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- 2025-12-24 02:09:09
- Policy
- Discussions began on the scope of Mifegymiso license
- by Lee, Tak-Sun Nov 24, 2021 05:53am
- Moon Eun-hee, head of the pharmaceutical policy division at the MFDSAn expert meeting was held on the 24th, and the review was conducted regardless of the revision of the criminal law. The MFDS, which is reviewing the product license of Mifegymiso, a drug for abortion, has begun a discussion process on the specific scope of use rights. It is a policy to decide through collecting opinions from all walks of life. Moon Eun-hee, head of the pharmaceutical policy division, said on the 23rd, "We are scheduled to hold a meeting with experts on Mifegymiso screening measures on the 24th. We are thinking about whether to limit prescription authority to obstetrics and gynecology and what capabilities we will describe." She added that Mifegymiso will basically be classified as Rx drug and compare preparation and administration cases in various countries to discuss whether it will be inpatient Rx or outpatient Rx. However, she mentioned that an agreement with all walks of life is needed. She stressed that she does not conduct a permit review on the premise of revising the criminal law related to abortion, but that she hopes the law will be revised as soon as possible so that licensed products can be used. It is found to be contrary to the opinion that Mifegymiso's approval review should be delayed due to the lack of criminal law by Seo Jung-sook and others. The abortion crime was abolished in 2018 when the Constitutional Court ruled against the Constitution. At that time, the Constitutional Court recommended that supplementary legislation be completed by the end of 2020, and five bills, including related criminal laws, were submitted to the National Assembly, but have not been processed. The criminal law contains specific conditions and regulations that allow abortion. The MFDS expects that abortion drugs will not violate the revised law and plans to examine them according to scientific procedures and methods. She explained, "I don't think that the termination of pregnancy in efficacy will apply to the revised Pharmaceutical Affairs Act related to the expression of abortion suggestion." She said, "Even in the revised criminal law, drugs, including drugs, are not considered to be applied to abortion conditions and grounds, but it seems that (related drug permission) is not desirable because it varies depending on interpretation." However, as collecting opinions from all walks of life is important, she plans to continue to discuss drug use. "I don't think it will be concluded by a single meeting on the 24th," she said adding, "There has been a process of collecting opinions from all walks of life, but we will continue to receive opinions if necessary." The plan is to determine whether the method of collecting opinions will be a consultative body of experts or a larger scale such as public hearings depending on the situation. For now, it is known that expert organizations such as Korean Association of Obstructors & Gynecologists, Korean Society of Obstetrics and Technology, and Korea Society of Health System Pharmacists will attend the meeting on the 24th. Regarding Mifegymiso's Bridging Study, the Central Pharmaceutical Review Committee also had a number of opinions on the exemption of Bridging Study, but it was not finally confirmed. Currently, the Mifegymiso review has been requested to supplement the data, but the data has not been submitted yet.
