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- Company
- Latecomer psoriasis drug Bimzelx enters competition in KOR
- by Whang, byung-woo Jun 13, 2025 06:03am
- The new psoriasis treatment Bimzelx (bimekizumab) has cleared the reimbursement hurdle and is now officially entering Korea’s market competition. With numerous psoriasis treatment options already on the market, the drug is expected to target new patients based on its relatively low drug price. On the 12th, UCB Korea held a press conference to celebrate the launch of Bimzelx in Korea and highlighted the product's competitiveness. Bimzelx is the first plaque psoriasis treatment that dually inhibits interleukin-17A and 17F (IL-17A and 17F). IL-17A and IL-17F are key cytokines that trigger the inflammatory process in psoriasis, and Bimzelx selectively and directly targets and inhibits both simultaneously. In the BE READY trial, the global Phase 3 clinical study that became the basis for the approval, 90.8% of patients in the Bimzelx group achieved PASI 90 at Week 16, and 68.2% of patients achieved PASI 100. In a clinical trial that compared Bimzelx with another biological agent, there was a clear difference in the percentage of patients who achieved complete clearance of skin lesions at Week 16, which is referred to as 'PASI 100'. Specifically, ▲BE VIVID: Bimzelx 59%, ustekinumab (Stelara) 21% ▲BE SURE: Bimzelx 60%. 8%, adalimumab (Humira) 23.9% ▲BE RADIANT: Bimzelx 61.7%, secukinumab (Cosentyx) 48.9%, etc. The introduction of Bimzelx as a new psoriasis treatment option is significant because of its dual inhibiting mechanism of action that blocks IL-17A and IL-17F. Dr. Stevan Shaw, Head of Research at UCB UK and developer of Bimzelx, said, "Bimzelx’s dual inhibition of interleukin-17A and interleukin-17F showed a higher skin lesion improvement rate in psoriasis patients compared to secukinumab, which only inhibits interleukin-17A.” He further explained, “The dosing regimen, which involves administration every 8 weeks for maintenance therapy, also enhances patient convenience, representing a significant advantage over existing interleukin-17A inhibitors.” In addition, Professor Jeong-Eun Kim of Hanyang University Hospital's Department of Dermatology said, “Even in a meta-analysis conducted over a long period of 52 weeks, Bimzelx showed better efficacy than other drugs in terms of the cumulative number of days achieving PASI 100. No new safety issues were reported during long-term treatment that continued for over three years, with no special events reported overall.” In other words, despite the emergence of various psoriasis treatments, there is still unmet demand due to resistance and other factors, for which Bimzelx is considered to be competitive. The reimbursement price for Bimzelx, which has been covered by health insurance since June, is KRW 801,332. In order to compare the specific drug prices with existing treatments, it is necessary to consider the dosage and administration, and Bimzelx does not have a significant advantage in terms of cost competitiveness, which is a strategy often chosen by later entrants. Bimzelx is administered subcutaneously at 320 mg (two 160 mg doses) at 0, 4, 8, 12, and 16 weeks, and then every 8 weeks thereafter. Considering that competing treatments have administration schedules ranging from 4 weeks to 12 weeks, Bimzelx has a moderate dosing schedule. Regarding this, Professor Kim stated that prescriptions will be tailored to individual patient characteristics and the doctors’ discretion. He added, “While consideration should be given to the patient's comorbidities and prior treatment history, there is no guideline on which drug must be used as the first or last option based on efficacy. However, as more treatment options become available, the therapeutic paradigm for psoriasis is expected to shift and become more segmented.” Finally, Professor Kim added, “Personally, I think Bimzelx should be considered first for patients who do not respond well to biological agents.”
