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- 2026-04-10 23:45:48
- Opinion
- [Reporter’s View] Can new drug listings really be accelerat
- by Eo, Yun-Ho Jan 11, 2023 05:59am
- The measures to accelerate reimbursement listing of new drugs is expected to be implemented in earnest this year. However, the practicality of the measure – on whether it will really accelerate drug listings – remains in question. The health authorities made a preannouncement on the amendment of the pharmacoeconomic evaluation exemption guidelines and drug pricing negotiations to expedite the listing of anticancer drugs and severe disease treatments as promised by the Yoon Suk-Yeol administration for implementation next year. Through this, the reimbursement listing of new drugs with no alternatives will be reduced by 60 days at most. Reducing the reimbursement listing period of drugs has been a regular agenda that had been discussed every year. With every discussion, the regulatory deadline was reduced incrementally. This applies to both the evaluation and negotiation process conducted by the Health Insurance Review and Assessment Service and National Health Insurance Service. However, this deadline is only the term set for the authorities to review reimbursement after someone (a pharmaceutical company) applies for reimbursement listing. The fault is on both parts. Quite a lot of pharmaceutical companies spend a considerable amount of time before applying for reimbursement after approval to discuss strategies with their headquarters. In other words, the companies take their time to thoroughly calculate their strategies and options. In the process, the companies weigh the timing of reimbursement to receive a higher price or forgo some indications in consideration of competition with other products. Companies really deliberately defer pricing negotiations waiting to be included in the government’s coverage reinforcement measure or decided to cancel the introduction of their drugs determining that Korea's marketability is poor. The decision to pass Korea, the ‘Korea passing’ phenomenon of “deciding to enter Korea after OO country” has become too common. The government's stance to “take discussions to the Drug Reimbursement Evacuation Committee after addressing most issues in the front end” has also played a role. When tracing back the listing process of drugs that have long exceeded the review deadline, applications for many of these drugs have been voluntarily withdrawn by the company after experiencing delays at the Drug Reimbursement Standard Subcommittee level. However, many companies have spoken out on how this voluntary withdrawal is not so ‘voluntary.” The deferral decision is very common during drug pricing negotiations between the NHIS and pharmaceutical companies. However, we need to remember that the 60-day deadline set for negotiations is a promise, and a deadline is a deadline. Also, the NHIS has referred to the negotiation deadline as a sort of "benefit" when announcing its plan to shorten the deadline for new drugs. The problem is that there is no transparency in the progress made in that 60-day period. Nothing is disclosed on what happened to the drugs that exceeded the listing review deadlines. As a result, only the patients are left to suffer in endless await. No answer nor explanation on the direction of progress is provided to those that wait in dire need. This new year, all the stakeholders involved should make collaborative efforts to reduce the period to actual reimbursement listing.
- Company
- Rx Drugs permits have fallen by 73% in 3 years
- by Chon, Seung-Hyun Jan 10, 2023 05:35am
- Stair-type drug price systems and joint development regulations have dampened the entry power of generics Last year, the number of Rx drug permits decreased significantly. The number of market entries has been reduced by more than 70% compared to three years ago. Analysts say that the government's all-around regulatory pressure, such as the reorganization of the drug price system and regulations on joint development, has greatly reduced its entry into the generic market. According to the Ministry of Food and Drug Safety on the 9th, a total of 1,118 Rx drugs were approved last year. It decreased by 30.1% in a year from 1,600 in 2021. Last year, the number of Rx drug permits was less than half of the 2616 two years ago. Compared to 4,195 in 2019, it decreased by 73.3%. The number of Rx drug permits has decreased by 3077 compared to three years ago. The number of Rx drug permits averaged 130 per month to 1,562 in 2018, but more than doubled to 4,195 per month in 2019. In May 2019, 584 professional drugs were approved for a month. However, since 2020, the number of Rx drug permits has gradually decreased and seems to have regained the previous year's level. From October 2018 to July 2020, more than 100 Rx drugs were poured out every month, and in August 2020, Rx drug permits fell to less than 100 in 23 months. Last year, there were only four Rx drug licenses per month. It is analyzed that the number of generic permits, which account for the largest proportion of Rx drugs, has decreased. The reorganization of the drug price system is