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- 2026-05-14 05:31:35
- Policy
- Crysvita, referred to the welfare committee
- by Lee, Jeong-Hwan Nov 28, 2022 05:50am
- A petition for national consent calling for quick approval of the rapid use of "Crysvita," a treatment for hypophosphatemia, a rare disease, was recently referred to the National Assembly's Health and Welfare Committee with 50,000 consent. Crysvita is a treatment for XLH hypophosphatemia rickets and osteomalacia supplied by Kyowa Kirin Korea in Korea. XLH (X-Linked Hypophosphatemia, X chromosome dominant hypophosphatemia) is a genetic disease and has a characteristic of severely bending legs. The prevalence of XLH is about one person per 20,000 to 60,000 people, and most of them are found after the disease has progressed considerably due to signs around the age of two. Early detection of XLH is essential for future treatment and management of patients. If you miss the timing of treatment, you may suffer from side effects such as limb deformity, growth delay, reduced height, increased risk of fracture, kidney calcification, and elevated parathyroid levels. In severe cases, you may not be able to walk. Kyowa Kirin Korea's Crysvita was approved by the Ministry of Food and Drug Safety in September 2020 as a treatment for XLH and osteomalacia. However, it has not been eligible for salary for two years since the permission. The petitioner, who introduced himself as the patient's mother, explained, "XLH chromosome-dominant hypophosphatemia is a disease that requires living in pain for the rest of your life because early detection is essential for the patient's future treatment and management. She appealed, "In Korea, it is excluded from the standard of fewer than two years of survival threat or life expectancy, so treatment cannot be used even before the eyes." The petitioner appealed, saying, "The mother of a patient who is having a hard time every day because health insurance is not covered even before the treatment for hypophosphatemia rickets, which has been waiting for more than 20 years." She said, "Since health insurance is not covered, individuals have to pay hundreds of millions of won in treatment costs." Crysvita was approved by the FDA in April 2018, is used as a treatment for adults and children over 6 months, and has been approved for sale in major countries such as Europe, the United States, and Japan.
- Policy
- IVI-Biovac has signed an agreement to develop an OCV
- by Lee, Hye-Kyung Nov 28, 2022 05:49am
- The International Vaccine Research Institute (IVI) announced on the 24th that it has signed a license and technology transfer agreement with Biovac, located in South Africa, for the local manufacture of IVI's OCV. This agreement is meaningful in securing the manufacturing capacity of raw materials, that is, the ability to produce antigens/raw materials necessary to actually manufacture vaccines, through the project. The agreement comes at a time when recent outbreaks of cholera have been triggered by climate change, armed conflict, and forced migration in countries such as Pakistan, Nigeria, and Malawi, seriously hurting already vulnerable health systems. This situation is already causing additional demand for the supply of cholera vaccines, which are in short supply worldwide. In recent years, the area of cholera outbreak has expanded further amid growing supply-demand imbalances caused by a lack of supply of cholera vaccines. The purpose of the agreement signed by IVI and Biovac is to permit and transfer vaccine manufacturing technologies, and ultimately to solve the shortage of vaccines by increasing vaccine production worldwide to prevent cholera. In addition, this technology transfer is expected to be an opportunity to establish and demonstrate the full capacity of GMP expansion, local manufacturing of clinical trial products, and production of vaccines available in Africa and around the world. The agreement is expected to be an important step in enabling vaccine production on the African continent decades later. In the African market, locally produced vaccine production is currently less than 1%, and infectious diseases are still one of the main causes of death, especially for children under the age of five. African leaders have expressed their commitment to creating a local vaccine industry, aiming to raise the proportion of vaccines manufactured in Africa from 1% in 2021 to 60% in 2040 The agreement is the first step in the project's launch and will receive $6.9 million in donations from the Wellcome Trust Foundation and the Bill and Melinda Gates Foundation. Through this agreement, Biovac will be able to expand its capabilities from vaccine vial filling and packaging to all areas of vaccine product development and raw material drug manufacturing. The technology transfer process begins in January 2023, and the first batch of vaccine prototypes for clinical trials is expected to be produced in 2024. The South African National Regulatory Authority (SAHPRA) approval for product use and the WHO Pre-Qualification Certification (PQ), which will take place immediately after approval, is scheduled to be completed in 2026.
