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- 2026-07-22 03:12:21
- Policy
- New pediatric brain tumor drug enters expedited review in KOR
- by Lee, Tak-Sun Jun 30, 2026 09:21am
- ‘Ojemda (tovorafenib),’ a long-awaited breakthrough therapy for pediatric brain tumor, has finally entered Korea’s expedited review pathway. The progress comes approximately two years after the drug received approval from the U.S. Food and Drug Administration (FDA).The Ministry of Food and Drug Safety (MFDS) has officially designated Ipsen Korea’s pediatric low-grade glioma (pLGG) drug Ojemda as a product eligible for Korea’s Global Innovative products on Fast Track (GIFT) program. The designation was granted on June 24. Ojemda is being reviewed for the treatment ofPediatric low-grade glioma is one of the most common brain tumors in children. Although the term ‘low-grade’ may mistakenly suggest a relatively mild disease, these tumors frequently develop in critical areas such as the optic pathway or the center of the brain, making surgical removal impossible in many cases. They can cause lifelong neurological complications including paralysis and vision loss due to brain damage and may progressively become life-threatening.Until now, treatment has largely relied on conventional chemotherapy agents such as carboplatin and vincristine. However, tumors often develop resistance and begin growing again after 1-2 years of treatment. Children have also had to endure severe treatment-related adverse events, including hair loss, impaired growth, and neuropathy.Ojemda is regarded as the first highly effective treatment capable of overcoming these limitations. It is a ‘selective Type II RAF kinase inhibitor’ specifically designed to penetrate the central nervous system and target abnormal signaling within the MAPK (mitogen-activated protein kinase) pathway, which drives tumor cell growth.Whereas previously available therapies achieved response rates (tumor shrinkage percentage) of only 20-30% in patients with recurrent disease, Ojemda demonstrated response rates of approximately 50-60% and attracted widespread attention from the global medical community. In Korean clinical trials, encouraging outcomes were observed, including cases in which tumors shrank markedly in children who were progressively losing their vision and another in which a pediatric patient with leptomeningeal metastasis (terminal stage), who had been diagnosed with a limited life expectancy, has survived for 3 to 4 years with brain and spinal tumors having almost completely disappeared.The drug has already gained recognition for its innovativeness from major global regulatory authorities. The FDA granted it Breakthrough Therapy Designation (BTD) before approving it on April 23, 2024, while the European Medicines Agency (EMA) approved the therapy through its Conditional Marketing Authorization (CMA) pathway on April 22, 2026.In Korea, however, delays in the regulatory process left pediatric patients unable to benefit even from humanitarian compassionate-use programs and to continue receiving highly toxic chemotherapy. Clinical experts have repeatedly urged the MFDS to expedite the review, noting that “large-scale clinical trials are inherently difficult in rare pediatric diseases because of the limited number of patients. Even delays of one or two months caused by administrative procedures could result in children losing their vision—or even their lives.”With the MFDS’s GIFT designation, Ojemda will be eligible for an expedited review process that can shorten the formal review period by up to 25%. In Korea, the indication is for the treatment of recurrent or refractory pediatric low-grade glioma harboring a BRAF fusion, rearrangement, or BRAF V600 mutation in patients aged six months or older who have previously received systemic therapy.Although the drug has now taken the first step toward commercialization in Korea by entering the expedited review pathway, pediatric patients must still overcome another major hurdle before they can access the treatment without significant financial burden—National Health Insurance reimbursement.A medical official said, "Expedited review is tremendously encouraging news for children with rare brain tumors who have no alternative treatment options. However, the reimbursement review process must also reflect the unique characteristics of pediatric diseases and the realities of clinical practice. Flexible reimbursement criteria should allow treatment to be resumed without unnecessary restrictions after temporary interruptions due to adverse events, so that these children are no longer left in a therapeutic blind spot."
