassed 200 billion won in annual sales for the first time last year. The figure rose 28.5% to 2.1 billion won from the previous year's 155.7 billion won. The growth of Gardasil 9 and others also contributed to the expansion of sales. Based on IQVIA, Gardasil 9 recorded 72.6 billion won last year, up 70.9% from 42.5 billion won a year earlier. Another representative item of MSD Korea, the Januvia, reached 171 billion won in outpatient prescriptions last year. The expansion of MSD's performance is expected to continue in the future. This is because Keytruda's indication continues to expand, and from this year, it will be paid in the primary treatment of non-small cell lung cancer and the secondary treatment of Hodgkin's lymphoma. In fact, even when it was first listed in August 2017, Keytruda's sales rose vertically from 10 billion won to 100 billion won. At this rate, it is expected that the scale before the organon spin-off will be restored within a few years. According to an audit report by MSD Korea two years ago, when the obligation to disclose audit reports of limited companies was implemented, the sales of all companies of Organon spin off are estimated to be about 800 billion won. In the calculation of discontinued business profit and loss due to the division, the sales of organon products in the sales of organon products amounted to 326.8 billion won as of 2019. As of 2019, product sales of MSD accounted for 98% of total sales, and product sales are total sales. At that time, MSD's total sales amounted to 471.6 billion won. Operating profit turned into a surplus last year as other sales increased and management costs due to spin-off decreased. MSD Korea lost 18.4 billion won in 2019 and 5.8 billion won in 2020. Last year, other sales rose 42.8% year-on-year to 15.8 billion won, while sales and administrative costs fell 2.9% to 97.2 billion won. MSD Korea said, "Representative items such as Keytruda, Gardasil 9, and Januvia have driven sales growth, and we invested about 74.6 billion won in clinical research last year, up 33% from the previous year, which accounts for 13% of total sales."
- Company
- Imbruvica fails CDDC twice and reattempts 1st-line reimb.
- by Eo, Yun-Ho Apr 05, 2022 05:59am
- Once again, the blood cancer drug ‘Imbruvica’ is attempting to expand reimbursement to first-line treatment. According to industry sources, Janssen Korea has applied for the reimbursement extension of its Imbruvica (ibrutinib) as a first-line treatment for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Leukemia (SLL) to once again attempt at deliberations by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee. Imbruvica’s first-line indication was unable to pass deliberation by the CDDC twice, one of which was held in October last year. The company was able to receive reimbursement extensions to the second line after being listed through the PE exemption pathway but is having trouble extending its indication further into the first line. Therefore, how Janssen will progress discussions on reimbursement based on what adjustments remain to be seen. Imbruvica is a first-in-class oral Bruton's Tyrosine Kinase (BTK) inhibitor that is taken once daily. With its oral formulation, the drug has the strength of being able to be administered in the outpatient setting. Since it was approved in April 2018, the drug is being used as ▲ a second-line treatment for adult patients with CLL, ▲monotherapy for the treatment of adult patients over the age of 65 with previously untreated CLL, ▲in combination with obinutuzumab for the treatment of adult CLL patients over the age of 65 or those who have comorbidities or at high-risk and those under the age of 65 with previously untreated CLL. Meanwhile, CLL is a type of blood cancer that occurs mainly in adults over the age of 60, characterized by increased production of mature but dysfunctional B lymphocytes Around 120 to 130 patients are newly diagnosed with CLL every year, and 60-70% of the CLL patients in Korea are discovered in a state that does not require treatment. Like its name, this “chronic” condition progresses slowly, sometimes insignificantly for several years.
- Opinion
- [Reporter's view] Commercialization of innovative new drugs
- by Lee, Tak-Sun Apr 05, 2022 05:58am
- #iLast month, immuno-cancer drug Keytruda was listed as the primary treatment for non-small cell lung cancer patients, and this month, the first chemical antigen receptor-T cell therapy (CAR-T) Kymirah received insurance benefits. Innovative treatments using patient immunity have succeeded in commercializing them in Korea one after another. The registration of the two drugs is significant. In terms of health insurance finance, the entry of ultra-high-priced drugs became a reality, leaving homework on rational financial management. From the perspective of medical staff and patients, the emergence of new paradigm drugs that go beyond the limits of existing treatments is raising expectations to increase the treatment effect. Immuno-cancer drugs such as Keytruda block the interaction of certain proteins that deactivate immune cells (T cells), making T cells more aware of cancer cells. CAR-T collects the patient's immune cells, mounts special receptors, puts them back into the patient's body, and finds and kills cancer cells that avoid attacks from T cells. While existing anticancer drugs directly attack cancer cells, there is a big difference in that immuno-cancer drugs or CAR-T treat cancer using the immune system. Moreover, it is in the spotlight as a next-generation drug that will lead chemotherapy in the future as it proves its high therapeutic effect in certain areas. Although next-generation drugs with such high therapeutic effects are expensive, it is encouraging that they have been commercialized in Korea. It is very unfortunate that the technology gap with the global market is gradually widening when looking back on the domestic pharmaceutical industry, which the state promotes as a future growth engine. Domestic pharmaceutical and bio companies are also developing immuno-cancer drugs and CAR-T, but they are still in the stage of seeking commercialization success. There is a big difference in level from Big Pharma, which has already completed commercialization and has grown into the highest-ranked drug. Contrary to investors' expectations, which are driven to pharmaceutical and bio stocks only by the possibility of development, it is necessary to calmly realize that the domestic pharmaceutical and bio industries are falling further behind. The new government also intends to actively invest in the pharmaceutical and bio industries. However, there seems to be no specific way to invest in an industry with any competitiveness. The current government and the new government also seem to focus solely on finding domestic pharmaceutical companies as a consignment production destination for overseas development COVID-19 vaccines, with biosimilars jumping into large companies. The government's diagnosis of the domestic pharmaceutical industry is to realize that it lacks thorough reflection than cheers and expectations for short-term performance. If there were mid- to long-term support for cell therapy when the world's first cell therapy was born in the early 2000s, wouldn't it have imitated CAR-T?
