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- 2026-05-02 11:39:35
- Policy
- Trial for targeted drug 'VERT-002' for NSCLC begins in KOR
- by Lee, Hye-Kyung Nov 28, 2024 05:55am
- A clinical trial of 'VERT-002,' an innovative targeted treatment for degrading a c-MET gene, will begin in South Korea. C-MET gene is known as one of the cancer-inducing factors of non-small cell lung cancer (NSCLC). On November 27, the Ministry of Food and Drug Safety (MFDS) has granted approval of 'a first-in-human (FIH) multi-center, dose-escalation, dose-expansion Phase I/II clinical trial with VERT-002 for patients with locally advanced or metastatic solid tumors, including NSCLC.' This clinical trial will be conducted at the Asan Medical Center in Seoul and the Severance Hospital. The VERT-002 candidate product was developed by Vertical Bio, a Swiss-based biotechnology company specializing in developing antibodies for cancer treatment. The French pharmaceutical company Pierre Fabre Laboratories acquired Virtual Bio last year, adding a pipeline of cancer agent discovery. A degrader of MET, VERT-002 is a monoclonal antibody with a unique and differentiating mechanism of action. The company anticipates that VERT-002 will likely become a best-in-class treatment for cancer associated with MET alterations. Global clinical trials for the candidate are being conducted worldwide, including in South Korea. The Phase ½ clinical trial for a first-in-human (FIH) multi-center, dose-escalation, and dose-expansion in patients with NSCLC harboring MET alterations began in October. NSCLC is the most common form of lung cancer, accounting for about 85% of newly diagnosed lung cancer cases. Also known as the hepatocyte growth factor receptor (HGFR), MET is a factor regulating tumor genes in a patient sub-group with NSCLC. 1-4 MET exon 14 (METex14) skipping mutations and MET amplification have been identified as the major tumor gene, and MET amplification appears to be mechanisms of tolerance to selected targeted treatment. With its unique and differentiating mechanism of action, VERT-002 works by targeting clinically proven tumor-inducing factors and induces degradation of the c-MET tumor gene. Meanwhile, Pierre Fabre recorded sales of 467 million euros in 2020 just with anticancer agents.
- Policy
- Handok’s thrombocytopenia drug Doptelet approved in KOR
- by Lee, Hye-Kyung Nov 28, 2024 05:54am
- Handok's new rare disease drug ‘Doptelet (avatrombopag)' was approved in Korea on the 26th. The Ministry of Food and Drug Safety approved Doptelet as a treatment for thrombocytopenia for patients with liver disease. Handok is reaping the benefits of forging a strategic partnership with the global biopharmaceutical company Sobi-Handok last year. At that time, the company decided to introduce two new drugs, Empaveli (pegcetacoplan) and Doptelet, a rare disease treatment, into the country, both of which have now been approved in Korea. Doptelet is an orally administered second-generation thrombopoietin receptor agonist (TPO-RA) approved in the U.S. for the treatment of thrombocytopenia in adult patients with liver disease. Patients with moderate-to-severe thrombocytopenia are at increased risk for serious or fatal bleeding events. Patients with thrombocytopenia are commonly known to receive platelet transfusions to increase their platelet count prior to surgery. The approval of Doptelet was based on safety and efficacy data from two Phase III clinical trials on 435 patients. Doptelet is the first oral treatment option for patients with chronic liver disease which offers the advantage of eliminating the need for platelet transfusions prior to surgery for many patients. Meanwhile, Handok formed a joint venture with Sobi in April this year, following a strategic partnership last year. Sobi-Handok will be responsible for developing and selling Sobi’s rare disease drugs in Korea, with a 49:51 shareholding ratio between Handok and Sovi, respectively.
