- LOGIN
- MemberShip
- 2026-04-13 10:24:09
- Policy
- MFDS reviews Pfizer COVID-19 vaccine used without dilution
- by Lee, Tak-Sun Dec 02, 2021 05:54am
- On the 30th, the Ministry of Food and Drug Safety had announced that it had started reviewing the approval of Pfizer’s COVID-19 vaccine that does not require dilution – ‘Comirnaty inj. 0.1㎎/㎖ (registered name)’ – after the company applied for the authorization of its import product license. The product contains the same active ingredient as the previously approved Pfizer vaccine, ‘Comirnaty inj,’ but is more user-friendly as it may be used directly without dilution. Its single dose is 30㎍, same as that of the already approved vaccine. The ‘Comirnaty inj. 0.1㎎/㎖’ vaccine that is applying for approval this time comes in a vial with a gray cap, which can be differentiated from the purple cap of the already approved vaccine. The product has already been authorized(approved) in Europe and the U.S. The EU approval came on November 3rd and the US emergency approval on November 19th. The MFDS stressed that it will continue to be committed to the rapid provision of safe and effective vaccines for the Korean people.
- Policy
- Did Mooncare truly reinforce coverage for rare diseases?
- by Eo, Yun-Ho Dec 01, 2021 05:57am
- The voice requesting expanded coverage for patients with rare diseases had been exceptionally high this year in the 4th year of Mooncare. Starting with NA discussions held to enhance coverage of innovative new drugs for rare genetic disorders in May by the NA Health and Welfare Committee member Sunwoo Kang, NA members Byungwon Kang, Woni Kim, Young Seok Seo, Hyunyoung Shin held a public hearing to discuss ways to resolve the medically unattended areas, continuing on the effort to foster a policy environment that in which patients with rare diseases are not marginalized. The main contents that were discussed included the need to apply special exemption of calculation to diseases that are not being covered due to non-designation as a rare disease, and the strong proposal on the need to expand patient access to new rare disease treatments. The discussion continued to the NA Audit, where the NA Health and Welfare Committee member Sunwoo Kang, and members of the ruling and parties including JaeKeun In and Jongseong Lee all unilaterally urged improvement. ◆100% reimbursement rate for rare disease treatments in 2020? However, the public hearing revealed the different views held by the Health Insurance Review and Assessment Service. At the public hearing in May, HIRA presented that the reimbursement rate for rare disease treatments was 85.3%(2016~2020) and 100% in 2020. The numbers indicate that patient access to rare disease treatments is perfect. But if this is the case, why is the voice to expand reimbursement for rare disease treatments continuing to rise? 출처: 희귀유전질환 혁신신약 접근성강화를 위한 국회 토론회The results announced by HIRA were the reimbursement rate of drugs that went through the review and assessment process, not the actual reimbursement rate among all rare disease drugs. In other words, HIRA’s result excluded various factors including rejected and voluntarily withdrawn items. Data studied by the Korean Research-based Pharma Industry Association and the Korea Pharmaceutical and Bio-Pharma Manufacturers Association showed that only 50% of the pharmaceuticals that were designated orphan drugs over the past decade were listed on the reimbursement list. ◆Industry "Need to expand the pharmacoeconomic evaluation exemption system" The two associations joined forces to address the issue. Dailpharm found that KPBMA and KRPIA saw consensus on the need to expand accessibility to rare disease treatments and submitted a statement on the need to expand the pharmacoeconomic evaluation exemption system for rare disease treatments. In the statement, the two associations pointed out the existence of many rare diseases that greatly affect households with indirect medical costs and deteriorate the quality of life of patients but are not qualified for the ‘life-threatening (less than 2 years of life expectancy)’ condition that needs to be fulfilled to be able to utilize the current special exemption system (RSA and pharmacoeconomic evaluation exemption system) Therefore, the associations insisted that evaluating the ‘clinical need’ only with life expectancy does not take into account the characteristics of rare diseases, and diseases that do not meet the ‘less than 2-year life expectancy’ part of the clinical need requirement should also be allowed PE exemption if it is authorized through expedited approval processes abroad (US BTD, EU PRIME). The government had said that it would make efforts to improve access to rare disease treatments in the several public hearing and NA audits, but no specific plan or goal seems to be in place. An industry official said, “The government had recently adjusted the price evaluation criteria of PE exemption drugs by 20% from the lowest A7-adjusted price to improve the price transparency of PE exemption drugs. If the authorities decided to reduce the risk factors in price as such, they also should increase its scope of benefits.”
