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- 2026-05-01 13:45:24
- 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.
- Company
- "Paradigm shift in follicular lymphoma treatment: CAR-T"
- by Whang, byung-woo Feb 13, 2025 05:58am
- "Although CAR-T cell therapy or bispecific antibody respectively offers an advantage for treating follicular lymphoma, CAR-T data demonstrating positive results over 10 years in 60% of patients indicate that it is an effective treatment option." As various treatment options are introduced to treat relapsed/refractory follicular lymphoma (FL) with a poor prognosis, how these treatments can be utilized is of great interest. In South Korea, Kymriah (tisagenlecleucel), which is known as the chief CAR-T therapy, was approved for expanded indications in 2023 to treat patients with relapsed/refractory FL who had previously undergone two or more treatments. After that, doctors are gaining treatment experiences with the drug. Dr. Stephen J. Schuster, Professor of the Department of Hematology/Oncology at the University of Pennsylvania Abramson Cancer CenterDuring a meeting with Daily Pharm, Dr. Stephen J. Schuster, Professor of the Department of Hematology/Oncology at the University of Pennsylvania Abramson Cancer Center, who has years of prescription experience in the United States, emphasized the necessity of CAR-T therapy for treating follicular lymphoma. Follicular lymphoma (hereafter, FL) is a type of non-Hodgkin Lymphoma (NHL) that occurs when cells in the lymph system turn malignant. Because the symptoms of the disease progress slowly, about 80% of the cases are identified at stage III or Stage IV after the disease progresses. The prognosis for patients who relapse is poor. Dr. Schuster said, "The prevalence of FL seems to be increasing in Asia." He added, "As FL progresses in various ways, clinical characteristics significantly vary by patient." Dr. Schuster explains that considering the characteristics of FL, characterized by low-risk disease cases and slow disease progression, most diseases can be managed through proactive treatments. The disease becomes problematic if a disease has a poor prognosis requiring more than one treatment due to relapses. According to Dr. Schuster, data from patients with FL who need more than one treatment indicate that the remission period shortens as patients repeatedly receive treatment. "About 20% of the patients with FL relapse after two years following the initial treatment. Even after further treatment, the remission period shortens, and patients have a poor prognosis, thereby needing strong treatments, including CAR-T cell therapy," Dr. Schuster said. "Despite increased overall survival, patients repeatedly need treatments, and the disease can become fatal, ultimately leading to death." There are several treatment options for FL, but Dr. Schuster highlights the clinical benefits of CAR-T cell therapy because CAR-T cell therapy does not require further treatment after the initial therapy. The clinical effect of Kymriah (tisagenlecleucel) has been proven through the ELARA clinical study regarding relapsed/refractory FL. The four-year long-term follow-up results of the study were presented at the American Society of Hematology (ASH) conference held in December 2024. The four-year long-term assessment results of the ELARA study (median follow-up period at 53 months) showed that patients with relapsed/refractory FL treated with Kymriah had consistent treatment response over 4 years and a favorable safety profile. The median progression-free survival (PFS) of all patients was 53.3 months. At 48 months, 50% PFS was reported in all patients, and 66% of patients were reported to have gained complete remission (CR). "The follow-up on patients who participated in the 2014 study has been about 10 years, and the data indicate that the overall response rate (ORR) is about 80%, similar to the recently presented ELARA clinical study result," Dr. Schuster said. "In contrast to FL requiring repeated blood tests, various scans, and drug administration for additional therapy, CAR-T cell therapy can lessen the physical and mental burden." Will the introduction of bispecific antibody change the treatment paradigm?..."CAR-T cell therapy's advantage" Kymriah received expanded indication in April 2023 in South Korea to treat FL, broadening treatment options. (모네투주맙)However, there are even more options available at clinical practices. For instance, the bispecific antibody Lunsumio (mosunetuzumab) has been introduced. Regarding this, Dr. Schuster acknowledges the role of bispecific antibodies but favors CAR-T cell therapy, which demonstrates positive long-term results over 10 years. "Each CAR-T cell therapy and bispecific antibody has an advantage, and there are no concrete answers to the treatment sequence. The CAR-T data demonstrating positive results over 10 years in 60% of patients is unbeatable," Dr. Schuster said. In particular, Dr. Schuster highlights that antigen can be easily lost during the treatment course of bispecific treatments, like MabThera or mosunetuzumab, that target CD20. "The biopsy results from patients treated with bispecific antibody drugs showed that 5.5-6% of patients had losses of CD20. However, CD19-targeting CAR-T cell therapy rarely led to losses of CD19," Dr. Schuster remarked. Dr. Schuster views that bispecific antibody drugs are important but may not replace CAR-T cell therapy. Long-term follow-up data on the remission period and response rate are needed for bispecific antibody treatment outcomes. Dr. Schuster mentions that drug tolerance is an advantage for Kymriah. The most common adverse event (AE) of CAR-T cell therapy is cytokine release syndrome (CRS). Kymriah has a relatively low AE rate and low severity. Dr. Schuster also emphasized, "In the past, there have been cases where FL patients received therapies repeatedly, but ultimately, the disease led to death. However, Kymriah offers a single treatment that can help maintain a remission state. It is also a cost-effective treatment option compared to previous therapies." Lastly, Dr. Schuster said, "Even if FL patients experience relapse after treatments, they may receive CAR-T cell therapy and maintain remission state for about 10 years, as well as having improved quality of life." He added, "Because an index for predicting survival varies by disease and disease shows characteristics, making a treatment choice through clinical follow-up assessment is important."
