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- 2025-12-18 15:32:59
- Opinion
- [Reporter's View] Healthcare AI and diversity·expandability
- by Whang, byung-woo Mar 28, 2025 06:37am
- During the 'KIMES 2025,' held last week, artificial intelligence (AI) gained the most attention. The exhibition booths were filled with companies that showcased AI at the forefront, including hospital systems and diagnostic imaging to patient monitoring, chatbot consultations, and electronic medical records (EMR). Large booths prominently displayed slogans like 'AI-based' and 'AI solution,' drawing visitors’ attention to the cutting-edge AI technologies. With AI emerging as a spearhead of technological innovation, this emphasis was anticipated at the recent KIMES event. However, upon closer inspection, there were also elements of disappointment. Most of the AI technologies exhibited by these companies focused on aiding image interpretation and enhancing diagnostic accuracy. For instance, AI systems trained on existing medical imaging data from CT, MRI, and X-ray scans are being used to quickly and accurately identify specific diseases. Of course, in clinical settings, rapid and accurate diagnosis is critical, and a detailed review of each company’s AI innovations does reveal clear differentiators in their approaches. Although exhibition booths are limited in fully showcasing the company's strengths, one common question we encountered during our coverage was, "So, what's different?" This reaction suggests growing skepticism about whether the AI focus at this year's KIMES represents a departure from previous years. Recently, the government, industry, and the healthcare sector have all been touting the growth potential of digital healthcare and AI-driven medical innovation. Despite ongoing advancements, challenges remain with AI technology diversity. A conservative perspective still exists regarding their practical applications. As global medical device companies integrate AI into their products, domestic startups still face the challenge of overcoming capital gaps through technological advancement. Achieving diversity in AI technology is clearly a collective challenge that requires collaboration among companies, the government, and hospitals. A key hurdle is the limited accessibility of data. Due to privacy protections and legal constraints, medical data is confined mainly to major hospitals and select research institutions. To develop diverse AI solutions, diverse data from various medical institutions, patient populations, and lifestyle sources are essential. There is an urgent need to create an ecosystem that securely de-identifies such data for industrial use. It also includes accelerating the standardization of AI technologies. Differing computer systems, EMR formats, and data processing methods across hospitals impede the scalability of AI solutions. It is imperative to proactively establish related interfaces and data standards that facilitate seamless collaboration between AI companies and hospitals. Reflecting on KIMES 2025, it is clear that simply declaring 'we have adopted AI' is no longer enough to achieve differentiation. Instead, the focus must shift to 'diversity' so that AI is integrated throughout healthcare settings. Industry, policymakers, and the healthcare community must address this challenge together. We look forward to seeing even more diverse AI solutions at next year's KIMES event.
- Opinion
- [Reporter’s View] New Drug Trends and Choline Alfoscerate
- by Lee, Tak-Sun Mar 21, 2025 05:57am
- The Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee, which holds meetings every month, is the biggest hurdle to reimbursement in Korea and helps identify the latest new drug trends. For several years now, the keywords that have led the trend were “anticancer drugs,” “rare drugs,” “biological drugs,” and “high-priced drugs.” Contrary to how the trend leaned toward chronic disease treatments that owned a large patient population in the past, biologic targeted treatments for a small number of patients have become the trend these days. The characteristic of these drugs is that they are expensive. In line with the trend, the Health Insurance Review and Assessment Service and the National Health Insurance Service are in the process of establishing a system to manage such high-priced anticancer and rare drugs. Global pharmaceutical companies are now investing in anticancer and rare drugs with fewer patients and less competition, rather than developing synthetic drugs for chronic diseases, which become flooded with generics upon patent expiry. The companies’ investments have now been making results at the Drug Reimbursement Evaluation Committee level. However, the names of domestic pharmaceutical companies are rarely mentioned at DREC due to their lack of new drug development. Occasionally, the release of a new homegrown drug arises as a hot topic, but usually, the main players deliberated by DREC are multinational pharmaceutical companies. Domestic pharmaceutical companies are increasingly drifting apart from the new drug trend. Traditional pharmaceutical companies have missed the timing when biosimilar development began in the mid-to-late 2000s. When a bio-venture called Celltrion announced its challenge into the biosimilar field, the other companies ignored it, saying things like “there is no real profit” and “there is little chance of success.” When Samsung followed into the biosimilar market and achieved economies of scale, it was already too late. Currently, the top 2 pharmaceutical and bio companies in Korea are Celltrion and Samsung Biologics. I wonder what would have happened if domestic pharmaceutical companies had invested in biosimilars with the capital they had at the time, with a view to the future. Biosimilars are just one trend. The