cited as a major factor in the decrease in the number of generic permits. The key to the revised drug price system, which took effect in July 2020, is to maintain the upper limit of 53.55% of the original drug before the expiration of the current patent only when generic products meet both the direct BA test and the use of the registered raw drugs. The reorganized drug price system includes a stepped drug price system in which the upper limit decreases as the salary registration period is delayed. If more than 20 generics are listed in the specific ingredient market, the upper limit of newly listed items will be up to 85% of the existing lowest price. Analysts say that the permission for the entire process of manufacturing consignment generics has decreased significantly due to the structure in which drug prices fall significantly if pharmaceutical companies do not develop generics themselves and conduct BA tests. Since more than 20 generics have already entered most markets with high marketability, late generics will inevitably lose their motivation to enter new markets as drug prices fall significantly due to the application of the step-type drug price system. Some say that regulations on the joint development of drugs, which took effect in July last year, have promoted the decline in generic permits. The revised Pharmaceutical Affairs Act, passed at the plenary session of the National Assembly in May last year, calls for limiting the number of improved new drugs and generics that can be approved as a clinical trials. If all manufacturing processes are manufactured the same way with the same prescription and manufacturing method at the same manufacturing plant as the pharmaceutical company's drug that directly conducted the BA test, the use of BA data is limited to three times. This means that only four generics can be approved for one BA test. Clinical trial data can also be agreed to only three items other than drugs from direct-performing pharmaceutical companies. In the past, dozens of pharmaceutical companies often received consignment generic licenses with the same data if certain pharmaceutical companies were approved for generics through BA tests, but joint development regulations have made it impossible to "unlimited generic replication." Critics point out that the government provided the cause of the surge in Rx permits in 2019 and 2020. The government's move to tighten regulations on generics has led to a surge in generics permits. In 2018, 175 items containing valsartan, a hypertension treatment, were banned from selling due to the detection of excess impurities. At that time, the Ministry of Health and Welfare and the Ministry of Food and Drug Safety set up a "consultative body for improving the generic drug system" and began to come up with measures to curb the generic crisis. As the government's move to tighten regulations showed, pharmaceutical companies moved to install generic products in advance, temporarily increasing generic permits. The number of generic permits surged due to the government's move to tighten regulations and returned to the previous level after the system was reorganized.
- Company
- HIV drug Pifeltro may be prescribed at hub hospitals in Kore
- by Eo, Yun-Ho Jan 10, 2023 05:35am
- ‘Pifeltro,’ a single-ingredient drug used for HIV, can be prescribed at general hospitals in Korea. According to industry sources, MSD Korea’s HIV treatment Pifeltro (dovavirine) passed the Drug committees of tertiary hospitals such as the Seoul National University Hospital and Sinchon Severance Hospital as well as local hub hospitals (national and public hospitals) that are in charge of HIV treatment in Korea, including the Kyungpook National University Hospital, National Medical Center, Pusan National University Hospital, Soonchunhyang University Hospital, Ulsan University Hospital, Chonnam National University Hospital, and Hanyang University Hospital. MSD’s fixed-dose combination drug ‘Delstrigo (dovavirine, lamivudine, tenofovir disoproxil) also contains the main active ingredient in Pifeltro, dovavirine. Both Delstrigo and Pifeltro were listed for reimbursement in October 2021. The final listed price was set at KRW 7,975 per tablet for Pifeltro, and KRW 19,491 per tablet for Delstrigo. Delstrigo is already being prescribed at major medical institutions in Korea. Both drugs are indicated for the treatment of HIV-1 infection in patients without prior antiretroviral therapy (ART) treatment history in Korea. The efficacy of the drugs was identified through the DRIVE-AHEAD trial, in which Delstrigo demonstrated noninferiority to efavirenz·emtricitabine·tenofovir(EFV/FTC/TDF). In the trial, the proportion of patients who sustained viral suppression through 48 weeks (viral suppression of HIV-1 RNA
- Policy
- “Will dvlp blockbusters and systemize non-F2F treatment”
- by Lee, Jeong-Hwan Jan 10, 2023 05:35am