- Company
- Celltrion wins, Samsung loses Eylea patent trial
- by Kim, Jin-Gu Feb 13, 2025 05:58am
- Companies have seen mixed results regarding the preliminary injunction applications over the biosimilar version of the macular degeneration drug Eylea (aflibercept). While Samsung Bioepis lost the preliminary injunction application for patent infringement filed by Bayer, Celltrion won its case. The conflicting results have also led to conflicting reports on whether or not the Eylea biosimilar will be sold in Korea. Sales of Samsung Bioepis and Samil Pharmaceutical's Afilivu will be discontinued in Korea after the existing inventory. On the other hand, Celltrion and Kukje Pharm will be able to continue selling Eydenzelt as before. According to industry sources on the 12th, the Seoul Central District Court's 60th Civil Division recently reached conflicting conclusions in the preliminary injunction applications for patent infringement filed by Bayer and Regeneron against Samsung Bioepis and Celltrion. On July 30, 2019, Bayer filed a petition with the court for a preliminary injunction against Samsung Biologics, Samsung Bioepis, and Samil Pharmaceutical for infringement of the patent on the composition of Eylea along with Regeneron. On the same day, Bayer also filed a petition with the court for a preliminary injunction against Celltrion and Kukje Pharm. Their request was to discontinue sales of Samsung Bioepis and Celltrion’s Eyelea generics as they infringe on Eylea’s unlisted patents. On the 7th, the court made a decision. It decided to “acknowledge” Bayer's claims in the petition for a preliminary injunction against Samsung Bioepis. On the other hand, it decided to “dismiss” the petition for a preliminary injunction against Celltrion. The conflicting court decisions have rendered sales of the two companies biosimilars in Korea in opposite positions. Furthermore, Samil Pharmaceutical and Kukje Pharm, which have signed joint sales contracts with the two companies, are also experiencing mixed fortunes. Samsung Bioepis has been jointly selling Afilivu with Samil Pharmaceutical. Celltrion has been jointly selling Eydenzelt with Kukje Pharm. Due to the court’s decision, sales of Samsung Bioepis and Samil Pharmaceutical's Afilivu will be discontinued. Samsung Bioepis received approval for Afilivu in February last year and began joint sales with Samil Pharmaceutical in May. However, the company explained that the remaining stock can be prescribed to patients. “We will file an objection to the preliminary injunction,” said an official at Samsung Bioepis. ‘We cannot carry out any additional sales activities, but the stock that is already in circulation in the market can be prescribed to patients.’ On the other hand, Celltrion and Kukje’s Eydenzelt from Kukje Pharmaceutical can continue to be sold. Celltrion received approval for Eydenzelt in May last year. Kukje Pharm signed a joint sales agreement with Celltrion in April last year. It then began full-scale sales in September last year. The industry estimates that Samsung Bioepis and Samil Pharmaceutical, which launched their products one step ahead, have gained an advantage in the competition. However, the court's decision to grant a preliminary injunction is expected to accelerate the pace of the latecomers, Celltrion and Kukje Pharm’s product, in their pursuit.