pharmaceutical market has been changing rapidly for the past decade. New diabetes drugs have been introduced one after another, and the cancer drug market has evolved from treatments targeting resistant mutations to immuno-oncology drugs such as Keytruda. The pace of pharmaceutical trends is too fast for Korean pharmaceutical companies to keep up with them, with the big pharma companies aggressively buying rare disease treatments through mergers and acquisitions. Nevertheless, Korean pharmaceutical companies are still stuck in the past. Many of the top-selling products of Korean pharmaceutical companies are the brain function enhancer, choline alfoscerate, which is already nearly 30 years old. In 2020, the government’s re-evaluation reduced the indications for the drug, and even though clinical trials are still underway due to doubts about their efficacy, sales of choline alfoscerate drugs have grown. It is a reliable cash cow for pharmaceutical companies. On the 13th, the Supreme Court ruled in favor of the government in a lawsuit filed by 26 pharmaceutical companies to cancel the notice of selective reimbursement of choline alfoscerate. With this ruling, it is likely that their selective reimbursement, which has been deferred with the lawsuit, will soon become a reality. If reimbursement for the drug is only applied to dementia diseases and excludes mild cognitive impairment, choline alfoscerate will no longer be able to serve as a cash cow for domestic pharmaceutical companies. While domestic pharmaceutical companies have managed to maintain their sales by defending the reimbursement reduction for their choline alfoscerate products for 5 years, this may have rather pushed companies to fall further behind in the market trends of anticancer drugs and orphan drugs. Of course, there are also pharmaceutical companies, such as Boryung and Handok that are increasing investment in the anticancer and orphan drug markets. However, there is concern whether most pharmaceutical companies will lose their investment timing as they struggle to maintain domestic sales, as was the case during the biosimilar boom. The global market's number one immuno-oncology drug, Keytruda’s follow-on is a biosimilar, not a generic drug. Celltrion and Samsung Biologics have just begun development efforts, but it is just a hope for domestic pharmaceutical companies.
- Opinion
- [Reporter’s View] Being a global clinical trial powerhouse
- by Kim, Jin-Gu Mar 18, 2025 05:56am
- Korea is a global clinical trial powerhouse. According to the Korea National Enterprise For Clinical Trials, Korea's share of global clinical trials was 4.04% as of 2023. It is in 4th place after the United States (22.02%), China (13.59%), and Spain (4.09%). By city, Seoul has been in first place since 2017. Korea’s outlook is also positive. Korea’s global clinical trial market share rank rose one step each year, from 6th in 2021 to 5th in 2022 and 4th in 2023. The share gap with Spain is only 0.05%, and if the current trend continues, Korea is expected to rise to become one of the Top 3 clinical trial countries in the world. However, there are some drawbacks. Although Korea has established itself as a clear clinical trial powerhouse in terms of quantity, there are indications that it is not so in terms of quality. The most straightforward example is the clinical trials related to antibody-drug conjugates (ADCs), which have recently emerged as a new trend in drug development. According to the Korea National Enterprise For Clinical Trials, as of May last year, more than 600 ADC-related clinical trials were registered on ClinicalTrials.gov worldwide, but there is not a single ADC clinical trial registered or being conducted in Korea. This cannot be simply attributed to Korea’s small population. This is because 27 ADC clinical trials are underway in Taiwan, which has a population of about half that of South Korea. It is time to improve the quality of Korea’s clinical trials. In particular, improving regulations related to clinical trials may be a way to improve the quality of clinical trials. From this perspective, it is encouraging that the first step has recently been taken in the development of “decentralized clinical trials (DCT)”. DCTs refer to de-hospitalized clinical trials that collect clinical data using wearable or mobile devices and deliver test drugs by mail, etc. Patients can participate in clinical trials without having to visit a medical institution in person. A representative success story of decentralized clinical trials is Moderna, which developed the COVID-19 vaccine. The industry has consistently called for the introduction of decentralized clinical trials. In response, the government has decided to launch a pilot project for decentralized clinical trials starting this year. The government plans to conduct 6 decentralized clinical trials during the pilot project period until 2027, and then institutionalize the system based on these trials. Korea’s high-quality infrastructure is considered the main reason why Korea has grown into a global clinical trial powerhouse. This includes excellent medical staff, hospital facilities, and the high level of education of clinical trial participants. This has enabled Korea to become a clinical trial powerhouse in terms of quantity. However, there is still much that needs to be done in terms of quality. Now is the time to improve the quality of clinical trials based on excellent infrastructure. Regulatory improvement is the surest way to improve the quality of clinical trials. This can foster an environment in which clinical trials of advanced drugs such as ADC can be conducted in Korea. Only when innovative new drugs can be developed in Korea will Korea be able to go beyond being a clinical trial powerhouse and become a pharmaceutical powerhouse.