- Company
- New ADC drug Padcev seeks reimb again in Korea
- by Eo, Yun-Ho Jun 13, 2025 06:03am
- The ADC bladder cancer drug Padcev is once again attempting reimbursement listing in Korea. According to Dailypharm coverage, Astellas Pharma Korea recently submitted a reimbursement application for its antibody-drug conjugate (ADC) Padcev (enfortumab vedotin). Accordingly, it will be interesting to see whether the company will be able to make progress in the discussion on insurance reimbursement for Padcev as a monotherapy and combination therapy. This is the company’s third attempt at reimbursement listing. Padcev was first approved in Korea in March 2023, and has remained non-reimbursed for over 2 years since. The monotherapy option passed the Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee review in February this year, but the application was rejected after the government and pharmaceutical companies failed to agree on the cost-effectiveness after the company completed the pharmacoeconomic evaluation. At the end of last year, Astellas Pharma applied for Padcev’s reimbursement as a monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who have previously received PD-1 or PD-L1 inhibitors and platinum-based chemotherapy, and as first-line therapy for advanced metastatic urothelial carcinoma in combination with the PD-1 inhibitor ‘Keytruda (pembrolizumab)’ However, the applications were also rejected by the Cancer Disease Deliberation Committee in February. Astellas Pharma plans to supplement the relevant data and reapply for reimbursement. The drug is recommended as Category 1 in the National Comprehensive Cancer Network (NCCN) guidelines. It is a new treatment option for urothelial cancer patients whose cancer has progressed or recurred even after receiving treatment with immunotherapy drugs and platinum-based chemotherapy. The drug was approved in March in Korea for the treatment of patients with locally advanced or metastatic urothelial cancer who have received prior treatment with PD-1 or PD-L1 inhibitors and platinum-based chemotherapy, then was approved in combination with Keytruda in July. Padcev’s efficacy as a monotherapy was demonstrated through the EV-301 study, an open-label, Phase III trial that was conducted on 608 patients with locally advanced or metastatic urothelial cancer who have previously been treated with platinum-based chemotherapy and PD-1 or PD-L1 inhibitors. Study results showed that Padcev reduced the risk of death by 30% compared to chemotherapy. The median overall survival (OS) of the Padcev group was 12.9 months, demonstrating a significant improvement in survival compared to chemotherapy's 9.0 months. In addition, Padcev significantly improved progression-free survival (PFS) with a 38% reduction in disease progression or death risk, with the median progression-free survival (PFS) for Padcev being 5.6 months and 3.7 months for the control group. In the case of the Keytruda-Padcev combination, its efficacy was demonstrated through the randomized Phase III EV-302 trial that was presented at the European Society for Medical Oncology Annual Meeting (ESMO 2023). The trial evaluated Padcev+Keytruda versus conventional chemotherapy in 886 patients in 25 countries. Trial results showed, that at a median follow-up of 17.2 months, the median overall survival in the Padcev combination therapy group was 31.5 months, approximately twice as long as the 16.1 months in the platinum-based chemotherapy group, reducing the risk of death by 53%.
- Policy
- Ruling party proposes bill for free HPV vaccination
- by Lee, Jeong-Hwan Jun 13, 2025 06:02am
- The Democratic Party of Korea has submitted a bill to the National Assembly to significantly expand the scope of Korea’s National Immunization Program for human papillomavirus (HPV) vaccines. The bill proposes to provide free HPV vaccinations to all males and females aged 12 to 26, regardless of gender or income level. This legislation is in line with President Lee Jae-myung's campaign pledge to expand the National Immunization Program (NIP) for HPV vaccines. On the 12th, Rep. Lee Su-Jin (Seongnam City) of the Democratic Party of Korea submitted a bill titled “Partial Amendment to the Infectious Disease Control and Prevention Act” as representative. The bill aims to expand HPV vaccination coverage to all men and women aged 12 to 26, regardless of income or gender, for the prevention of HPV infection. The current law stipulates that the government shall provide NIP for HPV prevention to “female adolescents aged 12 to 17” and “low-income women aged 18 to 26.” However, Rep. Lee pointed out that individuals who are not eligible for government support are equally exposed to the risk of HPV infection, yet receive no assistance at all. Depending on age, two to three doses may be required, and each dose costs over KRW 150,000, placing a financial burden on individuals who must cover the expense themselves. President Lee included the expansion of the HPV NIP support program in his campaign pledge for the 21st presidential election, and Rep. Lee has proposed a corresponding legislative bill. Rep. Lee stated, “By providing HPV vaccination to all individuals aged 12 to 26, regardless of income or gender, we can prevent HPV infection and cervical cancer. I pledge to spare no legislative support to ensure women's right to health through proactive prevention.”
