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- 2026-06-06 11:22:07
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- AZ launches Tezspire in Korea with expanded indication
- by Son, Hyung Min Apr 10, 2026 08:27am
- AstraZeneca Korea (CEO Eldana Sauran) announced on the 8th the domestic launch of Tezspire (tezepelumab) as an add-on maintenance treatment for severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP).With this domestic launch, Tezspire has simultaneously expanded its indication to include its use as an add-on maintenance treatment for adults with inadequately controlled CRSwNP, broadening its use as an anti-TSLP (Thymic Stromal Lymphopoietin) treatment option for severe asthma to CRSwNP.TSLP is a driver of multiple inflammatory responses and is expressed at higher levels in CRSwNP patients than in patients without polyps. Tezspire is an anti-TSLP monoclonal antibody that blocks TSLP activity at the upstream level of inflammatory pathways. Tezspire’s clinical efficacy and safety profile were confirmed in the global Phase III WAYPOINT trial.The WAYPOINT study was a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial conducted in 10 countries involving 408 patients aged 18 years and older with CRSwNP who had severe, uncontrolled symptoms.Results showed that at Week 52, the Tezspire treatment group demonstrated statistically significant improvements compared to the placebo group, with a decrease of -2.07 in the Nasal Polyps Score (NPS), which assesses the size and extent of nasal polyps, and a decrease of -1.03 in the Nasal Congestion Score (NCS), which assesses the degree of nasal congestion. Furthermore, these improvements were observed as early as week 4 and week 2 of treatment, respectively, and were sustained through week 52.Ji-young Kim, Executive Director of AstraZeneca Korea’s Respiratory Division, said, “We are pleased that we were able to expand Tezspire’s indication in Korea following FDA approval in October last year for CRSwNP. Clinical trials confirm Tezspire can be an effective treatment option not only for asthma but also for patients with CRSwNP, and we expect it to help patients manage their respiratory conditions.”Rhinosinusitis is characterized by two or more symptoms, including nasal congestion, nasal obstruction, or a runny nose, and becomes chronic when these symptoms persist for 12 weeks or longer. Additionally, when accompanied by nasal polyps, it is classified as CRSwNP.
- Company
- Boston Scientific Korea’s sales surpass ₩200 billion
- by Hwang, byoung woo Apr 10, 2026 08:26am
- Boston Scientific Korea has surpassed KRW 200 billion in sales following portfolio restructuring.Analysts attribute this revenue expansion to the robust growth of the Pulse Field Ablation (PFA) system, coupled with concurrent growth across all major therapeutic areas.According to a recent audit report, Boston Scientific Korea posted KRW 218.5 billion in sales in 2025, up 18.4% from KRW 184.6 billion the previous year.This marks the first time the company has surpassed KRW 200 billion in revenue since entering the Korean market, continuing its four-year growth streak from KRW 151.6 billion in 2022, KRW 175.3 billion in 2023, and KRW 184.6 billion in 2024.Operating profit also grew in tandem with topline growth, from KRW 9 billion in 2022, KRW 10.5 billion in 2023, KRW 11 billion in 2024, to KRW 13 billion in 2025.Increased PFA procedures for arrhythmia drive growthThe key driver behind the company’s growth lies in changes to the business portfolio. The product lines currently supplied by the company to domestic medical institutions span the cardiovascular, oncology, and urology fields. After previously attempting to enter the structural heart disease segment with TAVI before discontinuing the business, the company restructured its portfolio.Representative products include the AVIGO Plus coronary ultrasound imaging device, the TheraSphere liver tumor embolization device, and the Rezum system for benign prostatic hyperplasia.Among these various products, the PFA system had the greatest impact on growth last year.Unlike conventional radiofrequency ablation or cryoballoon ablation, PFA selectively destroys myocardial cells only, reducing procedure time by more than half and lowering complication risks, thereby expanding its influence in major domestic general hospitals.The Korean PFA market is currently contested by Boston Scientific, Medtronic, and Johnson & Johnson (J&J).Boston Scientific was the fastest to enter the Korean market, securing catheter certification for its FARAPULSE platform in April 2024 and generator approval in September.Analysts attribute this growth to the expanding market for electrophysiological procedures, driven by an increase in atrial fibrillation patients amid an aging population, with a recurring revenue model centered on related catheters and systems serving as the foundation for growth.In a Korea Health Industry Development Institute report on PFA, Professor Bo-young Joung of the Department of Cardiology at Severance Hospital stated, “PFA cuts procedure time by half compared with conventional methods and lowers complication risk, leading to high satisfaction among both physicians and patients. Currently, 35% of atrial fibrillation ablation procedures at Severance are performed using PFA, and this trend is expected to continue.”Given this, Boston Scientific Korea’s growth momentum is expected to strengthen further.Rezūm expansion and global M&A broaden business scopeAnother factor contributing to growth is the continued expansion of the Rezūm System, a medical device introduced in 2023 for benign prostatic hyperplasia, which has now surpassed 6,000 cumulative procedures in Korea.The Rezūm System received approval from the U.S. Food and Drug Administration (FDA) in 2015, obtained authorization from the Ministry of Food and Drug Safety in 2022, and was designated as a new health technology by the Ministry of Health and Welfare in 2023. Currently, Rezūm procedures are expanding their scope of application in clinical settings as a treatment option that can be considered even for patients unsuitable for medication or surgery.Regarding this, Boston Scientific Korea Country Manager Ae Ri Jung said, “Achieving 6,000 Rezūm procedures is a meaningful milestone demonstrating its establishment as a treatment option for BPH in Korea. We will continue contributing to expanding treatment options that improve patients’ quality of life.”As the portfolio expands, the company appears to be strengthening its field sales capabilities. Looking at the sales and administrative expenses, promotional expenses rose from KRW 6.3 billion in 2024 to KRW 7.1 billion in 2025.In particular, as Boston Scientific is pursuing mergers and acquisitions (M&A) on a global scale involving tens of trillions of won, its influence in the domestic medical market is expected to continue to grow in the future.The company acquired Axonics in 2024 to strengthen its urology portfolio, and in January, decided to acquire neurovascular treatment company Penumbra.In addition, it has also recently fully integrated Valencia Technologies, a urinary incontinence treatment company, rapidly expanding its portfolio.As the company expands its business scope to include new disease areas in addition to those that generate synergies with existing businesses, its business scale in the Korean market is also expected to grow.