- Opinion
- [Reporter’s View] Worth of ease in administration
- by Eo, Yun-Ho Mar 11, 2025 05:54am
- You can now orally take injectables, change the daily doses to monthly doses, and manage your disease with once a year injections. Such 'convenience of administration' has now become a competitive edge in the pharmaceutical market. Convenience, which had been mainly emphasized for chronic diseases, is now being highlighted in various other disease areas including anticancer drugs and autoimmune diseases. The emergence of one-shot drugs played a role, but other advanced new drugs have also been putting forth not only their efficacy but also their convenience. The convenience of administration literally means 'that taking the medication is convenient.' The question arises, 'If I'm taking medication because I'm sick, is comfort really that important? Shouldn't a drug’s efficacy be the most important aspect for the company?’ Nevertheless, pharmaceutical companies are quite obsessed with showing off their drug’s convenience. In many cases, convenience is the main slogan for marketing and sales of the relevant drugs. As such, “convenience” is emerging as a keyword in the healthcare industry. However, the value of such ‘convenience’ is not very recognized in the process of reimbursement listing. In particular, health authorities tend to be reluctant to accept the higher price of next-generation drugs that offer improved convenience compared to existing drugs for severe diseases such as cancer, which is a life-threatening disease. From the government’s standpoint, it’s a valid argument. If a drug receives a higher price simply because of its improved convenience, this may rather lower the opportunity cost for patients with other diseases that share the nation’s limited budget. However, there is a high possibility of new drugs that offer improved convenience while showing the same efficacy as existing drugs being introduced to the market. However, convenience is not unconditionally important. It depends on the situation. Common sense dictates that in the case of cancer, which is a life-threatening condition, there are not many cases where the prescription is changed for the sake of convenience. Therefore, the convenience of such anticancer drugs must be accompanied by a significant breakthrough in the method of administration or offer improved efficacy. A doctor would not give a patient a new drug if he or she is seeing efficacy with their currently prescribed drug, as this may cause unexpected side effects. In addition, the convenience of the drug may be reduced when it is used as part of a combination therapy regimen or when the patient has relevant diseases. However, it is also worth considering whether blindly rejecting the worth of convenience in administration is right. There are cases where such improvements in convenience can lead to improvements in treatment outcomes. There are also cases where long-acting drugs reduce the burden of monitoring and save health finances. In the current healthcare trend where cancer is also turning into a chronic disease, the 'quality of life' of the patients cannot be ignored. Convenience is a value that is difficult to either blindly support or ignore. However, if a drug has been developed to treat a major condition, that values convenience in administration, the value of this drug that met this need should be recognized, amid the increasing number of drugs that are facing difficulties in the listing process that offer improved convenience.