- Company
- Prevenar 13 sales take ‘roller-coaster’ ride with COVID-19
- by Chon, Seung-Hyun Dec 01, 2021 05:56am
- Sales of the pneumococcal vaccine ‘Prevenar 13’ took a rollercoaster ride in one year, enjoying an upsurge for a short period of time then plummeting in just a single year. The vaccine enjoyed reflective benefits in the early phases of the COVID-19 pandemic but dropped sharply after COVID-19 vaccinations began in earnest. According to the pharmaceutical research institution IQVIA on the 30th, Q3 sales of Prevenar 13 dropped 69.6% compared to the same quarter of the previous year and recorded 7.4 billion won. The cumulative sales by Q3 was 24.9 billion won, also a 58.5% decrease from last year, indicating sluggish sales. Such cases where sales of a product suddenly drops after making unprecedented records just a year ago are rarely observed. ‘Prevenar 13’ is a PCV13 that prevents infection from 13 Streptococcus pneumoniae serotypes. It may be administered to all those aged 6 weeks or older. Prevenar 13 for adults is being distributed in Korea by Chong Kun Dang, and for infants by Korea Vaccine. Quarterly Prevenar 13 sales trend (Unit: 1 million KRW, Source: IQVIA) Sales of Prevenar13 had been steadily rising before the COVID-19 pandemic, recording approximately 10 billion in quarterly sales. Then, its sales surged with the spread of COVID-19. Its sales in Q1 last year was 17.6 billion, a 52.2% increase from the previous year, and rose to 24.2 billion won by Q3 last year. Prevenar13 sold 81.2 billion last year, which was a 64.8% YoY increase. With the claim of some experts that although Prevenar13 cannot prevent COVID-19, it can weaken the pneumonia symptoms of COVID-19 gaining credibility, demand for Prevenar 13 among adults surged temporarily. However, entering this year, its sales had greatly dropped. Sales of the vaccine in Q1 was 9.4 billion won, a 55.5% decrease from the previous quarter, and continued to drop across the following quarters. Analysts believe the rise in demand for Prevenar13 has been watered down due to the prolonged COVID-19 pandemic. Also, the start of COVID-19 vaccinations in earnest had affected the number of other vaccine recipients. Most of the vaccine market for adults is slow this year because of the priority given to COVID-19 vaccines. Also, other analysts see that the temporary surge in demand for COVID-19 vaccines last year lead to the relative gap in demand this year, and the demand for vaccination to reduce pneumonia symptoms has also decreased. The sluggish sales of Prevenar 13 also affected the performance of its distributor, Chong Kun Dang. Chong Kin Dang’s Q3 operating profit fell 23.7% from the same quarter of the previous year and recorded 37 billion won, and its sales recorded 341.3 billion won, a 4.5% YoY decrease.
