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- 2025-12-24 13:21:13
- Policy
- Ongentys will be reimbursed upon accepting the committee
- by Lee, Hye-Kyung May 12, 2020 06:27am
- SK Chemicals' new drug 'Ongentys (Opicapone)', which is a new treatment for Parkinson's disease, ,accepts below the evaluation amount of the Pharmaceutical Benefits Advisory Committee the reimbursed price will likely pass. The HIRA (President Seon-min Kim) released the results of the deliberation on the adequacy of the medical care benefits of the decision-making drug that was deliberated by the 5th Pharmaceutical Benefits Advisory Committee on the 8th. The only drug that has been evaluated for reimbursed adequacy at this time is MSD Korea's CMV infection treatment, 'Prevymis (Letermovir) 250mg and 480mg'. Prevymis, a drug that prevents giant cell virus infection in hematopoietic stem cell transplant patients, has been approved for use in the prevention of CMV infection and disease in adult patients who have undergone allogeneic hematopoietic stem cell transplant (HSCT) from the MFDS in 2018. The U.S. permit was in 2017, and the FDA has also designated Prevymis as a breakthrough therapy, a priority review drug, and a fast track drug. Ongentys 50mg deliberated by the committee and the ovarian stimulant 'Rekovelle Prefilled Pen (Follitropin delta)', which is a controlled ovarian stimulant in women receiving supplementary reproductive therapy from Ferring Pharmaceuticals, has a reasonable reimbursement, but the amount requested by the pharmaceutical company is high. Ongentys is a standard treatment for Levodopa/Dopa decarboxylase inhibitor (DDCI), and is an adjunct to Levodopa/Dopa decarboxylase inhibitor (DDCI) in patients with Parkinson's syndrome with symptoms of motor agitation, which do not improve symptoms. It was approved in Korea on November 26, last year. Rekovelle Prefilled Pen received domestic approval as an indication for controlled ovarian stimulation to mature multiple follicles in women receiving adjuvant reproductive procedures, such as in vitro fertilization or intracellular sperm injection, on December 27 last year. The HIRA said that Ongentys and Rekovelle Prefilled Pen are recognized for the appropriateness of the reimbursement when they are accepted below the evaluation amount. However, if the pharmaceutical company does not accept it, non-reimbursement price will be continued. On the other hand, in accordance with Article 11-2 of the Rules on the Regulation for Criteria for Providing Reimbursed services in the NHI, the HIRA evaluates the adequacy of pharmaceuticals through the deliberation of the Pharmaceutical Benefits Advisory Committee. The final evaluation result can be changed if changes in details of the scope of the drug and the standard items of the drug, changes in the permission of the item requested for decision, and withdrawal of the permission.
- Policy
- Will generic for Nexavar be released?
- by Lee, Tak-Sun May 11, 2020 06:18am
- The attention is focused whether the generic drug of Nexavar (Sorafenib, Bayer) which has an absolute position as the first drug for liver cancer will be available in the market soon or not. Access to the patient is expected to improve further if the generic for Nexavar which has established an almost exclusive position in the liver cancer treatment market is launched. According to the MFDS, as of 29th of last month, a generic company filed an application for permission for generic for Nexavar. According to the patent linkage system, the patent holder Bayer was informed of the application for permission. Currently, Nexavar is registered in the patent list only crystalline form patent until September 20, 2025. Hanmi decided to evade the patent in December 2017 after a lawsuit to the Supreme Court. In addition, Hanmi claimed to be invalid in the formulation patent & the method of use patent that were due to expire on February 22, 2026, and the patent was invalidated after a lawsuit to the Supreme Court. And only the crystalline form patent avoided by Hanmi is effective after the active ingredient patent expires on January 12th. In the meantime, Hanmi has been developing generics through bioequivalence tests. On the 24th, Kwangdong Pharmaceuticals was also approved for the bioequivalence test plan for Nexavar’s generics. It is not known which company applied this time. However, given the recent development history, it is possible that it is Hanmi. If approved, it is expected to raise expectations in the market as the first generic for Nexavar. Nexavar acquired a domestic product license in January 2008, and established an exclusive position in the market until Lenvima (Lenvatinib mesylate) by Eisai Korea was released last year. According to IQVIA, the sales amount was ₩25.4 billion last year. It is noteworthy whether generic will succeed in launching early and threaten the original company’s absolute share.