- Company
- K-similars compete for Canada's ₩31 tril market
- by Nov 25, 2022 06:05am
- Biosimilars manufactured by domestic bio companies are targeting Canada, the world's 10th largest pharmaceutical market With an increasing number of provinces in Canada actively implementing policies to mandate the use of biosimilars, usage of biosimilars in the country, which had been in the 10% range, is expected to increase significantly. According to industry sources on the 25th, Samsung Bioepis launched its oncology drug ‘Avastin’ biosimilar ‘Aybintio’ through its partner company Organon. Aybintio is a VEGF inhibitor prescribed for metastatic colorectal cancer, metastatic or recurrent non-small-cell lung cancer, platinum-sensitive recurrent ovarian cancer, etc. With the approval, a total of 5 Samsung Bioepis biosimilar products have been released in Canada as of this month. When including the 4 Celltrion biosimilars, a total of 9 biosimilars from Korea are now in the Canadian market. Starting with its Enbrel biosimilar ‘Brenzys’ in 2016, Samsung Bioepis received approval for 6 biosimilars including its Remicade biosimilar ‘Renflxis’ in 2017, Humira biosimilar ‘Hadlima’ in 2018, Avastin biosimilar ‘Aybintio’ in 2021, Herceptin biosimilar ‘Ontruzant’ and Lucentis biosimilar ‘Byooviz’ in 2022. Among the products, Byooviz has not been released to the market yet due to patent issues. In the case of Celltrion, it received approval and has marketed 4 biosimilars including its Remicade biosimilar ‘Remsima,' Rituxan biosimilar ‘Truxima,’ and Herceptin biosimilar ‘Herzuma’ in 2014, and Humira biosimilar ‘Yuflyma’ in 2021. Among the 50 biosimilar products approved by the health authorities in Canada, 10 are Korean products. ◆Canada ranks 10th in the global market...receives attention for its policy pro-biosimilar policy The Canadian pharmaceutical market is worth UDS 23.8 billion (KRW 31.58 trillion) based on IQVIA in 2020, and is the 10th largest market in the world. The country has been pointed to as the ‘land of opportunity' by domestic biopharmaceutical companies with the government’s recent implementation of biosimilar-friendly policies in provinces to reduce the cost of prescription drugs. The Province of British Columbia after implemented a policy three years ago that only allows the use of biosimilars for certain diseases, with exceptions, to raise the usage of biosimilars that remained at the 8% level at the time. British Columbia has mandated that prescriptions be switched to biosimilars, except in exceptional cases for indications for autoimmune diseases such as plaque psoriasis, psoriatic arthritis, and Crohn's disease. Some provinces in Canada have a policy that mandates the use of biosimilars instead of originals for certain diseases. (Source: Northwest Territories website) The unconventional policy significantly increased the use of biosimilars in the province. As of the end of last year, the share of biosimilars in the private biopharmaceutical market, which had been 12% in other provinces, had reached 65% in the Province of British Columbia. From December last year to this year, other provinces including Alberta, New Brunswick, Quebec, Nova Scotia, Northwest Territory, and Saskatchewan also adopted policies to encourage the use of biosimilars, therefore, the biosimilar market is expected to grow further. The number of biosimilar approvals has also increased. Since approving 9 biosimilars last year, Health Canada additionally approved 7 products by November this year. In total, 50 biosimilars have now been approved in Canada so far, which is more than the 39 approved in the US. The Canadian government projects that it will be able to save about KRW 1 trillion (USD 768.7 million) a year with the implementation of the pro-biosimilar policy. An official from Samsung Bioepis said, “We have established a diverse product portfolio in Canada, the world's 10th largest pharmaceutical market, and plan to work more closely with our partners to expand their sales in the North American market."