- Company
- SGLT-2i Jardiance adds chronic heart failure indication
- by Eo, Yun-Ho Nov 30, 2021 05:52am
- The SGLT-2 inhibitor ‘Jardiance’ may now be prescribed for chronic heart failure in Korea as well. According to industry sources, the Ministry of Food and Drug Safety had additionally approved a new indication for Jardiance (empagliflozin),' the SGLT-2 inhibitor used for the treatment of diabetes, to be used for adults with chronic heart failure with reduced left ventricular ejection fraction, regardless of their diabetes status. With the approval, Jardiance became the second SGLT-2 inhibitor following ‘Forxiga (dapagliflozin)’ allowed to be prescribed for chronic heart failure. Forxiga had been approved for the same indication in December last year. Jardiance's heart failure indication was granted Fast Track designation, then approved by the US FDA in June. Its heart failure-related efficacy was confirmed through the Phase III EMPEROR-Reduced clinical trial. Results showed that Jardiance met the primary endpoint, composite of cardiovascular death or hospitalization for heart failure in adults, by reducing the risk by 25% compared to placebo, demonstrating statistical significance. In the analysis of key secondary endpoint, Jardiance reduced the risk of first and recurrent hospitalization for heart failure by 30% and significantly delayed the kidney function index, eGFR, compared to placebo. Also, the sub-analysis results of the EMPEROR-Reduced trial that were presented at the American Society of Nephrology (ASN) ‘Kidney Week 2020’ last year showed that Jardiance’s benefit was consistent across various patient subgroups including patients with severe renal dysfunction, regardless of chronic kidney disease status at baseline in the analysis for the overall population. Meanwhile, Jardiance also made remarkable achievements in acute heart failure. The Phase III EMPULSE study demonstrated Jardiance’s treatment benefit in patients who were hospitalized for acute heart failure. In the EMPULSE study which evaluated the efficacy and safety of Jardiance in adults with and without diabetes that were hospitalized for acute heart failure and have been stabilized, Jardiance demonstrated its clinical benefit by improving all-cause mortality, reducing cases of heart failure, and improving heart failure symptoms.
- Policy
- 30 new drug items reimbursed or extended coverage this year
- by Kim, Jung-Ju Nov 30, 2021 05:52am
- 30 new drugs were newly listed on the reimbursement list or extended reimbursement standards from January this year to this month. Among these, 25 were newly listed new drugs, and 5 were already-listed new drugs that have extended their scope of reimbursement and increased coverage. The reinforced coverage of new drugs this year benefited only 107,000 patients in Korea until last month, but the new listing of Bronpass Tab had increased the number of beneficiaries sevenfold to record 781,725. First, 30 drugs (based on representative dosages) were enhanced coverage being newly listed on the reimbursement list or extended reimbursement standards from January to November. Drugs that were newly listed as of the 1st this month are the severe neutropenia treatment Rolontis Prefilled Syringe inj and acute bronchitis treatment Bronpass Tab. No drugs were extended reimbursement standards this month. The two drugs that were newly listed differ greatly in the expected number of patients in Korea and annual financial requirements. Reimbursement for Rolontis Prefilled Syringe inj is expected to be applied to 4,000 people, costing ₩10 billion. On the other hand, Bronpass Tab is reimbursed for 670,000 people and will be applied to the most amount of patients among all newly listed drugs this year, however, its annual fiscal spending is relatively small, by ₩2.9 billion. This is interpreted as a result of comprehensively reflecting to flexibly expand coverage even for expensive drugs required for a small number of rare diseases and the social maturity to accommodate them. The number of beneficiaries greatly varies due to policies that now allow flexible expansion of NHI coverage to high-price drugs that are used for a small number of rare diseases, that were established based on the increased social maturity that can now accept such policies. The government and payer expect the new listing and extended reimbursement standards to cost ₩256.4 billion and grant access to 781,725 people.
- Policy
- Review period & material improved for COVID-19 Txs, etc.
