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- 2026-05-01 00:25:47
- Policy
- Bill for consigned manufacture of advanced biologics
- by Lee, Jeong-Hwan Feb 06, 2024 06:10am
- A bill is being promoted to allow advanced biological products such as cell and gene therapies Kymriah and Zolgensma to be manufactured by government-authorized consignment organizations and facilities. The goal of the bill is to expand the domestic production infrastructure for advanced biological products to reduce the time and cost of manufacture while increasing patient access to treatments. Rep. Hye-sook Jun of the Democratic Party of Korea submitted a bill for the partial amendment to the ‘Act on the Safety and Support for Advanced Regenerative Medicine and Advanced Biological Products’ as representative. Cell and gene therapies are highly complicated and expensive to produce as they require the harvesting of patient cells, but if developed successfully, it is highly effective in treating serious and incurable diseases and are therefore attracting attention in the global pharmaceutical market. Currently, most of the cell and gene therapies used in Korea are developed by foreign pharmaceutical companies, and it takes a lot of time and money to send the patients’ cells overseas, manufacture them into therapeutic products, and then bring them back to Korea to be administered to patients. If the therapies can be manufactured in Korea, it will be possible to reduce this time and cost, thereby increasing patient convenience. Rep. Jun explained that she saw the need for this bill in this aspect. In particular, Jun pointed out that even if Korean companies succeed in developing and receiving approval for homegrown cell and gene therapies in the future, it is not realistically possible for all domestic cell and gene therapy developers to build and operate large cell processing facilities for manufacture. Therefore, to encourage the development and use of cell and gene therapies in Korea, Jun explained that it is necessary to reorganize the system and allow proactive consigned manufacture of cell and gene therapies. For this, Jun introduced a bill to allow advanced biological products to be manufactured on consignment by institutions and facilities authorized by the Ministry of Food and Drug Safety. Jun said, "The bill aims to increase patient access to treatment by reducing the time and cost of developing cell and gene therapies as well as time to administering it to patients. It also aims to expand the domestic infrastructure for the manufacture of advanced biopharmaceutical drugs."
- Policy
- Reimb of Enhertu, Ilaris pass DREC review…deemed adequate
- by Lee, Tak-Sun Feb 05, 2024 05:53am
- High-priced drugs such as Enhertu and Ilaris have passed the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee review. This means that they have crossed the 80% mark to reimbursement, as the drugs can now be covered by health insurance after negotiating drug prices with the National Health Insurance Service. The Health Insurance Review and Assessment Service (HIRA) announced that it recognized the adequacy of reimbursement for Enhertu Inj and Ilaris at the 2nd DREC meeting that was held on the 1st. Enhertu Inj is indicated for HER2-positive breast cancer and HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. Although it has a high cost, of over KRW 5 million per single administration, it has demonstrated higher survival rates than existing breast cancer treatments. The company had difficulties passing the reimbursement evaluation process for Enhertu due to differences in views with insurance authorities, as the authorities were concerned about financial losses due to the high cost of treatment. This was why the committee failed to conclude the first DREC meeting that was held in January. However, it seems that DREC was unable to delay the decision-making process any longer due to the patient’s continued call for its coverage and the favoring public opinion. Ilaris, which was also deemed adequate for reimbursement with Enhertu at the 2nd DREC meeting, is a treatment for a hereditary recurrent fever syndrome, which affects only 13 patients in Korea. During the NA audit in October, HIRA president Jung-Gu Kang announced that he would make efforts to reimburse the drug as soon as possible. Ilaris is also a high-priced drug that costs KRW 8 million to KRW 100 million per year with once every 8-week dose. However, Ilaris was recognized as appropriate for reimbursement on the condition that the pharmaceutical company submit further evidence in the future. Meanwhile, reimbursement of 7 morning sickness treatments for pregnant women, including Diclectin Enteric Coated Tab, was also deliberated at the meeting. The result was a conditional approval of reimbursement adequacy, deeming the drugs reimbursable if the companies accept a price below the assessed amount.