- Policy
- Hanmi expands domestic reimbursement lineup for Rolontis
- by Jung, Heung-Jun Jun 30, 2026 09:21am
- Hanmi Pharmaceutical's biologic therapy for severe neutropenia, Rolontis (eflapegrastim), will expand its reimbursed product lineup next month with the addition of an autoinjector formulation.The autoinjector is a pen-type device in which the needle remains hidden from view, offering greater convenience for self-administration than the existing prefilled syringe (PFS) formulation.As Rolontis has continued to post solid sales growth in both domestic and overseas markets, the expanded formulation lineup is expected to further boost sales.According to industry sources on June 29, Rolontis Autoinjector Inj. 3.6 mg/0.6 mL will be added to the National Health Insurance reimbursement list next month. The product received approval from the Ministry of Food and Drug Safety (MFDS) in April.Rolontis is Hanmi Pharmaceutical's first novel biologic that was launched in Korea in 2021. The drug became eligible for National Health Insurance reimbursement in July 2024.The newly reimbursed autoinjector formulation delivers the drug by deploying a concealed needle once the device is pressed firmly against the injection site. Although the existing prefilled syringe can also be self-administered, the new formulation is designed to offer greater ease of use.The reimbursement price for Rolontis Autoinjector Inj. has been set at KRW 484,283, the same as the existing prefilled syringe formulation. The broader treatment lineup and improved ease of administration are expected to enhance patient access to the therapy.The new formulation lineup is also expected to support sales growth in both domestic and overseas markets. Rolontis is marketed under the brand name Rolvedon in the United States. Hanmi licensed the product to Spectrum Pharmaceuticals (now acquired by Assertio Holdings) in 2012.U.S. sales began in the second half of 2022 and have continued to grow, reaching USD 55.6 million in 2023 and USD 60.1 million in 2024.In addition to its U.S. commercialization as Rolvedon, Hanmi signed a supply agreement with Middle Eastern partner Tabuk in September last year to expand exports of the finished product to additional countries.The product has also maintained strong growth in Korea. According to IQVIA data, domestic sales increased from KRW 3.3 billion in 2022 to KRW 11.4 billion in 2023, reaching KRW 16.5 billion in 2024.With improved convenience in self-administration and expanded prescribing options, Rolontis’s domestic sales are expected to continue to increase in the second half of this year.
- Company
- Fist instance ruling for 5 out of 7 Jardiance unlisted patent disputes
- by Kim, Jin-Gu Jun 30, 2026 09:21am
- Product photo of JardianceThe dispute surrounding the unlisted patents for the SGLT-2 inhibitor diabetes treatment 'Jardiance (empagliflozin)' is nearing its end.As generic companies have recently succeeded in invalidating another unlisted method-of-use patent, first-instance decisions have been closed for five of the seven complexly unlisted patents. A resolution for the remaining two patents is also expected in the near future.Consequently, the focus in this dispute is projected to shift to the Patent Court. Both the original drug company and generic companies have already appealed a first-instance decision each after contesting the initial rulings.Invalidating use patent set to expire in 2034…5 out of 7 unlisted patents received a first instance rulingAccording to pharmaceutical industry sources on June 26, the Intellectual Property Trial and Appeal Board (IPTAB) issued a favorable ruling on June 25 in an invalidation trial petitioned against Boehringer Ingelheim by Genewone Sciences, Chong Kun Dang, Korea Prime Pharm, Boryung, Huons, and Hanmi Pharm regarding a Jardiance use patent (10-2138213).This patent is set to expire in April 2034 and is not listed in the Ministry of Food and Drug Safety (MFDS) Patent List. It covers the treatment and prevention of diabetes or prediabetes using empagliflozin in patients with renal disease.Generic companies petitioned for an invalidity trial against Boehringer Ingelheim in January 2024 and secured a first-instance victory after 2.5 years.With this ruling, disputes over five out of the seven unlisted Jardiance patents received a first-instance ruling. Between 2023 and 2024, generic companies targeted these seven unlisted Jardiance patents by filing invalidation trials or passive scope confirmation trials.At the time, pharmaceutical companies had to individually identify and respond to patents that were not listed in the official patent registry. Although overcoming unlisted patents is not a prerequisite for obtaining generic marketing authorization, the presence of these patents posed a significant