- Policy
- Betmiga PR prices fluctuated 3 times Between 15 days
- by Kim, Jung-Ju Nov 24, 2021 05:53am
- It is a drug with a lot of stories. Betmiga PR (Mirabegron) of Astellas Pharmaceutical of Korea, which is in a lawsuit with the government to cancel the drug price drop, is a drug with a lot of price fluctuations. The drug has repeatedly filed lawsuits against the government's drug price cut, returning, cutting and raising drug prices as the results of the Price-Volume Agreement and additional calculations are added, with at least three drug price changes expected this month alone. In the aftermath, continued settlement and fluctuations in pharmacies and distributors are expected to follow, signaling chaos. According to the Ministry of Health and Welfare, the price of two Betmiga PR (Mirabegron) items, whose suspension of drug prices was lifted on the 14th, will rise slightly as of the 22nd as the price hike was adjusted this time. The increased price is KRW 314 for Betmiga PR and KRW 471 for 50mg of Betmiga PR. Up to two additional changes from the new generic registration to the new suspension of execution It is now common for drug price changes to occur frequently due to drug price lawsuits against the government. However, Betmiga PR is experiencing price hikes and cuts due to additional criteria, application and cancellation of the Price-Volume Agreement results, and price changes due to further litigation. Since the drug was lowered on the 14th due to the previous ruling of the administrative court (2021a 10434), the government has considered the additional application of the drug. This drug is subject to additional application. Therefore, it was raised to the 22nd by applying an additional calculation as of the standard from the 14th application at the time. In addition, the cancellation of the Price-Volume Agreement conducted earlier this year was reflected, making it different from the drug price (price before 14 days) at the time of the administrative court suit. The company is filing an appeal with the High Court. At the same time, the company raised a suspension to the effect of maintaining the actual initial price, but on the 12th, the High Court did not accept it unusually. However, since the suspension of execution can be carried out separately from the lawsuit on the merits of our law, the company immediately applied for a separate suspension of execution to the Supreme Court, and the results have not yet been released. If the Supreme Court results are decided to cite suspension of execution, the price will change again if the price changes to its original state Price fluctuations do not stop here. As Mirabegron's generic is scheduled to be additionally registered on December 1, the drug price change, which was expected to be adjusted to December 22, will change again in December. In other words, since there are three companies based on registered companies and the number of new generics exceeds three companies, the additional mechanism applied by the government will be lifted and the price will fall again. This is a change in drug prices that has progressed or is scheduled for only 15 days since the application of the administrative court results on the 14th, and the number of times alone is as many as three or up to four times. Confused by frequent fluctuations in drug prices and wholesale and retail prices of pharmacies and distribution prices As a result, the return and settlement of distributors and pharmacies, which are wholesale and retail branches of drugs, and confusion in face-to-face patients are inevitable. First of all, pharmacies should pay attention to discrepancies in claims if they miss the update of drug prices. In addition, it should be notified when facing the patient. In the case of distributors, they must make predictable plans for returns and settlements to check the volume with trading pharmacies and customers. Due to the nature of wholesale and retail dealing with tens of thousands of drugs, such confusion is expected to continue unless the system and law improve. In order to solve such a legal battle, the ruling party is currently pushing for a revision of the law aimed at banning and recovering corporate lawsuits, and the government and insurance authorities are also closely watching it. The MOHW said, "The part to be raised and adjusted as of the 22nd will end on December 1st," adding, "Astellas is appealing to the Supreme Court (related to suspension of execution), so if there is any change, additional information will be provided immediately."
- Policy
- MFDS cautious on waiving bridging trial for abortion pill
- by Choi-sun Nov 24, 2021 05:53am
- The Ministry of Food and Drug Safety, which had been accelerating the approval of the induced abortion pill Mifegymiso (misoprosto + mifepristone), has taken a step back in response to the caution urged by the National Assembly among others at the NA audit. Despite being advised to waiver the bridging study by the Central Pharmaceutical Affairs Council, the MFDS turned to take a more reserved position on the exemption of such trials. Considering the progress of the review, as Hyundai Pharm would need to prepare the supplementary data and receive another review for the submitted materials, it is predicted that it will be difficult for the company to obtain approval within this year. According to the MFDS on the 17th, the authorities requested supplementary data for Hyundai Pharm’s application on Mifegymiso but deferred providing a definite answer on whether it will exempt a bridging clinical for the drug. # A bridging study is added when it is difficult to apply foreign clinical trial results locally due to ethnic differences in evaluations. In early September, the MFDS received a recommendation to waiver the bridging trial after holding a CPAC meeting. Since the addition of a bridging trial could postpone the approval of a drug by 2 to 3 years, whether the bridging trial will be initiated was the center of focus to the company as well as women’s and academic societies. At the time, the prevailing opinion was that the MFDS would waive the bridging trial and rapidly progress the approval process in accordance with the advice from external experts. However, the ministry later changed its position, faced with opposition from the Korean College of Obstetrics & Gynecology and the concerns raised on the hasty introduction of the drug. An MFDS official said, “We are aware of the great need for relevant regulations and drugs after abortion was decriminalized. However, we are also aware of the rising concerns over its safety, which is why we need to exercise caution on the matter.” He added, “The ministry had requested Hyundai Pharm’s to submit supplementary data on the approval of Mifegymiso. We had requested supplements after consulting with external experts and conducting data review, and the company has not submitted the additional data yet.” “We have set a deadline for the supplementary data submission, however, the deadline may be extended upon the company’s request. We can only proceed further after we receive the data,” said the official. Regarding the initiation of a bridging study, the MFDS plans to reexamine the issue through further expert review. The MFDS official said, “We have already completed seeking expert advice on conducting a bridging study for Mifegymiso, but did not make a decision at the ministry level on whether to request or waiver a bridging study.” He added, “This seems to be an issue that should be reviewed after the additional data are submitted. We plan to once again review expert opinions on the matter after receiving the supplementary data.”