- The government will reinforce R&D support in the pharmaceutical industry to develop 2 new global blockbuster drugs by 2027, by increasing public-private investments and expanding customized policy support. The government also selected the institutionalization of non-face-to-face treatment and increasing the admissions quota of medical schools as key policies required to reinforce essential healthcare, and expressed its will to promote the policies promptly through the operation of a permanent consultative body. On the 9th, the Ministry of Health and Welfare announced the above as part of its 2023 major task plan. ◆Full-fledged support to fostering the biohealth industry and exports=The MOHW will be preparing measures to train 110,000 manufacturing and research personnel by 2027 and lay the foundation for fostering the biohealth industry. Also, through the operation of the WHO training hub for mid to low-income countries, the authorities promote partnerships between vaccine and raw material companies in Korea and abroad to support overseas expansions of Korean companies. It will also promote a pre-entry/post-evaluation system through an integrated review system for innovative medical devices and extending deferment period for new health technology assessments, etc., and promote the expansion and commercialization of treatment opportunities for advanced regenerative medicine Also, a pan-ministerial governance body called the ‘Pharma-Bio Innovation Committee’ will be organized to provide efficient and borderless support ranging from basic R&D to commercialization. Biohealth exports will also be strategically supported. In Korea, biohealth exports have been growing 19.5% on average annually from USD 12.5 billion in 2017 to USD 25.4 billion in 2021. The Comprehensive Plan for Healthcare Exports contains measures to support the creation of 2 global blockbuster new drugs by 2027 and systematic measures for Korea to achieve the 5th place in medical device exports. To this end, a plan for the pharma-bio industry and the medical device industry will be established by January next year. More specifically, the authorities will public-private investments and reinforce customized support. This year, it will expand R&D by investing KRW 3.8 trillion in the pharmaceutical industry and KRW 1.6 trillion in the medical device industry. At the same time, the government will invest in the K-Bio vaccine fund in earnest and create an additional fund worth KRW 1 trillion by 2025. In line with the movement to strengthen licensing and regulations in major countries, the government will actively respond to protect Korea’s industry and implement strategic support by industry and region to develop new markets. ◆Strengthening welfare for the weak and essential healthcare= The MOHW will also operate a permanent consultative body to promptly implement policies including the systemization of non-face-to-face treatment and increasing the admissions quota of medical schools. In the mid-to-long term, the MOHW will present a comprehensive healthcare vision in consideration of its relation and consistency with various other policies, such as the reform of the healthcare delivery system. The healthcare development plan will be prepared by the second half of this year. Specifically, in order to expand essential healthcare, which was a topic of focus last year, the first stage will be to establish a reinforced system for severe, urgent, childbirth, and pediatric treatments. Also, the pediatric treatment support plan will further be supplemented by reflecting opinions from public hearings. In the second stage, MOHW will provide support for essential healthcare, in areas that have difficulty providing proper treatment due to lacking medical environment or a lack of professional manpower. In order to resolve the imbalance between regions and areas of treatments that remain, compensation in fields that lack supply will be strengthened, and public policy fees such as regional fees will continue to be developed. Also, eligibility for catastrophic medical expenses will be lowered, the amount raised, and applicable diseases expanded. ◆ Establishing health security and driving entry to new markets with advanced technology = The MOHW will also prepare for the rise of future pandemics and rare diseases by investing in new technologies in the bio sector. To prepare for infectious diseases, the government will localize essential vaccines that are import-dependent and also develop next-generation vaccines and treatments. By 2029, the MOHW will support KRW 215.1 billion to localize essential vaccines, support KRW 21 billion for the development of mRNA vaccines, and KRW 46.4 billion for the development of antivirals. To advance technology for disease control, prevention, and medical safety, the MOHW will invest KRW 85.7 billion by 2027, and KRW 28.8 billion by 2027 with the goal of developing non-face-to-face treatment technology for use in future pandemics. Also, it will prepare a 'Korean ARPA-H' that supports target-oriented strategic R&D tasks such as technologies for treating rare diseases to its success. In order to prepare for the transformation into a digital and data-oriented medical paradigm, the MOHW will develop the MyData service model as well as pioneer models for digital transformation such as smart hospitals, while operating transformation expansion support centers to provide customized support for the smartization of public-private hospitals.
