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- 2026-04-11 06:00:36
- Policy
- Avastin biosimilar will be reimbursed starting next month
- by Lee, Tak-Sun Nov 29, 2022 05:53am
- Celltrion VegzelmaCelltrion's Avastin biosimilar Vegzelma will be listed on the 1st of next month. As a result, Roche, which owns the original Avastin, has joined Alvogen Korea, a biosimilar company, Samsung Bioepis, and Celltrion, making the market competition a four-way race. According to industries on the 25th, Celltrion Vegzelma's 0.1g and 0.4g will be listed at 208,144 won and 677,471 won, respectively, on the 1st of next month. The price is the same as Samsung Bioepis' Onbevezy and Alvogen's Arimcis. Bevacizumab formulations are anticancer drugs used in various carcinomas, with the domestic market reaching about 100 billion won. The original Avastin recorded 38.1 billion won in the first half of last year based on IQVIA. In September last year, Samsung Bioepis Onbevezy received a salary and was released for the first time in Korea as a biosimilar. This product is currently being sold by Boryung Pharmaceutical. Onbevezy's one-year monopoly in the biosimilar market was broken when Albogen Korea released Arimcis last month. Arimcis is sold by Daewoong Pharmaceutical. Competition for Bevacizumab formulations is expected to begin in earnest as Celltrion joins in December. Although biosimilars are less popular in the domestic market, Celltrion is also looking forward to Bevacizumab as it is only Remsima that performs as well as the original. Since the drug price difference between the original and biosimilars is not significant, the performance difference is expected to appear depending on marketing and distribution capabilities. However, the fact that Alvogen Arimcis is limited in use in relation to ovarian cancer due to patent problems is considered a weakness in the indication. Although Samsung Bio and Celltrion are raising their stock prices with biosimilars overseas, it is true that they have been negligent in marketing in the domestic market, which is small in size. However, the Avastin biosimilar is expected to be active in investing in domestic sales due to its large domestic market size. Attention is focused on who will win the four-way race for biosimilars.
- Company
- First targeted PIK3CA Piqray reapplies for reimb
- by Eo, Yun-Ho Nov 28, 2022 05:51am
- An anticancer drug that targets the PIK3CA gene will once again attempt reimbursement listing in Korea. According to industry sources, Novartis Korea submitted a reimbursement application for the reimbursement of its breast cancer treatment Piqray (alpelisib) recently. The drug was unable to pass deliberations by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee in February this year. Piqray, which was approved in Korea in May last year, is a 'PIK3Caα-inhibitor that blocks the overactivation of the PI3K enzyme which, when overactivated because of a mutation in the PIK3CA gene, stimulates cancer cells to divide and grow in an uncontrolled fashion. The targeted cancer therapy is prescribed in combination with Faslodex (fulvestrant) to treat metastatic and advanced-stage, hormone-receptor-positive/ HER2-negative breast cancer in patients who failed previous treatment. Piqray’s safety and efficacy were demonstrated in the SOLAR-1 trial, which was conducted on 572 postmenopausal women, and men, with HR+, HER2- advanced (locoregionally recurrent or metastatic) breast cancer whose disease had progressed or recurred on or after an aromatase-inhibitor-based treatment (with or without CDK4/6 combination) Results showed when used in combination with Faslodex, Piqray improved the median PFS (Progression- Free survival) of cancer patients with the PIK3CA mutation from 5.7 months to 11 months. The Objective Response Rate (ORR), which indicates the proportion of patients whose tumor size was reduced by over 30%, was 35.7% for the combination therapy group, which is twice more than the 16.2% in the fulvestrant monotherapy group. The secondary endpoint, Overall Survival (OS) in patients with PIK3CA mutations, was 39.3 months in the combination therapy group. This was 8 months longer than the 31.4 months in the fulvestrant monotherapy group but did not have statistical significance.