- Policy
- Nam In-soon's drug price recovery bill excludes rebates
- by Lee, Jeong-Hwan Nov 23, 2021 05:55am
- The "Return and refund of suspension of execution of drug prices" bill proposed by Rep. Nam In-soon of the Democratic Party of Korea varies in scope of application to benefits deletion, suspension of benefits, and drug price reduction due to revaluation of starting drugs. However, Rep. Nam In-soon's bill does not include the disposition of drug price reduction due to the detection of illegal rebates. The two bills differ in that the previously proposed Democratic Party lawmaker Kim Won-yi's bill was subject to redemption and refund of only the original patent expiration drug price and the rebate detection drug price. As Rep. Nam recently proposed an additional revision to the National Health Insurance Act, pharmaceutical companies that have conventionally applied for suspension of execution shortly after the patent expiration drug price was lowered have become more interested in the bill. The National Assembly's Health and Welfare Committee announced the subcommittee on the first bill on the 23rd and 24th. Therefore, it is not yet known whether the bill proposed by the two lawmakers will be reviewed by the end of this year. Rep. Nam's bill laid the groundwork for ex officio adjustment of the benefits, scope of benefits, and upper limit of registration drugs, as set by the Minister of Health and Welfare by Ordinance of the MOHW.(New Article 41-35) In particular, regarding the ex officio adjustment of the Minister of Health and Welfare, the NHIS specified the basis for collecting or refunding losses incurred by pharmaceutical companies filing administrative trials and administrative litigation.(New Article 101-2(1)-6) The ex officio adjustment of the Minister of Health and Welfare includes the expiration of the original patent, the registration of generics, and the deletion of benefits, suspension of benefits, and drug prices due to revaluation of registered drugs. The disposition of drug prices for drugs caught in rebates was excluded. This part is different from Kim Won-yi''s bill. In the case of exclusion or suspension of benefits, the upper limit of losses cannot exceed 40/100 of the difference in medical care benefits. The supplementary provisions stipulate the enforcement date of the bill as the day six months have elapsed since its promulgation. The revised regulations were to be applied from administrative trials or administrative litigation filed for the first time since the enforcement of the law, so that past lawsuits for drug price reduction were not retroactively applied.