- Product
- Lagevrio prescriptions exceed 2,000… Paxlovid's up 25.6%
- by Kang, Shin-Kook Apr 05, 2022 05:58am
- The number of oral COVID-19 treatment Largevrio’s prescriptions has exceeded 2,000 in only 5 days since it was supplied to pharmacies in Korea. Also, the number of total Paxlovid prescriptions has exceeded 150,000 courses. According to the Korea Disease Control and Prevention Agency on the 1st, a total of 150,321 prescriptions were made from January 14th to the 31st of this month. This is a 25.6% increase from 118,738 prescriptions made the previous week (week of March 24th). By subjects of Paxlovid use, ▲121,676 were at-home treatment cases, ▲1,312 residential treatment center cases, ▲1,312 Infectious Disease Hospital cases, ▲1,052 others (military camp support, etc.) The more newly introduced Largevrio was prescribed 2,110 times. Among those, 1,835 were used at home, followed by 261 at Infectious Disease Hospitals and 14 at residential treatment centers. 100,969 courses of Paxlovid and 98,690 courses of Lagevrio remain in stock in Korea. The courses of Paxlovid left in stock in reach region are as follows: ▲Seoul 11,231 ▲Busan 3,987 ▲Daegu 2,542 ▲Incheon 3,685 ▲Gwangju 1,455 ▲Daejeon 1,271 ▲Ulsan 1,077 ▲Sejong 164 ▲Gyeongi-do 10,449 ▲Gangwon-do 2,679 ▲Chungcheongbuk-do 1,891 ▲Chungcheongnam-do 2,623 ▲Jelloabuk-do 1,998 ▲ Jelloanam-do 2,693 ▲Gyeongsangbuk-do 2,268 ▲Gyeongsangnam-do 3565 ▲Jeju-do 971 ▲Central 46,420 The courses of Lagevrio left in stock in each region are as follows: ▲Seoul 5,267 ▲Busan 1,779 ▲Daegu 874 ▲Incheon 1,552 ▲Gwangju 461 ▲Daejeon 693 ▲Ulsan 359 ▲Sejong 187 ▲Gyeongi-do 4,806 ▲Gangwon-do 1,230 ▲Chungcheongbuk-do 1,259 ▲Chungcheongnam-do 1,590 ▲Jelloabuk-do 755 ▲Jelloanam-do 1,276 ▲Gyeongsangbuk-do 1,089 ▲Gyeongsangnam-do 1,262 Jeju-do 345 ▲Central 73,906. Meanwhile, 460,000 courses among the 1,004,000 courses of oral COVID-19 drugs procured by the government will be introduced within this month. 184,000 courses have been already introduced to Korea in March, and the other 276,000 courses are to arrive within April.
- Policy
- Kymriah has been listed, hope of cure
- by Lee, Jeong-Hwan Apr 05, 2022 05:57am
- Patients immediately welcomed the confirmation of health insurance benefits of the acute lymphocytic leukemia and lymphoma CAR-T treatment Kymriah (Tisagencleucel). The patients urged the transition committee of the next presidential post and Yoon Seok-yeol to quickly register new drugs directly related to life as health insurance benefits. On the 31st, Korea Leukemia patient organization said, "The cost of one-time non-reimbursement payment is 460 million won, and the ultra-high-priced Kymriah passed the Health Policy Review Committee and acquired health insurance benefits to even hope for cure." Kymriah will be listed with an upper limit of 360 million won for one-time health insurance from the 1st. The Korea Leuchemia patient organization believes that the appeal of Cha Eun-chan's mother, Lee Bo-yeon, who left for heaven while preparing for Kymriah treatment, and the consent of tens of thousands of Cheongwadae petitioners influenced Kymriah's health insurance registration in a year and a month. The National Human Rights Commission of Korea expressed its opinion to the MOHW to establish a rapid registration system for Kymriah's health insurance system, which was raised by the Korea Leukemia patient organization, also positively affected benefits. The Korea Association of Patients urged the government to manage the risk sharing based on patient-level performance-based risk sharing that applies only to lymphoma, as well as Refund risk sharing and Extended Cap risk sharing, which are conditions for health insurance registration for Kymriah. The Association of Patients argued, "The next presidential transition committee and the Yoon Seok-yeol government should also introduce a rapid registration system for new drugs that show excellent effects without alternative drugs for life-threatening patients such as Kymriah."