- Company
- Will Verzenio’s reimbursement be extended to early breast cancer?
- by Eo, Yun-Ho Apr 10, 2026 08:25am
- Hope has been rekindled once again for expanded reimbursement of Verzenio in early breast cancer after three failed attempts.According to industry sources, the Breast Cancer Division of the Korean Society of Medical Oncology submitted an application to expand insurance reimbursement for Verzenio (abemaciclib), Eli Lilly Korea’s CDK4/6 inhibitor, in February. This marks the first time a medical society, rather than a pharmaceutical company, has taken the initiative to seek reimbursement coverage of a drug for early-stage breast cancer.Additionally, the society recently submitted a petition urging the Health Insurance Review and Assessment Service (HIRA) to expedite the review schedule for Verzenio’s listing, including the results of a signature campaign organized by the Union of Breast Cancer Patients.Accordingly, there is growing speculation that Verzenio could be brought before the Cancer Disease Deliberation Committee of the Health Insurance Review and Assessment Service in May, alongside Kisqali (ribociclib), another breast cancer treatment with the same mechanism that is currently undergoing the reimbursement process.Furthermore, Verzenio has secured data demonstrating an improvement in overall survival (OS), which was the biggest obstacle in the coverage expansion process last October.According to results from the monarchE study presented at the ESMO 2025 Annual Congress, at a median follow-up of 6.3 years, Verzenio combination therapy reduced the risk of death by 15.8% compared with endocrine therapy alone. The 7-year survival rates were 86.8% for Verzenio combination therapy and 85.0% for endocrine monotherapy, with an absolute difference of 1.8%.Verzenio faced difficulties in being reviewed by CDDC from its first attempt for early breast cancer. After a long wait of 6 months after submitting the reimbursement application, it was finally reviewed by CDDC in May 2023, but the result was “reimbursement criteria not set.” Five months later, in October, Lilly resubmitted the reimbursement application to HIRA, and in March and July last year, it was submitted to CDDC for review, to face the same results.Keun Seok Lee, Professor of the Center for Breast Cancer at the National Cancer Center, said, “The Verzenio+endocrine therapy combination is recommended with a high level of evidence in major national and international practice guidelines as adjuvant therapy for patients at high risk of recurrence. With various clinical studies and major academic society reviews confirming its clinical utility, we need to enable rapid access to the treatment through prompt reimbursement to improve the survival of patients at high risk of recurrence.”Meanwhile, a considerable number of drugs in the breast cancer field are still struggling to obtain expanded reimbursement. Perjeta (pertuzumab), which has become a standard of care in the postoperative adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence, has been approved in Korea for eight years but has yet to clear the hurdle for coverage.Unlike neoadjuvant chemotherapy (preoperative adjuvant therapy), which is covered under selective reimbursement at 30%, the postoperative adjuvant indication failed to obtain during the 2019 review because the drug lacked high-level recommendations in global guidelines and long-term follow-up data.However, the 10-year follow-up results from the global Phase III APHINITY study, released last year, are expected to fill this gap. According to the study, adjuvant therapy with Perjeta plus Herceptin (trastuzumab) demonstrated clear improvement, including a 21% reduction in the risk of death compared with trastuzumab alone in lymph node-positive patients at high risk of recurrence.