- by Lee, Jeong-Hwan Nov 29, 2021 05:58am
- The government will lead the improvement of administrative effectiveness and predictability by preparing specific standards on the review period and scope of materials submitted for the marketing approval of pharmaceuticals. The measure was made as means for the government to preemptively respond to the expedited approval of new drugs, anticancer drugs, orphan drugs, and infectious disease treatments such as COVID-19 drugs. On the 25th, Prime Minister Boo-Kyum Kim held the 137th State Affairs Inspection and Coordination Conference and announced “the 8th measure for regulatory innovation to address difficulties in the new industry” The regulatory innovation that will directly affect the pharmaceutical industry is the measures made for the bio-health industry. In line with the Ministry of Food and Drug Safety, the Office for Government Policy Coordination had agreed on the need to improve the priority review system for pharmaceuticals. Currently, the MFDS has an expedited review process in place during marketing authorization for the prompt introduction of new drugs such as new drugs, anticancer drugs, orphan drugs, and infectious disease treatments. However, unlike the US FDA, the system does not specify the review period or the scope of materials submitted in detail, which undermines the administrative effectiveness and predictability of the system. On this, the Ministry of Food and Drug Safety decided to prepare specific standards on the review period and scope of submitted materials by revising the Pharmaceutical Affairs Act & Regulation on Safety of Drugs, Etc. The pre-announcement of legislation was issued on October 19th, and the revised Regulation on Safety of Drugs will be in full effect from January 21st next year. The scope of submitted materials will be specified to define the evidence data, development process, manufacturing method, dosage/administration, efficacy/effect of drugs subject to priority review. The MFDS expects the regulatory innovation to preemptively respond to the need for pharmaceuticals and promote the protection of national health. The regulations on chemical materials used for pharmaceutical manufacturing and quality inspections will also be alleviated. The MFDS exempts import requirements for raw materials that are essential for drug manufacturing when importing chemicals for drug manufacturing or quality inspection. The problem is, the MFDS reviews the cases case-by-case, only after the importer inquires to the ministry whether its chemical material is applied the exemption of import requirements. Due to this, criticism arose that the lack of criteria within the system is causing inconvenience for the importers. Accordingly, the MFDS decided to provide detailed criteria for determining substances subject to the exemption of import requirements and provide detailed case examples to aid better understanding among civilians and improve administrative processes for its employees. More specifically, the ministry plans to revise the ‘Tacts for recommending pharmaceuticals among those subject to import requirement confirmation exemption’ guidelines for business conduct in the coming December.
- Opinion
- [Reporter’s View] On the best way to issue impurity recalls
- by Lee, Tak-Sun Nov 29, 2021 05:58am
- Once again, impurities were detected in the losartan ingredient of antihypertensive drugs that are being used by many patients. Some pharmaceutical companies have already started product recalls under orders from the Ministry of Food and Safety. With the results of the companies’ impurity investigations being released one after another, the number of items subject to recall will continue to increase. The problem is in recalling drugs that were already taken by the patients. The MFDS had held roundtable meetings with doctors’ and pharmacists’ associations that had prescribed and sold the affected drugs and their manufacturers in preparation of the consumer recall in plan. The purpose of the meetings was clear: Who will bear the burden of the cost incurred during consumer recalls? As the government, doctors’ and pharmacists’ associations have unanimously pointed to the manufacturer/seller, these companies are expected to bear most of the recall costs. But what about the consumers? No discussions have been made with consumers on the consumers' part. Of course, for the consumers to receive re-prescriptions and switch drugs, advance discussions with medical/ pharmaceutical associations and manufacturers are inevitable. However, with the risk that medicines containing the impurities may continue to be prescribed, a ban should first be issued on the release and prescription of drugs that had excess impurities. If it is difficult to issue bans on the release and prescriptions of individual drugs, ton how to address this problem should be first discussed. However, the MFDS had warned and forbade individual action on the companies’ part before it issues a compressive announcement, fearing confusion. The MFDS' priority seems to be on muddling the voice of confusion and dissatisfaction that may arise in the recall process rather than on the prompt ban of harmful drugs. If consumer recall measures are implemented, we need to put more consideration into how to recall even one more tablet that contains such impurities. Looking at the past measures made by the MFDS, the authority had prepared a manual for the recall and let the consumers handle the exchange for themselves. With such inadequate publicity and post-measures, it is questionable whether any statistics have been collected on how much was recalled during the last impurity-related drug recall. Maybe the consumer recall is just a publicity gimmick to arouse public opinion rather than a sincere measure. In fact, neither the pharmaceutical associations nor pharmaceutical companies welcome consumer recalls, as such measures give rise to many cumbersome tasks including re-prescription, redispensing, and reimbursement of costs, etc. If consumer recall is inevitable, the MFDS should first consider measures that would minimize its effect on the consumers rather than discussing recalls with medical/pharmacist associations and pharmaceutical companies. And as the consumer recall is already considered certain, we need to now ask whether we are missing the ‘golden time’ for the recalls busy making pre-arrangement discussions before full recalls.