- Company
- Braftovi can be prescribed at tertiary hospitals
- by Eo, Yun-Ho Jan 10, 2023 05:34am
- The new colorectal cancer drug Braftovi has settled in tertiary hospitals. According to related industries, Ono's BRAF-inhibitory ELECTRIC CANCER (colorectal cancer) treatment Braftovi passed the Drug Commission (DC) of Korea University Anam Hospital, including Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, and Asan Medical Center. Braftovi is still a non-reimbursed drug. It was approved in August 2021 and passed the Cancer Disease Review Committee in January of the following year. It quickly passed the HIRA Cancer Disease Deliberation Committee, the highest level in anticancer drug benefits, but failed to present the agenda of the Drug Benefit Evaluation Committee. If it succeeds in registering this year, it is expected to lead to actual prescriptions quickly. Braftovi can be used as a combination therapy with Erbitux of Merck Korea for adult patients with direct bowel cancer with previous treatment experience and confirmed BRAF V600E mutation. Braftovi combination therapy confirmed efficiency through a three-phase clinical BEACON CRC study in patients with unstoppable progressive or recurrent direct bowel cancer with BRAF V600E mutation after primary or secondary treatment. Braftovi -Cetuximab combination therapy showed statistically significant elongation (HR 0.60, p=0.0003) in OS compared to the control Irinotecan-Cetuximab-based combination therapy. The median OS value was 8.4 months in the Braftovi group and 5.4 months in the control group. In ORR according to BICR, Braftovi-Cetuximab combination therapy was 20%, showing statistically significant improvement compared to 2% of the control group. The median PFS value was 4.2 months for Braftovi-Cetuximab combination therapy and 1.5 months for the control group. In this study, there was no unexpected toxicity of Braftovi-Cetuximab combination therapy. In Korea, BRAF V600E gene mutation is positive in 4.7% of patients with direct bowel cancer. It is known that if there is a BRAF V600E mutation, the prognosis is worse than that of patients who do not. There were no approved drugs based on efficacy and effectiveness in direct bowel cancer with BRAF gene mutation, so a new treatment option was needed.
- Company
- Obesity drug Saxenda’s sales surge with expanded indication
- by Moon, sung-ho Jan 10, 2023 05:33am
- Saxenda (liraglutide) has been recording dominant sales in the growing obesity treatment market in Korea. Therefore, the drug is expected to monopolize the obesity treatment market until other new obesity treatments such as ‘Wegovy (semaglutide, Novo Nordisk)’ and ‘Mounjaro (tirzepatide, Lilly)’ are released in Korea. #According to the market investigation institution IQVIA on the 25th, Novo Nordisk’s Saxenda showed a surge in quarterly prescription sales recently. More specifically, Saxenda’s sales recorded KRW 10.4 billion in Q1 last year, then increased to KRW 15.4 billion in Q2, then recorded a quarterly best record of KRW 16.6 in Q3 last year. In other words, the company succeeded in bringing in more than KRW 40 billion in only three quarters last year. Compared to the same three quarters of the previous year, the drug recorded a 70% growth in its sales and solidified its lead in the domestic obesity treatment market. Sales of its competitor Qsymia((phentermine / topiramate ER) have been pushed back by Saxenda's rapid growth, and the sales gap between the two drugs seems to be rather widening despite Qsymia’s sales increase. Alvogen Korea’s Qsymia recorded prescription sales of KRW 8.2 billion in Q3 last year, which is over twice the difference in quarterly sales compared to Saxenda. Qsymia is currently sold by Chong Kun Dang in Korea. Then why has Saxenda been able to enjoy such rapid growth in sales? The medical and pharmaceutical industry pointed to how the drug’s indication was expanded to treat children and adolescents this year. In December 2021, the indication for Saxenda had been expanded to treat adolescents aged 12 to 18 with obesity in Korea with a body weight above 60 kg and an initial BMI corresponding to ≥30 kg/m2 for adults. Novo Nordisk had implemented active sales and marketing activities, such as opening a 'Saxenda portal' exclusively for doctors and launching a digital weight management application to support weight control for patients who have been prescribed Saxenda. A PM that requested anonymity, said, “In the case of Saxenda, its indication expansion to adolescents was the key driver of its sales growth. The number of obesity patients has surged with the COVID-19 pandemic, and the timely indication expansion to pediatric and adolescent patients brought a synergistic effect.” Also, the industry saw that the lowered price and MFDS’s ‘warning’ in addition to the COVID-19 pandemic was behind the rise in sales of Saxenda