- Company
- K-biosimilars gain influence in domestic market
- by Chon, Seung-Hyun Apr 08, 2026 07:46am
- Domestically developed biosimilars have gradually expanded their influence in the domestic market. Celltrion’s Remsima and Samsung Bioepis’s Onbevezi competed for the top spot by a narrow margin, both recording sales in the KRW 40 billion range. Celltrion’s Prolia biosimilar, joined by Daewoong Pharmaceutical, surpassed KRW 10 billion in sales in its first year of release. This trend reflects the increasing involvement of traditional pharmaceutical companies in biosimilar sales, which has strengthened market penetration.According to the Financial Supervisory Service on the 7th, Celltrion’s Remsima recorded KRW 45.5 billion in sales last year, up 3.4% year-on-year, securing the top spot among domestically developed biosimilars. In 2024, Samsung Bioepis’s Onbevzi took the lead with KRW 45.2 billion, but last year Remsima overtook it by KRW 5.5 billion. The figures are based on sales disclosed by Celltrion Pharm and Boryung, which handle domestic sales for Celltrion and Samsung Bioepis biosimilars, respectively.Remsima is a biosimilar of the autoimmune treatment Remicade. It was approved in 2012 as Korea’s first domestically developed antibody biosimilar. It is used to treat Crohn’s disease, ankylosing spondylitis, ulcerative colitis, and rheumatoid arthritis.Onbevzi is a biosimilar version of the oncology drug Avastin. It is an anticancer drug used to treat metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer, advanced or metastatic renal cell carcinoma, glioblastoma, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and cervical cancer.Being the first biosimilar product introduced to the domestic market, Remsima had long led sales, but the rapid growth of Onbevzi since its introduction shifted the market into a duopoly structure.In 2023, Remsima maintained a narrow lead of KRW 0.8 billion, but in 2024, Onbevzi overtook it for the first time by KRW 1.2 billion. However, Onbevzi’s sales declined 11.5% year-on-year to KRW 40 billion last year, allowing Remsima to regain the top position.The domestic biosimilar market is drawing attention as a battleground driven by traditional pharmaceutical companies’ sales capabilities.In the Avastin market, Samsung Bioepis launched Onbevzi in September 2021, followed by entries from Celltrion and Alvogen Korea. As the first entrant, Onbevzi maximized its advantage by leveraging tailored sales strategies. Samsung Bioepis also secured an exclusive domestic sales agreement with Boryung immediately after approval. Boryung is known for its strong presence in oncology sales.Celltrion’s biosimilars are marketed domestically through Celltrion Pharm. Celltrion’s Herzuma, a biosimilar version of Herceptin, recorded KRW 21.9 billion in sales last year, up 2.8%, ranking behind Onbevzi and Remsima. Truxima, a biosimilar version of MabThera, recorded KRW 12.3 billion in sales, up 7.9%.While domestically developed biosimilars are still far from achieving commercial success in the global market, they appear to be gradually expanding their influence with the support of traditional pharmaceutical companies.Last year, 8 of Celltrion’s 12 biosimilar product lines sold in the global market exceeded KRW 100 billion in sales. Remsima recorded sales of KRW 1.0495 trillion last year, surpassing the KRW 1 trillion mark for the second consecutive year.Remsima SC generated KRW 717.2 billion in sales, up 27.1% year-on-year. Zymfentra grew from KRW 36.6 billion in 2024 to KRW 122.2 billion last year, more than tripling and surpassing KRW 100 billion. Remsima SC is a subcutaneous formulation developed from the original intravenous Remsima, and it has been approved in the U.S. as a new drug under the name Zymfentra. Truxima and Herzuma generated sales of KRW 526.3 billion and KRW 217.1 billion, respectively, in the global market last year.Recently, sales competition has been intensifying with traditional pharmaceutical companies joining the biosimilar market en masse.Samsung Bioepis has established disease-specific sales capabilities tailored to biosimilars.It initially partnered with Daewoong Pharmaceutical for its Herceptin biosimilar in 2017 but switched to Boryung in 2021. Immediately after receiving domestic approval for Onbevzi, a biosimilar of Avastin, in 2021, the company signed an exclusive domestic sales agreement with Boryung. Samsung Bioepis selected Samil Pharmaceutical as the sales partner for biosimilars of Lucentis and Eylea, treatments for ophthalmic diseases.Last year, Samsung Bioepis selected Hanmi Pharmaceutical as its domestic sales partner for its Prolia biosimilar Obodence. Samsung Bioepis handles production and supply, while both companies jointly manage marketing and sales. Its original version, Prolia, which was developed by Amgen, works by inhibiting the activity of osteoclasts that break down bone, thereby preventing bone resorption and increasing bone density. It prevents bone loss in postmenopausal women and reduces the risk of fractures, while in cancer patients, it inhibits bone metastasis and protects bone structure to reduce complications.Daewoong Pharmaceutical signed a joint sales and distribution agreement with Celltrion Pharm last year and began domestic sales of Celltrion’s Prolia biosimilar, Stoboclo. Daewoong Pharmaceutical is conducting joint sales of Stoboclo with Celltrion Pharm at general hospitals and clinics nationwide. Celltrion has sold biosimilars in the domestic market through its affiliate, Celltrion Pharm. Stoboclo is the first Celltrion biosimilar to be sold by a pharmaceutical company other than Celltrion Pharm. Stoboclo generated sales of KRW 11.8 billion last year.Daewoong Pharm’s strategy is to expand prescriptions at major general and university hospitals nationwide to grow Stoboclo into a ‘mega blockbuster’ with annual sales exceeding KRW 100 billion. Currently, Stoboclo has been introduced to more than 50 major general and university hospitals nationwide, rapidly expanding its prescription base. Daewoong has also joined the sales efforts for LG Chem’s Humira biosimilar Xelenka.