risk of patent infringement liability and subsequent damages claims upon product launch.Notably, analysis suggests that the existence of these unlisted patents continues to pose a risk for generic manufacturers, even as generic versions were launched concurrently following the expiration of the Jardiance substance patent in October last year.The remaining unlisted formulation patent and use patent are expected to receive ruling soonJardiance has two listed patents and seven unlisted patents. Generic companies successfully avoided one of the listed patents in 2019. The other listed patent was the substance patent, which expired in October last year. The remaining unlisted patents include ▲three use patents for empagliflozin monotherapy ▲one use patent and one formulation patent for empagliflozin+metformin combination ▲one use patent for empagliflozin+linagliptin combination ▲one use patent for empagliflozin+linagliptin+metformin triple combination therapy.Among these, a conclusion was reached first regarding a Jardiance use patent (10-2318207) expiring in April 2034. Generic companies won the first instance in November last year, and Boehringer Ingelheim has appealed the decision.In February of this year, the original drug company emerged victorious in the composition and use patent dispute (expiring in August 2028) for Esgliteo (empagliflozin+linagliptin). IPTAB issued a ruling dismissing the generic companies' arguments regarding the passive scope confirmation and invalidation. Dissatisfied with the outcome, three generic manufacturers chose to appeal to the Patent Court.In April, generic companies won a dispute over the use patent (expiring in November 2027) for Jardiance Duo (empagliflozin + metformin). Following this, generic manufacturers have now also secured a favorable first-instance ruling in the Jardiance use patent dispute. Separately, the use patent dispute concerning the empagliflozin+linagliptin+metformin triple combination therapy was concluded when Genewone Sciences voluntarily withdrew its trial petition.The remaining patents include unlisted formulation patent expiring in October 2030 and another concerning a use patent expiring in April 2034.The pharmaceutical industry anticipates that first-instance decisions for both remaining disputes will be made within the second half of this year. In this regard, IPTAB designated administrative patent judges to formulate patent cases in May. On the first of this month, judges were also assigned to the use patent case. Given that rulings are typically issued within 4 to 6 months of judge designation, a decision this year is highly probable.Once the remaining two trials are completed, the dispute is expected to narrow and shift into a legal battle over a few core patents in the Patent Court.Boehringer Ingelheim has already appealed to the Patent Court against the favorable decision that generic companies secured for the Jardiance use patent (10-2318207). Conversely, the domestic generic alliance that lost the Esgliteo patent (10-1491554) dispute due to a dismissal ruling has also filed an appeal, indicating an upcoming higher-court battle. Meanwhile, Boehringer Ingelheim has not yet decided whether to appeal its June 25 first-instance defeat in the other Jardiance use patent case.
- Policy
- MOHW abruptly drops debate on hair loss drug reimbursement
- by Lee, Jeong-Hwan Jun 30, 2026 09:21am
- The Ministry of Health and Welfare (MOHW) has abruptly halted plans to conduct a ppublic forum on expanding National Health Insurance coverage for hair loss treatments, a highly controversial issue. The ministry has decided not to proceed with the planned public forum.The decision comes just before the forum, which had been scheduled for early July. Some observers speculate that the ministry may have reconsidered its plans, pressured by intensifying debate.Although the MOHW has canceled the Ministry of the Interior and Safety-led 'Everyone's Forum,' it stated that it will continue exploring policies to strengthen National Health Insurance coverage, particularly for younger people.On the 29t the MOHW abruptly issued a press release explaining that “Discussions on expanding insurance coverage for hair loss treatment would not be pursued through the public debate forum.”The MOHW explained that it decided to take more time for review, considering that various opinions have been presented and diverse perspectives on expanding health insurance coverage for hair loss treatment have been sufficiently raised ahead of the forum.The MOHW stated only its general stance, saying, 'Even though the forum will not be held, we plan to continue our efforts to develop policies aimed at resolving health issues for the public, including young people, and strengthening the coverage of national health insurance."