- Policy
- Brilinta’s price cut 30%, Nexavar’s premium stays 1 year
- by Kim, Jung-Ju Nov 23, 2021 05:54am
- The insurance price of AstraZeneca Korea’s Brilinta tab. 90mg (ticagrelor) and Daxas tab. 500μg (roflumilast) will be reduced by 30% through the government’s ex-officio adjustment starting next month. On the other hand, the price of Bayer Korea’s Nexavar 200mg (sorafenib tosylate) will be maintained at its level for one more year. The price of Hanlim Pharm’s Entelon, whose indications for blood circulation and ophthalmologic diseases survived the Pharmaceutical Benefit Adequacy Assessment, was voluntarily lowered by 2.6-2.9% for each dose. According to the industry, the Ministry of Health and Welfare is working to apply the ‘Amendment to the drug reimbursement list and reimbursement ceiling price table’ that contains the abovementioned changes by December 1st. First, two drug items that were newly applied premiums will end in December. The government applies a 59.5% premium or one year from the listing of the first generic. For 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 two items subject to this form of price cuts are Handok Teva’s ‘Teva Bendamustine Inj. (bendamustine hydrochloride)’ 25mg and 100mg. The price of the two drugs will fall 10% each from coming March 1st, 2022. One product will be maintained the premium pricing status. The government allows premium pricing period extensions for drugs produced with identical ingredients by 3 or fewer companies. The product that will be subject to an extension this time is Bayer Korea’s Nexavar 200mg. Although Nexavar’s premium pricing period was set to expire, it was able to maintain its premium due to 3 or fewer companies producing drugs with identical ingredients. Therefore, Nexavar’s premium pricing will be terminated on December 1st, 2023. If the company applies for an evaluation to maintain its premium pricing, the government and HIRA would need to conduct an evaluation to determine whether to continue applying premium. If the authorities decide to terminate the term, the price falls 23.5%. The premium pricing period for Hanmi Pharmaceuticals’ Mirabeg 50mg (mirabegron) has also expired, and its price will be cut 21.3% from the first of next month. Also, the price of Astellas Korea Betmiga (mirabegron), which had been fluctuating due to the suit filed by the company to cancel the government’s price cut decision, will be reduced by 23.6% on the same day due to the premium pricing period expiry. Three items will undergo price cuts next month through ex-officio adjustments. The government makes ex-officio price adjustments to the first-listed product and the product with the same route of administration, ingredient, and formulation as the first-listed product. The three items are AstraZeneca Korea’s Brilinta tablets and Daxas tablet. The price of Brilinta 90mg will be cut by 30%, 60mg by 29.9%, and Daxas 500μg by 30%. The premium pricing period of the ex-officio price adjusted items is set to expire on November 2022. When a generic is listed for the first time, the price of the first-listed product is given a 70% premium for a year, then returned to the original level. If 3 or fewer companies sell the same product with the identical ingredient, the government allows the company to maintain the premium for up to 5 years until the number of companies becomes 4 or more. The price of Brilinta will be reduced by 23.5% for each dose from November 21st, 2022, and the price of Daxas 500μg will be reduced by 23.5% from November 1st, 2022.
- Policy
- Benefit for 46 generics for Eliquis will be kicked out
- by Kim, Jung-Ju Nov 22, 2021 05:52am
- BMS won the patent dispute between BMS' Eliquis (Apixaban) and it's generics, which had a patent dispute between companies due to generics released before the patent expired. Dozens of generics have been forced to withdraw their benefits. Generics will be legally removed from the list immediately on the 1st of next month due to the establishment of patent infringement, and the original drug, Eliquis, will return to its original price (upper limit price). According to the industry, the MOHW is pushing for a revision (proposal) of the drug benefit list. This lawsuit is a patent dispute after being released after listing the benefit before the expiration of the original patent. Patents related to Lactam-Containing Compounds and Derivatives thereof asFactor Xa Inhibitors' are valid until September 9, 2024. In the case of original drug prices, when generic is listed, prices fall under the collective drug price reduction system. Accordingly, a lawsuit was filed against the MOHW in July 2019 and has continued to this day. In December of the same year, the MOHW already won the first trial, but in April this year, a patent registration invalidation lawsuit against generic companies was reversed and remanded, and in August, BMS Korea won the case. Until now, coordination between the MOHW and BMS is still underway. The mediation plan included ▲ adjusted and announced by promptly proceeding with the Eliquis adjustment procedure,▲ deletion the benefits of the previously listed Apixaban products ▲transitional measures not applied to drugs that have been adjusted for non-reimbursement. The MOHW is sequentially taking follow-up measures accordingly. The number of Apixaban's generics currently listed on the list is 46 items. Generic price is 635 won per tablet. The government has decided to delete these drugs' benefit as of December 1. This is because drugs recognized for patent infringement cannot be sold immediately according to Article 13(4)5 and Article 13(4)16 of the "Rules on Standards for National Health Insurance Medical Care Benefits". Therefore, all of these drugs will not be available for sale on December 1st without any further transitional measures. At the same time, the original drug, Eliquis, recovers its existing drug price on the same date. This is because all competitive generics disappear as the patent court recognizes all generics for Eliquis as patent infringement drugs. The original price is 1,132 won per tablet as a result of the Price-Volume Agreement. However, the actual drug price of Eliquis in the field of medical institutions is expected to remain unchanged. Because when the legal battle for this drug began, the drug price remained unchanged because the company immediately applied for a suspension of execution and the court accepted.