- Company
- Tepmetko shifts MET-mutated lung cancer treatment paradigm
- by Son, Hyung Min Apr 08, 2026 07:46am
- The treatment landscape for non-small cell lung cancer (NSCLC) MET exon 14 skipping alterations is undergoing significant changes within one year of Tepmetko’s reimbursement introduction. In a rare mutation area where targeted treatment options were previously limited, both clinical efficacy and patient access have improved with the introduction of Tepmetko, prompting a redefinition of treatment strategies and highlighting the growing importance of biomarker-based precision medicine.On the 7th, Merck Korea held a press conference at the Fairmont Hotel in Yeouido, Seoul, to commemorate the first anniversary of the reimbursement of Tepmetko (tepotinib), a treatment for non-small cell lung cancer (NSCLC), and shared clinical outcomes and changes in the actual clinical setting.A view of the press conference marking the first anniversary of Tepmeco’s reimbursement coverage in KoreaTepmetko was approved in Korea in 2021 as a treatment for locally advanced or metastatic NSCLC with MET exon 14 skipping alterations and has been reimbursed since April last year. It works by selectively inhibiting MET phosphorylation and downstream signaling, thereby blocking tumor cell proliferation and migration.MET exon 14 skipping is a representative mutation that causes dysregulation of MET signaling and is known to promote tumor growth and metastasis. Although it is a rare mutation found in approximately 3–4% of metastatic NSCLC patients, it is associated with a poor prognosis and aggressive disease.Clinical evidence has also accumulated. In the global Phase II VISION study, Tepmetko demonstrated tumor reduction in over 90% of patients, with an objective response rate (ORR) of 58.6%, progression-free survival (PFS) of 15.9 months, and overall survival (OS) of 29.7 months. The duration of response was 46.4 months, confirming long-term treatment benefits.Subgroup analysis in Asian patients showed similar results, with an ORR of 56.6%, PFS of 13.8 months, and OS of 25.5 months, indicating consistent therapeutic benefits in patient populations including Koreans.Professor Ji-Youn Han of the Department of Hematology and Oncology at the National Cancer Center said, “Before Tepmetko’s introduction, there were no reimbursed treatment options targeting MET mutations, limiting patient access. Significant changes have emerged in the treatment landscape for rare lung cancers in the year since Tepmetko’s reimbursement.”Need grows for NGS-based testingProfessor Ji-Youn Han of the Department of Hematology and Oncology at the National Cancer Center\As targeted therapies for NSCLC continue to emerge, the need for next-generation sequencing (NGS) is also increasing.In NSCLC, multiple biomarkers exist, including MET, EGFR, ROS1, ALK, BRAF, KRAS, and RET. NGS offers the advantage of being able to test for these biomarkers all at once.While Professor Han positively noted that personalized treatment has become possible even for rare lung cancers such as those with MET mutations, she also pointed out the limitation of how access to NGS-based testing is limited for patients in practice.She explained, “In Korea, factors such as turnaround time (TAT), cost burden, and difficulty in obtaining adequate samples limit the broader adoption of NGS. While the current 50% patient co-insurance rate is acceptable, further efforts are needed to reduce cost burden and improve testing access to ensure accurate testing for more patients.” She added, “Tepmetko has demonstrated consistent response rates and durable treatment effects regardless of biopsy method (tissue or liquid biopsy) or line of therapy. NGS-based biomarker testing offers the advantage of proactively identifying patients who stand to benefit from treatment and providing concrete evidence for establishing treatment strategies and selecting medications.”
- Company
- Domestic approval of high-dose 'Spinraza' imminent
- by Son, Hyung Min Apr 08, 2026 07:46am
- SMA treatment 'Spinraza'Ahead of the introduction of 'Spinraza,' a high-dose regimen of the spinal muscular atrophy (SMA) treatment, to Korea following global approvals, the possibility of a shift in treatment strategy is being raised.The trend of improving effectiveness through dose optimization is evident, moving away from the existing low-dose (12mg) treatment.According to industry sources on the 8th, the domestic approval of Biogen Korea's Spinraza (nusinersen) high-dose formulations (50mg/5mL, 28mg/5mL) is imminent. An approval decision is expected within this month.Previously, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved the high-dose regimen. The strategy involves administering 50mg twice at 14-day intervals during the initial loading phase, followed by a 28mg maintenance therapy at 4-month intervals, thereby maximizing therapeutic effects by increasing the drug concentration compared to the existing regimen.Spinraza is an antisense oligonucleotide (ASO) that continuously increases SMN protein levels. To deliver treatment to the cause of the disease, it can be administered directly into the central nervous system, where motor neurons are located, via intrathecal injection. Since Spinraza allows multiple administrations, it can demonstrate differentiation in its administration method.Spinraza has confirmed a consistent effect and safety profile across all ages and types based on clinical research data and real-world evidence (RWE) accumulated over more than 8 years of treatment.The efficacy of the high-dose Spinraza was confirmed through the Phase 2/3 DEVOTE study. In the primary cohort analysis, the treatment-naïve symptomatic infant patient group showed a statistically