- Product
- Discussion on hADM safety…traceability tracking from the donation phase
- by Hwang, byoung woo Jun 29, 2026 09:42am
- The Symposium of the Korean Society for Anti-Aging DermatologyAmid growing interest in human-derived extracellular matrix (ECM), the industry is also focusing on its safety profile. Currently, ECM is reported to be properly regulated through rigorous validation protocols.Human acellular dermal matrix (hADM) used in aesthetic and reconstructive fields is supplied to patients through a strict full project lifecycle management system that spans from donor consent and infectious disease screening to processing, sterilization, quality review, and traceability tracking.At the 16th Summer Symposium of the Korean Society for Anti-Aging Dermatology held on June 28, Faith P. Case, a tissue bank expert, introduced the ethical standards, regulatory compliance, and safety validation frameworks of US tissue banks during a session titled 'hADM, The center of the ECM era, Their similar yet different stories.'Case is an American Society for Quality (ASQ) Certified Quality Manager and an American Association of Tissue Banks (AATB) Certified Tissue Bank Specialist, currently serving as the Vice Chair of the AATB Accreditation Committee. She also has extensive experience conducting inspections and audits for the US Food and Drug Administration (FDA) and the South Korean Ministry of Food and Drug Safety (MFDS).The hADM safety management system initiates from donor consentCase emphasized that human-derived tissue allografts, such as hADM, fundamentally differ from synthetic biomaterials from their very origins. She noted that a donor's decision precedes the manufacturing process, serving as the critical first step in safety management.Faith P. Case, a tissue bank expert"Human tissue does not originate in a laborator. It begins with a human decision to donate," she stated. "This decision leads to a moral responsibility to manage the donation process with absolute transparency."The ethical foundation of the US tissue banking system is the Uniform Anatomical Gift Act (UAGA). This legislation serves as the legal bedrock for voluntary tissue donation and informed consent protocols. Donors or their families provide explicit authorization for which specific tissues may be recovered and the exact clinical fields, such as reconstructive or aesthetic purposes, in which they may be used.Case explained, "Securing high-caliber tissue and maintaining rigorous safety standards is not merely a regulatory compliance, but a pledge to honor the donor's intent," and added, "When public trust is protected, the continuity of sustainable therapeutics for patients is guaranteed."Case further explained the structurally integrated relationship between donor consent and FDA regulations. While the donor's authorization serves as the trigger for tissue recovery, FDA regulations provide the mechanism to validate whether the recovered tissue meets the standards required for patient administration."Donation is merely the starting point. It does not automatically guarantee the production of an allograft," Case said. "If a donor fails to pass the initial safety screening protocols, the process stops at that stage, and no tissue is recovered."Only validated tissues reach patients following infectious disease screening and aseptic recoveryFollowing recovery, the timeline proceeds through infectious disease screening, aseptic recovery, and validated processing and sterilization.According to Case, US tissue banks review donors' medical and behavioral histories and use Nucleic Acid Amplification Testing (NAT) to minimize the risk of acute asymptomatic infections. The screening panel comprehensively covers HIV, Hepatitis B, Hepatitis C, Syphilis, HTLV, and West Nile Virus, among others.Case highlighted that the regulatory directions of the US FDA and the Korean MFDS converge on the singular goal of patient protection."While the FDA and the MFDS may vary in procedural and administrative actions, their ultimate destination is identical, which is absolute patient protection," Case said. "The core safety values demanded in donor screening and infectious disease testing remain fundamentally aligned."Regarding safety validation, operational environmental control was proposed as a key factor. Case stressed that "Microorganisms do not read documentation. They react to the environment. Tissue safety validation must function as a multi-layered defense system that actively mitigates contamination risks across every single phase of the tissue lifecycle."Contamination risks are strictly controlled from the recovery phase onward, after which processing eligibility is determined through formal evaluations by physicians and the tissue bank's medical director. The processing phase operates under a strict protocol in which only one donor's tissue is processed in a designated zone at any given time, supported by cleanroom environments, HEPA filtration, validated sterilization protocols, and cold-chain management.Finished products are never distributed immediately. A dedicated quality professional must independently review the medical director's release determination, donor testing records, processing logs, and sterilization data before the tissue can finally advance to the patient administration phase.Completing safety validation via unique ID-based traceability systemsCase detailed traceability as another core benchmark that substantiates hADM safety.Every donor is assigned a unique identification number, which remains seamlessly linked from tissue recovery through processing, storage, international logistics, and final clinical administration at the point of care. This system ensures that if an adverse event or issue arises, the system can trace the lineage back to the initial donation phase or pinpoint exactly which patient received a specific tissue unit.Case mentioned, "The true sophistication of modern allografts does not lie merely within the clinical application itself, but within the invisible safety nets that ensure patient safety." "Tissue banking is ultimately about honoring the gift of donation and protecting the patients who receive it," Case added. "This responsibility is sustained through error-proof operating systems and precise accountability frameworks."Concluding the session, the chairperson tied the lecture's implications directly to the broader discussion on ECM safety. The chair evaluated, "This lecture provided a clear, scientific evidence-based understanding of the ethical considerations and safety concerns previously raised by some regarding ECMs, based on validated international management and regulatory standards."