- Policy
- Lixiana latecomers apply for approval as an ODT
- by Lee, Tak-Sun Nov 22, 2021 05:52am
- Latecomers of Daiichi Sankyo’s novel oral anti-coagulant (NOAC) ‘Lixiana (edoxaban tosylate hydrate)’ were found to have applied for approval to the Ministry of Food and Drug Safety. Although Lixiana’s substance patent does not expire until November 10th, 2026, with the PMS (post-marketing surveillance on new drugs) period expiring on August 24th, the companies have immediately applied for the approval of their latecomers. One characteristic of the latecomer drugs is that they are orally disintegrated tablets (ODT) that dissolve or disintegrate in the tongue without water. According to the MFDS on the 21st, other edoxaban tosylate hydrate products that contain the same ingredient as Lixiana applied for approval on August 25th. Latecomer drugs were blocked from applying for approval during Lixiana's PMS period, which lasted August 24th. Therefore, companies applied on the 25th, immediately one day after the end of the PMS period. On how many companies have applied for approval remains unknown. However, considering the number of companies that filed patent challenges, around 10 companies could have applied for approval at the same time, because the companies need to apply for the approval to receive first generic exclusivity. 10 companies including Boryung Pharmaceuticals have succeeded in avoiding Lixiana's composition patent (which lasts until August 21st, 2028). Boryung Pharmaceutical was the first to file a passive trial to confirm the scope of the patent in July 2018 and receive confirmation in July last year. Hanmi Pharmaceutical and Chong Kun Dang followed and received confirmation. The decision was finalized after the patentee Daiichi Sankyo did not file an appeal. However, Lixiana’s substance patent stays effective until November 10th, 2026, therefore the latecomer drugs will have to wait 5 more years before their release. The latecomer drugs that applied for approval this time are orally disintegrating tablets (ODT). On the other hand, Daiichi Sankyo’s Lixiana was approved in 3 doses, all in traditional tablet formulations. However, in Japan, Daiichi Sankyo had also released orally disintegrating tablet (ODT) formulation of Lixiana. ODTs dissolve in the mouth without water and is useful for older adult patients who have difficulty swallowing traditional oral tablets. However, unlike in Japan, the Korean market prefers traditional tablets over ODTs. Therefore, the latecomers' ODT formulations are interpreted to be a means to evade the composition patent rather than market preference. DongA-ST is already conducting a bioequivalence test for its latecomer ODT formulation. Lixiana is the lead product in the domestic NOAC market over other NOACs including Xarelto, Eliquis, and Pradaxa. The market recorded ₩17.2 billion in prescriptions in Q2 alone. Also, the anticoagulant treatment market was reorganized around NOACs, supporting the steady growth of the market. In line with the trend, domestic companies have been continuously knocking to enter the latecomer NOAC market. After many twists and turns, the Xarelto latecomer market opened its doors in October this year. Domestic latecomer companies are targeting clinics to expand sales as promotion of the original drug was focused around large hospitals.