- Opinion
- [Reporter's View] K-Bio's global entry and transparency
- by Whang, byung-woo Mar 10, 2025 05:51am
- The active overseas expansion of domestic bio companies is considered to be one of the essential strategies for continuous growth. News is coming in on domestic companies participating in overseas academic societies and conferences. This has become an important strategy for strengthening competitiveness and building trust in the global market, beyond simply expanding the scope of a company's international activities. However, efforts are also being emphasized to ensure that their activities on the international stage do not simply end at 'participation' and lead to 'substantial results'. First, the transparent disclosure of the participation results is necessary. Many companies participate in academic conferences and conferences held abroad, but information about what they have achieved or what challenges they have faced is often not disclosed. This lack of information can affect not only internal development but also the long-term building of trust with investors and partners. From the company’s perspective, it may not share subsequent information due to a lack of performance or substantial results. However, transparently disclosing the results of participation, regardless of the achieved results, can send a positive signal to stakeholders and contribute to increasing the credibility of the company. Many domestic companies are entering the global arena, so no one expects much with a single participation. It is more reasonable to look at the lessons and experiences gained in this process as the drive to move on to the next step. That is why experts emphasize transparency and continuity as a way to ensure the success of companies. One-time participation may generate short-term interest, but continuous participation is believed to help companies build in-depth networking and long-term partnerships in the global market. In fact, many biotech company representatives say that when they participate in events like BIO USA, discussions develop further and progress in the following years with continuous participation rather than in the first year. Until now, the word “continuum” has been used much when mentioning government support for the development of the domestic pharmaceutical and bio industry. As a later entrant to the global market, continuous government support is an indispensable element for the development of the domestic pharmaceutical and bio industry. However, fundamentally, individual companies must lay the groundwork for the domestic pharmaceutical and bio-industry to become competitive on the global stage. Many companies have been seeking to enter overseas markets from the beginning of the year. Participation in overseas academic societies and conferences is an important opportunity for domestic bio companies to achieve sustainable growth in the global market. To this end, companies need to make efforts to strengthen the transparency of the companies' attempts to enter overseas markets and their continuous participation.
- Opinion
- [Reporter's View] Concerns about new drugs for rare diseases
- by Son, Hyung Min Mar 07, 2025 05:56am
- Duchenne muscular dystrophy is a rare muscular disorder caused by the lack of dystrophin, primarily affecting boys. The symptoms typically begin before the age of 3 and rapidly deteriorate, eventually leading to the loss of ability to walk before the age of 10 and above. To date, various genetic targeted therapies for Duchenne muscular dystrophy won FDA approval, including U.S.-based Sarepta Therapeutics' 'Amondys 45,' 'Exondys 51,' 'Vyondys 53,' and 'Elevidys,' the American subsidiary of Japan's Nippon Shinyaku NS Pharma's 'Viltepso,' and Italfarmaco's 'Duvyzat.' Since these new drugs have not been introduced to South Korea, so patients with Duchenne muscular dystrophy are relying on steroids. The Korea National Enterprise for Clinical Trials (KoNECT) ranked 'Amondys 45' as the No.1 new drug for domestic entry candidates through the '2021 Report priority ranking international new drugs not yet introduced in South Korea.' However, it has not been introduced to South Korea to date. New drugs have been introduced to various rare diseases, not only Duchenne muscular dystrophy but also metachromatic leukodystrophy and hemophilia, but patient access to these drugs is still limited. Rare diseases have limited treatment options and often patients have limited treatment opportunities. Fortunately, innovative new drugs for rare diseases have emerged in recent years. Introducing new drugs for rare diseases provides not just simply new drugs but opportunities for patients to improve their quality of life substantially. Notably, new drugs such as genetic therapy offer the possibility of fundamental treatment. Patients who have already received treatments give favorable reviews that their quality of life has significantly improved. However, the discussion on whether new drugs can be provided to Korean patients remains a crucial issue. Many pharmaceutical companies face challenges to commercialize new drugs for rare disease due to the lack of treatment infrastructure and limited treatment targets. Eventually, to promote domestic entry of new drugs for diseases with high unmet needs and limited treatments, supportive policies are essential, including government funding and insurance reimbursement. Until now, most evaluations indicate that the existing supports and policies toward patient access to new drugs for rare diseases have been inadequate. Clinical trial opportunities for Korean patients with rare disease must be discussed in depth. If the Korean market is not considered, there is no need for pharmaceutical companies to conduct new drug clinical trials subjecting Korean patients. If clinical trial opportunities involving potential new drug candidates are unavailable to patients without further treatment option, patients have no other resorts. It is of utmost importance to broaden patient access so that pharmaceutical companies would consider the Korean market. It is also essential for Korean pharmaceutical companies to pursue new drug introductions and make R&D investments. Importantly, pharmaceutical companies and the government must collaborate to establish ways to introduce effective new drugs. Fortunately, Korean pharmaceutical companies strive to introduce new drugs for rare diseases. Pharmaceutical companies like Dong-A ST and Boryung are pursuing new drugs in collaboration with KoNECT. Also, many Korean pharmaceutical companies like Handok have been distributing new drugs for rare diseases. No disease is unimportant, from rare diseases, cancer, brain tumors, severe diseases, and chronic diseases. However, patients should not have to travel abroad for domestically unavailable treatments.
