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- 2026-03-11 14:10:35
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- Enhertu seeks reimb for HER2-low breast cancer and NSCLC
- by Eo, Yun-Ho Mar 14, 2025 05:56am
- The ADC anticancer drug 'Enhertu' has started a new reimbursement journey in Korea. According to industry sources, Daiichi Sankyo Korea submitted an application to receive reimbursement for two additional indications of its antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) in December last year and recently began discussions with the Health Insurance Review and Assessment Service. Specifically, the company applied for reimbursement of the following indications: ▲ the treatment of patients with unresectable or metastatic HER2-low expression (IHC 1+ or IHC 2+/ISH-) breast cancer who have previously received systemic therapy in the metastatic setting or have relapsed during, or within six months of completing adjuvant chemotherapy, in the case of hormone receptor-positive (HR+) breast cancer patients, those who have received additional endocrine therapy or are not suitable for endocrine therapy; and ▲ patients with unresectable or metastatic non-small cell lung cancer with an activating HER2 (ERBB2) mutation in the tumor who have previously received systemic therapy including platinum-based chemotherapy. These indications were approved in Korea in May 2024. Enhertu was first listed as a treatment for HER2-positive breast cancer in April of the same year, but there have been persistent calls for the prompt expansion of its coverage to the HER2 low-expression indication, which is currently under discussion. In fact, a petition calling for the expansion of Enhertu’s reimbursement has garnered the support of more than 50,000 people. Therefore, it will be interesting to see whether Enhertu will be reimbursed for breast cancer patients with low HER2 expression and the newly added lung cancer indication. Meanwhile, Enhertu has confirmed its efficacy for 2 additional indications through the DESTINY-Breast04 and DESTINY-Lung02 studies. DESTINY-Breast04 compared the efficacy and safety of Enhertu and a chemotherapy regimen of the physician’s choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in 557 patients with unresectable or metastatic HER2-low breast cancer who had previously received first or second lines of chemotherapy. Results showed that the median progression-free survival (mPFS) of the Enhertu group in the cohort of patients with hormone receptor-positive tumors was 10.1 months, demonstrating a significant improvement compared to the 5.4 months of the control group. Enhertu also reduced the risk of disease progression or death by 50% compared to the control group in the overall patient cohort, which included both hormone receptor-positive and negative tumors. In addition, Enhertu showed antitumor activity in the second-line treatment of HER2-mutated metastatic non-small cell lung cancer in the DESTINY-Lung02 study. The study evaluated the efficacy and safety of Enhertu in patients with unresectable or metastatic non-small cell lung cancer whose disease progressed after one or more systemic therapy treatments, including platinum-based chemotherapy. Results showed Enhertu recorded a confirmed objective response rate (Confirmed ORR) of 49%, complete response (CR) of 1%, and partial response (PR) of 48%, as assessed by a blinded independent central review (BICR).