- Company
- Officially launched Vantive Korea targets renal care market
- by Whang, byung-woo Feb 13, 2025 05:58am
- As Baxter's 'Renal Care and Acute Therapies Businesses' launches as an independent global company completes, it has begun officially operating under a new company name. Vantive LogoAccording to medical devices industry on February 5, a fund managed by global investment firm the Carlyle Group has completed the acquisition of Baxter International’s Renal Care business, finalizing the spin-off of the division. As a result, the 'Renal Care and Acute Therapies Businesses' newly launched as Vantive, a company specializing in Vital Organ Therapy. The decision to spin off the business aims to enhance agility in responding to rapidly evolving healthcare needs, establish more precise business strategies, and focus on innovation within each company's specialized division. Vantive has set its mission as 'Extending Life, Expanding Possibilities.' The company plans to set its business strategy based upon its 70-year legacy of pioneering innovations in renal care. As the company's spin-off is completed globally, the spin-off process has also been finalized in South Korea. While business registration updates remain completed, Baxter and Vantive have already been operating as separate entities. Before the launch of Vantive Korea, Baxter relocated its office to the Samil Building on Cheonggyecheon-ro last year. The move was a strategic decision to create a more efficient work environment in the heart of Cheonggyecheon. The global renal care market is currently valued at US$ 15 billion, with an anticipated annual growth rate of 3–4% over the next three years. As of 2021, the 'Renal Care and Acute Therapies Businesses,' which has now been spun off into Vantive, generated approximately US$ 5 billion (KRW 6.4895 trillion) in sales under Baxter, holding a significant share of the company's business. Based on the audit report, Baxter's sales for the past four years were reported to be ▲KRW 242.6 billion for 2020 ▲KRW 244.9 billion for 2021 ▲KRW 192.7 billion for 2022 ▲KRW 188.1 billion for 2023. During the same period, operating profits were reported as ▲KRW 11.9 billion for 2020 ▲KRW 12 billion in 2021 ▲KRW 5.8 billion in 2022 ▲KRW 5.6 billion in 2023. Baxter Korea Apart from the spinoff, the company already needed a turnaround opportunity to rebound its revenue. Following the separation, Vantive Korea is expected to focus on maintaining and expanding its domestic market presence. In December 2023, during a general meeting of shareholders, the company established Baxter Korea as a new entity through a corporate spinoff. As a result, Baxter Korea will now handle pharmaceutical imports and distribution, excluding the renal business. Vantive will remain the surviving company, responsible for all remaining business segments, including the renal care division. High hopes for Vantive Korea's future directions after a parallel company shift Vantive's 'Renal Care and Acute Therapies Businesses' aims to strengthen leadership in renal disease and vital organ therapy. Even regarding employee distribution, Vantive remains the primary entity after spinoff. According to Baxter Korea's 2023 audit report, the company had 267 employees. After the spinoff, Vantive Korea retained approximately 200 employees, while Baxter Korea downsized to about 50 employees. Based on its 70-year legacy, Vantive Korea plans to differentiate itself by integrating innovative technology and digital connectivity services. At the end of last year, before the launch of Vantive Korea, Baxter relocated its office to the Samil Building on Cheonggyecheon-ro. The move was a strategic decision to create a more efficient work environment in the heart of Cheonggyecheon. During announcing the company name Vantive, Lim Kwang-hyuk, CEO of Baxter Korea, said, "The renal care expertise accumulated over the past 70 years will be further expanded under Vantive. We will continue investing in innovative treatments and vital organ therapy to extend and improve patient lives." The company's logo also reflects its future strategy. The "V" in Vantive's logo is divided into three sections, representing innovative therapies, digital solutions, and advanced services. As peritoneal dialysis and home dialysis are encouraged, the 'digital patient management platform' is becoming increasingly significant. Vantive is expected to enhance its market share by integrating digital innovations into dialysis equipment. Kieran Gallagher, Chairman of Vantive's Board, said, "The launch of Vantive will be a significant milestone in the ongoing advancement of renal care and life-sustaining vital organ therapy. Vantive is committed to providing enhanced connectivity, visibility, and insights across the entire patient treatment journey."