- Policy
- Lagevrio prescription age raised from 60 to 70
- by Kang, Shin-Kook Nov 28, 2024 05:54am
- The prescription age for the government-supplied COVID-19 treatment, Lagevrio, will be raised from 60 to 70 from the 27th. According to the Korea Disease Control and Prevention Agency (KCDA), the three COVID-19 drugs (Paxlovid, Lagevrio, Veklury Inj) that were initially supplied by the government, were planned to be included in Korea’s national health insurance system and transitioned to a general drug status within the year. Accordingly, Paxlovid and Veklury Inj have already been granted marketing authorization in Korea and have been covered by Korea’s health insurance since the 25th of last month. Change in prescription target for Lagevrio On the other hand, Lagevrio has not completed the marketing authorization process in Korea yet and is still being used under emergency use authorization. A considerable period of time may be needed before the approval process is resumed due to the need for additional evidence. The KDCA stated that although a marketing authorization is required to include Lagevrio in the general medical system, it plans to continue supplying Lagevrio on a limited basis within the scope of the government inventory for the time being, considering the COVID-19 winter epidemic and expert opinions. However, the government will limit prescriptions to those for whom domestic and international studies have shown increased efficacy, and will only allow Lagevrio prescriptions to those aged 70 years and older. National support for Lagevrio will continue throughout the winter season, after which the government will monitor the COVID-19 pandemic and comprehensively review the situation, including adjustments to the COVID-19 crisis phase, which is currently in the “interest” stage of concern. Youngmee Jee, Commissioner of KDCA, said, “We will continue to work to ensure a stable supply of COVID-19 drugs, including Lagevrio, to effectively protect high-risk populations from the COVID-19 winter pandemic.”
- Policy
- Limiting new drug patent term extensions would be beneficial
- by Lee, Jeong-Hwan Nov 25, 2024 05:53am
- The domestic pharmaceutical industry's attention is focused on whether the proposed amendment to the Patent Act, which would limit the drug patent term to 14 years and stipulate the number of patent rights that can be extended to one (singular), will pass the Bill Review Subcommittee of the National Assembly's Standing Committee review. The proposed amendment to the bill aims to address the issue of how pharmaceutical companies with new drugs have been operating a de facto “market monopoly” on new drug patents by 'overlapping' the patent term extension system, delaying the timing of generic launches, infringing on the public's right to choose medicines, and causing losses to health insurance finances. The legislation, which institutionalizes the drug patent system that is being used by a number of countries overseas including the United States, Europe, and China, is expected to harmonize domestic standards with patent laws deemed as world standards while strengthening the foundation for fostering the domestic generic industry. On the 24th, the Trade, Industry, Energy, SMEs, and Startups Committee announced that it would review the Patent Act amendment bill introduced by Rep Dong-Jin Koh of the People Power Party at a bill subcommittee scheduled for the 26th. A similar bill had been introduced during the 21st National Assembly by Representative Il-Young Jung of the Democratic Party of Korea but was abandoned upon the NA term expiry. 14-year cap set for patent extensions in the US, Europe…Extension limited to 1 patent The main amendments to Rep Koh’s bill, which will soon be reviewed, are ▲ establishing a 14-year cap on the patent term, and ▲ limiting the number of patents that can be extended to a single drug. The reasoning behind the bill is that the patent term extension system prescribed by Korea’s Patent Act is different from that of developed countries such as the United States and Europe, which may cause reverse discrimination against the domestic pharmaceutical industry. Specifically, the United States, Europe, and China limit the number of patents that can be extended for a single drug to a singular patent - just one. Korea and Japan, on the other hand, allow an unlimited number of patents to be extended for a single drug. For example, if a drug has a product patent, a use patent, and a formulation patent, the U.S., Europe, and China only allow extensions for the product patent, while Korea and Japan allow extensions for each of the substance, use, and formulation patents. Korea also does not stipulate a separate cap period for patent extensions. This differs from the U.S., which allows patents to be extended for up to 14 years from the date of approval, and Europe, which allows patents to be extended up to 15 years. If Koh’s bill passes review, it is expected that Korea's domestic law on drug patent extension will be harmonized with those in the U.S. and Europe, and an environment will be fostered where patients can opt to use cheaper and high-quality generic versions quickly. If Korea trims Korea’s excessive drug patent protection laws being granted to global pharmaceutical companies in Korea to the global level, patients will have greater rights and access to generics without having the need to pay for expensive original drugs. Korea’s pharmaceutical industry “New drug patents cause market monopoly side effects...a legislation is needed” The Korean pharmaceutical industry is concerned that the current patent law in Korea grants too wide a right for new drugs patent term extensions, which has caused the unexpected side effect of guaranteeing market monopoly. The industry has been arguing that legislation should be enacted as soon as possible to limit the new drug patent term extension period to no more than 14 years from the date of approval, and to stipulate the number of patent rights that can be extended for a single new drug as a singular number in order to eradicate the side effects of market monopoly and foster the domestic health and pharmaceutical industries. In particular, their logic is that if the regulations to protect unreasonable patent extension rights for new drugs are improved, the launch of quality generics will be accelerated, expanding the public's choice of medicines while saving healthcare finances. The domestic pharmaceutical industry's position is that international harmonization of the regulations with those of the U.S. and Europe is also needed to allow only a singular patent extension for a single new drug. The current system that allows multiple patent extensions puts too much pressure on pharmaceutical companies that seek to launch generics early by forcing them to bear litigation costs and long litigation periods until the final invalidation ruling. A Korean pharmaceutical industry official said, “Korea’s patent law has strongly protected the patent extension rights of new drug patent holders. This is the reason why the launch of generics is unreasonably delayed in reaching the market. We should adopt the U.S. and European regulations that limit the duration of the patent to 14 years, including the extension period, and limit the allowed number of extensions to a single patent.” “If the launch of generics by domestic pharmaceutical companies are delayed due to Korea’s stronger new drug patent protection laws than in developed countries, there is a greater risk of deteriorating public health finances,” the official said, adding, ” To invalidate multiple patent extensions, pharmaceutical companies bear the burden of litigation costs and endure a long time until the final invalidation ruling, which in result lacks practicality.”