- Company
- Janssen Korea to reduce workforce...conducts VSP
- by Eo, Yun-Ho Nov 25, 2022 06:05am
- Janssen Korea plans to restructure its labor force. According to industry sources, Janssen finalized its decision to conduct a Volunteer Separate Program (VSP) in its town hall meeting. The company will receive applications for VSP until the 30th of this month and does not have a fixed number of reductions planned. The specific terms of compensation for the VSP have not been disclosed. While conducting the VSP in 2015, the company had proposed ‘'years of service X2+2 months (average wage)+2 months (normal wage)' as compensation for early retirement. Also, Janssen’s VSP will exclude those in charge of market access (MA) and regulatory affairs (RA). Other multinational pharmaceutical companies including Novartis Korea, GSK Korea, and Sanofi Korea have also implemented early retirement programs in the second half of this year.
- Opinion
- [Reporter's view] Godex benefit adequacy will be further di
- by Lee, Tak-Sun Nov 25, 2022 06:05am
- At the Health Insurance Policy Deliberation Committee held on the 23rd, it was decided to further discuss the appropriateness of the salaries of Godex and Imotun at the next deliberation committee. Although the HIRA Drug Benefit Evaluation Committee recognized the appropriateness of the benefit, the final organization, the Health Insurance Policy Review Committee, put the brakes on it. The review committee plans to revisit whether it is appropriate to recognize the appropriateness of benefits just because drugs with unclear clinical usefulness are cost-effective. The decision of the Health Insurance Policy Review Committee should serve as an opportunity to look back on whether the re-evaluation of drug benefits, which has been underway since last year, is proceeding correctly. First of all, it is necessary to check whether the basis for judging the clinical usefulness being evaluated is playing its role. The HIRA first evaluates clinical usefulness based on the basis of evidence such as textbooks, clinical care and guidelines. Items with ambiguous clinical usefulness and unclear items are emerging. Godex and Imotun were those kinds of drugs. If so, it is necessary to look back on whether the data on which the evaluation is based lack of reliability or the threshold of evidence is too low. Unlike the salary re-evaluation, the Ministry of Food and Drug Safety's re-evaluation of efficacy is much clearer. If the effectiveness of the drug is unclear, the basis is provided through clinical trials. The permission also varies depending on the success of the clinical trial. The evaluation of the clinical usefulness of the HIRA is supposed to be skipped if it is ambiguous. In other words, if the clinical usefulness is unclear, the appropriateness of the salary is evaluated by considering the cost effectiveness. Even if the clinical usefulness is not accurately proven, there is a way to maintain the salary. In some ways, I don't know if it's effective or not, but it's cheap, so it can be seen as maintaining benefit. The deliberation committee also points out this point and asks if it fits the purpose of re-evaluation of benefit adequacy for the purpose of optimizing drug expenditure. Even if Godex and Imotun are recognized for their appropriateness as determined by the committee at the next hearing, the existing clinical usefulness evaluation part should be revised. It is necessary to provide clues that make it clear whether it is clinical useful without intermediate or if the clinical usefulness is unclear. In that respect, the current evaluation of benefit adequacy is not clear. It may be a way to leave drugs with unclear clinical usefulness to the Ministry of Food and Drug Safety to conduct clinical re-evaluation. I would like to ask again whether it is efficient to undergo double verification because the efficacy verified by the Ministry of Food and Drug Safety and the clinical usefulness evaluated by the HIRA are different. The HIRA should not dismiss the review committee's decision as a kind of distinction, but should use it as an opportunity to double-check whether the re-evaluation of salaries has been carried out correctly.
- Policy
- SGLT2+DPP4 standards expanded, will it be over again?