- Company
- Ildong started developing a treatment for COVID-19
- by Nho, Byung Chul Nov 29, 2021 05:58am
- Ildong Pharmaceutical and Shionogi Pharmaceutical have begun joint development of oral COVID-19 treatments, drawing keen attention to whether they will succeed in commercializing them in the future. Ildong Pharmaceutical officially announced on the 17th that it will participate in the development of S-217622 as a candidate for oral COVID-19 treatment along with Shionogi Pharmaceutical, and attention is being paid to whether it will create the third drug in the world to contribute to the end of the pandemic after Pfizer and MSD. Accordingly, Ildong Pharmaceutical plans to start the development process as soon as the recruitment of patients is completed after obtaining IND approval for the domestic clinical trial (P2/3) of S-217622 from the Ministry of Food and Drug Safety in Korea. According to Ildong Pharmaceutical, it aims to become the EUA of the Ministry of Food and Drug Safety within the first half of 2022. Although Pfizer and MSD, two global big pharmas, are already set to commercialize oral treatments for COVID-19, the pipeline should be expanded in terms of high drug costs worth nearly 850,000 won and protection of doctors and patients' drug options. In particular, S-217622 is a candidate substance for a new drug targeting the COVID-19 virus from the beginning, so it is different from drug re-creation development cases that utilize existing substances that have already been licensed or developed with other indications. According to previous studies, S-217622 prevents virus proliferation by inhibiting protease (3CL-protase), which exists only in the SARS-CoV-2 virus, the source of infection that causes COVID-19. It has also been confirmed that alpha, beta, gamma, and delta COVID-19 mutations all have similar levels of virus proliferation inhibition capabilities. More efficient medication convenience is also drawing attention. Pfizer's Paxlovid requires a total of 30 tablets, twice a day for 5 days, and the 5-day dose of MSD's Lagevrio reaches 40. On the other hand, S-217622 is being developed once a day for 5 days. It is expected to be smaller than the previous two treatments. The prospect that localization of treatments according to the terms of the joint development contract and improvement of access to domestic patients will have an advantage over other competitive drugs is also receiving positive reviews. If Ildong Pharmaceutical succeeds in developing the S-217622, it is planning domestic production through technology transfer. An official from Ildong Pharmaceutical said, "Korea's clinical design aims at more than 200 asymptomatic, mild, and severe patients. If development is successful, stable drug production and supply are expected by establishing sovereignty over treatments. Considering the data so far, it shows excellent safety, he said. Ildong Pharmaceutical and Shionogi Pharmaceutical have maintained a partnership for 40 years since the 1980s. Japan Pharmaceutical introduces and sells Shionogi Pharmaceutical's antibiotic Flumarin and Pirespa, a treatment for idiopathic pulmonary fibrosis, in Korea, and cooperates in the clinical phase for the first time. Shionogi is the world's top 50 pharmaceutical company that has focused on developing innovative treatments by focusing on treatment areas in the fields of anti-infectious diseases and central nervous system disorders, including antibiotics and antiviral drugs, for 144 years since its foundation in 1878. It has also developed large global new drugs such as flu treatment Xofluza, antibiotic Petroja, and hyperlipidemia treatment Crestor.