- Policy
- Once-weekly Icodec nears approval in Korea
- by Lee, Hye-Kyung Nov 25, 2024 05:53am
- A once-weekly insulin drug for diabetics is close to being approved in Korea. According to the minutes of the Central Pharmaceutical Affairs Council meeting released by the Ministry of Food and Drug Safety (MFDS) on the 21st, the safety and efficacy feasibility of the basal insulin preparation was discussed. As a result of the deliberation, the council recognized the safety and efficacy of the preparations, based on which a risk management plan for hypoglycemia management will now be required. The drug being discussed was Novo Nordisk's Icodec, a fixed-dose combination of a once-weekly GLP-1 RA Ozempic (semaglutide, Novo Nordisk) contained in a pen at a ratio of 1 unit to 0.0029 mg. Icodec was developed as the first once-weekly formulation of basal insulin with potent hypoglycemic effects and had demonstrated non-inferiority to the existing once-daily formulation of basal insulin. The CPAC members noted that although Icodec’s clinical results in patients with type 1 diabetes were positive, there was a need for management to reduce hypoglycemic episodes. Patients whose blood glucose is not controlled with insulin and require insulin intensification therapy, which involves the addition of mealtime bolus doses of insulin, are at increased risk of increased injection frequency, hypoglycemia, and weight gain. Regarding such concern, a council member said, “Although the incidence of hypoglycemic episodes tended to be higher than in the control group, the safety profile was as expected for the basal insulin and there was no increase in hypoglycemic episodes over the entire study period. The management of hypoglycemic episodes with existing once-daily long-acting insulin formulations in practice is not a major concern and is manageable for the item under review.” In other words, as the drug’s clinical results showed that all patients did not have recurrent hypoglycemic episodes, the CPAC deemed the risk as manageable. There were also mentions about the convenience of once-weekly dosing versus lifelong injections. “A long-acting formulation would be very helpful in terms of patient convenience and adherence,” said another member, explaining that “This is similar to the use of long-acting osteoporosis medications that have extended dosing intervals.” In terms of improving adherence, some pointed out that the once-weekly injections would be of great benefit to patients. “While we agree with the safety and efficacy rationale, the risk of hypoglycemic episodes with this drug should be emphasized in the patient information leaflet to ensure that the risk of hypoglycemic episodes and risk mitigation measures are not overlooked in practice,” said an official. Regarding the same concern, another committee member commented “Fatty acid-binding long-acting peptide formulations are already available in the form of once-daily Tresiba, which has been used as basal insulin for about 10 years without any major issues.” “Overall, all members of the committee agree on the item’s safety and efficacy,” the CPAC chairman concluded, ”However, we would like to emphasize the need for caution for hypoglycemic episodes in the instructions for use submitted by the company.” Meanwhile, in July, the U.S. Food and Drug Administration (FDA) put Icodec's approval on hold, stating the need to address issues with the manufacturing process and labeling related to its type 1 diabetes indication.