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- Wegovy dominates the obesity drug market
- by Chon, Seung-Hyun Mar 13, 2025 05:59am
- The introduction of Novo Nordisk's Wegovy has shaken the market substantially. Since its launch in Q4, Wegovy has captured 60% of the entire market. Given the introduction of Wegovy, the obesity market expanded to the largest in history. It also consumed the market for Saxenda, containing the same class of active ingredients as Weogvy. It is unclear whether such growth will continue because of restricted non-face-to-face medical prescriptions of obesity drugs. However, the market continues to shake up whenever effective and safe new obesity drugs from multinational companies are launched. Record sales in 2024 obesity drug market…Wegovy's Q4 sales amounted to KRW 60.3 billion, with 64% market share According to pharmaceutical market research firm IQVIA, on March 10, last year's obesity drug market amounted to KRW 236.3 billion, up 32.8% compared to the previous year. The obesity drug market continued to set the largest size for seven consecutive years since 2018, exceeding KRW 200 billion for the first time in history. Last year's growth of the obesity drug market was led by Novo Nordisk's Wegovy. Wegovy launched in October last year and recorded KRW 60.3 billion in three months. Quarterly sales figures for key products in the obesity drug market. (Legend from left) Wegovy, Qsymia, Saxenda, obesity drug market (unit: KRW 100 million, source: IQVIA) Wegovy received approval from the Ministry of Food and Drug Safety (MFDS) in April 2023. It is a GLP-1-containing semaglutide that has been shown to reduce glycated hemoglobin. While conducting clinical trials for GLP-1 diabetes treatment candidates, Novo Nordisk confirmed the effects of lowering patient body weight and developed semaglutide-containing Wegovy as an obesity drug with a once-weekly formulation. Last year's Q4 obesity market size amounted to KRW 93.8 billion, an expansion of 154.5% Year-over-Year (YoY). Wegovy accounted for 64.4% of the entire obesity drug market. Wegovy is trending globally with its outstanding weight loss effects. Wegovy recorded last year's sales of NOK 58.2 billion (About KRW 11.7 trillion), an increase of 85.7% compared to 2023 sales of NOK 31.3 billion. Since its launch in the United States, the drug has been sold out with a rapid increase in demand. Before its official launch, Wegovy was already regarded as a secret weight loss solution among celebrities, including Tesla CEO Elon Musk, and there was a global shortage. Despite being priced KRW 500,000 higher than the other drugs, Wegovy generated significant interest following its domestic launch and was in short supply. Due to the introduction of Wegovy, the sales of Saxenda and Qsymia, which previously dominated the obesity drug market, have significantly decreased. Last year, Saxenda recorded sales of KRW 65.6 billion, down 1.7% from the previous year. The decrease in sales of Saxenda was seen three years after 2021. Saxenda reported a significant decline in sales in Q4 of last year. Saxenda's sales in Q4 of last year amounted to KRW 7.3 billion, down 27.3% YoY. The sales declined by 78.9% in a quarter from KRW 18.9 billion in Q3 of last year. Analysis suggests Wegovy, a GLP-1 drug similar to Saxenda, has captured the market for Saxenda. However, Qsymia's sales have not changed much since the launch of Wegovy. Qsymia recorded sales of KRW 39.1 billion last year, up 10.1% from the previous year. In Q4 last year, when Wegovy launched, Qsymia recorded sales of KRW 9.3 billion, down 7.1% from the previous year. However, it is unclear whether Wegovy will show marked growth this year. Previously, Wegovy was prescribed through non-face-to-face medical sessions. As concerns have been raised regarding unrestricted prescription of Wegovy through non-face-to-face medical sessions regardless of weight or obesity status, the health authority discontinued non-face-to-face prescription of obesity drugs as of December 16, 2024. The obestiy drug market fluctuates whenever new drugs launch…Saxenda has led the market for the past five years The obesity drug market underwent restructuring whenever promising new products are launched. Products containing sibutramine, which inhibits appetite, sold the most and once dominated the market. However, it has no longer been in sale due to the risk of cardiovascular side effects since 2010. The Korean market of obesity drug market was sluggish for a long time. Once worth a market size of KRW 116.2 billion in 2009, it dropped to KRW 66.7 billion over five years. Since 2015, the introduction of new products has led to a rebound in the market. In February 2015, Ildong Pharmaceutical obtained domestic approval for 'Belviq,' which the company acquired from the U.S.