- Policy
- Actilyse's price to rise 15% from next month
- by Kim, Jung-Ju Nov 28, 2022 05:50am
- The price of Boehringer Ingelheim’s acute myocardial infarction treatment Actilyse Inj. (alteplase) will rise 15% from next month after applying for drug pricing adjustments. Aju Pharm’s acute back pain reliever (aceclofenac, eperisone hydrochloride) will newly receive a 10% premium for 1 year. Also, the 30.4% premium pricing for Hanmi Pharmacueetical’s allergic rhinitis treatment Potastine OD Tab (bepotastine calcium dihydrate) will be maintained due to the small number of companies producing the same product, and Kyowa Kirin Korea voluntarily opted for a 1.5% reduction in the price of its Romiplate 250μg (romiplostim). According to industry sources, the Ministry of Health and Welfare is working to amend the ‘drug reimbursement list and reimbursement ceiling price table’ to implement the changes above for implementation on December 1st. First, Aju Pharm’s Afexon Tab has been newly listed with premium pricing for 1 year. The premium pricing rate will be wet at 10%. For incrementally modified combined new drugs, the government applies a 59.5% premium for first generics for one year from listing. For drugs from innovative pharmaceutical companies, the premium is set at 68% of the original drug price in the first year, then subsequently lowered to 53.55% after the term is terminated. The premium pricing for Hanmi Pharmaceutical’s Potastine OD Tab will be maintained for the time being due to the small number of companies manufacturing the same item. The premium rate of the drug is set at 30.4%. The government applies premium pricing to drugs when there are 1 or less companies that produce a drug with the same route of administration, ingredient, and formulation as the first-listed incrementally modified new drug. However, if no other companies produce the same product even after the 5-year premium pricing period, the premium pricing is maintained until the number of companies becomes 2 or more. On the other hand, some companies have opted for strategic price reductions for marketing, etc. Kyowa Kirin Korea applied for drug pricing adjustments to reduce the price of its Romiplate 250μg by 1.5%, and the reduction will be applied from the next month. Boehringer Ingelheim Korea applied for a price increase for its Actilyse Inj. (alteplase), and after undergoing negotiations, the price of Actilyse will be raised by 15% for each strength from next month. The application to adjust the ceiling price for price increases can be submitted when the drug is ▲essential to the treatment of patients, ▲has no alternatives, ▲is supplied by one company and its administration is cheaper than its alternatives. After the drug passes deliberation by the Health Insurance Review and Assessment Service’s Drug Reimbursement Review and Assessment Service and undergoes drug pricing negotiations with the National Health Insurance Service.
- Opinion
- [Reporter's view]There should be no recurrence of COVID kit
- by Lee, Hye-Kyung Nov 28, 2022 05:50am
- Demand for self-examination kits is increasing rapidly as Twindemic, where COVID-19 and seasonal flu are prevalent at the same time, becomes a reality. According to the pharmacy site data analysis service Care Insight (www.careinsight.co.kr), 12,629 self-kits were sold at 396 pharmacies in the 47th week of this year (11/13-19), with daily sales of about 4.56 pharmacies. As the average daily sales per pharmacy in the 43rd week of this year increased every week from 2.45 to 2.87 (44 weeks) → 3.28 (45 weeks) → 3.91 (46 weeks), some are concerned about the recurrence of the supply shortage of self-kits in the first half of this year. The Ministry of Food and Drug Safety said it is continuously monitoring domestic production and inventory, adding that it is not at a stage where it is concerned about the reproduction of supply shortages. The reason is that as of November 15, the inventory of self-kits is 70 million people, which can produce about 40 million people a week. Front-line pharmacies are concerned that if the number of people looking for self-kits increases due to the Twindemic, the supply shortage that occurred earlier this year could be reproduced if demand suddenly increases more than supply. In particular, as pharmacies were confused by the Ministry of Food and Drug Safety's management system, which changes every day at the time of the supply of self-kits, they have no choice but to worry about securing inventory of self-kits in preparation for Twindemic. When the shortage of self-kits occurred in February, the government's policy changed several times in just 10 days. On February 11, the Ministry of Food and Drug Safety announced a ban on online sales on February 10, followed by then Prime Minister Kim Boo-kyum's "consideration of introducing the highest price system," limiting sales to pharmacies and convenience stores, allowing small sales, and limiting purchases. Pharmacists could not trust the government as they announced the designation of 6,000 won for each sale on Feb. 14, announced the application of 50 quotas per seller, and changed their words to abolish the 50 quota system on Feb. 16. The problem occurred once more last August. Complaints from pharmacies have increased as convenience stores that have not reported medical device sales businesses have been allowed to sell their own kits from July 20 to September 30. It is said that the supply of self-kits is sufficient now, but if there is a shortage again, the Ministry of Food and Drug Safety is expected to actively intervene as in the cases in February and July. However, if another unprepared policy and plan to ignore the existing system are announced, trust will eventually be broken. The Ministry of Food and Drug Safety should predict demand with experts in advance and create natural solutions together, not urgent measures so that there is no confusion and dissatisfaction at the site.
- 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."