significant improvement in motor function assessment (CHOP-INTEND).The treatment group recorded an average increase of +15.1 points, while the comparison group (untreated group) showed -11.1 points, resulting in a mean difference of 26.19 points. While motor function improved in the high-dose regimen group, it worsened in the untreated group, proving a distinct therapeutic effect compared to the natural course of the disease.Regarding safety, a profile similar to the existing low-dose regimen was confirmed. However, pneumonia, aspiration pneumonia, and malnutrition were reported as major adverse reactions in infant SMA patients.The high-dose drug can also be used in patients already receiving treatment. Patients who were maintaining low-dose treatment can continue maintenance therapy at the same 4-month intervals after a single high-dose loading, allowing for a dose increase while maintaining treatment continuity.This high-dose strategy is seen as a variable that can change the SMA treatment paradigm beyond simply adding an option. The approach to maximize treatment response is considered to have begun, given that dose optimization was pursued based on long-term (over 10 years) data from the existing treatment.In particular, as approvals have already been granted in major countries such as the U.S., Europe, and Japan, attention is focused on the timing of introduction and the reimbursement strategy in Korea. If the high-dose drug becomes a differentiated option compared to existing treatments, its impact on the overall SMA treatment landscape is expected to be significant.More treatment options…treatment choice based on mechanisms of action·administration methods·reimbursement The domestic SMA treatment includes Spinraza, Roche's 'Evrysdi (risdiplam)', and Novartis' 'Zolgensma (onasemnogene abeparvovec)'. All share the common goal of improving SMN protein deficiency but differ in their mechanisms of action and administration methods.Spinraza is an ASO-based treatment that acts on the central nervous system via direct intrathecal administration and has dominated the market based on long-term clinical data and prescribing experience. Evrysdi is an oral small-molecule treatment that regulates SMN2 splicing, characterized by its ability to cross the blood-brain barrier and act systemically.Zolgensma is a gene therapy that directly delivers the SMN1 gene, with therapeutic effects expected after a single administration.Recently, with the expansion of reimbursement criteria for Evrysdi, the flexibility of treatment strategies has greatly improved. The introduction of the tablet form, the extension of the prescription period (up to approximately 2 months), and the allowance of bidirectional switching with injections are evaluated as having made treatment choices based on patient conditions much more flexible.Ultimately, the SMA treatment trend is shifting away from a single, treatment-centered approach toward a customized strategy that considers the mechanism, administration method, and reimbursement criteria.
- Company
- Mounjaro reimb for diabetes remains uncertain in KOR
- by Eo, Yun-Ho Apr 08, 2026 07:46am
- Mounjaro, the star of the obesity treatment boom, has encountered a roadblock in its expansion of reimbursement for diabetes in Korea.According to industry sources, Eli Lilly Korea and the National Health Insurance Service (NHIS) failed to conclude pricing negotiations for Mounjaro (tirzepatide), a dual GIP/GLP-1 receptor agonist, within the deadline. A decision has now been made to extend the negotiation period.Whether Lilly and the NHIS will be able to reach an agreement and secure reimbursement listing for Mounjaro remains to be seen. Its competitor, Novo Nordisk’s Ozempic (semaglutide), which contains the same active ingredient as Wegovy, has been listed for reimbursement for diabetes since February.Mounjaro had previously passed the Drug Reimbursement Evaluation Committee (DREC) review under the Health Insurance Review and Assessment Service (HIRA) in December last year.Although it has generated exceptional sales as an obesity treatment, Mounjaro is also indicated in diabetes as an “adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (monotherapy or combination therapy) and for chronic weight management in adults with obesity (initial BMI ≥30 kg/m²) or overweight patients with at least one weight-related comorbidity (hypertension, dyslipidemia, type 2 diabetes, obstructive sleep apnea, or cardiovascular disease), in conjunction with a reduced-calorie diet and increased physical activity.”For both indications, the recommended starting dose is 2.5 mg once weekly (intended for treatment initiation, not for glycemic control or weight management). After four weeks, the dose is increased to 5 mg once weekly. If further dose adjustment is necessary, the dose may be increased by 2.5 mg increments after at least 4 weeks at the current dose, up to a maximum of 15 mg once weekly.Meanwhile, Mounjaro is drawing attention as the first treatment to suggest the possibility of “remission” in diabetes.In the Phase III SURPASS study, which became the basis for its approval, Mounjaro demonstrated its potential for diabetes remission by achieving statistically superior improvements in HbA1c and body weight compared to all control groups, including semaglutide (1 mg, brand name Ozempic), insulin degludec, and insulin glargine.Furthermore, at the European Association for the Study of Diabetes (EASD) meeting held last September, the company presented results from the Phase III SURPASS-CVOT clinical trial, which directly compared Mounjaro with Lilly’s GLP-1 receptor agonist Trulicity, thereby reinforcing data on cardiovascular prevention effects and improvements in overall survival.