- Company
- ‘Employees work long-term at Daiichi Sankyo for a reason'
- by Eo, Yun-Ho Feb 13, 2025 05:58am
- To survive and develop, we need to change and adapt to change. This is easy to say, but never easy to do. Daiichi Sankyo is a master of adaptation. The company has established itself in the domestic market by supplying drugs for chronic diseases, mainly cardiovascular diseases. Starting with hypertension drugs such as Olmetec, Sevikar, and Sevikar HCT, the company has launched the antiplatelet drug Effient and anticoagulant Lixiana and has achieved continuous growth by launching new leading products in crisis, such as patent expiry. Maybe it's the products, but it's also the strategy. The story of how Daiichi Sankyo stopped promoting its antibiotic Kravit independently when Olmetec’s patent expired and focused on its circulatory system pipeline through co-promotion with a Korean company is still much talked about. Now, Daiichi Sankyo is looking to take a new leap forward with its oncology business. Last year, Enhertu, an antibody-drug conjugate (ADC) that was listed for reimbursement in Korea, began to gain popularity in the anticancer field, supported by its excellent clinical results. With an average annual growth rate of 15% from 2014 to date, Dailypharm sought to learn more about the talents behind the company's growth. Daily Pharm met with Mr. Hyundong Ryu (50), Managing Director of Management Headquarters at Daiichi Sankyo to learn more about the people behind the company’s growth. Hyundong Ryu, Managing Director of Management Headquarters, Daiichi Sankyo Korea-Tell us about the company's organizational structure. What does the Management Headquarters do? Daiichi Sankyo Korea has 4 headquarters. The Primary Business Unit, responsible for chronic diseases and specialty drugs; the Oncology Business Unit, is responsible for anti-cancer drugs; the Development Medical Headquarters, which is responsible for clinical development, licensing, and follow-up; and the Business Management Headquarters, which is responsible for the overall management and operation of the company. I am currently in charge of the entire Business Management Headquarters, which includes human resources, general affairs, finance, distribution, IT, business planning, and external relations. -Daiichi Sankyo is very good at coming up with products that are needed at the time and achieving good results with those products. This cannot be done without the right “people.” Daiichi Sankyo is known for its job longevity, especially in the industry. What is the secret behind this? We have our own management philosophy and values with regard to human resources, on how to develop talent and treat them at Daiichi Sankyo. We don't just run a company for business, for sales, but for people to come together and work together. The mindset of not using people as tools is something that has been passed down as part of our culture. I think the sincerity of the management in valuing talent and caring to not make employees feel like they are being used as a tool is one of the important reasons behind our employees’ job longevity. -Regarding the new Oncology BU, it’s not easy to create a business unit that didn't exist before, get it up and running, and then have it drive the company's future strategy. What did you focus on and what difficulties did you face in creating the Oncology BU? When you create a new business unit (BU), you're bringing in new people, and the success of the business depends on them. We've been through this process twice in the past where new people come in, intertwine with existing employees, and grow. The company has learned from these experiences how to integrate and resolve cultural conflicts that can arise when bringing in new businesses and bringing in a lot of new talent. We believe that it is best to provide as many opportunities for communication as possible to help people understand the value of the organization's values of 'together' and 'togetherness' rather than trying to artificially seal conflicts. #SB-You seem to have a good internal mindset to deal with change. What does Daiichi Sankyo look for in its employees? Daiichi Sankyo Korea has created new business units and recruited new talents, so in Korea, since the 2020s, we have emphasized and valued “Collaborate & Trust” the most. We don't look at a candidate's experience or specifications but rather how they want to contribute to our organization. For example, we try to select candidates who value work and take responsibility for their work, rather than candidates who emphasize the resonance of “I did it” or “I am the best” or those who want to prioritize their career path. - Interest in multinational pharmaceutical companies has been rising these days. There aren't many new hires at each company, but in the overall framework of multinational companies, this seems to be happening to some extent. Does Daiichi Sankyo have any procedures or requirements for hiring new employees? We hire new employees on a case-by-case basis. It's not a regular program, but we have an intern program that has been up and running for more than 10 years. We hire people who have a good work attitude and understand the value of “working together” as marketing representatives (MRs). We don't look for any specific qualifications. Unless we need a pharmacy professional, we look for a 4-year graduate with some language level, etc., and their attitude towards work and contribution to the team and organization's goals is important. -What programs do you offer to foster talent after they join the company? In terms of fostering talent, the company has a systemic roadmap in place for overall talent growth and support. When you first join the company, we spend 2-3 days training you on the company's systems and other things you need to learn. At the one-year mark, we have a week-long training session at a separate location with other new hires and experienced employees. This is called the first-year onboarding training, which focuses on improving your understanding of the company's mission, values, and culture. In the second year, we hold a reminder training (vision training) where employees reflect on the goals and visions they set in the first year and what they want to achieve within the company. In the third year, you go to the headquarters in Japan for a week of training. When it comes to work-level job training, some parts cannot be fully covered in-house, so we offer training support without a specific budget limit for all training needs. Individuals can request individualized competency training, which they discuss with their manager and then receive support from the company. At the