- by Lee, Tak-Sun Nov 24, 2022 05:51am
- from left to left, Forxiga, Jardiance, Xigduo XR, Jardiance Duo The expanded application of salary standards for the combination of diabetes treatment SGLT-2 inhibitor-based drugs and DPP-4 inhibitor-based drugs is expected to pass another year. Since the Korean Diabetes Association requested expansion in 2016, there have been expectations for application within this year as full-scale discussions have been underway, but in fact, it is unlikely to be applied this year. According to the industry on the 23rd, the Ministry of Health and Welfare is expected to receive a voluntary cut rate from related companies by this week and conduct a financial impact analysis based on it. If the expected financial scope is satisfied by the weak reduction, it will be reflected in the salary through a report by the Health Insurance Policy Review Committee. Analysts say that it is difficult to apply this year because each company has a different position and the constitutional review was held on the 23rd to reflect benefits in December. The Ministry of Health and Welfare held a meeting with pharmaceutical companies last week regarding the expansion of the benefit standards for diabetes treatments and asked each company to suggest ways to voluntarily cut them. As a result, pharmaceutical companies are expected to submit data on how to cut the upper limit through their own analysis to the Ministry of Health and Welfare by this week. The Ministry of Health and Welfare's mention of the option of voluntary cuts is interpreted as a move to quickly conclude that the expansion of salary standards has a greater impact on finances than expected. In June, the HIRA announced that it is currently analyzing the financial direction while reviewing the salary standards for three drugs such as Metformin+SGLT-2+DPP-4, metformin+SGLT-2+TZD, and some items of SGLT-2+sulfonylurea or insulin combination. It was necessary to complete the change in standards and drug price evaluation after completing the financial impact and deliberation by the Drug Benefit Evaluation Committee. The drug price is determined by the standard according to the increase in the expected amount of claims. Drug prices will be lowered by a maximum of 5%. However, the Ministry of Health and Welfare encouraged pharmaceutical companies to voluntarily cut the price before deliberation by the committee. This is because the voluntary reduction drug to expand the scope of use can be applied through the report of the Health Policy Review Committee immediately after skipping the committee's deliberation. Analysts say that this is because even if the upper limit is cut by up to 5% according to the set procedure, it far exceeds the expected fiscal range. Accordingly, it is known that the government plans to reduce the level of fiscal input as much as possible by inducing a larger range of voluntary cuts. In particular, the Ministry of Health and Welfare reportedly ordered pharmaceutical companies with SGLT-2 drugs, which are expected to see a high rise in claims, to make a large cut. The pharmaceutical companies that accepted the proposal are in different positions. It is said that some pharmaceutical companies with low-claimed items have already voluntarily replied that they will not cut drug prices. On the other hand, pharmaceutical companies with large claims are expected to accept voluntary weak cuts and present a cut rate to the Ministry of Health and Welfare. Some analysts say that if the voluntary cut rate falls short of expectations through financial impact analysis, it may be difficult to expand the combined salary. On the other hand, if the cut-rate meets expectations, the pace of salary application is expected to accelerate. The overall atmosphere is that it will be difficult to apply this year. In addition, it is unknown at the moment whether to apply expansion to items that have not chosen voluntary cuts. The HIRA official said, "We know that we will receive voluntary cuts from each company and then examine whether it is appropriate to expand benefits through financial impact analysis." He said, "I understand that nothing has been decided yet about the subsequent procedure."