- Policy
- Price of drugs listed in 2002-2006 may be adjusted next year
- by Lee, Tak-Sun Feb 02, 2024 12:28pm
- The Health Insurance Review and Assessment Service will be selecting drugs subject to reimbursement adequacy reevaluations in 2025. The drugs to be reevaluated next year are expected to be those listed from 2002 to December 2006, before Korea implemented the Positive List System. According to industry sources, the Drug Reimbursement Evaluation Committee met on February 1st to discuss the targets for the 2025 drug reimbursement adequacy reevaluations. After the committee selects the targets, the decision is expected to be finalized through the Health Insurance Policy Deliberation Committee the same month. The target ingredients are expected to be disclosed after the DREC or HIPDC’s decision. However, drugs listed from 2002 to December 2006 will likely be subject to reevaluation in 2025. This is because the 2024 reevaluations are being conducted for 6 ingredients listed from 1998 to 2001. The reevaluations are being conducted sequentially in order of the year of reimbursement. Since the Positive List System was implemented in December 2006 as part of the drug cost rationalization plan, it is expected that drugs listed under the Negative List System will first be subject to reassessments. Subsequently, drugs subject to reevaluation among those listed after the implementation of the PLS are expected to be decided upon through separate discussions. Meanwhile, thioctic acid, pranlukast hydrate, itopride hydrochloride, sarpogrelate hydrochloride, levodropropiaine, mosapride, and formoterol fumarate hydrate are subject to reevaluations in 2024. Of these, mosapride has the largest insurance claims amount, which amounts to KRW 130 billion a year. Sarpogrelate hydrochloride has the second largest amount of KRW 110 billion a year.
- Policy
- Referencing lowest A8 price will result in a supply crisis
- by Nho, Byung Chul Jan 29, 2024 06:05am
- Health authorities and the pharma-bio industry are at an impasse over the implementation of 'A8 external reference pricing reassessments.’ Engaged in a tug-of-war, the two parties have difficulty finding common grounds. The Ministry of Health and Welfare, the Health Insurance Review and Assessment Service, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, and the Korea Research-based Pharmaceutical Industry Association, have been meeting since the end of 2022 and have completed the 5th round of negotiations as of this month, but they have been unable to reach a consensus, with each being busy making mutual claims. The ‘reassessment for the A8 external reference pricing system’ was proposed to add Canada to the existing list of A7 countries (U.S., U.K., Germany, Switzerland, Italy, France, and Japan) as a detailed reference point for drug price reevaluations. During initial discussions, there was talk of expanding the number of countries to A9, to include Australia and Canada, but Australia was removed due to strong public opinion that the 2 countries with the lowest drug prices were selected to cut prices. The issue that remains in the restructured external reference pricing system is that health authorities are sticking to using the lowest listed prices among A8 countries, while the industry believes using the average of the highest listed price is best. The average and median values, excluding the upper and lower extremes and U.S. drug price, are also considered options but are not on the table. Following a comprehensive discussion process scheduled for the end of next month, health authorities are now looking to implement the program as soon as 2025 after an appeal process in the middle of this year. Initially, the A8 external reference pricing system was planned to be applied only to diabetes, hypertension, and hyperlipidemia drugs, but there always remains a possibility that it could be extended to virtually all drugs, including anticancer drugs. If the health authorities adhere to their original proposal, the ramifications of its megatonne drug price cut are self-evident. Moreover, it is likely to add fuel to the fire of essential drug supply disruptions that arose due to the unstable price of drug substances due to the aftermath of the COVID-19 pandemic and the Ukraine-Russia war. In addition, the A8 drug price reference countries do not have a large number of data submission drugs or salt-modified drugs compared to Korea, therefore major price cuts for these drugs are also expected. An industry insider said, "Following the bulk drug price reduction in 2012 and the linkage of drug prices upon fulfillment of the ‘self-bioequivalence tests-DMF registration' requirement in 2019, there is a lack of objective basis for conducting drug price cuts using reference countries overseas that is currently being planned by the health authorities. Imposing such a policy is nothing short of an invasive act against domestic medicines and could lead to a serious industry contraction." As it is common for drug prices to be determined by taking into account all the specificities of the country's economy, society, and culture, therefore, it is not common sense to use the low drug prices set in one or two countries as a reference or standard. In addition, according to some research service data, Korea's generic price is 53.55% of the original price, ranking fourth among OECD countries, so it is difficult to say that Korea has a high drug price structure. The drug price reevaluation using the A8 external reference pricing system had been sparked by a booklet that had been published by Canada’s Patented Medicine Price Review Board, which was released at the 2022 National Assembly Audit, but the booklet seems to be an intuitive interpretation that is far from a precise report, as it lacks the correction values of domestic new drug and generic drug prices at that time and now. In other words, concluding that domestic generic drug prices are higher than those of external reference countries is highly likely to cause distortions in the drug pricing system, as it does not consider how the generic drug prices were set to the high insurance drug prices the multinational pharmaceutical companies received at the time of initial listing. Another industry insider said, "There is a strong sentiment that we should expand the drug price referencing to Canada and use it as a reference point for reevaluation. If the application of the system is expanded to include new drugs introduced from abroad and homegrown new drugs, this may not only discourage R&D efforts but also deprive patients of the right to treatment."