- Company
- Shingrix dominates herpes zoster vaccine market…66% share
- by Chon, Seung-Hyun Jun 29, 2026 09:42am
- The herpes zoster vaccine market, now worth approximately KRW 100 billion a year, continues to be led by ‘Shingrix.’ Despite being the newest entrant, the vaccine has captured nearly two-thirds of total market revenue. Meanwhile, Korea-developed vaccine SKYZoster has also maintained steady growth, accounting for nearly half of total vaccine doses sold.According to IQVIA, Korea's herpes zoster vaccine market reached KRW 30.9 billion in Q1, up 25.9% YoY. Quarterly sales exceeded KRW 30 billion for the first time, marking the largest quarterly market size ever recorded. Compared with KRW 8.9 billion in Q1 2022, the market has expanded more than threefold over the past four years.The rapid expansion is attributed to growing public awareness of the need for shingles prevention. GSK's recombinant vaccine Shingrix is widely regarded as the primary driver of market growth. AI-generated imageDuring Q1, Shingrix generated KRW 20.4 billion in sales, a 32.5% increase YoY. Since its launch in December 2022, the vaccine has enjoyed strong market acceptance thanks to its superior preventive effect.Shingrix's greatest strength lies in its high efficacy. In the ZOE-50 trial involving adults aged 50 years and older, it demonstrated 97.2% efficacy over a median follow-up of 3.2 years. In the ZOE-70 study involving adults aged 70 years and older, efficacy remained 89.8% after 3.7 years of follow-up. By comparison, Zostavax showed efficacy of 51% in adults aged 50 years and older and 41% in those aged 70 years and older. SKYZoster has demonstrated efficacy comparable to that of Zostavax.Shingrix has also confirmed its safety profile through 5 clinical studies involving immunocompromised adults aged 18 years and older. Based on these data, vaccination is indicated for high-risk immunocompromised populations, including recipients of autologous hematopoietic stem cell transplants, patients with solid tumors or hematologic malignancies, and solid organ transplant recipients.After immediately taking the top spot in the market with quarterly sales of KRW 11.1 billion in Q2 2023, Shingrix has maintained its lead and strong growth trajectory.Initially, some observers argued that Shingrix's premium price could hinder early market adoption. The two-dose regimen costs approximately KRW 400,000-500,000, more than twice the KRW 150,000-200,000 price of conventional vaccines at the time. Nevertheless, its superior efficacy has enabled rapid expansion of market share despite the higher price.As of Q1, Shingrix accounted for 66.2% of total market revenue, representing roughly two-thirds of the entire shingles vaccine market.Meanwhile, the Korean SKYZoster has also posted encouraging growth.SK Bioscience reported KRW 10.4 billion in Q1 sales for SKYZoster, representing a 47.3% YoY increase and marking the vaccine's first-ever quarterly sales exceeding KRW 10 billion.SKYZoster is a live attenuated shingles vaccine developed using SK Bioscience's proprietary technology. In a domestic clinical trial conducted at eight medical institutions involving adults aged 50 years and older, the vaccine demonstrated non-inferiority to the reference product, Zostavax.SK Bioscience received approval from the Ministry of Food and Drug Safety in October 2017 for the ‘prevention of herpes zoster in adults aged 50 years and older.’ At that time, the market had been dominated by MSD's Zostavax, but it has shifted to a competitive system with the introduction of SKYZoster.After posting sales of KRW 9.5 billion in Q1 2023, SKYZoster’s quarterly revenue dropped below half that level to KRW 3.9 billion in Q1 2024 before recovering its growth. Sales exceeded KRW 7 billion in Q1 last year, and this year, it has broken a new record for the first time in three years.AI-generated imageAlthough SKYZoster generated only about half the sales of Shingrix during Q1, thanks to its relatively lower price, it showed a comparable market share in terms of sales volume.SKYZoster accounted for 49.7% of total vaccine doses sold during Q1, compared with 50.3% for Shingrix. SKYZoster’s share has risen dramatically from 28.5% in Q1 2024, an increase of more than 20 percentage points over two years.Industry observers believe SKYZoster has absorbed a substantial portion of demand left behind following the withdrawal of Zostavax from the market.MSD Korea decided to discontinue Zostavax supply in June 2024 and voluntarily withdrew its marketing authorization in October of the same year.Approved in Korea in 2009, Zostavax was the country's first homegrown shingles vaccine that effectively opened the domestic market. It reached peak annual sales of KRW 83.7 billion in 2017. However, its position gradually weakened after the launch of domestically developed vaccines in 2018, and Shingrix further accelerated the decline. No sales have been recorded since Q3 last year.