in local clinics. Since last year, the MFDS has been strengthening control over antipsychotics that contain ▲ phentermine, ▲ phendimetrazine, ▲diethylpropion, and ▲mazindol to address concerns over the misuse and abuse of drugs. A doctor from an internal clinical in Seoul who requested anonymity said, “The obesity treatment market is one representative non-reimbursed treatment market. Its average price had been up to KRW 150,000 at the highest, but its price has now fallen to the KRW 70,000-80,000 range in some areas. In the case of Qsymia, no dumping sales of the product are being made yet as the drug is still new to the market.” “Qsymia costs KRW 4,000 per tablet, therefore, a 30-day prescription of the drug will cost KRW 120,000. Saxenda’s lowered price has therefore led to the increase in sales as well.” Professor Hee-Jin Hwang of the International St. Mary’s Hospital (Department of Family Medicine) who also serves as an executive member of the Korean Society for the Study of Obesity, said, “The MFDS had issued a warning disposition to some doctors in the course of reinforcing management of antipsychotic drugs. As some obesity treatments contain controlled substances, this would inevitably affect the prescription behavior of doctors.”
- Policy
- ↑63% of the average annual SA bill
- by Lee, Tak-Sun Jan 10, 2023 05:33am
- Among ultra-high-priced drugs with an annual drug cost of more than 10 million won per patient, RSA contract drugs have increased significantly. It was confirmed that the claims for RSA drugs increased by an average of 62.6% per year. This fact was found in the "Research on the Performance Evaluation and Development Direction of RSA" conducted by the Industrial-Academic Cooperation Group of Seoul National University (Professor Lee Tae-jin), at the request of the NHIS. The results of this study were partially released on the 2nd through the management information disclosure system (Alio) of public institutions. The research team surveyed the cost of claiming risk-sharing drugs among high-priced drugs exceeding 10 million won per year from 2010 to 2021, and the number of RSA drugs increased from 31.9 billion won in 2014 to 959 billion won in 2021. The amount is equivalent to an average annual increase of 62.6%. RSA drugs accounted for 57% of the total 1.6927 trillion won in claims for expensive drugs in 2021. RSA emergency high-priced drugs increased only 4.9% annually from 50.8 billion won in 2014 to 65.8 billion won in 2021. The research team evaluated, "The RSA system seems to have provided new opportunities for high-priced drugs." In the meantime, he suggested financial management measures for expensive drugs that need to check the RSA system and evaluate the performance of the financial-based types, Refund type, and Expenditure Cap type. However, the research team added, "One-shot treatments, which have recently received great attention, are not included in this analysis, so we propose additional analysis including one-shot treatments in the future, and in the long run, it is necessary to establish a high-priced financial monitoring system based on this data extraction and analysis." The research team also said that it is necessary to prepare financial management measures for RSA non-emergency drugs. The research team explained, "Among non-RSA drugs, anti-cancer drugs are not expensive, and hemophilia drugs and enzyme drugs are high," adding, "Hemophilia drugs are worth 200 billion won in 2021, and enzyme drugs are worth 100 billion won, which has steadily increased." "Unlike RSA drugs, where financial uncertainty is managed, non-RSA drugs have no financial management plan other than price cuts at the expiration of patents," he said. "It is necessary to review re-evaluation or renegotiation considering environmental changes such as changes in foreign prices and listing alternative treatments." The research team said, "To reduce the uncertainty of ultra-low benefit, different approaches are needed depending on the type of uncertainty, the prospect of resolving uncertainty, and decision-making uncertainty. If the primary goal is to apply the CED method, it is better to apply the refund or Expenditure Cap type." As of July 2022, a total of 60 drugs were found to have signed RSA contracts. Anti-cancer drugs and rare disease treatments have increased their registration rates since the introduction of risk-sharing systems, and from 2015 to 2021, the drug cost of risk-sharing drugs increased by 50.9% annually, and RSA drugs averaged about 1.8 million won. RSA is an anticancer drug or rare disease treatment without an alternative and can be applied to serious diseases, omitted drugs submitted by PE, or phase 3 conditionally licensed drugs. When the NHIS RSA contract is signed, pharmaceutical companies will refund a certain percentage to the corporation based on their finances and performance.