- Policy
- Remote GMP inspections not recognized from April
- by Lee, Hye-Kyung Jan 29, 2024 06:05am
- The GMP inspections, which were temporarily allowed non-face-to-face due to the difficulty of on-site evaluations during the COVID-19 outbreak, are gradually returning to ordinary procedures. After switching the pre-approval GMP item inspections back to full on-site inspections in December last year, the Ministry of Food and Drug Safety (MFDS) now decided to recognize only on-site reports rather than the written reports, which had been recognized for a limited time due to difficulties in conducting on-site inspections. From April 25, the only written reports the MFDS will accept are vendor audit results from on-site inspections. In order to import active pharmaceutical ingredients (API), the company must submit a GMP certificate of API issued by the government or public institution of the country of manufacture. However, when the company seeks to receive a supply of the APIs for the manufacture of finished pharmaceutical products, vendor audit results based on an on-site inspection of the finished pharmaceutical product manufacturer are also recognized as a GMP certificate. Due to the COVID-19 pandemic, It had been difficult to conduct on-site inspections, which was why the MFDS had recognized written inspection result reports. The MFDS stated, "During the COVID-19 pandemic, it was difficult to conduct on-site inspections, which was why we temporarily recognized written inspection reports. However, with the end of the COVID-19 pandemic, we will give a 3-month grace period and then recognize only on-site GMP inspection reports from April." Previously, the MFDS had replaced GMP on-site inspections with remote inspections such as by reviewing PIC/S report data during the COVID-19 outbreak, but since September last year, it has been phasing out the flexibilities that were put in place and started on-site inspections for some items, new drugs, or aseptic preparations, conducting a phased transition back to on-site inspections. As regulatory agencies such as the U.S. and PIC/S have announced that non-face-to-face inspections cannot replace on-site inspections, the MFDS is also converting some parts of the non-face-to-face inspections back to on-site inspections.
- Policy
- Lilly’s UC drug Omvoh is soon to be approved in KOR
- by Lee, Hye-Kyung Jan 26, 2024 05:51am
- Lilly's ulcerative colitis treatment Omvoh (mirikizumab-mrkz) is nearing approval in Korea. Omvoh received U.S. FDA approval in October last year and settled as the first and only interleukin-23p19 (IL-23p19) antagonist for the treatment of moderately to severely active ulcerative colitis (UC) in adults. According to industry sources, the Ministry of Food and Drug Safety recently completed a safety and efficacy review for Omvoh’s marketing authorization in Korea. MFDS’ completion of the safety and efficacy review means that marketing authorization for the drug is imminent. Omvoh is the only ulcerative colitis treatment that selectively binds to the p19 subunit of IL-we and inhibits interaction with the receptor. Ulcerative colitis is a chronic inflammatory disease of unknown cause characterized by inflammation localized in the mucosal or submucosal layers of the large intestine, and the p19 subunit plays an important role in the development of inflammation associated with ulcerative colitis. The FDA’s approval was based on results from the LUCENT program, which included two randomized, double-blind, placebo-controlled Phase 3 clinical trials consisting of LUCENT-1 - a 12-week induction study (UC-1) - and LUCENT-2 - a 40-week maintenance study (UC-2) for 52 weeks of continuous treatment. All patients in the LUCENT program had past treatments, including biological treatments, that did not work, stopped working, or that they could not tolerate. After 12 weeks of treatment with Omvoh, 65% of patients achieved clinical response and 24% achieved clinical remission compared to placebo (43% and 15%, for clinical response and clinical remission, respectively). Among those who achieved clinical response at 12 weeks, one-half (50%) achieved steroid-free clinical remission at one year, compared to placebo (27%). Per a post-hoc analysis, 99% of patients who achieved clinical remission at 1 year were steroid-free. Patients in steroid-free clinical remission were steroid-free for at least 3 months prior to the end of the 52-week assessment. In 2018, a Phase III trial for Omvoh was approved by the Ministry of Food and Drug Safety under the same details as the LUCENT program, and completed in Korea. Omvoh was approved in Japan in March and in Europe in June last year.