- Company
- Drug pricing re-evaluation lawsuit reverses the situation
- by Kim, Jin-Gu Apr 07, 2026 07:22am
- The lawsuit Medica Korea filed to cancel the price reductions on its existing drugs, challenging the government's re-evaluation of maximum prices, has concluded in the pharmaceutical company's favor. This ruling is expected to have a significant impact beyond the relief to an individual company, influencing the implementation of future government drug price reduction measures.In particular, the significance of this ruling has grown as the government announced a reform plan last month that strengthens the drug price reduction rate from the current 15% to 20% when generic standard requirements are not met. Analysis suggests that pharmaceutical companies facing price cuts due to administrative delays now have a clear justification for pursuing legal action.3-Year Legal Battle Concludes... A Litigation Started by 'Re-evaluation of Listed Drugs'The origin of this case was the "Generic drug price system reform" implemented in July 2020. The government decided to apply differential drug prices based on whether two standard requirements were met: ▲ conducting independent bioequivalence tests and ▲ using registered drug master files (DMF). Additionally, the government conducted a re-evaluation by applying these standards to drugs already listed on the reimbursement list.In September 2023, following the re-evaluation, the Ministry of Health and Welfare (MOHW) announced a price reduction for five items, including Medica Korea's 'Telmisartan Tab,' citing noncompliance with standard requirements.Medica Korea responded immediately by filing a lawsuit to cancel the disposition and an application for a stay of execution. Both the first and second-instance courts ruled in favor of the pharmaceutical company. Subsequently, on the 2nd, the Supreme Court finalized the original verdict by dismissing the government's appeal through a "discontinuation of proceedings." The three-year legal dispute ended in a complete victory for the pharmaceutical company. This is considered unusual, given that cases in which pharmaceutical companies win drug price lawsuits against the government have been very rare.“Violation of Administrative Procedures + Abuse of Discretion”... The Court Highlights Three Illegalities in the Government's MeasureAccording to the Article 8(2) issued by the Seoul High Court's ruling, confirmed by the Supreme Court, the court found that the MOHW's disposition not only violated administrative procedural principles but also constituted a deviation and abuse of discretionary power.◆“Administration Cannot Change Its Word” = The court pointed out the "unauthorized change of grounds for disposition" applied by the government to some items. The MOHW initially issued a price reduction for Medica Korea's five items because they failed to meet 'Standard Requirement 1' (independent bioequivalence testing). However, during the lawsuit, they argued that the items also failed to meet 'Standard Requirement 2' (the use of a registered DMF).Regarding this, the court stated that it is unacceptable to present separate facts that lack identity with the original grounds at the time of disposition. This is interpreted as a reaffirmation of the principle that the executive branch must not infringe upon a party's right to defense by arbitrarily changing the basis for a disposition.◆“Substantial Fulfillment is More Important Than Paperwork” = The court ruled that 'substantial fulfillment of requirements' should take precedence over the 'formal completeness of documents.' Medica Korea was unable to submit the final "DMF Change Authorization Certificate" within the government-set deadline. However, they had already submitted an 'Application for change authorization' before this, clearly indicating their intent to use registered drug master files. Despite this, the government issued the price reduction citing 'failure to submit documents within the deadline.'The court judged that “submitting the authorization certificate is merely one means of proving fulfillment, not the sole evidentiary material,” and that “if a pharmaceutical company has made its best efforts, it should be recognized.”◆A Warning Against ‘Administrative Convenience’ = The court clarified that the situation where the Ministry of Food and Drug Safety's (MFDS) review was delayed due to an explosion of change authorization applications following the drug price reform 'cannot be viewed as the responsibility of the plaintiff (pharmaceutical company).'The court ruled that it is unreasonable to hold a company responsible for document-submission delays caused by external factors beyond its control, to reduce drug prices. This is interpreted as a court warning against the government's drug price reductions driven by administrative convenience.Will 'Second Medica' Cases Follow Amid Concerns of Recurring ‘Administrative Bottlenecks’?This ruling is expected to have a greater ripple effect, as it coincides with the government's last month's drug-pricing reform plan. Under the reform, the basic calculation rate for generic drug prices will be reduced from 53.55% to 45%. Concurrently, the reduction rate for failing to meet standard requirements will be raised from 15% to 20%.Under the existing system, if one standard requirement was not met, the generic drug price was applied at 45.52% (53.55 x 0.85); if two were not met, at 38.69% (45.52 x 0.85). Under the new system, it will drop significantly to 36.00% (45.00 x 0.8) for one failure and 28.8% (36.00 x 0.8) for two failures.Upcoming drug-pricing reform plan. Under the reform, the basic calculation rate for generic drug prices will be reduced from 53.55% to 45%. Concurrently, the reduction rate for failing to meet standard requirements will be raised from 15% to 20%.These standards also apply to already-listed generics. Industry concerns are that the chaos of 2023 will repeat itself. In September 2023, the government simultaneously lowered the prices of 7,355 items. This was a measure that applied the drug price system, reformed in 2020, to existing items en masse. However, during the large-scale price reduction process, delays in data submission and review bottlenecks occurred, leading to continuous confusion and administrative conflicts regarding the interpretation of standards.The Medica Korea lawsuit is also analyzed to have occurred against this backdrop. Analysts believe that, in the process of evaluating and disposing of numerous items in a short period, the government failed to adequately review individual cases, leading to 'formalistic judgments' taking precedence.There is a possibility that even more listed items will be subject to price reductions in this reform. In this case, the administrative burden on the government will inevitably increase. It is noted that this process could create a vicious cycle of administrative errors, leading to more lawsuits.Reduction Rate Increased from 15% to 20%... Potential for Mass Recurrence of ‘Defensive Bioequivalence’ TestsThe measures taken by the pharmaceutical industry for 'price defense' are also factors fueling market confusion. Specifically, there is a high possibility that so-called 'defensive bioequivalence' tests to meet standard requirements will flood the market again.After the 2020 system reform, pharmaceutical companies rushed to conduct bioequivalence tests to defend prices. Companies developed generics themselves through internal formulation research and then conducted bioequivalence tests. Based on the equivalence results, they adopted a strategy of shifting from outsourced to in-house manufacturing to meet the 'conducting bioequivalence tests' requirement and maintain drug prices. In fact, the annual number of bioequivalence test approvals, which was 178 in 2018, surged to 323 in 2020 and 505 in 2021.The number of bioequivalence test approvals by month (unit: case, source: MFDS)The cost per bioequivalence test is estimated at KRW 300-500 million. Criticisms have been raised that spending hundreds of millions of won on bioequivalence tests to maintain drug prices, when the drugs are already being sold without issue after the government has recognized their safety and efficacy, is a waste of resources. Nevertheless, because the scale of price reductions has increased, the structure forces companies to increase additional bioequivalence tests to prevent losses."Litigation is Profitable"... The 'Learning Effect' Presented by the Medica Korea PrecedentConcerns are rising in the pharmaceutical industry that the litigation wars that followed the simultaneous reduction of 7,300 items in September 2023 will be repeated.With the Supreme Court's ruling now established, pharmaceutical companies' response is expected to become more aggressive. From a company's perspective, rather than accepting a 20% reduction, it is a rational choice to file a lawsuit to cancel the price reduction and seek a stay of execution under the Medica Korea precedent. Voices are high that unnecessary litigation will proliferate socially.Consequently, the government has a significant administrative burden during the large-scale drug price adjustment process. Following this Supreme Court ruling, the government's mechanical administrative convenience will find it difficult to gain legal legitimacy. Moving forward, the government faces the task of establishing flexible administrative guidelines that take into account realistic factors, such as the MFDS's review status, rather than insisting solely on the 'formal completeness of documents' during the price adjustment process for listed generics.A pharmaceutical industry official stated, "This ruling clearly established that substantial efforts by companies should not be ignored for administrative convenience. This case is expected to serve as an important legal reference for pharmaceutical companies to respond to the government's administration in the upcoming large-scale drug price reductions."