-based Arena Pharmaceuticals and led the recovery of the entire market. Belviq selectively works on the neurotransmitter serotonin receptor, which regulates appetite and emotion, suppressing appetite and increasing meal-related satiety. It has gained attention for being the new drug approved for weight-loss medication by the U.S. Food and Drug Administration (FDA) in 13 years. Kwang-dong Pharm has contributed to the market expansion after launching 'Contrave' in 2016. Kwang-dong Pharm acquired Contrave from the U.S.-based biotech company Orexigen Therapeutics. Contrave was approved by the European Medicines Agency (EMA) in 2015, and it is used to manage the weight of adults who are overweight or obese. After the launching of Belviq and Contrave, the obesity drug market expanded to KRW 92.8 billion and KRW 96.8 billion in 2017 and 2018, respectively. Yearly obesity drug market size (unit: KRW 100 million, source: IQVIA). Belviq, Saxenda, and Wegovy were launched in 2015, 2019, and 2024, respectively. Saxenda, launched in Korea in 2018, is the first glucagon-like GLP-1 agonist medication for obesity. It contains the same ingredient as Victoza (ingredient: liraglutide), which is prescribed to patients with type 2 diabetes but with different methods of administration and dosages. Saxenda became the top-selling drug in the market after recording sales of KRW 42.6 billion in 2019, just after its launch, and maintained the place for five consecutive years until 2023. Saxenda recorded sales of KRW 66.8 billion in 2023. Saxenda took up a 37.5% market share of the obesity market in 2023. The obesity drug market set a record in 2019 with KRW 134.1 billion in 10 years. In 2023, it recorded KRW 178 billion, setting a record for five consecutive years. Qsymia, marketed by Alvogen Korea, has also contributed to the expansion of the obesity drug market. Launched in late 2019, Qsymia is a combination therapy containing 'phentermine' and 'topiramate.' Alvogen Korea secured domestic sales rights from the U.S.-based VIVUS in 2017. In late 2019, Alvogen Korea signed a co-promotion agreement with Chong Kun Dang to begin full-scale domestic sales. Qsymia recorded sales of KRW 35.5 billion in 2023. The sales of Qsymia were comparable to Saxenda. Despite oral administration, Qsymia has a relatively small amount of psychotropic drug ingredients, and it has the advantage that it can be prescribed for an extended period. Alvogen Korea's extensive sales networks in the domestic obesity market, gained from its previous experience selling Furing and Furimin, synergized with Chong Kun Dang's business power to penetrate the market with Qsymia rapidly. With the launch of Wegovy last year, the obesity drug market underwent another restructuring, and the introduction of Mounjaro and other next-generation obesity treatments is expected to reshape the landscape further. Eli Lilly’s Mounjaro received approval from the MFDS in June 2023. Mounjaro, a once-weekly injectable, is a next-generation GLP-1 analog that activates GLP-1 and GIP receptors. It has been demonstrated that Mounjaro has superior weight loss compared to Wegovy.
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- "High hopes for Blincyto as consolidation therapy for ALL"
- by Whang, byung-woo Mar 13, 2025 05:58am
- Blincyto (blinatumomab), a treatment for acute lymphoblastic leukemia (ALL), is approved for an expanded indication as a consolidation therapy. Its role in clinical settings will be broadened. Experts view that having more treatment options is favorable, as the consolidation therapy option has been limited following the first-line treatment of B-precursor ALL until now. Dr. Jae-Ho Yoon, Professor in the Department of Hematology at Seoul St. MaryOn March 12, Amgen hosted a press conference celebrating the approval of an expanded indication for Blincyto as a consolidation therapy to treat B-precursor ALL. The company highlighted the potential role of the drug. On the 14th of last month, the Ministry of Food and Drug Safety (MFDS) granted approval of indication for Blincyto as a consolidation therapy for Philadelphia chromosome-negative (Ph-negative) B-precursor ALL. The approval broadened the treatment area of the drug from treating adults with relapsed or refractory B-cell precursor ALL with minimal residual disease (MRD) to treating adults of young children with Ph- B-cell precursor ALL as a consolidation therapy up to Stage 4. Patients with Ph- B-cell precursor ALL are known to relapse often despite reaching MRD negative through remission induction therapy using existing chemotherapy. Patients with ALL may experience difficulties in long-term survival despite undergoing stem cell transplantation. Therefore, ALL still has high unmet needs. Approval of a new indication for Blincyto as a consolidation therapy for patients who already had induction therapy using existing chemotherapy has gained attention since it was based on clinical data demonstrating statistically significant effects on patients diagnosed early or who relapsed. According to the E1910 clinical study results, administering Blincyto as the first-line consolidation therapy after chemotherapy to adult patients (n=112) with B-precursor cell ALL who had MRD-negative remission (