- Opinion
- [Reporter's View] CSO Association set to receive official legal status
- by Kim, Jin-Gu Jun 29, 2026 09:42am
- Amid President Lee Jae Myung's administration designating illicit rebate eradication as a governmental 'national normalization project' and warning of rigorous enforcement, the Ministry of Health and Welfare (MOHW) has confirmed that it is reviewing the authorization for the incorporation of the Contract Sales Organization (CSO) Association. This indicates that the MOHW has shifted to a proactive stance in reviewing the application, which had been rejected twice previously. The MOHW's shift in stance signifies more than merely granting official recognition to an organization. It serves as a signal for shifting CSO from being long viewed in the shadows as conduits for bypassing anti-rebate regulations to the mainstream, and for recognizing them as official dialogue partners within the regulatory framework. For the CSO Association, which has remained a temporary organization for 4 years, and forCSO companies envisioning a clean sales ecosystem, this presents a critical window to enter the formal regulatory framework. While the government has laid down a path toward normalization, a fierce 'commission rate war' continues on the front lines of sales operations. Even as the government launches comprehensive status surveys on CSOs and weighs measures such as a "statutory commission rate cap", the competition over commission fees is intensifying. Recently, six to seven mid-tier and small-scale pharmaceutical companies implemented a wave of hikes for specific products, raising CSO commission rates by 5 to 20 percentage points. For certain hypertension combination therapies, commission rates for new prescriptions have skyrocketed to an astronomical 75%. It is a highly distorted structure where generating KRW 100 million in prescription sales results in paying out KRW 75 million to the sales agency. So-called "100:100 promotions," which pay out the full prescription value as a commission, also remain active. This is the outcome of an alignment of interests. Pharmaceutical manufacturers are desperate to finalize prescription accounts before the implementation of generic drug price reductions scheduled for the second half of the year. At the same time, CSOs seek to offset their mounting regulatory compliance costs. The industry’s duplicity, demanding integration into the formal regulatory framework while simultaneously engaging in distorted commission betting that reaches 75% to 100%, lacks credibility. It is difficult to accept the industry's assertion that it is "specialized sales organizations independent of illicit rebates," while leaving unaddressed a structural dynamic in which most revenue flows through agency fees. If this overactivation on the ground persists and fails to pass the MOHW's Non-Profit Corporation Review Committee, it will only lend further justification to mandatory interventions currently under executive review, such as the statutory commission rate cap system. Regulatory intervention is inevitably required when a market loses its capacity for self-regulation. Now that the government has opened the door to legalization and extended an entry path via the 'review of incorporation approval,' it is the absolute golden hour for the CSO industry to demonstrate its internal control and baseline corporate value. Ahead of electing its new chairman this summer, what the CSO Association must prepare is more than supplementing administrative paperwork. It must monitor its member firms to halt the mutually destructive race toward hyper-elevated commission rates and demonstrate tangible self-policing capabilities by expelling rogue, fragmented sub-agents that distort the market. Will CSOs successfully transition into the mainstream regulatory framework and emerge as legitimate partners in the pharmaceutical industry? Or will they remain blinded by short-term profits, trapped as an underground channel for illicit rebates? The government has unlocked the door. Proving that they are worthy of accepting it now depends entirely on the CSO industry.