- Opinion
- [Desk's View] Regulatory changes disrupt the generic mkt
- by Chun, Seung-Hyun Mar 05, 2025 06:00am
- The strategies of Korean pharmaceutical companies for entering generic markets have significantly changed over the past few years. Pharmaceutical companies made entries and withdrawals indiscriminately because of the government's regulatory changes. According to the Ministry of Food and Drug Safety (MFDS) report, prescriptions with approval declined by 35.6%, with 589 items. Compared to 4,195 counts in 2019, it shrunk by 86.0% over 4 years. The number of prescription drug approvals was 1,618 counts and 1,562 counts in 2017 and 2018, respectively. In 2019, it surged more than two-fold, with 4,195 counts. In 2020, it increased by 67.5% than two years before, with 2,616 counts. In 2021 and 2022, it decreased to 1,600 counts and 1,118 counts, respectively. In 2023 and last year, it was less than 1,000 counts. Although it may seem that pharmaceutical companies' motivation for entering the prescription drug business has decreased, the reality is that government has created regulatory confusion. In 2018, there was a ban on the sale of 175 pharmaceutical products containing the active ingredient valsartan, used to treat high blood pressure, due to excessive impurities. In response, the Ministry of Health and Welfare (MOHW) and the MFDS established the "Committee for Improving of Generic Drugs Policies" to formulate measures to control the excessive production of generics. The revised drug pricing system, implemented in July 2020, is one of the major policies by the government to suppress the overabundance of generic drugs. The revised drug pricing system requires generic products to meet both bioequivalence testing and the use of registered raw materials to maintain a maximum reimbursement price of 53.55% compared to the current patent-expired original drugs. The revised drug pricing system includes a stepwise pricing system, which involves a lower maximum reimbursement price for drugs that are newly listed for reimbursement. Pharmaceutical companies attempted to secure as many generics as possible before the government strengthened its regulations on generic drugs. It has been reported that most generics eligible for approval had already been obtained before implementing the new drug pricing system. However, many indiscriminately introduced generics failed to sell and eventually vanished from the market. In November last year, 1,000 drug items were removed from the National Health reimbursement list due to a lack of production or claims. Health authorities have recently been deleting drugs from the reimbursement list if there have been no insurance claim records in the past two years or if there has been no production or import data for three years. Among these 1,000 removed items, those approved in 2000 and 2019 were the most prevalent, accounting for 334 and 187 items, respectively. In other words, over half of the deleted drugs were new products on the market for less than five years. On May 1, 2023, 322 drug items were removed from the reimbursement list, with those approved in 2019 and 2020 were 221 items, which accounted for 68.6% of the total. The government’s regulatory strengthening encouraged pharmaceutical companies to obtain generic approvals indiscriminately, accelerating market saturation. Ultimately, many of these generics failed to sell, disappearing from the market while only losing unnecessary approval costs. Since 2021, the number of prescription drugs withdrawn from the market has exceeded the number of new approvals. Between 2015 and 2020, the annual approvals of new prescription drugs consistently outnumbered the products withdrawn. In 2015, there were 2,406 newly approved prescription drugs, more than twice the 977 canceled or withdrawn products. In 2016, new approvals were more than three times the number of withdrawals. In 2019, however, canceled or withdrawn products reached 1,283, amounting to only 30.6% of new approvals, and in 2020, new approvals exceeded market withdrawals by 691 products. In 2021, the number of canceled or withdrawn prescription drugs increased to 1,687, surpassing the 1,600 new approvals, and this gap gradually expanded. Last year, market withdrawals increased to 2,432, more than four times the 589 newly approved products. Analysis suggests that pharmaceutical companies indiscriminately secured generics in response to the government’s regulatory strengthening without thinking of countermeasures, disappearing in mass quantity from the market after a certain period, ultimately leading to significant social and economic cost waste. Additionally, critics point out that the government’s frequent regulation changes have exacerbated the abundance of generics and caused strategic confusion among pharmaceutical companies. In 2012, the MOHW abolished the stepwise drug pricing system through a revision. After that, it allowed pharmaceutical companies to actively launch generics, even in markets long past patent expiration, on the premise that they could still receive high prices despite a late market entry. However, due to the ongoing issue of the abundance of generics, the stepwise pricing system was reinstated after 8 years. Moreover, the mandatory production requirements for contract-manufactured generics have been repeatedly