- Policy
- P2T for LG Chem’s obesity drug LB54640 approved in Korea
- by Lee, Hye-Kyung Jan 26, 2024 05:51am
- LG Chem’s generic obesity treatment, 'LB54640,' has been approved for a Phase II clinical trial in Korea. On the 24th, the Ministry of Food and Drug Safety approved LG Chem’s application to initiate a randomized, placebo-controlled, double-blind Phase II study with an open extension period to evaluate the efficacy and safety of LB54640 in patients with acquired hypothalamic obesity. Hypothalamic obesity is a type of syndromic obesity that results from abnormalities in endocrine, hypothalamic, genetic, frontal, and metabolic systems. It is classified as a rare form of obesity that occurs in approximately 1% of pediatric obesity patients. The Phase II study will be conducted at Seoul National University Hospital until March 1, 2025. Global clinical trials for LB54640 had previously been approved in the U.S. and Europe. LB54640 is a once-daily (oral) treatment for obesity that targets the action pathway of the MC4R (melanocortin-4-receptor) protein, which is known to deliver satiety signals. According to LG Chem, results of the Phase I study showed LB54640’s potential with up to 3% reduction in body weight in the highest-dose group over 28 days of treatment. The drug received orphan drug designation from the U.S. Food and Drug Administration (FDA) as a treatment for LEPR deficiency in September 2020 and for POMC deficiency in June 2022. Meanwhile, LG Chem signed an agreement with Rhythm Pharmaceutical to transfer the global development and marketing rights for its orphan drug LB54640 on the 5th. The agreement, which amounts to USD 350 million (KRW 400 billion), includes an upfront payment of USD 100 million (KRW 130 billion). Upon successful commercialization, the company will receive separate sales royalties based on annual sales.
- Policy
- MOHW “Drug pricing for listed drugs is set to be reduced"
- by Lee, Jeong-Hwan Jan 26, 2024 05:50am
- The Ministry of Health and Welfare (MOHW) In February, the government will post the outcomes of notifications of the second-round review & assessment, analyzing the upper limit of standards and requirements associated with the drug pricing reduction of currently listed generics. The adjusted prices will take effect on March 1st. The drug pricing reduction related to market-based actual transactions will be determined in the next round of implementation due to an incomplete review of national essential drugs and drugs in short supply. On the 24th, the Ministry of Health and Welfare (MOHW) representative explained the notifications mentioned earlier during a meeting with KSPANEWS. The MOHW initially planned to implement the drug pricing reduction in January, following re-assessment of reimbursement listed drugs and a survey of prices in actual transactions. However, this implementation was postponed. The MOHW has decided to implement the drug pricing reduction, reflecting the outcomes of the second-round reassessment of listed drugs, beginning on March 1st, following the notification process in February. Yet, the reduction related to the actual transaction will be postponed until further notification. There are approximately 1,000 items related to drug pricing reductions for listed drugs. However, the MOHW has clarified that considering the significant changes in drug pricing for a substantial number of drugs, they have included a preparatory period to minimize misunderstandings between pharmacies, marketing companies, and pharmaceutical companies. The MOHW has sought the opinions of companies to prevent the recurrence of the confusion that occurred during the first-round reevaluation of drug pricing reduction for listed drugs. In the initial round, the simultaneous processing of drug pricing reduction related to the volume-price linkage negotiations led to confusion among pharmacies and pharmaceutical companies. "We have not yet finalized the implementation date of price reduction associated with actual transactions due to ongoing reviews related to essential drugs and concerns surrounding the drugs in short supply," a representative of MOHW explained.