- Policy
- AML drug that returned after 7 years is approved in Korea
- by Lee, Tak-Sun Nov 19, 2021 05:52am
- An acute leukemia treatment that withdrew its new drug application (NDA) and then was reapproved by the FDA in 2017 has now been approved in Korea. The drug is Pfizer’s ‘Mylotarg (gemtuzumab ozogamicin).’ On the 18th, the Ministry of Food and Drug Safety approved Prizer’s 'Mylotarg inj.4.5mg.’ The drug is indicated for the treatment of newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen (CD33-positive AML). The approval gained attention because it was the second time the company received approval for the drug after voluntarily withdrawing its treatment from the market. Wyeth first received approval for Mylotarg in 2000. At the time, the drug received attention as the first antibody-drug conjugate (ADC) approved in the market. However, Pfizer, which acquired Wyeth in 2010, voluntarily withdrew Mylotarg’s FDA approval. In a clinical trial, the drug did not show clinical benefit and the rate of fatalities as a result of treatment-related toxicity was significantly higher in the Mylotarg arm compared to the chemotherapy arm. Then in 2017, Pfizer received approval from the FDA again for Mylotarg in response to the high demand among doctors for its use due to a limited amount of options being available for AML. For the new approval, the company demonstrated the efficacy of Mylotarg in a lower dose in an investigator-led trial. In the clinical trial (ALFA-0701) that was conducted on 271 patients aged between 50 to 70 with newly-diagnosed AML, the median event-free survival (period from the date of randomization to death from any cause, including induction therapy failure, recurrence, etc.) of patients who were treated with Mylotarg was 17.3 months for patients receiving Mylotarg, compared with the 9.5 months for those receiving chemotherapy alone. The MFDS approved the drug as an orphan drug and designated it as a Risk Management protocol (RMP) drug to monitor post-marketing adverse reactions.
- Policy
- The CSO reporting system will be reviewed
- by Lee, Jeong-Hwan Nov 19, 2021 05:52am
- A bill that mandates government reporting of drug sales and promotional agencies (CSOs) and a bill that regulates illegal hospital subsidies between hospitals, pharmacies, and agents in exchange for prescriptions will be reviewed by the National Assembly's subcommittee on the 24th.The government has also published a bill to designate late night operated pharmacies and support budgets, a survey of pharmacies illegally opened through license, and a bill to announce information on illegal pharmacies to the public. In order to strengthen regulations on illegal office managers' hospitals, a bill will also be reviewed to give the NHIS the authority to review the establishment of medical institutions and strengthen the authority to request data submission by the medical institution's opening review committee. On the 18th, Kim Min-seok, chairman of the National Assembly's welfare committee, and the ruling and opposition parties' secretaries agreed on the agenda of the 1st and 2nd Legislation Subcommittees containing such information. The first subcommittee on the bill, where major bills in the health and pharmaceutical sectors will be reviewed, will be held at 9 a.m. on the 24th. The first agenda to be reviewed is the CSO government reporting system bill proposed by Rep. Kim Sung-joo of the Democratic Party of Korea. The bill enforces government reporting by individual drug promoters or corporate CSOs and regulates that drug promotions cannot be entrusted if they are not reported. The goal of the bill is for CSO to improve the reality of illegal rebates. A revision to the Pharmaceutical Affairs Act, which further clarified CSO's regulations on banning rebates on illegal drugs and medical devices, was also listed on the second screening list. The bill is expected to be reviewed by Rep. Kang Byeongwon of the Democratic Party and Rep. Seo Jung-sook of the People's Power, respectively. A bill to support the designation and budget of public night operated pharmacies and local governments, proposed by Rep. Kim Do-eup, the People's Power, will also be reviewed. The key is to allow the Mayor/Do Governor or the Mayor/Gun/Gu Head to designate pharmacies operated during late-night hours and holidays, and to support expenses necessary for operation within budget. This is the same as the bill recently proposed by Democratic Party lawmaker Seo Young-seok, and the bill will be able to be pushed forward at the same time