- Company
- Distributors Association plans "strong response"
- by Son, Hyung Min Jun 13, 2025 06:01am
- The Korean pharmaceutical distribution industry is rallying around the Korea Pharmaceutical Distributors Association in response to Janssen Korea's reduction of&160;distribution margins. Park Ho-young, Chairman of the Korea Pharmaceutical Distributors Association, described Janssen Korea's margin reduction as an&160;arbitrary act&160;rather than a negotiation, indicating a firm stance of strong countermeasures. The Wednesday Forum (Chairman Nam Sang-gil), a private gathering within the pharmaceutical distribution industry, recently held its regular monthly meeting in June to discuss key issues, including countermeasures against Janssen Korea's margin reduction, and foster camaraderie among members. At the forum, opinions were raised that small and medium-sized hospitals must seek alternatives for Janssen Korea products, such as the&160;biologic Remicade. Additionally, it was argued that with the reduced distribution margins, pharmacy deliveries are practically difficult, thus necessitating the minimization of orders for Janssen Korea pharmaceuticals. Notably, Chairman Park Ho-young of the Korea Pharmaceutical Distributors Association also attended the meeting to explain the association's response plan to the issues threatening the distribution industry. Park stated, "The 2%p distribution margin reduction being pushed by Janssen Korea goes beyond the scope of a simple negotiation; it is an act of tyranny." Park added, "Member companies have conveyed their concerns to the association. The association will step forward and respond proactively." He further emphasized, "The association will exert all its capabilities to eliminate elements that threaten the pharmaceutical distribution industry." Park repeatedly urged unity among member companies, stating, "If we fail to properly defend against this Janssen Korea issue and fail to demonstrate the united power of the distribution industry, a greater crisis will come in the future." An advisor to the Wednesday Forum who attended the meeting also supported Chairman Park, saying, "Now is the time to build a strong front, centered on the association, against Janssen Korea's attempt to cut distribution margins." He added, "Sanctions are also necessary for member companies that act against the association's policy." Following the Wednesday Forum, the Korea Pharmaceutical Distributors Association plans to hold a series of follow-up response meetings. The Seoul Pharmaceutical Distributors Association will have an expanded board meeting on the 18th to discuss key issues in depth, including the Janssen Korea margin reduction issue. The Seoul Pharmaceutical Distributors Association, which had initially sought countermeasures through hospital branch meetings, is said to have shifted the discussion among the board of directors, considering the seriousness of this matter. The Gyeonggi-Incheon Pharmaceutical Distributors Association also expressed deep concern about Janssen Korea's move to reduce distribution margins. It will lend its support to the association's response, including preparing a statement of opposition. The heads of regional branches under the Korea Pharmaceutical Distributors Association are expected to meet next Monday, and pharmaceutical distributors in the Busan, Gwangju, and Daegu regions are also expected to voice their concerns, centered around the association. As they have delegated negotiation authority for margin reductions to the association, regional pharmaceutical distributors are likely to strengthen their resolve to participate actively. A high-ranking official from the Korea Pharmaceutical Distributors Association warned, "The latest margin reduction is not just a simple profit structure adjustment; it is an issue directly linked to the survival of small and medium-sized distributors," and added, "If we fail to withdraw Janssen Korea's measure this time, a crisis will sweep over the entire distribution industry." He further pointed out, "Margins are like a cost concept for distributors, and pharmaceutical companies must accurately recognize this concept."