reversed. In 2014, the MFDS introduced the 'GMP Compliance Certificate' system, which exempted contract-manufactured generics from the requirement to submit GMP evaluation data for approval purposes. Then, starting in October 2022, the requirement for submitting GMP evaluation data for contract-manufactured generics was reinstated to strengthen quality and safety management. Yet, in October of last year, the requirement for GMP evaluation data covering the manufacturing process for outsourced drugs was waived again under regulatory relaxation. In response to the government's regulatory changes, pharmaceutical companies strategized to maximize profits, further disrupting the market. The government is partially responsible for failing to anticipate the market impact of these regulatory changes. Implementing policies aimed solely at suppressing the overabundance of generics without understanding market dynamics has resulted in unnecessary social costs. Government policies do not always yield favorable market outcomes. We want to ask whether the government has considered reviewing the generic-related policies implemented over the past few years. Their efforts failed to identify any positive outcomes from these regulatory changes. It has been reported that the government is considering a new system to cut generic drug prices. The government reviews the proposal to lower domestic drug prices by comparing them with those in eight major countries (the United States·Japan·Germany, the United Kingdom·France·Switzerland·Italy·Canada). They plan to adjust domestic prices to match the adjusted average price derived from six countries after excluding the highest and lowest figures among the so-called A8 nations. The pharmaceutical industry has strongly opposed this. The rationale is it's reasonable to consider market entry timing when comparing generic drug prices internationally. However, whether the government will hear the industry's concerns remains uncertain. There is a growing fear that, once again, a one-sided policy will be imposed, ignoring the warnings from the pharmaceutical industry. To minimize the failure of the government's policy, the government should at least listen to the voices of the industry.
- Opinion
- [Reporter's View] Gov't OKs JAK inhibitor drug switching
- by Eo, Yun-Ho Feb 26, 2025 06:30am
- It has been a flexible and swift measure. Drug-switching between JAK inhibitors and biological agents for the treatment of severe atopic dermatitis will be reimbursed starting in March. The Ministry of Health and Welfare (MOHW) issued an administration notice of a partial revision draft of the pharmaceutical long-term care reimbursement requirement standard. In this administrative notice, the MOHW improved the standard so that despite previous treatment with biological agents, when a patient does not adequately respond or has no tolerability, drug switching to JAK inhibitors will be covered by reimbursement. Also, when a patient does not benefit from JAK inhibitors or cannot continue treatment due to side effects (the switched drug is recommended to be administered for at least 6 months), one can switch to biological agents. Reimbursement is not provided when a patient switches to another drug more than once. Concerns have been raised often regarding drug switching not being covered by reimbursement in South Korea. At the end of last year, an issue in one area was resolved. The MOHW decided to approve drug switching for rheumatoid arthritis patients when tumor necrosis factors (TNF) or JAK inhibitors are not effective or cannot continue treatment due to side effects. Of course, there is still room for improvement regarding expanded reimbursement for atopic dermatitis medicines. Drug switching between the same class medicines has been excluded from the reimbursement list. We must acknowledge that this is the first step. The current expanded reimbursement is a result of the government's swift response. Until now, the government has been hesitant to reimburse JAK inhibitor drug switching due to insufficient clinical evidence. For atopic dermatitis, reimbursement was no longer provided when a patient used biological agents, such as interleukin, or oral agents, like JAK inhibitors, and then switched to another medicine. Despite experiencing side effects after the initial treatment or ineffectiveness, patients were not easily switched to another medicine. Academics have consistently provided opinions. However, the government faced difficulty revising the system without documents showing clear evidence. It was reviewed multiple times but did not result in expanded reimbursement. Amid this situation, the Korean Atopic Dermatitis Association submitted a statement that drug switching must be allowed for the atopic dermatitis area. Furthermore, the association stated that after the revision of the guidelines after nine years, there were no therapeutic differences between biological agents and oral agents. The government responded again to multiple requests. At the end of last year, a review was started again regarding drug switching for atopic dermatitis. Soon after, the government responded to requests swiftly. Clear communication can provide another opportunity. The effective communication between the health and welfare authority and clinical practices deserves praise.