as the welfare committee has decided on a budget of KRW 4,041 billion for next year's pilot project. Rep. Seo Young-seok's proposal is unlikely to be reviewed with that of Kim Do-eup due to the late timing of the proposal, but the contents are similar, so there is a possibility that it will be implemented next year if the review opportunity is obtained. A survey of illegal pharmacies and herbal pharmacies represented by Rep. In Jae-geun of the Democratic Party of Korea and a bill to announce the results were also on the list. The purpose is to solve the problem of unfairly defrauding health insurance finances by opening a pharmacy where unlicensed people, not pharmacists, rent licenses. The main goal is to regularize surveys of illegal opening, operating pharmacies, and herbal pharmacies and disclose the results of illegal confirmation to the public. With the aim of tightening regulations on the hospital of the secretary, the NHIS staff will be included in the medical institution's opening committee, and the bill will also be reviewed to allow the NHIS to request necessary data or opinions. The two bills were submitted by Rep. Kang Byeongwon. A bill will also be reviewed to announce the results of an investigation into illegal pharmacies (herbal pharmacies) proposed by Rep. In Jae-geun of the Democratic Party. The purpose is to solve the problem of unlicensed people, not pharmacists, opening licensed rental pharmacies to unfairly defraud health insurance finances. The main goal is to regularize surveys of illegal opening, operating pharmacies, and herbal pharmacies and disclose the results of illegal confirmation. The government is expected to strengthen its obligation to ventilate medical institutions to prepare for quarantine such as COVID-19, and revise the Medical Service Act to raise the level of regulations on illegal medical advertisements.
- Policy
- Is Celltrion developing a combination of HBP?
- by Lee, Tak-Sun Nov 19, 2021 05:51am
- Attention is focusing on whether Celltrion, which has secured domestic copyrights for ARB-based hypertension treatment Edarbi (Azilsartan Medoxomil), will develop a combination that combines Edarbi and Amlodipine. Attention is focusing on whether Celltrion will also stand out in the hypertension treatment market, which is the domain of traditional pharmaceutical companies. The Ministry of Food and Drug Safety approved the plan which Celltrion applied to verify the effectiveness and safety of Azilsartan Medoxomil and Amlodipine Besylate for eight weeks on the 17th. This test is a multicenter, randomized, double-blinded test to compare the effectiveness and safety of 8-week combined administration in patients with essential hypertension who do not respond appropriately to each of Azilsartan Medoxomil and Amlodipine Besylate. Seoul National University Hospital plans to conduct 852 test subjects in Korea. The industry believes that this test first verifies the effectiveness of the combination of Azilsartan Medoxomil and Amlodipine Besylate for the development. It is known that combination of Azilsartan Medoxomil and Amlodipine Besylate has already been commercialized and sold in Japan. However, it has not yet been approved for items in Korea. Edarbi was approved in Korea in 2017, and Edarbyclor, which combines Chlorhalidone, a diuretic, was approved the following year. Celltrion invested about 307.4 billion won last year to buy 18 kinds of medicines owned by Takeda in the Asia-Pacific region. This also includes Edarbi, a treatment for hypertension. Edarbi has been sold by Dong-A ST, a domestic partner, since it was approved in Korea. However, it is the ninth ARB-based new drug released in Korea, and has struggled in the market dominated by selected drugs. As of last year, the amount of outpatient prescriptions was 8.2 billion won according to UBIST, which is still less than the blockbuster standard of 10 billion won. The development of this combination system is interpreted as an attempt to increase the domestic market share by expanding the product lineup. Celltrion is competing with traditional pharmaceutical companies in the domestic synthetic drug market, but its main business is also biosimilar. Celltrion also has a blockbuster called Godex, but Edarbi is the first hypertensive new drug.The hypertension treatment market is not an easy market because existing pharmaceutical companies are fiercely competing in Clinics. Attention is focusing on whether Celltrion, which is seeking global big perm through biosimilars, will show its presence as Edarbi.