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- ‘Keytruda’s 10-year milestones show its core value’
- by Whang, byung-woo Mar 13, 2025 05:58am
- Although many drugs have left their mark on the domestic pharmaceutical market, it is difficult to talk about the last decade without mentioning the immuno-oncology drug, Keytruda (pembrolizumab). As a drug that holds the title of the No. 1 in global sales, it has left various milestones in Korea, from sales to approved indications. This year marks the 10th anniversary of Keytruda’s approval in Korea, and the company is gearing up to drive another decade. The fact that Keytruda has recently been approved for a number of indications by the Cancer Disease Deliberation Committee is one of the reasons why the company's progress is drawing attention. The Oncology Business Unit of MSD Korea has been delivering its sincerity with the mindset that “cancer treatment is KEY TRUE DA (Key to the truth).” Dailypharm met with Min-kyung Kim, Associate Director (oversees lung cancer, gastrointestinal cancer, head and neck cancer, etc), and Joo-hyun Shin Associate Director (oversees breast cancer, gynecological cancer, urinary cancer, etc) of the Oncology Business Unit at MSD Korea to hear about the company’s blockbuster treatment, Keytruda. Keytruda’s 10-year approval holds title for being the immuno-oncology drug with the most indications in Korea As of February 2025, Keytruda is the most widely prescribed immuno-oncology drug in Korea indicated for 34 indications in 18 cancer types. In addition to the 2 directors who act as managers for the many indications, a total of 11 product managers (PMs) are in charge of Keytruda at MSD Korea. Specifically, under Director Kim, there are a total of 5 PMs for lung cancer, stomach cancer, biliary tract cancer, and head and neck cancer, and under Director Shin, there are a total of 6 PMs for breast cancer, gynecological cancer, and urinary cancer. Keytruda is regarded to have changed the paradigm of cancer treatment. How do the two directors feel about this? Min-Kyung Kim, Associate Director of the Oncology Business Unit at MSD Korea “Immunotherapy drugs are more effective when used early in the treatment process, when the patient's condition is good, and when used at the front line of treatment, they can bring the patients a step closer to a complete cure than before,” said Shin. “I am proud to be part of a team that is leading this change in the treatment paradigm and saving many lives.” Kim added, “I have been working at MSD for about 19 years, and I felt that all the team members are elite members who work with a great sense of mission because Keytruda is a treatment that is closely related to life. I joined the team in 2021, and I found that the team members are even more committed than they appear, and I think this is the driving force behind the growth of Keytruda over the past decade.” However, due to the vast indications for Keytruda, it is positive that there is a PM for each indication, but conversely, there may be concerns about a lack of communication or synergy between the PMs. This means that there may be concerns about the size of sales and team management. In response, the two directors emphasized that, although the role of each indication is important, a long-term strategy matters most due to the nature of Keytruda. “As the No. 1 drug, the company has organized the team with passionate and proactive PMs for the drug that collects industry-wide attention,” said Kim. “Sales are important, but we need to adjust our focus and efforts depending on new indications and momentum, and are trying to operate with clear standards while thinking about the results that can be achieved over the long term.” “The indications that are reimbursed and non-reimbursed, and the cancer types that have synergistic effects and those that do not, are creating a market or producing results,” said Shin. ”As a leader, we are constantly looking to derive new results through a process of constant feedback to see if there is anything we can do better or if there are any points to consider further.” The dilemma of expanding a treatment’s indications is 'Competition'... differentiation and market exploitation Although Keytruda has made great strides in the market over the past decade, its many indications for various types of cancers are also one of the tasks that must be resolved to compete with other treatments. Joo-hyun Shin, Associate Director of the Oncology Business Unit at MSD Korea On this, the two directors each brought up the topics of differentiation and market development, in