- Policy
- Competition for Faslodex generics intensify in Korea
- by Jung, Heung-Jun Jun 29, 2026 09:42am
- Competition among generics targeting AstraZeneca's breast cancer therapy Faslodex (fulvestrant) is set to intensify in the second half of the year. With Dongkook Pharmaceutical and Samjin Pharmaceutical’s generic versions set to enter Korea's reimbursement market next month, a four-way competition landscape will be formed, alongside Boryung and Korus Korea.According to industry sources on the 26th, Dongkook's Fulverant Prefilled Inj (0.5 g/1 pack) and Samjin's Fulveserd Inj (0.5 g/1 pack) will be added to the national reimbursement list next month.Generic competition began in 2022 when Boryung's ‘Fulvet Inj’ obtained reimbursement. Korus Korea’s ‘Elbracan Inj’ followed in February last year.Dongkook received marketing approval for Fulverant Prefilled Inj in October last year and is expected to secure reimbursement listing 9 months later.Samjin's Fulveserd is manufactured under consignment by Dongkook Pharmaceutical. Depending on whether reimbursement pricing requirements are met, Fulverant Prefilled Inj is expected to receive a reimbursement price of KRW 288,194, while Fulveserd is expected to be priced at KRW 244,965.The original product, Faslodex, was approved in Korea in 2007 but was not granted reimbursement until 2019.Following the entry of generics, reimbursement prices have undergone several adjustments. Prices were first reduced after the listing of Boryung's Fulvet, and additional reductions followed after Korus Korea’s Elbracan entered the market, bringing premium pricing to an end.AstraZeneca even sought an injunction to prevent the price cuts but ultimately lost the legal battle, resulting in a substantial reimbursement price reduction in February this year.Following the reimbursement price cut, speculation emerged that AstraZeneca might withdraw Faslodex from the Korean market. However, the company is continuing supply. Moreover, the company signed a Flexible Pricing Contract with the National Health Insurance Service in June. As a result of the agreement, its listed reimbursement price increased to KRW 974,917 last month, which is more than a threefold increase.Faslodex recorded approximately KRW 3.3 billion in import sales in 2024, roughly half the level seen in 2023. Meanwhile, Boryung's Fulvet, the first generic, posted import sales of approximately KRW 500 million in 2024.Fulvestrant injections have been designated as essential medicines in Korea. The addition of more follow-on products is expected to help ease concerns over potential supply shortages.