- Policy
- A new pre-approval system for Ultomiris was established
- by Lee, Hye-Kyung Nov 29, 2021 05:58am
- The pre-approval application system for Ultomiris, a treatment for night hemoglobin (PNH) in Handok, has just been established. The HIRA recently established a new Ultomiris pre-approval application system in the nursing institution business portal. The application for pre-approval of Ultomiris is in the same position as Soliris, which is previously prescribed in the benefit certificate. Nursing institutions that want pre-approval of Ultomiris and Soliris can register their applications after selecting the drug name from the pre-approval of medical standards management → Eculizumab and Ravulizumab on the nursing institution portal. Monitoring application data can also be submitted through the same menu. Monitoring data should be submitted for each subject every six months after treatment begins. In accordance with Article 6 of the Method and Procedure for Pre-Approval, etc., approval application and monitoring data related to pre-approval, such as Ultomiris and Soliris, shall be submitted from the 1st to the 10th of the even month in accordance with the subject's deliberation period. Meanwhile, Ultomiris was listed at KRW 5,598,942 per bottle on June 7, and should be administered once every eight weeks after the initial dose per patient is administered. Soliris is an insurance cap of 5,132,364 won per vial (30 ml), and if three vials are administered every other week, the drug price alone reaches 400 million won per year. Both Ultomiris and Soliris were expensive new drugs, and pre-approval and monitoring were essential for registration. Since the registration of Ultomiris in June, pre-approval has been steadily made since July, and in August, one Soliris and four Ultomiris were approved for new PNH patients during the deliberation of the HIRA Medical Review and Assessment Committee.
- Company
- Samsung BIOEPIS set a new sales record in a year
- by Chon, Seung-Hyun Nov 29, 2021 05:58am
- Samsung BIOEPIS has generated the largest quarterly sales since its launch. Overseas sales of biosimilars have increased, and milestones have flowed in due to overseas permits for subsequent biosimilar products. According to the Financial Supervisory Service on the 23rd, SAMSUNG BIOEPIS saw its sales rise 14.4% year-on-year to 271 billion won in the third quarter. It surpassed the previous maximum sales of 236.9 billion won recorded in the third quarter of last year in a year, breaking a new quarterly sales record. The company's cumulative sales in the third quarter were 625.2 billion won, up 9.2% from the previous year. Samsung Bioepis Most of Samsung BIOEPIS sales are generated through overseas sales of its own biosimilar products. SAMSUNG BIOEPIS succeeded in commercializing biosimilars of six products, including Enbrel, Remicade, Herceptin, Humira, Avastin and Lucentis. In Europe, all six products were approved, and in the United States, five products excluding Avastin were approved for sale. SAMSUNG BIOEPIS's performance has slowed slightly as sales have been on the decline for the second consecutive quarter since the third quarter of last year. Sales in the first quarter of this year amounted to KRW 166.7 billion, down 29.6% from the third quarter of last year. With the aim of securing inventory in preparation for the prolonged COVID-19, pre-orders from hospitals and wholesalers in Europe have recovered their performance. However, it rebounded in the second quarter and broke a new sales record in the third quarter, recovering from the sluggishness caused by COVID-19. Overseas sales sold by Biogen and Organon showed growth. Samsung Bioepis biosimilar's overseas sales in the third quarter were $342.8 million (about 406 billion won), up 11% from $369.9 million a year earlier. SAMSUNG BIOEPIS is selling five biosimilars in global markets excluding Korea through marketing partnerships with Biogen and Organon. Quarterly SAMSUNG BIOEPIS sales (unit: 1 million won, data: Financial Supervisory Service) Biogen is in charge of distributing and selling three types of autoimmune disease treatments in Europe, including Enbrel biosimilar Benepali, Remicaid biosimilar Flixabi, and Humira biosimilar Imraldi. Organon (formerly MSD) sells these three products under the product names Renflexis (Remicade biosimilar), Brenzys (Enbrel biosimilar), and Hadlima (Humira biosimilar) in the rest of the world except the United States, Korea, and China. Organon is also in charge of overseas sales of two types of anticancer drugs, Herceptin biosimilar Ontruzant and Avastin biosimilar Aybintio. Sales of biosimilars sold by Biogen reached $22.8 million in the third quarter, up 2% from the previous year. Organon's biosimilar sales in the third quarter rose 41% year-on-year to $140 million. The combined sales of biosimilars sold by Biogen and Organon in the third quarter amounted to $916.2 million (about 1.8 trillion won), up 11% from the previous year. In the third quarter, additional milestones were also introduced with the overseas approval of biosimilars. Lucentis biosimilar Byooviz, developed by Samsung Bioepis in August, was approved for sale by the European Commission (EC), and a month later, it was approved by the U.S. Food and Drug Administration (FDA).