- Company
- Trodelvy approved for reimbursement with the ICER value
- by Whang, byung-woo Jun 12, 2025 06:06am
- As Trodelvy (sacituzumab govitecan), the first antibody-drug conjugates (ADC) for treating Triple-Negative Breast Cancer (TNBC) available in South Korea, becomes reimbursed, a paradigm shift in the treatment is expected. Experts assess that the metastatic TNBC treatment, which has been challenging due to a high risk of metastasis and relapse and relied on chemotherapy, has undergone a transition. There is a high demand for Trodelvy, as demonstrated by two previous National Petitions with over 50,000. In the future, the survival benefit is expected to rise. On June 11, Gilead Sciences Korea hosted a session to celebrate reimbursement approval of Trodelvy, and the company shared the latest updates on TNBC treatment and the significance of reimbursement. TNBC is a type of breast cancer that is negative for three receptors: two types of hormone receptors and the HER2 receptor. TNBC has unmet needs because there is no receptor that treatment can target, and treatment options have been limited to cytotoxic anticancer agents. Trodelvy is known to bind Trop-2 protein, releasing the medicine inside tumor cells. It minimally affects healthy cells, and it can destroy not only tumor cells but also the tumor microenvironment (TME). Besides cytotoxic anticancer agents, Trodelvy is the only treatment approved by the Ministry of Food and Drug Safety (MFDS) as a second-line treatment for patients with metastatic TNBC, regardless of existing genetic mutations or biomarkers. When MFDS granted approval in May 2023, Trodelvy presented a cost burden of KRW 10 million per cycle. It was approved for national health insurance reimbursement in June, thereby expanding patient accessibility. Specifically, Trodelvy can be reimbursed for treating locally advanced or metastatic TNBC as a third-line or later treatment. If recurrence occurs during or within one year of completing neoadjuvant or adjuvant chemotherapy, previous treatments are considered as first-line treatment, allowing for reimbursement of Trodelvy in the second-line setting as well. Trodelvy was categorized as having innovativeness. It gained attention for becoming the first case to clear the DREC review, with its price being measured based on its an Incremental Cost-Effectiveness Ratio (ICER) values. Dr. Joohyuk Sohn, a Professor at Yonsei Cancer Hospital's Department of Oncology, who presented during the meeting, assessed that reimbursement approval of Trodelvy will bring a new shift in the treatment of TNBC. Dr. Sohn explained, "While there has been remarkable progress with the emergence of various new drugs for breast cancer, treatment options for TNBC have remained limited. It has been challenging to treat due to its faster and more aggressive progression compared to other types of breast cancer." Additionally, Trodelvy, with efficacy confirmed through the Phase 3 ASCENT study and now reimbursed, is considered a potential new game changer. Dr. Sohn stated, "The final analysis results of the ASCENT study showed that the overall survival (OS) of the Trodelvy treatment group, including patients with brain metastases, was 11.8 months, approximately twice as long as the single-agent chemotherapy group (6.9 months), and it reduced the risk of death by 49%." The breast cancer guidelines of the National Comprehensive Cancer Network (NCCN) and the European Society for Medical Oncology (ESMO) foremost recommend Trodelvy as a second-line treatment for metastatic triple-negative breast cancer. Dr. Sohn emphasized, "For patients who were hesitant to receive treatment because Trodevly was not reimbursable, despite the clear clinically confirmed treatment benefits, the reimbursement listing of Trodelvy will bring survival benefits." "When new drug efficacy is proven, rapid reimbursement approval is needed to expand patient access" In particular, Dr. Sohn suggested that if a new drug's efficacy is sufficient, a rapid reimbursement approval is necessary. Dr. Sohn stressed, "Regarding (new drug) accessibility, it takes too long, usually 3 to 4 years, and I think it's problematic that we consider it a good thing when it takes only 2 years," and added, "While reimbursement listings can be delayed due to health insurance finances. If the research data is not accurate, it can also be delayed. However, if the benefit in OS is proven, rapidly expanded reimbursement is necessary." Meanwhile, Trodelvy is recently expected to expand its indication as a first-line treatment for TNBC through combination therapy with the immunotherapy Keytruda. In the interim analysis results of the Phase 3 'ASCENT-04/KEYNOTE-D19' clinical trial, presented at the recent American Society of Clinical Oncology (ASCO 2025) Annual Meeting, the median progression-free survival (mPFS) for the Keytruda-Trodelvy group was 11.2 months, showing a significant improvement over the control group's chemotherapy+Keytruda at 7.8 months. The duration of response (DOR) for the Trodelvy-Keytruda treatment group was 16.5 months, while chemotherapy+Keytruda was limited to 9.2 months. The OS data were yet incomplete, but a positive trend was observed with Trodelvy plus Keytruda.
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