- Company
- First ASMD treatment Xenpozyme to land in Korea
- by Eo, Yun-Ho Nov 24, 2022 05:51am
- The first-ever pediatric storage disorder treatment is expected to be introduced to Korea. According to industry sources, Sanofi Genzyme’s treatment for acid sphingomyelinase deficiency (ASMD) ‘Xenpozyme (olipudase alfa)’ is undergoing processes for marketing authorization by the Ministry of Food and Drug Safety. Starting with Japan in March, the drug was also approved in Europe in July and by the US FDA in August and received Breakthrough Therapy designation in the countries. The efficacy of Xenpozyme, the only existing ASMD treatment, was identified through the ASCEND and ASCEND-Peds trials. The ASCEND trial evaluated the efficacy and safety of Xenpozyme in 36 adult patients with ASMD type A/B or type B. The patients were randomized to receive Xenpozyme or placebo for 52 weeks (primary analysis). At Week 52, Xenpozyme improved lung function from baseline by 22% in terms of the predicted diffusing capacity of the lung for carbon monoxide (DLco). Compared with the 3% improvement shown in the placebo group, the difference between the two treatment arms of 19% was statistically significant. Also, at Week 52, patients treated with Xenpozyme had a mean reduction in spleen volume by 39.5% compared with the 0.5% increase in the placebo group. All patients that were treated with Xenpozyme showed an improvement in one or two primary endpoints. The single-arm ASCEND-Peds trial studied 20 pediatric patients younger than 12 years of age with ASMD type A/B or type B. The primary objective of the trial was to evaluate the safety and tolerability of Xenpozyme for 64 weeks, and the explored efficacy endpoints of progressive lung disease, spleen, and liver enlargement, and platelet count were also explored in the trial. 9 patients who could take the test for diffusing capacity of the lung for carbon monoxide in the trial showed a 33% improvement in diffusing capacity after 1 year. The patients also showed a mean reduction in spleen volume of 49%. ASMD is caused by the lack of an enzyme needed to break down a complex lipid, called sphingomyelin, which accumulates in the liver, spleen, lung, and brain. Patients with ASMD experience enlarged abdomens that can cause pain, vomiting, feeding difficulties, and falls at 3 to 6 months of birth. The most severely affected patients have profound neurologic symptoms and rarely survive beyond two to three years of age.
- Company
- Shaperon applies for a patent for biomarkers,
- by Lee, Seok-Jun Nov 24, 2022 05:50am
- Shaperone announced on the 23rd that it has applied for a patent to prove the correlation between NuGel, an atopic dermatitis treatment under development, and biomarkers (biological markers). The patent is the result of analyzing the data of phase 2 patients with atopic dermatitis in Korea and confirming that biomarkers in the blood can be effectively used to predict the treatment reactivity of atopic dermatitis patients to NuGel. It is also a new technology that has revealed that the biomarkers can be used in Companion Diagnostics, which is required to maximize the therapeutic effect. Until now, most of the development of biomarkers for companion diagnosis has been focused on the field of anticancer drug development. It is evaluated that the Shaperon patent is meaningful because it has discovered a biomarker that can predict drug reactivity of new drugs in the field of atopic dermatitis for the first time in the world. It proposed a new paradigm that the diagnosis criteria for "Type A" (tentative name) atopic dermatitis can be prepared and the treatment effect can be maximized in the patient group. It is the same as requiring a different approach to the treatment of type 1 and type 2 diabetes. It is evaluated that it has developed a new personalized treatment technology based on NuGel for individual atopic patients through a patented technology that can differentiate between A-type atopic and non-atopic atopic patients with biomarkers discovered by Shaperon. The precision medical technology used in the patent is not limited to atopic dermatitis but plans to expand it to patients with intractable inflammatory diseases who have high market demand for accompanying diagnosis. In particular, it is expected that it can be used to develop new drugs that can increase the treatment effect by selecting patients with good treatment prognoses early. An official from Shaperon said, "In order to increase the success rate of new drug development in the era of precision medicine, it is important to develop joint diagnostic technology. The discovery of biomarkers has re-proven technology. "We will provide customized treatment options to patients with patent-based atopic dermatitis."