- Opinion
- [Reporter’s View] Concerns over US drug tariffs
- by Kim, Jin-Gu Feb 13, 2025 05:58am
- The US President Donald Trump has hinted at the possibility of imposing tariffs on drugs imported into the country. Although he says he is still “reviewing” the matter, it would not be surprising if he signs a tariff declaration at any time. The United States has played a major role in the recent development of the Korean pharmaceutical and biopharmaceutical industries. Korean pharmaceutical and biopharmaceutical companies have steadily expanded their exports to the world's largest pharmaceutical market. Just a decade ago, the export value of domestically produced pharmaceuticals to the United States was only USD 33 million, but last year it increased more than 40-fold to USD 1.359 billion. The U.S. accounted for 18% of Korea's total pharmaceutical exports last year, the largest share of any country. The U.S. has now developed into an inseparable relationship with Korea's pharmaceutical and bio industries. In this situation, if tariffs are imposed on domestically produced drugs exported to the United States, it is expected that a considerable blow will be inevitable. For the time being, it is expected that there will be no major damage in the process of exporting existing orders, but if the situation is prolonged, the accumulated damage is expected to have a negative impact on pharmaceutical and biopharmaceutical companies. The unfortunate thing is that there is no government control tower to respond to the reality of the US tariff bomb. Since the state of emergency at the end of last year, there has been a long-term leadership vacuum. Sang-mok Choi, the acting president, has been filling the void, but it is clear that he has limitations as an acting president. It is difficult to expect measures such as a breakthrough through a summit with an acting president. If drug tariffs are imposed, we will have no choice but to suffer helplessly. Each pharmaceutical and biopharmaceutical company must fend for itself. With the absence of government leadership, the options for each company are limited. They can only set up production facilities in the US or find new markets. Even this is not a solution that can be solved immediately. Small and medium-sized pharmaceutical companies with insufficient financial resources are expected to face even greater difficulties. It is not just the pharmaceutical tariff. From the perspective of the pharmaceutical industry, there are many issues that the government needs to resolve. The conflict between the medical and pharmaceutical industries is a prime example. The conflict over the increase in the number of medical school admissions has continued for years. Its damage to the pharmaceutical industry is gradually accumulating. With the government lacking leadership, there is no sign of a solution. The shadow of crisis is looming over the pharmaceutical and bio-industry due to concerns over Trump’s imposition of tariffs on pharmaceutical products and the prolonged medical-political conflict. However, the bigger crisis is the current reality where pharmaceutical and bio companies are forced to fend for themselves due to the lack of government leadership.
- Opinion
- [Reporter's View] KRW 400m drug approval fee
- by Lee, Hye-Kyung Feb 12, 2025 06:13am
- Now, the new drug approval fee in South Korea costs KRW 410 million. On September 9th, 2024, the Ministry of Food and Drug Safety (MFDS) issued an administrative notice of 'Revision to the Regulation of Fees for Pharmaceutical Approval.' The revision specifies details of increasing the new drug approval fee to KRW 410 million and reducing the approval duration from 420 days to 295 days, effective January 1st of this year. The industry draws attention to the first product to pay a significant fee hike. The approval fee of KRW 410 million includes a preliminary consultation session prior to the submission of the application for marketing approval. Once the application is submitted, a task force team is assigned. It has been reported that two to three companies requested preliminary consultation sessions last year. Thus, it is projected that there will be a company submitting a marketing approval application this January. After the New Year's holiday, this year's first marketing approval application was submitted on the last day of January. Lily Korea's new breast cancer drug, 'imlunestrant.' The company has applied for marketing approval of imlunestrant (product name in South Korea: "Inlurio") to the US Food and Drug Administration (FDA) and Europe's EMA, in addition to MFDS. Given that South Korea implemented an innovative measure for new drug approval this year, a shortened approval duration than before will enable domestic approval within this year and a potential launch as well. Since the submission date of the first product's approval application has been disclosed, the industry watches whether it will obtain approval within 295 days. Since it is the first product since the implementation of the system, MFDS must strive to launch a task force quickly so that approval can be announced within this year. It has been reported that a taskforce team comprising 10-15 experts has been launched for the approval of imlunestrant. If Lily accurately submits the supplementary documents, approval is expected to be granted within 295 days. Companies with other new drug candidates aim to obtain approval within 295 days. To achieve this result, the MFDS must hire more expert reviews using the new drug approval fees as planned. Additionally, the MFDS must expand the percentage of expert reviewers with specialized backgrounds from 31% to 70%. Since the first product has been submitted for approval review after the implementation of the system, the industry anticipates proactive administrative actions in line with these expectations.