manager level, we offer an annual 360-degree, multi-faceted assessment to identify strengths and weaknesses and provide one-on-one coaching on how to overcome them. Key talent, such as potential next-generation leaders, is developed separately by HR. For example, we support MBA and pharmacy-related graduate programs. There is also a program called STDP (Short-Term Development Program) to help employees gain a global perspective. This program is mainly offered at our Japanese headquarters but has recently been expanded to include offices in the ASCA region (Asia and South America). -Is there a system in place that encourages employees to move between departments? Many programs in the pharmaceutical industry allow people to experience different roles. We have a very active job posting program. When we have a vacancy, we encourage job posting, preferably among existing employees. It is difficult to verify the potential and capabilities of people who have specialized experience from outside the company. On the other hand, we have expectations that people with sufficient internal potential can perform well if they are given time to develop their careers, and this has proven to be true in many cases. -How are employees and executives evaluated? We perform two main types of evaluations: Performance Evaluation and Competency Evaluation. First, in performance evaluation, the basic framework is performance-based relative evaluation for sales and absolute evaluation for internal employees. However, for both sales and internal employees, we make sure that the attitude and effort in the process of performance are fully reflected, not just the arithmetic results. After setting goals, we conduct feedback interviews about four times a year. Midterm feedback is used to correct the direction and track the process of achieving goals. -I'm also curious about the company’s reward system such as incentives. There are two types of performance pay: individual performance pay and management performance pay. Individual performance pay is based on the achievement of individual or team goals. For the base salary, many multinational companies adopt the merit increase system and set the increase rate according to performance, but Daiichi Sankyo does not differentiate the base salary increase rate by performance. We set the same base salary increase for all employees, reflecting the inflation rate of the previous year, and top it up with a performance bonus based on the performance of the organization. This is because cross-functional collaboration between teams and departments is of utmost importance. -Do you have annual longevity awards in addition to incentives? There are 5-yearly awards for 10, 15, 20, and 25 years of service. No one has reached 30 years of service yet, but there will be rewards when they do. For 10 years of service, you get a 10-day sabbatical. It's a valuable reward for contributing to the growth and development of the company over a long period of time, and in fact, long-term service is not uncommon in our company compared to other foreign companies. - The slogan “Cooperation” seems to be at the core of the company's foundation. That's right. At Daiichi Sankyo, individual achievement is important, but the performance of the underlying organization is also important, and this permeates the entire company as a corporate culture. The company takes its time and encourages individuals to develop their capabilities over time. The company focuses on “steadiness” rather than chasing short-term goals. We are creating a corporate culture where each person is not engrossed in their own role but rather has a company-wide perspective, that naturally leads to cooperation and trust.
- Product
- Non-face-to-face treatment takes another hit
- by Jung, Heung-Jun Feb 12, 2025 06:13am
- Following obesity treatments such as Wegovy, the medical community is now raising voices to restrict non-face-to-face artificial tears prescriptions. Following the restriction of Wegovy prescriptions through non-face-to-face medical care, voices are rising on the need to regulate the prescription of artificial tears as well. The platform industry believes that overprescription is an issue that occurs regardless of whether the patient receives face-to-face or non-face-to-face care. The Korean Ophthalmologists Association believes that prescriptions should be managed so that they are only given to appropriate patients, regardless of the route of care. During a press conference on the 9th, the Korean Ophthalmological Association argued on the need to increase restrictions due to the increase in non-face-to-face prescriptions of artificial tears. The purpose is to establish standards for non-face-to-face treatment of artificial tears and to develop a reasonable plan for the operation of non-reimbursed medical services. Due to an increase in non-face-to-face prescription of obesity drugs such as Wegogy, non-face-to-face prescription of such drugs has been restricted since December last year. A platform official said, “I understand that it should be prescribed appropriately to those who meet the indications. However, this problem is not only seen in non-face-to-face medical care but also in face-to-face medical care. We plan to communicate further to address the concerns that the medical community has.” Pharmacists have pointed out that in non-face-to-face medical care, artificial tears are prescribed in non-ophthalmic departments, increasing the possibility of overprescription. Pharmacist A from Seoul said, “Artificial tears are often overprescribed during face-to-face medical care. Of course, we cannot know how much a patient needs when we are not face-to-face, so there is a high possibility that they will be overprescribed according to patient demand.” Pharmacist B said, “Artificial tears are also being prescribed in non-ophthalmic departments. The reality is that it is not a problem for gynecologists to treat patients with hair loss during non-face-to-face medical care.” According to the ratio of patients by disease among non-face-to-face patients announced by the Telehealth Industry Council last year, artificial tears account for 4% of the total population. However, the industry explained that the ratio may be even lower if the total non-face-to-face patients are included, as only 4% of the patients that use the platform were counted. “4% of patients using the platform have been prescribed artificial tears, and 11 million cases are all non-face-to-face patients,” said a platform official. ”If all non-face-to-face patients are included, the number of chronic diseases will increase, so the rate of artificial tear prescriptions will be lower.”