- Policy
- Treatment standards are changed in the early stage of MDR-TB
- by Kim, Jung-Ju May 11, 2020 06:17am
- In order to combat multidrug-resistant tuberculosis (MDR-TB), health authorities have changed treatment standards so that new drugs such as Bedaquiline can be used as core drugs even in the early stages of disease. This is to increase the success rate of treatment. The KCDC (Director Eun-Kyeong Jung) has published Korean guidelines for tuberculosis 4th edition, which includes rapid diagnosis and use of new drugs to combat multidrug-resistant tuberculosis (MDR-TB). MDR-TB refers to tuberculosis caused by Mycobacterium tuberculosis resistant to two anti-tuberculosis drugs: Isoniazid and Rifampin. This TB treatment guideline is the fourth revised version since the first edition of 2011, and suggests a treatment and management method for tuberculosis that fits the reality of Korea. First, in order to increase the success of treatment, this amendment changed the criteria for rapid diagnosis and use of new drugs, such as diagnosing MDR TB patients more quickly and allowing new drugs to be used in the early stages. To increase the success rate of MDR-TB treatment, the KCDC classified Bedaquiline (new drug), Linezolid, and Quinolone-based drugs as core drugs to be included from the beginning of treatment for MDR-TB. Another new drug, Delamanid, was classified as a core drug by the WHO, but the domestic guidelines recommend that it be classified as a selective drug (C2 group) and used as an alternative to Bedaquiline. The KCDC explains that if treatment is possible with the core drugs (groups A and B), the risk of side effects is reduced and patient convenience is increased. Along with this, the KCDC recommended rapid susceptibility test of Isoniazid and Rifampin for the first culture strain or antibacterial smear positive sample of all tuberculosis patients to reduce the delay in the diagnosis of MDR-TB, and also recommended the rapid susceptibility test for Quinolone-based drugs that can be additionally used when MDR-TB is confirmed. Therefore, the government has established and operated a Quinolone rapid susceptibility test system so that recommendations can be applied at the medical treatment site. The guidelines were revised through the Joint Committee for the Revision of Korean Guidelines for Tuberculosis, which was organized by experts from the Korean Academy of Tuberculosis and Respiratory Diseases (KATRD). Based on the recommendations of the World Health Organization (WHO) in March of last year, the KCDC contained standardized MDR-TB diagnosis and treatment methods suited to the domestic reality. Meanwhile, the number of new tuberculosis patients in Korea last year was 23,821 (46.4 per 100,000 people), which has been declining for 8 consecutive years since 2011. The success rate of MDR-TB treatment was 64.7% in 2017, which is still low compared to 70-80% in advanced countries, and efforts to reduce disease burden are urgent. The Korean guidelines for tuberculosis 4th edition will be available on May 7th through the website (www.mois.go.kr, the KCDC, TBzero, the Integrated Control System for Diseases and Health) and printed copies will be distributed to private medical institutions and local governments by the end of this month.