- Company
- Mylotarg can be prescribed at general hospitals
- by Eo, Yun-Ho Jan 09, 2023 06:11am
- Mylotarg, a new drug for acute myelogenous leukemia, can be prescribed at general hospitals. According to related industries, Mylotarg, Pfizer's Acute myeloid leukemia (AML) treatment, passed the Drug Commission (DC) of medical institutions such as Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, and Sinchon Severance Hospital. Mylotarg can be used in the primary treatment of adult AML patients who are CD33 positive, and newly diagnosed with Antibody-Drug Conjugate (ADC). Mylotarg has not yet been applied to insurance benefits. The drug was introduced to the HIRA in May last year, but it was judged that the benefit standard was not set. Mylotarg, approved in Korea in December 2021, is an ADC composed of CD33 target monoclonal antibodies and a cytotoxic drug Calicheamicin, which acts on cells expressing CD33 antigens that appear in 90% of all AML patients. This blocks cancer cell growth and induces apoptosis. The Mylotarg permit was based on a clinical study conducted on 271 newly diagnosed AML patients with no treatment experience before the age 50 to 70. The clinical trial was ALFA-0701 clinical trial, which was conducted with open-label, random assignment, and multi-organ phase 3. The existing chemotherapy, Downorubicin or Citarabin combination therapy, Mylotarg, Daunorubicin, and Cytarabine combination therapy were compared and evaluated. As a result, the Mylotarg+Daunorubicin+Cytarabine combination group showed an effect of extending about 7.8 months compared to 9.5 months of the Event-free survival median value of 17.3 months. The risk of induction failure, recurrence, or death was reduced by about 44%. The median value of Relapse-free survival was 28.0 months in the Mylotarg+Daunorubicin+Cytarabine bottle administration group and 11.4 months in the Daunorubicin+Cytarabine combination administration group, showing a significant difference of about 16.6 months. In the case of the median value of Overall survival, there was no statistically significant difference between the Mylotarg+Daunorubicin+Cytarabine combination administration group for 27.5 months and the Daunorubicin+Cytarabine combination administration group for 21.8 months.
- Opinion
- [Reporter’s View] Decide whether to reimb diabetes combos
- by Lee, Tak-Sun Jan 09, 2023 06:11am
- Once again, discussions on expanding reimbursement to combination therapies to treat diabetes are at a standstill. The Ministry of Health and Welfare was unimpressed with the price reduction plans submitted by relevant companies under the assumption that reimbursements are expanded. This discussion, which had shown small progress only recently after being deliberated since 2016, has now again come to a standstill. Some have questioned whether the authorities intend to push back reimbursement of combination therapies for two more years until the patent expires for the original drugs. However, the issue cannot be ignored any longer. The combinations being discussed for reimbursement are triple-drug-combinations including metformin+SGLT-2+DPP-4, metformin+SGLT-2+TZD, as well as some SGLT-2 inhbitors+sulfonylurea or insulin combinations. The voices are strong in the field on the urgent need for their reimbursement due to wide use. The health authorities will not be able to dismiss the doctors’ claim that the combination therapies above are the best options available for the treatment of 6 million diabetes patients in Korea. On the pharmaceutical companies' part, they have also waited enough. Many companies have received approval for their combination therapies in anticipation of reimbursement expansions. The first new combination drug that had been approved is subject to reevaluations this year and is on the verge of being canceled. Domestic companies have invested immensely in the development of combination therapies, and many have already received approvals for the drugs. If the discussions are delayed or come to a full stop, the companies may incur significant losses in their investment. The biggest issue is the fiscal scale. If reimbursement is extended to combination therapies, its fiscal expenditure is expected to reach nearly KRW 100 billion. Therefore, the MOHW is seeking to minimize fiscal expenditure by lowering the insurance price ceiling of listed diabetes treatments. Now is the time to come to a conclusion. If expanding reimbursement to the combination of all classes cannot be made, the authorities should now seriously consider applying reimbursement to at least some substances at a level that will minimally affect the state’s fiscal expenditures. There is no time left. To reduce patient burden and industry damage, this is now the time for the government to derive an optimal plan and come to a conclusion.