- Policy
- Chong Kun Dang cuts price of its Lucen BS by half
- by Lee, Tak-Sun Jan 25, 2024 05:50am
- Chong Kun Dang is offering a bargain price for its biosimilar. The company has decided to cut the price of its 'Lucen BS', a biosimilar of the macular degeneration treatment Lucentis (ranibizumab, Novartis), by half from next month. As a result, the price difference between it and the original product, as well as it and Samsung Bioepis’s biosimilar, has widened significantly. According to the industry on the 23rd, Chong Kun Dang will voluntarily reduce the insurance price ceiling of its biosimilar 'Lucentis' by half from next month. Accordingly, the price of Lucen BS Inj 10mg/ml and Lucen BS Prefilled Syringe will be reduced from KRW 300,000 to KRW 150,000. Lucen BS was launched in January last year and is the first biosimilar of the macular degeneration treatment Lucentis in Korea. At the time, Lucen BS and Samsung Bioepis ‘Amelivu’ were listed simultaneously. The two companies set the price of their generic drugs at a much lower price than the original, at a price lower than the calculated amount. At the time of its reimbursement listing in January, the price of Lucen BS was KRW 300,000, which was 37% of the original drug’s price at the time. The price difference between it and the original drug as well as Samsung Bioepis’s product has become even greater now that Lucen BS’s price has been cut by half. Currently, the original Lucentis costs about KRW 580,000 per vial, while the biosimilar Amelivu costs KRW 350,000 per vial. With Lucen BS’s price set at KRW 150,000, patients will be able to access the biosimilar at 25% of the original price. Lucen BS’s price difference with another biosimilar, Amelivu, is KRW 200,000, making Lucen BS even more competitive in the market. Chong Kun Dang conducted a Phase III trial for Lucen BS from September 2018 to March 2021 at 25 hospitals, including Seoul National University Hospital on a total of 312 patients with neovascular (wet) age-related macular degeneration. Analysis of the primary efficacy endpoint, which compared the best-corrected visual acuity (BCVA) in 3 months after drug administration, showed that the proportion of patients with vision loss of less than 15 letters was 97.95% (143/146 patients) in the Lucen BS arm and 98.62% (143/145 patients) in the original drug arm, meeting the range of equivalence between the two drugs.
- Policy
- Handok-Sanofi launches hypertension combo drug Aprovasc
- by Lee, Tak-Sun Jan 24, 2024 05:45am
- Aprovasc, a hypertension combination drug co-developed by Handok and Sanofi Aventis Korea, will enter the market in earnest with reimbursement on the 1st of next month. The product is a combination drug of ARB-class irbesartan, which was developed by Sanofi, and CCB-class amlodipine besylate. This is the first irbesartan-amlodipine combination released to the market. It was approved in Korea in November last year and completed the reimbursement listing process time. According to industry sources on the 23rd, three dosage forms of Aprovasc Tab will be listed starting on Feb. 1. The drug is indicated for essential hypertension in adult patients in whom blood pressure is not adequately controlled on irbesartan or amlodipine monotherapy. Aprovasc received premium pricing as an incrementally modified new combination drug and for being a product of Handok’s, a company designated as a Korea Innovative Pharmaceutical Company. As a result, Aprovasc Tab 300/5mg will be listed at KRW 119.2/tablet. Aprovasc Tab 150/5mg and Aprovasc Tab 150/10mg also received a 68% premium in their pricing, but Handok listed them at lower prices, at KRW 854 and KRW 988, respectively. Aprovasc has gained industry attention as the two companies - Sanofi and Handok had partnered on the drug from development to sales. irbesartan (brand name: Aprovel) is an ARB-class hypertension drug developed by Sanofi. The two companies signed a license agreement in October 2019 for the development, manufacture, and licensing of Aprovasc in Korea. Since then, Handok has conducted domestic clinical trials and confirmed superior blood pressure-lowering effects compared with irbesartan monotherapy in two Phase III trials. The two companies will also collaborate on sales activities. Handok will be in charge of the manufacturing, and the two companies will copromote the drug in the highly competitive domestic hypertension combination drug market. Currently, the ARB+CCB hypertension combination drug market is crowded with products such as Hanmi Pharmaceutical’s Amosartan, Boehringer Ingelheim’s Twynsta, Novartis’s Exforge, Daiichi Sankyo’s Sevikar, and Chong Kun Dang’s Telminuvo that post annual prescriptions (based on UBIST) of more than KRW 50 billion. With such viable competitors already occupying the market, the industry expectation is that Handok and Sanofi will have difficulty generating high sales in the short term as a late entrant. However, the industry also predicts that the product will be able to secure basic demand from patients who had difficulty controlling their blood pressure while being on Aprovel, as the irbesartan monotherapy drug Aprovel is the best-selling antihypertensive drug with an annual prescription volume of KRW 10 billion.