- Policy
- Academia requests reimb expansion for Perjeta, Verzenio
- by Lee, Tak-Sun Nov 25, 2024 05:53am
- Lymph node-positive patients will now be reimbursed for their use of the breast cancer drug Perjeta inj (pertuzumab, Roche). The reimbursement extension was requested by the relevant medical societies and will take effect in December. It is interesting to note that the new criteria for reimbursement of anticancer drugs were established based on the opinions of academic societies rather than pharmaceutical companies. The Health Insurance Review and Assessment Service recently issued a notice for the opinion inquiry on the amendment to the 'Details on the Application Criteria and Methods of Medical Reimbursement Benefits for Drugs Prescribed and Administered to Cancer Patients' notice. The amendment is set to take effect on December 1. The most notable change in the amendment is that the expansion of reimbursement benefits was being made at the request of academic societies rather than pharmaceutical companies. One such example is the breast cancer drug ‘Perjeta inj.’ Currently, the Perjeta-based combination as neoadjuvant combination therapy is being reimbursed for “locally advanced, inflammatory, or early-stage (>2 cm in diameter) HER2-positive breast cancer. However, in other countries, its use is also covered for lymph node-positive patients. In other countries such as the United States (FDA) and Australia (TGA), lymph node-positive patients are included in the indication, and the NCCN guideline recommends the regimen subject to the application as category 2A for cN1 or higher, and ESMO recommends the regimen as [I,A] for lymph node-positive patients. As a result, HIRA decided to set the reimbursement standard to include lymph node-positive patients because HER2-positive lymph node-positive breast cancer patients are at high risk of recurrence and need to improve survival with neoadjuvant chemotherapy, and pertuzumab-based neoadjuvant chemotherapy for lymph node-positive patients is a therapy with proven clinical benefit, being recommended in major guidelines such as NCCN and ESMO. The application for this reimbursement expansion was made at the request of the relevant academic societies. Perjeta is not the only drug to benefit from reimbursement expansions at the request of a medical society this time. Verzenio Tab will also be added reimbursement standards for use in combination with endocrine therapy. It, in combination with endocrine therapy, will be approved as adjuvant treatment for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, lymph node-positive, early-stage breast cancer at high risk of recurrence. This regimen was mentioned in the textbook as an effective agent for hormone receptor-positive, HER2-negative, lymph node-positive, high-risk recurrent early breast cancer and is recommended as category 1 in the NCCN guidelines (2024. v.1.). As the combination demonstrated a significant difference in IDFS (invasive disease-free survival) compared to the group that received an alternative, endocrine monotherapy, HIRA set its reimbursement standard to grant 'Anastrozole, Letrozole, Exemestane, Tamoxifen ± LHRH agonist' partial co-insurance (5/100) and ‘Verzenio’ no co-insurance (100/100, full out-of-pocket cost) within the scope of Verzenio’s indication.. In addition, the new drugs ‘Qarziba Inj’ and ‘Vyxeos liposomal Inj’ have been added to the reimbursement list among anticancer drugs. In addition, a benefit expansion for ‘Trisenox Inj’ (induction of remission and consolidation in patients with newly diagnosed low-risk (white blood cell count ≤10×109/L) acute promyelocytic leukemia) was added. In addition, for the ‘Braftovi+Erbitux’ combination therapy, reimbursement was additionally approved as a biweekly treatment for previously untreated patients with BRAF V600E-mutant metastatic colorectal cancer. Currently, only the weekly regimen was granted reimbursement.