- Policy
- Felodipine indication to get limited to stable angina
- by Lee, Tak-Sun May 08, 2020 06:34am
- Original felodipine ‘Munobal’ by Handok Felodipine, used on patients with hypertension and angina, is facing an indication adjustment to only treat stable angina when used for angina. Korea Ministry of Food and Drug Safety (MFDS) is planning to finalize the order to change the medicine’s indication on May 22. A calcium channel blocker (CCB), felodipine has a brand-name drug like Munobal tablet (Handok), approved in 1990. After reviewing safety and efficacy data submitted for the oral felodipine’s license renewal, MFDS announced it has decided to alter the drug’s indication. The final order would be made on May 22 as the ministry has previously issued the preannouncement. Initially labeled as hypertension and angina treatment, the drug would be indicated to treat hypertension and stable angina. CCBs have been used to treat angina as it relaxes the blood vessels in coronary artery. Amlodipine, benidipine, efonidipine, felodipine and nifedipine are some popular CCBs. Generally used amlodipine is indicated to treat stable angina and variant angina. Angina can be categorized into three types—stable angina caused by chronic constriction with arteriosclerosis; variant angina caused by atherosclerotic plaque rupture; and variant angina caused by coronary vessel spasm-based blood flow dysfunction. Currently, nifedipine (brand name: Adalat (Bayer)) is limited to treat stable angina and soon felodipine would become the same. Total 33 felodipine items licensed by 31 companies would be subject to the indication change. Considered as an original felodipine drug, Munobal by Handok has made 1.6 billion won last year from outpatient prescription, according to UBIST.
- Policy
- People with hepatitis C tx shouldn't take birth control pill
- by Lee, Tak-Sun May 07, 2020 06:01am
- Patients receiving hepatitis C DAA (direct-acting antiviral drugs) will not be able to take the contraceptive containing Ethinylestradiol. This is because the MFDS is pursuing an order to change the permit to add the DAA administration group as a contraindication to patients taking contraceptives based on EMA’s information. Previously, only Viekirax (Ombitasvir/Paritaprevir/Ritonavir), the treatments for hepatitis C, was contraindicated. The MFDS announced that it will instruct the change on the 12th of May through the preliminary notice period until May 11th for the changes in the permits. Since Ethinylestradiol is one of the female hormones Estrogen, it regulates the menstrual cycle, so it is mostly contained in pre-contraceptives. It is also contained in domestic market leading items such as Mercilon (Alvogen Korea), Myvlar (Dong-A Pharm), and Yaz (Bayer Korea), and 26 items of 14 companies are instructed to change the permit including these items. It has significantly higher levels of ALT in females using Ethinylestradiol-containing agents in clinical trials of Ombitasvir/Paritaprevir/Ritonavir that are at least 5 times higher than normal peak (ULN). Only Ombitasvir/Paritaprevir/Ritonavir, the treatments for hepatitis C, was contraindicated when taking pre-contraceptives. On the other hand, it was added that ALT elevation was observed when the combination of hepatitis C antiviral agent containing Glecaprevir/ Pibrentasvir (Maviret) and oral contraceptives containing Ethinylestradiol was added. Accordingly, the target of contraindications was expanded to patients with direct hepatitis C direct-acting antiviral (DAA). The DAA-based hepatitis C treatments released in Korea are 8 items including Viekirax, Maviret, Exviera, Sovaldi, Harvoni, Zepatier, Daklinza, and Sunvepra. The MFDS said that after the comprehensive review of the current status of domestic and foreign permits and submitted opinions regarding the safety information of the European Medicines Agency (EMA) containing Ethinylestradiol, an opinion inquiry was conducted. On the 12th, it was announced that the final permit change order will be announced.