- Company
- Chong Kun Dang CKD-701, equivalent to Lucentis' original
- by Chon, Seung-Hyun Nov 24, 2022 05:50am
- A panoramic view of Chong Kun DangChong Kun Dang announced on the 23rd that the results of phase 3 clinical trials of the macular degeneration treatment Lucentis biosimilar CKD-701 were published in the SCI-level international academic journal PLoS One. Chong Kun Dang conducted phase 3 clinical trials of CKD-701 in 312 patients with neovascular age-related macular degeneration at 25 hospitals, including Seoul National University Hospital, from September 2018 to March 2021. In phase 3 clinical trials, the percentage of patients with vision loss of fewer than 15 characters in the primary efficacy evaluation index comparing the maximum calibration vision (BCVA) at 3 months after drug administration was 97.95% (143/146) in the CKD-701 administration group and 98.62% (143/145) in the original drug administration group. The change in maximum corrected vision (BCVA) improved by 7.14 characters in the CKD-701 administration group and 6.28 characters in the original administration group, showing no significant difference between the two drugs. It was confirmed that drug efficacy, safety, immunogenicity, and pharmacokinetic characteristics were clinically equivalent to the original drug through indicators such as the ratio of patients with less than 15 characters of vision loss and vision improvement, respectively, after 3, 6, and 12 months of drug administration. CKD-701, which was approved by the Ministry of Food and Drug Safety last month, is a high-purity Lucentis biosimilar mainly composed of Ranibizumab. Chong Kun Dang's pure independent technology, which is an antibody fragment raw material manufacturing technology, has been applied. CKD-701 is a drug with clinical equivalence compared to Lucentis, the original drug, in significant indicators, including maximum calibration vision, the primary evaluation index, said Professor Hyung-gon. "Pro Re Nata (PRN) is expected to stabilize the condition of macular degeneration disease and reduce the patient's burden of treatment." PLoS One is an online journal specializing in science and medicine published by the Public Library of Science (PLoS) since 2006. It has been listed on SCIE and SCOPUS, a global academic paper database platform for the past five consecutive years.
- Company
- SK Bio "hasn't manufactured SKYCovione after first batch"
- by Kim, Jin-Gu Nov 24, 2022 05:50am
- SK Bioscience On the 23rd, SK Bioscience publicly announced that the manufacture and supply of its self-developed COVID-19 vaccine ‘SKYCovione’ have currently been discontinued. SK Bioscience received marketing authorization for SKYCovione in Korea in July this year. In September, the company supplied an initial batch of 60 thousand doses of the 10 million doses that the government pre-purchased through an agreement. However, further manufacture and supply of the vaccine have been discontinued. One reason is that the overall vaccination rate has fallen with the slowdown of the COVID-19 outbreak and the increasing number of people with immunity. According to the Korea Disease Control and Prevention Agency, the cumulative number of people vaccinated with SKYCovione in Korea as of November 22nd was only 3,787. In other words, only 0.6% of the 600,000 doses supplied to the government were used. Its performance is sluggish compared to its competitors. The government has been recommending winter season COVID-19 vaccinations from October 11. People can choose from vaccines including SKYCovione, Pfizer’s BA1·BA.4/5-adapted vaccines, Moderna’s BA.1-adapted vaccine, and Novavax’s winter season vaccine. Among these, a cumulative 1,530,332 people received vaccination with Moderna’s vaccine. 754,058 received Pfizer’s vaccine, and 23,156 received Novavax’s vaccine. In the same period, only 1,759 people opted to receive SKYCovione. Due to such circumstances, SK Bioscience plans to continue producing the vaccine solution and wait for additional orders from the government. An official from SK Bioscience said, “Basically, the finished vaccine product is manufactured when requested by the government. We are not producing additional finished vaccines because we have not received additional requests after the initial supply." “Apart from the finished product, we have been manufacturing the vaccine solution. We will resume production and supply the request of the government in the future” The official added, “We are also undergoing global approval processes.” In July, the company applied for a Conditional Marketing Authorization (CMA) of SKYCovione (SKYCovion™ in Europe) to the Medicine and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA), and then submitted an Emergency Use Listing (EUL) application to the World Health Organization in September. However, the applications have not been approved yet.