- Company
- Vadanem launches in Korea…draws attention as oral option
- by Son, Hyung Min Apr 07, 2026 07:22am
- The treatment paradigm for renal anemia may shift from a traditional ESA-centered approach to a multi-layered structure that includes oral treatment options. Amid this trend, Tanabe Pharma Korea and HK inno.N announced the domestic launch of the renal anemia treatment ‘Vadanem (vadadustat),’ signaling potential changes in treatment strategy.The two companies recently held a launch symposium titled ‘New Paradigm VADANEM Symposium’ at the Lotte Hotel Busan. The event featured a wide range of discussions on the mechanism of action and clinical data of HIF-PHI class therapies, as well as strategies for their application in real-world clinical practice.A view of the ‘Vadanem’ launch symposium.Renal anemia is a common complication in patients with chronic kidney disease (CKD), primarily caused by reduced erythropoietin (EPO) production due to impaired kidney function. Consequently, current treatment primarily relies on recombinant erythropoiesis-stimulating agents (ESAs) administered via injection.However, since ESAs are administered subcutaneously or intravenously, limitations have been pointed out, including treatment inconvenience, adverse reactions such as increased blood pressure and vomiting, as well as storage constraints. Although long-acting formulations with improved half-lives have emerged, the inconvenience of injection-based administration remains unresolved.Against this backdrop, oral HIF-prolyl hydroxylase inhibitors (HIF-PHIs) are emerging as a new alternative. This class of drugs works by inhibiting the enzymes that degrade hypoxia-inducible factors (HIF), thereby stimulating endogenous EPO production while simultaneously regulating iron absorption and utilization. They also offer advantages in administration convenience and storage compared to injectables.Vadanem is an oral HIF-PHI that regulates the HIF pathway. It induces endogenous erythropoietin production and improves iron utilization efficiency through a mechanism distinct from that of conventional ESAs.The symposium reflected this shift, highlighting the potential transition from ESA-centered treatment to a multi-layered approach that includes oral therapies.The first day’s session focused intensively on the mechanisms of HIF-PHI-class therapies and the clinical evidence for Vadanem. Chaired by Professor Jong-soo Lee of Ulsan University College of Medicine, presentations were delivered by Professor Bong Soo Park of Inje University College of Medicine and Professor Eun-sil Koh of The Catholic University of Korea College of Medicine.Professor Bong Soo Park of Inje University College of Medicine explained, “While ESAs supplement exogenous EPO, HIF-PHIs activate the hypoxia response pathway to induce endogenous EPO production. This represents a more physiological treatment strategy, as it also regulates iron metabolism.”Professor Eun-sil Koh of the Catholic University of Korea College of Medicine introduced the clinical results of Vadanem, stating, “In the INNO2VATE 1 and 2 clinical trials involving dialysis patients, Vadanem demonstrated non-inferiority in terms of hemoglobin (Hb) improvement compared to the injectable drug darbepoetin alfa (brand name Nesp).”In fact, during the primary efficacy evaluation period (weeks 24–36), the change in hemoglobin (Hb) was 10.36 g/dL for Vadanem and 10.61 g/dL for darbepoetin alfa, and in INNO2VATE 2, these values were 10.36 g/dL and 10.53 g/dL, respectively. Vadanem met the predefined non-inferiority criteria in both studies. Hb levels remained stable and showed similar trends during the long-term evaluation from weeks 40 to 52.It also demonstrated non-inferiority compared to darbepoetin alfa in terms of the risk of major adverse cardiovascular events (MACE). In the overall population, the hazard ratio (HR) for MACE was 0.96, meeting the predefined non-inferiority criteria (FDA 1.25, EMA 1.3).Professor Koh explained, “Consistent results were observed for individual cardiovascular events such as death, myocardial infarction, and stroke. We have established clinical evidence regarding both efficacy and safety.”VADANEM launch symposiumDuring the second day’s session, titled ‘VADANEM in Practice and Beyond,’ discussions focused on how to apply the mechanisms and clinical evidence presented the previous day to actual clinical practice.In particular, given the confirmed clinical efficacy and safety data for Vadanem, attention centered on which patient groups should be prioritized for treatment.Professor Sungjin Chung of the Catholic University of Korea College of Medicine stated, “In patients with CKD-related anemia, various factors such as ESA hyporesponsiveness, iron deficiency, and inflammation interact in a complex manner. For this patient population, HIF-PHI agents could serve as a new treatment alternative.”He added, “In patients with reduced ESA responsiveness, Hb control is often difficult with existing treatments. HIF-based approaches provide a clinically meaningful option.”He further noted, “Depending on the patient’s condition, we can adopt a more flexible treatment strategy, such as switching from ESA or considering oral therapy from the outset. Given the nature of the disease, which requires long-term treatment, oral formulations are also significant in terms of adherence. Their scope of application is expected to gradually expand in practice.”With the launch of Vadanem, attention is focused on whether HIF-PHI therapies will establish themselves as a mainstream option in Korea. The convenience of oral administration and regulation of iron metabolism are considered key factors in future changes to CKD anemia treatment strategies.Professor Sehoon Park of Seoul National University College of Medicine predicted, “We are entering an era that requires patient-tailored approaches based on multiple options rather than a single treatment strategy. The role of HIF-PHI class therapies will expand within this trend.”