- Policy
- Truth behind COVID-19 and using antihypertensives
- by Lee, in-bok May 06, 2020 06:33am
- Although a hypertension treatment angiotensin-converting enzyme (ACE) inhibitor has aroused controversy while seeking for COVID-19 treatment, the drug’s safety issues is getting resolved by a series of related clinical investigations. Multiple clinical trials of using ACE inhibitors on COVID-19 patients have confirmed the safety of the drug and actually discovered it helps patients fighting against COVID-19. The safety concerns of using the antihypertensive and COVID-19 soon to be concluded According to medical scholars on May 5, safety concerns regarding the use of antihypertnesives amid COVID-19 pandemic has been raised early. A series of clinical studies have been published confirming the correlations between COVID-19 and antihypertensive ACE inhibitors Because the novel coronavirus uses ACE, especially ACE2, as a receptor to spread, some medical experts argued angiotensin II receptor blockers (ARBs) and ACE inhibitors could possibly worsened the disease condition. And an animal study result supported the theory as it found ARBs and ACE inhibitors upregulating the expression of ACE2, and hence, allow the virus to more actively invade lungs and heart, where ACE2 is expressed. Although internationally renowned medical organizations like World Congress of Cardiology (WCC), American College of Cardiology (ACC) and European Society of Cardiology (ESC) have urged the prescribers to maintain the prescription of the medications as suspending the treatment would cause more damage than benefit, the medical experts are still arguing over the issue. This is the background behind why so many COVID-19 related clinical trials around the world are testing the safety of using the hypertension treatments. In conclusion, however, the concerning theory was proven groundless. Three studies have already concluded in same findings—the hypertension treatments ‘do not affect COVID-19 patients at all.’ Safety test results on ACE inhibitors report “suspending prescription is more dangerous” A multiregional multicenter study led by Professor Yun Feng of Jiao Tong University at Shanghai found that halting the prescription of the hypertension drugs could threatened the patients with hypertension even worse (doi.org/10.1164/rccm.202002-0445OC). Clinical trials reported so far have refuted the claim that ARBs and ACE inhibitors affect prevalence and severity of COVID-19 Running a head-to-head comparison trial on 476 COVID-19 patients, the researchers confirmed the patient group that halted the antihypertensive prescription showed higher possibility of worsening their condition. In fact, only four out of 33 patients (12 percent) with hypertension who took ARB and ACE inhibitor have become severely ill, whereas 36 out of 80 patients (45 percent) who stopped taking the medications have become severely ill. As a result, the study has proven that stopping the medication out of the concern could actually worsen the COVID-19 condition. Another study also claims the concern over safety is baseless. Comparing groups of patients either taking or not taking the antihypertensive and without comorbidity has shown no significant difference. An investigation led by Professor Guang Yang of Hubei Provincial Academy of Traditional Chinese Medicine analyzed 126 patients with hypertension and 125 patients without the underlying condition, and also compared them to 1,942 patients who visited hospital prior to the spread of COVID-19 (doi.org/10.1101/2020.03.31.20038935). Moreover, the researchers subdivided the patient group with hypertension either administered with ARB and ACE inhibitor or not, and compared the effect of using the drugs. The study found 35.4 percent of hospitalized patients with hypertension before the spread of COVID-19 used ARB and ACE inhibitor and 34.1 percent of the patients after the spread of COVID-19 used the medications, which demonstrated no significant difference. It also meant the concern of administering ARB and ACE inhibitor raised from the animal study is not meaningful in clinical terms (P=0.756). In some cases, hospitalized patients with COVID-19 who were administered with ARB and ACE inhibitor showed lower severity level and mortality rate than the ones that did not take the medications. But the figure did not have statistical meaning, and the researchers recommended interpreting the result to understand that the medications do not worsen the disease severity. A study led by Professor Yingxia Liu at Southern University of Science and Technology of China also resulted in similar outcomes. The investigators analyzed 78 COVID-19 patients with the hypertension comorbidity, and discovered the administration of ARB or ACE inhibitor did not affect prevalence or severity of the disease (doi.org/10.1101/2020.03.20.20039586). 24.3 percent of the study participants had taken ARB and 3.8 percent had been prescribed with ACE inhibitor. But each group only had 15.8 percent and 2.6 percent of severe cases, respectively. The study also saw the group that was prescribed with ARB and ACE inhibitor had lower severity in the disease than the group with hypertension but had not taken the drugs. Compared to the control group, only 54 percent of the ARB-prescribed patient group had severe cases of COVID-19 and ACE inhibitor-prescribed group showed the similar result with 57 percent. Large-scale clinical trials in preparation to “seek evidences for continuing prescription” Based on the study results refuting the claim of ACE inhibitors affecting the prevalence and severity of COVID-19, the international scholars’ clinical reasoning and recommendation to continue the antihypertensive medications would likely to be accepted more widely. Medical experts anticipate these investigations would provide evidences supporting the medical scholars’ recommendations to continue prescribing the hypertension treatments WCC, ACC, ESC and Korean Society of Hypertension (KSH) have urged on maintaining the prescription, but it was rather a clinical reasoning than from concrete evidence. However, their recommendation is gaining more support as more and more clinical evidences are generated in continuous investigations on the matter. Besides the published study results, there are large-scale randomized, double-blinded, head-to-head clinical trials in progress globally, and they would provide more concrete evidences in May. A KSH official stated, “The already available study outcomes are sufficient enough to say ARB and ACE inhibitor prescription should be maintained,” but “the findings are only based on observational studies with limitation. Regardless, the soon-to-be-published randomized double-blinded placebo-controlled studies would provide more clear direction.”