- Policy
- Korea’s 2nd GIFT drug Nefecon is approved in KOR
- by Lee, Hye-Kyung Nov 22, 2024 05:55am
- Meditip's Nefecon (budesonide), which was designated as the 2nd Global Innovative Products on Fast Track (GIFT) drug, has been approved in Korea. The Ministry of Food and Drug Safety approved Nefecon on the 18th. Nefecon is used to treat primary IgA nephropathy in adults with a urinary protein-to-creatinine ratio of 1.5 or greater who are at risk of rapid progression. Budesonide, the main ingredient, is already on the market and in use in Korea, but the indication Meditip applied for budesonide's approval as a treatment for new patients who have no existing treatment option, which is why the government designated it as a GIFT drug in March last year. Nefecon was approved by the U.S. FDA on December 15, 2021, as an accelerated review (AA) and priority review (PR) drug, and was approved by the European Medicines Agency (EMA) on July 15, 2023, as an accelerated assessment (AA) and conditional marketing authorization (CMA) drug. In China, the National Medical Products Administration (NMPA) designated Nefecon as a Breakthrough Therapy Designation (BTD) in 2020, and the Taiwan Food and Drug Administration granted it an Accelerated Drug Designation (ADD). In Korea, it was designated as an orphan drug on November 17, 2022. In a presentation made at Kidney International, Nefecon was associated with a 27% lower urinary protein-to-creatinine ratio at 9 months of treatment compared to placebo. The glomerular filtration rate remained stable, with a difference of 3.87 ml/min/1.73㎡ compared with placebo. IgA nephropathy is a disease caused by the deposition of immune complexes, including IgA, in the glomeruli of the kidneys, causing an inflammatory response. About 9,000 patients are known to be affected by IgA nephropathy in Korea. In clinical practice, antihypertensive drugs such as ARBs and ACEIs, immunosuppressants, and diuretics are used to treat IgA nephropathy. However, these drugs are symptomatic treatments that prevent the worsening of symptoms, and there is no drug that fundamentally treats the condition.
- Policy
- CKD drug Kerendia seeks indication expansion in KOR
- by Lee, Hye-Kyung Nov 21, 2024 05:46am
- Bayer Korea's Kerendia (finerenone), which is used to treat adult patients with chronic kidney disease with type 2 diabetes, will enter Phase III clinical trials in Korea to expand its indication. On the 20th, the Ministry of Food and Drug Safety (MFDS), approved a ‘randomized clinical trial to determine the efficacy and safety of finerenone on the morbidity and mortality of heart failure patients with left ventricular ejection fraction greater than 40% who were hospitalized for acute non-targeted heart failure episodes.’ Kerendia, which received domestic approval in May 2022, is indicated for the sustained reduction in estimated glomerular filtration rate (eGFR), progression to end-stage renal disease, and reduction in the risk of cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease with type 2 diabetes. Kerendia is a first-in-class, orally administered, selective, nonsteroidal mineralocorticoid receptor antagonist (MRA) that has a novel mechanism that inhibits kidney inflammation and fibrosis in adult chronic kidney disease patients with type 2 diabetes. In addition, Kerendia has recently been shown to prevent heart failure-related secondary events in HF with mildly reduced ejection fraction (HFmrEF) and HF with preserved ejection fraction (HFpEF) with a left ventricular ejection fraction (LV ejection fraction) of 40% or greater and has entered into global Phase III trials. The clinical trial to expand the indication to heart failure has also been approved in Korea. Meanwhile, results from the Phase III FINEARTS-HF trial, which evaluated Kerendia in heart failure patients with left ventricular ejection fraction greater than 40%, were presented at the European Society of Cardiology Annual Congress 2024 (ESC 2024) in September. Data from the Phase III FINEARTS-HF study showed that at a median follow-up of 32 months, there were a total of 1,083 worsening heart failure events in 624 of the 3003 patients in the Kerendia arm and a total of 1283 events in 719 of 2998 patients in the placebo arm. The total number of worsening heart failure events was 842 in the Kerendia arm and 1024 in the placebo arm, with an 18% lower incidence rate in the Kerendia arm. In addition, the proportion of patients who died from cardiovascular causes was 8.1% and 8.7%, respectively, with a 7% lower hazard ratio observed in the Kerendia arm. However, there was no significant difference between death from cardiovascular events and all-cause mortality. According to drug research institution UBIST, prescriptions for Kerendia totaled KRW 1 billion in the first half of this year, and Bayer Korea is expected to expand the indications to further gain a competitive advantage.