- Company
- Reinforced drug regulations change generic drug approvals
- by Chon, Seung-Hyun Jan 09, 2023 06:10am
- The number of generic drugs approved per every bioequivalence test fell greatly. Affected by the reform made in Korea's drug pricing policy, the proportion of generic drugs approved per bioequivalence test dropped significantly. According to the Food & Drug Statistical Year Book published by the Ministry of Food and Drug Safety on the 6th, 648 items were approved after being recognized as bioequivalent to their alternative in 2021. This was a 58.8% decrease from the 1,573 approved in 2020. Compared to the 2,358 in 2019, this was a 72.5% decrease in 2 years. Drugs recognized as bioequivalent are products recognized as being equivalent to their original drug, and are mostly granted for newly approved generic drugs. No. of bioequivalent items (left) and No. of items approved per bioequivalence test (right) (Unit: items, Data: MFDS) The drastic reduction in the number of bioequivalent drugs in 2021 is considered to have been directly influenced by the reform of the drug pricing system. The main change that had been made with the reform of the drug pricing system that had been implemented in July 2020 was that only generic drugs that meet both requirements – those that directly perform bioequivalence tests and those that use registered APIs – are allowed to maintain a price level that is at 53.55% of the original drug price prior to patent expiry. The reformed system also contained a stepped drug pricing system that lowers the price ceiling of drugs by order of listing and reducing the price of those that are listed later. If 20 or more generic drugs are listed for a certain ingredient, the price ceiling set for the newly listed drugs afterward is set at 85% of the existing lowest price. As companies cannot receive a high drug price without directly performing bioequivalence tests, this reduced the companies’ attempts to receive approval for generic drugs after consigning the whole manufacturing process. Therefore, the number of generic drugs approved per bioequivalence tests has been reduced greatly. Among the 648 bioequivalent drug items approved in 2021, 75 performed a direct bioequivalence test. This roughly translates to 8.6 generics being approved for each test. In 2019 and 2020, the number has been 29 and 9.4 drugs per bioequivalent test each. The proportion of consigned generics among bioequivalent drug items reached 96.6% in 2019 but was reduced to 88.4% by 2021. By year, the number of bioequivalent drug items increased exceptionally in 2019 and 2020. The number, which had been 625 and 789, suddenly rose threefold in just a year to 2,358 in 2019. This explosive increase is analyzed to be caused by the government's move to tighten regulations on generic drugs. A total of 175 valsartan-containing hypertension drugs were suspended sales due to excess detection of impurities. At the time, the Ministry of Health and Welfare and the Ministry of Food and Drug Safety prepared measures to inhibit the flooding of generic drugs by organizing a ‘Consultative Body to Improve the Generic Drug System.’ In response to the government’s move to reinforce regulations, pharmaceutical companies have worked to receive approval for their generic drugs in advance, which greatly increased the number of generic approvals for a short period of time. In other words, the government’s work to reinforce regulations had caused an increase in generic approvals, and the level only returned to the previous level after the system reform. As the regulations for the approval of generics have also been strengthened, the proportion of approved consigned generics is expected to be further reduced. According to the amended Pharmaceutical Affairs Act, which took effect in July last year, the number of consigned generics that can be approved for each bioequivalence test has been limited to a maximum of three. Therefore, the proportion of consigned generics among generic approvals will not be able to exceed 75%.