- Policy
- Calculation criteria for COVID-19 are being considered
- by Kim, Jung-Ju May 06, 2020 06:32am
- The government said it was in the process of evaluating the calculation standards for medical institutions that participated in Corona 19 response. It means that various types of compensation appear due to treatment segmentation and environment different from that of MERS in the past. Yoon Tae-ho, a senior health ministry official of the Central Disaster Management Headquarters, answered this through a question and answer at the regular briefing at the COVID-19 Central Disaster and Safety Countermeasure Headquarters today (28th). The government had previously set up a committee for deliberation on compensation for loss and paid some of the losses from the hospitals participating in COVID-19 outbreak in the form of advance payment by rough estimate on the 9th. However, there are opinions that compensation is insufficient due to the fact that the official standards such as targets and items for compensation for loss have not been finalized. Regarding this, Yoon Tae-ho, a senior health ministry official of the Disaster Management Headquarters explained that it has the basic principle that appropriate compensation should be given to hospitals that actively participate in treatment and participate in government policies in relation to COVID-19. According to him, the 3rd Professional committee for deliberation on compensation for loss is held today. It is expected that some details will be made regarding loss compensation. Yoon Tae-ho, a senior health ministry official said that the advance payment by rough estimate on the 9th was only partially paid in consideration of the urgency, and further compensation measures will be made in the future. Also he added that new types of compensation are emerging, such as community treatment centers, screening clinics, and hospitalizations for severely ill patients, and appropriate calculation standards are prepared for each institution type and are being considered.
- Policy
- Issues to remain as restricting bioequivalence test scrapped
- by Lee, Tak-Sun Apr 29, 2020 06:19am
- The issues regarding highly saturated first generic market would likely to remain as the Regulatory Reform Committee has axed the Korea Ministry of Food and Drug Safety’s (MFDS) plan to restrict joint and cosigned bioequivalence test. Even if the government grants favorable pricing on generics with individual test data from July, the industry experts expect that many of pharmaceutical companies would still choose to run joint bioequivalence tests to not miss out on their market release timing. Accordingly, pharmaceutical companies can now save much on their R&D and production costs like on pharmaceutical research and bioequivalence test. But the issues of pharmacy and primary consumer’s difficulty in product dispensing and illegal rebate provision within the heated competition would remain the same in the saturated generic market. Moreover, the issue of multiple generic receiving preferential sales approvals, initially expected to be eliminated with the joint bioequivalence test restriction, would likely to continue causing inefficiency in the market. Nothing to cripple first generic market saturation On April 24, the Regulatory Reform Committee has disclosed its meeting minutes deliberating the MFDS’ revision on the Regulation on Pharmaceuticals Approval, Notification and Review that restricts joint and cosigned bioequivalence test, and recommended to abolish the plan. Sources report MFDS is reviewing on accepting the recommendation and issuing the regulation revision notice without the restriction on bioequivalence test. The Regulatory Reform Committee has recommended the ministry to abolish its plan to limit the number of generics with joint or cosigned bioequivalence test data as one (main tester) plus three (number of cosigned testers), which the restriction was supposed to be reevaluated after five years. The restriction on the joint bioequivalence test was temporarily imposed (one-plus-one) due