- Company
- ‘Padcev + Keytruda’ reimbursement imminent in KOR
- by Son, Hyung Min Apr 07, 2026 07:22am
- Immunotherapy ‘Keytruda’ and ADC ‘PadcevWith combination therapy using antibody-drug conjugates (ADCs) and immuno-oncology drugs on the verge of being reimbursed in Korea, the treatment landscape for bladder cancer (urothelial carcinoma) is increasingly likely to undergo a structural shift.According to industry sources, the Health Insurance Review and Assessment Service (HIRA)’s Drug Reimbursement Evaluation Committee recognized the appropriateness of reimbursement for the combination therapy of Padcev and Keytruda as a first-line treatment for adults with locally advanced or metastatic urothelial carcinoma on April 2. Padcev monotherapy, however, did not receive reimbursement approval.This decision comes approximately 6 months after the combination regimen passed the Cancer Drug Deliberation Committee last October. If price negotiations with the National Health Insurance Service (NHIS) are concluded successfully, Padcev + Keytruda will be listed for reimbursement.Padcev is an ADC that targets Nectin-4, comprised of a fully human anti-Nectin-4 immunoglobulin G1 kappa monoclonal antibody conjugated to the small molecule microtubule-disrupting agent monomethyl auristatin E (MMAE), via a protease-cleavable maleimidocaproyl valine-cituline (vc) linker. Its mechanism of action involves selectively binding to tumor cells, internalization, and the release of MMAE via proteolytic cleavage, which subsequently induces cell death.Its key feature is the expected synergistic effect when used in combination with PD-1 inhibitors. This mechanism maximizes antitumor efficacy by simultaneously inducing direct cytotoxicity via MMAE and immune activation.These mechanistic strengths have also been confirmed in clinical trials. In the EV-302/KEYNOTE-A39 Phase 3 study, the combination therapy of Padcept and Keytruda achieved a median overall survival (OS) of 31.5 months in treatment-naïve urothelial carcinoma patients. This figure is approximately double that of the chemotherapy group, which recorded 16.1 months.Based on these results, the National Comprehensive Cancer Network (NCCN) recommends Padcev + Keytruda as a Category 1 preferred first-line regimen, positioning it as an option capable of replacing existing immuno-oncology drug + chemotherapy focused treatment strategies.ADC + Immuno-oncology drugs take center stage… shifts maintenance therapy-centric structureIf the Padcev + Keytruda combination regimen is actually reimbursed, there is a high likelihood that the combination could shift the treatment axis in urothelial carcinoma.Currently, various options coexist in the first-line treatment setting for urothelial carcinoma, including the combination of ‘Opdivo (nivolumab)’ and GemCis (gemcitabine + cisplatin) and the ADC + immuno-oncology drug combination.In addition, a sequencing strategy, which involves maintenance therapy with Merck’s ‘Bavencio (avelumab)’ after chemotherapy, has also established itself as a major pillar. Among the therapies, Bavencio is currently the only reimbursed option.Merck has emphasized adopting a sequencing strategy in which Bavencio maintenance therapy is administered after chemotherapy, followed by Padcev upon disease progression.In fact, real-world data (RWD) from multinational studies such as Japan’s JAVEMACS, the U.S.’s PATRIOT-II, and France’s AVENANCE showed that the median overall survival (OS) with Bavencio maintenance therapy exceeded 30 months, with some analyses reporting survival extended to over 40 months.Furthermore, in strategies where ADC is used following Bavencio maintenance therapy, OS exceeded 41 months, supporting long-term survival through sequential treatment.Ultimately, the future treatment landscape is likely to evolve into competition between potent combination therapy in the first-line setting and maintenance-based sequencing strategies.Whether or not reimbursement is approved is expected to serve as a key factor that goes beyond the simple addition of a treatment option. It is likely to reshape the very paradigm of bladder cancer treatment.