- Policy
- Strengthed regulations on human drug use in vet clinics
- by Lee, Jeong-Hwan Nov 20, 2024 06:08am
- A bill that requires frontline pharmacies to record detailed distribution details on human specialty drugs sold to veterinary hospitals has passed the Bill Review Subcommittee review. Although there was a lot of disagreement over the bill between the professions subject to the regulation - the pharmacists and the veterinarians - the Health and Welfare Committee’s Bill Review Subcommittee members agreed on the need to address the issue of misuse of human specialty drugs in veterinary hospitals. On the 19th, the 1st Bill Review Subcommittee of the National Assembly's Health and Welfare Committee reviewed and voted, and passed the bill to amend the Pharmaceutical Affairs Act, introduced by Representative Young-Seok Seo of the Democratic Party of Korea. The core of Seo's bill is to impose reporting obligations on pharmacists when they sell specialty drugs for human use to veterinarians at veterinary hospitals. The bill establishes a distribution management system that requires pharmacists to report their sales to the Korea Pharmaceutical Information Center every time they sell specialty drugs to veterinarians to prevent misuse and abuse of human drugs through veterinary hospitals. In addition, when pharmacists sell specialized drugs to veterinarians, they are required to submit the name of the veterinary hospital, contact information, drug name, quantity, and date of sale to the Korea Pharmaceutical Information Center in accordance with the Ministry of Welfare decree. If a pharmacist fails to submit the sales details or submits them falsely, he or she will be fined up to KRW 1 million. In particular, the bill mandates the computer network of the Korea Pharmaceutical Information Center to be linked to the veterinary prescription management system operated under the Veterinarians Act to transparently manage the distribution channels of specialty drugs sold to veterinarians. The Korean Pharmaceutical Association submitted a position in favor of the bill and the Korean Veterinary Medical Association submitted a position against the bill, but the Bill Review Subcommittee decided to pass the bill. Although the bill passed the Bill Review Subcommittee, it remains to be seen whether it can pass the Legislation and Judiciary Committee as the two professions are at odds. Earlier, Rep. Seo explained the background of the bill, saying that the process of selling specialized drugs for human use to veterinary clinics is causing issues of misuse and abuse, while at the same time, 'drug delivery,' which is prohibited by the current law, is also being carried out covertly.
- Policy
- Stelara biosimilars face increasing competition
- by Lee, Tak-Sun Nov 20, 2024 06:08am
- Product photo of Janssen Competition among biosimilars referencing Stelara (ustekinumab) for treating autoimmune diseases heats up. Samsung Bioepis added its biosimilar to the reimbursement list in July, and Celltrion added theirs in September. Since Celltrion is set to cut the price starting next month, attention has been drawn to future competition. According to industry sources on November 19, Celltrion will cut the prices of existing products after their Steqeyma IV Inj, an intravenous formulation (IV), becomes listed for reimbursement in December. In September, Celltrion listed two Steqeyma PFS products for reimbursement, although the IV formulation was not included then. In contrast, the original Janssen Stelara and Samsung Bioepis Epyztek are available on the market with a total of three formulations, including the IV formulation. With the launch of Celltrion's IV formulation, the company has positioned well agaisnt the competitors. Additionally, by cutting its drug price, Celltrion has gained a competitive edge in pricing. The ceiling price for Steqeyma IV is KRW 1,278,313, making it more affordable than comparable formulations from Janssen and Samsung Bioepis. Janssen's Stelara S.C. Inj is priced at KRW 1,809,200, and Samsung Bioepis's Epyztek IV Inj is set at KRW 1,345,593. This makes Steqeyma approximately KRW 530,000 cheaper than the original product and about KRW 70,000 less expensive than the Samsung Bioepis formulation. Additionally, Celltrion has voluntarily reduced the price of its prefilled syringe formulation. Steqeyma PFS 45 mg price has been lowered from KRW 1,298,290 to KRW 1,233,376. For comparison, Janssen’s Stelara S.C. Inj·Stelara PFS are priced at KRW 1,745,600, while Samsung Bioepis’s Epyztek PFS is priced at KRW 1,298,290. This makes Celltrion’s product approximately KRW 510,000 cheaper than the original and about KRW 60,000 less expensive than Samsung Bioepis’ product. Additionally, the Steqeyma PFS 90 mg price has been reduced from KRW 1,342,320 to KRW 1,275,204. Currently, the original product is priced at KRW 1,804,800, and Samsung Bioepis' product is priced at KRW 1,342,320. Celltrion's prefilled syringe products were previously priced the same as Samsung Bioepis' products. However, Celltrion has officially entered the price competition with the recent price reduction. The price of the original Stelara will decrease to the KRW 1,500,000 range after its additional reimbursement ends in July next year. However, there will still be a significant gap compared to Celltrion's product, giving Celltrion an advantage in price competitiveness. According to IQVIA, Stelara's sales reached KRW 47.4 billion last year. It is reimbursed for treating moderate-to-severe plaque psoriasis in adults and children aged 12 and older, active psoriatic arthritis in adults, active Crohn's disease in adults, and moderate-to-severe ulcerative colitis in adults.