to the 2006 joint test manipulation incident, but it was lifted in 2010 by the Regulatory Reform Committee’s demand. Currently, an unlimited number of cosigned testers can share the bioequivalence test results and use CMOs to manufacture generic product. Since the discovery of impurity in valsartan products, MFDS pointed out the quality control as a reason for the restriction on the joint bioequivalence test, but it actually targeted prevention of further saturation in the generic market. Moreover, the Ministry of Health and Welfare (MOHW) has also started restraining the generics market by pricing the products depending on the submission of individual bioequivalence test results and the use of DMF registered substances. The differentiated drug pricing by MOHW would be enforced from coming July, starting from newly approved items. For instance, a product using pharmaceutical ingredients registered on DMF but submitted data from a cosigned bioequivalence test would be priced at 45.52 percent of the original’s price. Whereas the ones with individual test data are priced at 53.55 percent of the original’s price as stipulated by the existing drug pricing formula. But many of the pharmaceutical industry claim the differentiated pricing would inevitably change the cosigned manufactured generic policy, regardless of the joint bioequivalence test policy. As a result, the industry also projects the effect of abolishing the joint bioequivalence test policy would be insignificant. As for the effort to prevent saturation of generics market, however, the number of generic products in the first generic market would unlikely to be affected, because the joint bioequivalence test policy is scrapped. There are several reasons as to why the industry experts expect the demand on cosigned manufactured generic would not be crippled any time soon. Many of the pharmaceutical companies without individual bioequivalence test result would highly likely to resort to CMOs to not miss out on timely market release. And the CMOs without strong sales power would call for clients to generate as much profit as possible. On Apr. 17, 16 of benign prostatic hyperplasia (BPH) treating generics, tamsulosin 0.4 mg, were approved by the Korean government. All of them are manufactured by a same CMO, Dongkoo Bio&Phama. And other various items manufactured by CMOs like Kolmar Korea, Dasan Pharmaceutical and others are seeking for approvals. If the joint bioequivalence test was limited to one-plus-three, Dongkoo Bio&Pharma would only get to manufacture four items, which would then reduce the number by 12. Despite the policy that prices CMO generics 8 percent less, the industry experts see that the small and medium companies’ demand on CMO generics in the first generic market would remain the same, as they can still save on R&D cost and make profit from early release in the market. Questionable benefit of preferential sales approval on multiple items As long as the preferential sales approval grants exclusivity in the generic market for nine months, the generic market would never seize to get even more saturated. A number of pharmaceutical companies competing against each other for the patent-challenged first generic market would turn to the CMOs once they lose out in the game, and share its bioequivalence test data to join the generic market early. And generic makers with an option to opt out on investing on drug development would eventually sign the CMO deals. CMOs that have developed generics for client deals would have nothing to fear with the abolishment of the joint bioequivalence test restriction. The pharmaceutical industry has been constantly reprimanding the existing preferential sales approval system distributing the benefit to multiple companies. Some expected the restriction on the joint bioequivalence test would also eliminate the preferential sales approval issues, but now it seems it would remain the same as the plan has been shut off. Due to the government’s action, now the industry may demand for the change more than before.