- 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.
- Product
- Wegovy outpatient prescriptions ↓…pharmacy burden↑
- by Jung, Heung-Jun Feb 12, 2025 06:13am
- Wegovy, whose sales suffered due to inventory shortage in pharmacies, has now become an intractable inventory four months after its launch in Korea. Wegovy is a self-injectable drug that requires refrigeration and is a non-returnable product. Each unit costs tens of thousands of won, so pharmacies bear a heavy burden if it becomes a dead stock. At the time of its launch, its convenience of being administered once a week and the expectation of its dramatic effects were the main factors behind the craze, but the excessive enthusiasm gradually faded as public opinion grew concerned about the potential side effects. The government's restriction on non-face-to-face prescriptions since December last year also played a role. Not only did the amount of non-face-to-face prescriptions decrease, but sales were also affected by the transition to in-hospital dispensing. Pharmacist A in Gangnam, Seoul, said, “I brought in some stock because I thought there would be patients who would ask for it, but there were no prescriptions. It's an item that can't be returned, but I have about KRW 2 million worth of stock.” Some clinics sell Wegovy as a package with blood tests and physical examinations, and some dispense Wegovy after general medical examinations. An industry official said, “Clinics and hospitals were not interested in selling insulin because it was not profitable, but Wegovy and Saxenda are now being well sold in clinics. It is puzzling that there are no problems (even though they are dispensing it within their institutions rather than as outpatient prescriptions).” You can easily find examples of in-hospital prescriptions in obesity treatment-related communities. Some people say that they pay KRW 500,000 to 600,000 for a pen, and although they know its price at pharmacies, as the hospitals don’t issue outpatient prescriptions, they were buying it within hospitals. There are also reports that they pay for blood tests and physical examinations separately to buy Wegovy at the clinic, which demonstrates the rampant in-hospital prescription activities being carried out in Korea. The problem is that, with the exception of exceptional circumstances, outpatient prescriptions are the rule. The issue of in-hospital dispensing of self-injectable drugs for obesity treatment, including Saxenda, has been a constant issue. As cases where the doctor injects the drug first is an exception, some clinics have been selling the remaining quantity in-house after an initial injection. During the 2020 NA Audit, there was also a claim that outpatient prescriptions for self-injectable drugs such as Saxenda should be made mandatory. Legal experts also explain that unless in some exceptional circumstances, the sale of Wegovy within the hospital is against the law. They added that it is inappropriate to sell Wegovy within the hospital for reasons such as self-injections and education. “The government has also stated that outpatient prescriptions are the rule. In-hospital prescriptions (unless they are injected) can be problematic, and the justification for education on the use of self-injectable drugs is not a valid reason,” explained attorney Jong-Sik Woo (Qone Law).