- Company
- Tibsovo finally receives DREC review for reimbursement
- by Eo, Yun-Ho Jun 29, 2026 09:42am
- Tibsovo, a novel therapy for cholangiocarcinoma for which reimbursement has remained stalled for more than a year, is finally set to clear the last hurdle of the Health Insurance Review and Assessment Service (HIRA).According to Dailypharm coverage, Servier Korea's IDH1-targeted therapy Tibsovo (ivosidenib) for patients with IDH1 mutation-positive cholangiocarcinoma will be reviewed by HIRA's Drug Reimbursement Evaluation Committee (DREC) on July 2.Tibsovo was first approved as an orphan drug in Korea in April 2024. After passing the Cancer Drug Deliberation Committee on its second attempt in April 2025 for the cholangiocarcinoma indication, the product has spent more than a year under pharmacoeconomic evaluation.Recently, the government announced plans to improve access to innovative medicines for severe and rare diseases by raising the acceptable ICER threshold and revising the evaluation framework to better reflect disease severity and therapeutic value. As a result, whether Tibsovo will receive a flexible ICER application is expected to be the key issue at the upcoming reimbursement committee meeting.Cholangiocarcinoma is a representative high-risk cancer. Korea is known to have the world's highest mortality rate from biliary tract cancer, while the five-year survival rate for metastatic disease is only 4.1%. In the pivotal ClarIDHy trial, which served as the basis for the approval of Tibsovo, the median overall survival (mOS) of the control group was just 5.1 months.Its treatment landscape has recently improved somewhat in recent years. In the first-line setting, the 'Imfinzi (durvalumab)' combination therapy, and for second-line treatment, 'Pemazyre (pemigatinib)' for patients with FGFR2 fusion and 'Keytruda (pembrolizumab)' for MSI-H/dMMR patients have been granted reimbursement in Korea.However, patients with IDH1 mutations still have no reimbursed targeted treatment option, leaving a significant therapeutic gap.The socioeconomic burden of the disease is also substantial. Because cholangiocarcinoma is difficult to detect early, many patients are diagnosed at an advanced stage. Experts note that disparities in treatment access driven by socioeconomic status directly translate into disparities in survival rates in the disease.In the Phase III ClarIDHy trial, Tibsovo improved median overall survival to 10.3 months, nearly doubling survival compared with 5.1 months in the placebo group (HR 0.49). Median progression-free survival (PFS) also improved significantly to 2.7 months, versus 1.4 months with placebo. Based on these results, Tibsovo became the only second-line treatment for cholangiocarcinoma to receive a Category 1 recommendation in the NCCN Guidelines.More recently, findings from the Phase IIIb real-world ProvIDHe study also drew attention. Median overall survival reached 15.5 months in the overall study population, while the Korea-Australia subgroup, which included Korean patients, reported an mOS of 19.7 months.Meanwhile, Tibsovo has received reimbursement recommendations in seven of the eight A8 countries. The UK's NICE concluded cholangiocarcinoma is a severe condition as patients lose most of their expected life expectancy and quality of life, and applied the maximum severity modifier of 1.7. Scotland's SMC and Australia's PBAC also recommended reimbursement, citing the high unmet medical need and lack of alternative therapies.
- Company
- Nucala Autoinjector to soon enter Korean COPD market
- by Eo, Yun-Ho Jun 26, 2026 09:45am
- The monoclonal antibody ‘Nucala’ is seeking to expand its reach into the treatment of chronic obstructive pulmonary disease (COPD).According to industry sources, GSK Korea recently submitted an application to the Ministry of Food and Drug Safety (MFDS) to expand the indication of the Nucala Autoinjector (mepolizumab) to include COPD. Regulatory approval is expected in the second half of this year.Nucala is an IL-5-targeting biologic that received U.S. FDA approval for COPD last year. The drug was subsequently approved by the European Medicines Agency (EMA) in February.Specifically, the indication is for the treatment of COPD with elevated blood eosinophil counts in patients already receiving combination therapy with inhaled corticosteroids (ICS), long-acting beta2-agonists (LABA), and long-acting muscarinic antagonists (LAMA).Nucala's efficacy in COPD was demonstrated in the Phase III MATINEE trial.In the study, Nucala reduced the annual rate of moderate or severe exacerbations by 21% compared with placebo. It also reduced exacerbations that lead to hospitalization or emergency department visits by 35%. The incidence of adverse events was comparable to that observed in the placebo group.In Korea, Nucala is currently approved not only for the treatment of severe eosinophilic asthma in adults and adolescents aged 12 years and older, but also for ▲eosinophilic granulomatosis with polyangiitis (EGPA) in adults; and ▲hypereosinophilic syndrome (HES) in adults.Meanwhile, Nucala’s reimbursement was expanded to eosinophilic asthma in May. The revised reimbursement criteria now cover patients aged 12 years and older whose disease remains inadequately controlled despite treatment with ICS-LABA and LAMA.