- Policy
- The MOHW, support for pharmaceuticals entering overseas
- by Lee, Jeong-Hwan Apr 29, 2020 06:19am
- The government will create a ₩100 billion fund to support domestic biohealth companies that have excellent technology but are having difficulty attracting external investment. The final goal of the fund is to enhance the international competitiveness of Korean bio-health companies and to expand into the global market due to the COVID-19 crisis. The government's plan is to recruit fund managers by June and form a fund within the year. The policy is to focus on investment in the domestic pharmaceutical, bio, and medical device industries and overseas support areas for medical institutions. On the 27th, the MOHW (Minister Park Neung-hoo) said, "We will create a new fund worth ₩100 billion to support overseas expansion of K-BIO." Since 2013, the MOHW has raised and invested ₩80 billion in funds to foster the domestic bio-health industry and support overseas expansion. The MOHW said that it has created a number of successful cases by actively investing by discovering companies that have technological skills but are having difficulties in attracting investment. The MOHW added that there is no bio-health fund that has yet to be liquidated by investing for 4 years and operating for 8 years, but it has been recovering investments of ₩51 billion. The fund to be newly raised is about ₩100 billion by recruiting private investors with initial investment of ₩15 billion of investment funds and ₩25 billion of the Export and Import Bank of Korea contributions. In addition, the MOHW plans to unify the five funds that have been created and operated as K-BIO new growth funds. The new fund will be named 'K-BIO New Growth Fund No. 6'. The MOHW will announce the selection of managers to manage the fund through Korea Venture Investment and Korea Export-Import Bank from 28th to 20th next month. It will plan to select fund managers in June and close the fund formation in September at the earliest and this year at the latest. The MOHW's Eul-ki Lim, . the Health Industry Development Division Officer, said that COVID-19 is a concern for the global economic downturn, but it will be an opportunity for the domestic bio-health industry, which is attracting attention all over the world.
- Policy
- Amendment to cascading drug price revision proceeds as it is
- by Kim, Jung-Ju Apr 29, 2020 06:19am
- If the co-biological equivalence test 1 + 3 system is discarded by the Regulatory Reform Committee among the 'Regulation on Pharmaceuticals Approval, Notification and Review', what will happen to the 'cascading drug price revision' of ‘a partial revision of the Criteria for Decision or Adjustment on Drugs’? The MOHW plans to carry out the so-called 'the cascading drug price system' to be implemented in July. According to the government, the Regulatory Reform Committee previously recommended to withdraw the 1+3 system, that is, the MFDS' amendment, which restricts the number of items that are exempt from bioequivalence test submissions when drug approval is granted. The reason for this is that it is difficult to achieve the goal of improving the generic quality even if the exemption of co-biological equivalence test is limited based on this system. However, it was because the effectiveness of the regulation introduction was difficult, and there were large negative opinions within the regulatory framework, such as the problem of restrictions on market entry, lack of direct effect on quality and safety, and lack of effect on promoting R & D. The issue is insurance price. When the generic price revision was originally announced, the government said that it would grant the drug price by calculating the 'drug approval and price linkage system' based on the content of differentiating the generic insurance price depending on whether or not it has its own bioequivalence test. However, the MOHW plans to carry out the cascading drug price system, in July, in a scheduled order without change. According to the government, the core of the standard of drug price addition is ▲ self-biological equivalence test and ▲the use of DMF registration, the method of granting the drug price (53.55% of the original) by preferentially treating its own biological equivalence product is separate from the withdrawal of this 1+3 system. In addition, the reorganization of drug prices is a major source of stabilization for health insurance finance, and self-biological equivalence testing and the preferential treatment of DMF registration in cascading reorganization is different from the effectiveness of the system that the Regulatory Reform Committee made as a justification. However, even if the government pursues drug price revision, there is a concern that the reorganization of the 'drug approval and price linkage system' will be changed to a regulation pattern in a direction different from the original goal, even if the drug price lawsuits surrounding generics are still being pursued. This means that it could spread to another lawsuit issue between the government and the industry. For this reason, the company's position is expected to be divided according to the revision of the MFDS’ amendment (deletion of the new provision of the 1 + 3 system for co-biological equivalence test) and the realization of the MOHW's generic cascading drug price revision.