- Policy
- P3T for Sanofi’s Itepekimab in rhinosinusitis approved
- by Lee, Hye-Kyung Feb 12, 2025 06:13am
- Sanofi Aventis' biological drug 'Itepekimab' is entering Phase III trial in Korea to secure an indication for chronic rhinosinusitis following chronic obstructive pulmonary disease (COPD). On the 10th, the Ministry of Food and Drug Safety approved Sanofi’s 52-week Phase III randomized, double-blind, placebo-controlled, parallel-group clinical trial to investigate the efficacy, safety, and tolerability of Itepekimab in adult subjects with chronic rhinosinusitis with uncontrolled nasal polyps. Chronic rhinosinusitis is defined as inflammation of the nasal cavity and paranasal sinuses that lasts for 12 weeks or longer. Some doctors also describe inflammation of the nose and sinuses when nasal inflammation (rhinitis) is present. In Korea, it is said that about 8.4% of the total population has sinusitis, and the prevalence of chronic rhinosinusitis with polyps is 2.6%. With the approval, the number of clinical trials being conducted for Itepekimab since 2021 in Korea has increased to four in total. Since 2021, two Phase III clinical trials have been underway for COPD patients, and Phase II and III trials are being conducted simultaneously for chronic rhinosinusitis patients. Itepekimab is a monoclonal antibody that targets interleukin (IL)-33, an inflammatory cytokine. Autoimmune diseases associated with IL-33 include allergic diseases, atopic allergies, asthma, rheumatoid arthritis, multiple sclerosis, and systemic lupus erythematosus, and it plays an important role in the functioning of the immune system. Sanofi is developing Itepekimab as the next-generation drug to succeed Dupixent (dupilumab). Dupixent is the first biological agent that targets the signaling of interleukin (IL)-4 and IL-13, which are the main causative agents of type 2 inflammation and has been approved as an atopic dermatitis treatment in several countries, including South Korea, the United States, Canada, Europe, Japan, and Australia. It has since expanded its indications to include patients with moderate-to-severe asthma, nodular rash, COPD, and eosinophilic esophagitis. Currently, Sanofi is seeking to further obtain indications for Dupixent for chronic idiopathic urticaria (CSU), chronic pruritus of unknown origin (CPUO), and bullous pemphigoid (BP).
- Company
- Will 'Verzenio' be reimb for early breast cancer in 2025?
- by Eo, Yun-Ho Feb 12, 2025 06:13am
- Product photo of Verzenio The industry eyes whether 'Verzenio,' with expanding reimbursement challenges, will obtain results this year. According to sources, Lilly Korea's CDK4/6 inhibitor Verzenio (abemaciclib) is expected to be considered for the upcoming Cancer Disease Review Committee (CDRC) of the Health Insurance Review and Assessment Service (HIRA) for its indication for early breast cancer. Verzenio faced challenges in the first attempt at the CDRC review for its indication to treat early breast cancer. Despite submitting the application and waiting for six months, Verzenio was presented to the committee in May 2023, but the result was 'reimbursement standards non-established.' After five months, Verzenio re-submitted its reimbursement application to the HIRA in October. Then, the drug was considered for the CDRC, but the result was the same as before. Patients have high hopes for reimbursement approval of Verzenio for early breast cancer. In fact, the public petition yielded over 50,000 votes. The efficacy of the drug was demonstrated again through the five-year outcomes from the monarchE study, which was presented at the 2023 European Society for Medical Oncology (ESMO) Congress. The data used for the follow-up research were based on the four-year data presented at the 2022 San Antonio Breast Cancer Symposium held in December and an article published in The Lancet Oncology. The primary endpoints, which were invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS), showed clinically significant differences between the Verzenio treatment group and the control group (endocrine therapy alone) that was even more pronounced in five-year data compared to the four-year data. In year 5, the primary endpoint invasive disease-free survival (IDFS) demonstrated an approximately 8% difference. Verzenio appears to have a potential carry-over effect through the fifth year, even after completing the two-year treatment period. Besides the endocrine therapy letrozole generic, Verzenio is the only treatment option available in HR+/HER2- type early-stage breast cancer. On November 18, 2022, Verzenio was approved for expanded use in combination with endocrine therapy in the adjuvant treatment of patients with HR+/HER2- high-risk early-stage breast cancer and who have lymph node-positive recurrence. The following are specific indications: ▲Four or more lymph node metastases, ▲1-3 lymph node metastases with a tumor size of 5 cm or larger, ▲Histological grade 3 limited recurrent high-risk patients. Professor Keun Seok Lee, Professor at National Cancer Center's Center for Breast Cancer Korea, said, "The use of Verzenio in combination with endocrine therapy is recommended by the Korean and international chief guidelines as a post-surgical adjuvant therapy for relapsed and high-risk patients, based on significant evidence. Since the drug's clinical usefulness has been confirmed through clinical studies and chief academic reviews, we need improvements to patient treatment access through reimbursement to increase the survivability of patients who qualify as relapsed and high-risk conditions."