consideration of the teams they are in charge of. So far, Keytruda has been the leading brand that has changed the paradigm of the cancer treatment environment, and has been promoting the keywords “first” and “only.” However, as these messages are gradually losing power, the company believes that it needs to promote other keywords. “Competition can also be interpreted as the threshold for immuno-oncology treatments has been lowered, which is certainly good news in this respect,” said Kim. ”However, the marketing team has a clear goal of gaining an edge over the competition, so we are focusing most on how to communicate the differentiated value of Keytruda (compared to competing products).” In addition, Shin emphasized, “From a marketing perspective, competition is not simply a matter of dividing up the market pie, but also about growing the overall size of the market, so it may be a little difficult, but we believe that it is the role of the marketing team to pioneer new markets.” There are also positive factors in the competitive situation in which Keytruda is placed. This is because it has achieved some results after applying for reimbursement for a total of 17 indications in 2023, after the 13 indications it applied for reimbursement in 2023. The Health Insurance Review and Assessment Service (HIRA) established reimbursement standards for 11 indications at the 1st Cancer Disease Review Committee (CDRC) in 2025 after 6 reimbursement attempts. The indications that passed were also diverse, including stomach cancer, esophageal cancer, endometrial cancer, rectal cancer, squamous cell carcinoma, cervical cancer, breast cancer, small intestine cancer, and biliary tract cancer. Although there are still many processes to go through, such as the Drug Reimbursement Evaluation Committee (DREC) and the National Health Insurance Service (NHIS) drug pricing negotiations, the fact that the drug passed the Cancer Disease Deliberation Committee review holds significance, as it was regarded as a reckless challenge at the time. “We took on the challenge literally recklessly with the idea that ‘Keytruda is the only option,’ to improve access to treatment for all cancer types, and I think this was possible because we all worked together with the common goal of improving patient access,” said Kim. “I feel like we're just getting started. “I think that, as Keytruda has done so far, the remaining procedures should be carried out one by one to pave the path,“ said Shin. MSD Korea’s Oncology BU Product Managers ”Keytruda’s approach to the next decade aims to expand accessibility" The two directors intuitively expressed that Keytruda is the drug that can bring about ”more tomorrows” to patients. In addition to benefiting patients, this is also the goal of the Oncology Business Unit, which is responsible for Keytruda, which is looking beyond its 10th anniversary to a new decade. In the short term, the goal is to expand the indications for which it is being reimbursed, as well as newly approved or pending indications such as endometrial cancer and stomach cancer. “The primary goal is to grow the newly approved indications and to do well until the launch of new indications because there are still indications waiting to be approved,” said Shin. ”The most important thing is to improve patient access to treatment, and we will always think about and work on how to provide good treatment options to more patients.” Next, Shin cited the birth of new drugs that will bring about another paradigm shift as the most anticipated part of the coming decade. “MSD is investing heavily in clinical trials in Korea, which is a global leader in clinical trials, with more than 5,000 people in 500 centers in Korea alone. I believe that another innovative drug will arise as a result of this investment and effort, and in that sense, I think it would be good to look forward to the company’s next 10 years.”
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- Emergence of a next-generation lung cancer targeted drug?
- by Son, Hyung Min Mar 12, 2025 05:57am
- Clinical trials on 4th generation non-small-cell lung cancer targeted therapies by domestic and international pharmaceutical and biopharmaceutical companies are progressing smoothly. J INTS BIO, Voronoi, Therapex, and BridgeBio are continuing their development making clinical success. Among global pharmaceutical companies, Blue Diamond has entered Phase II clinical trials, and it has been confirmed that Boehringer Ingelheim has shown efficacy with its candidate in preclinical trials. Korean companies make research results studying next generation lung cancer targeted therapies According to industry sources on the 12th, J INTS BIO recently announced the results of a Phase I, high-dose clinical trial of JIN-A02, which is being developed as a treatment for epidermal growth factor receptor (EGFR) positive non-small-cell lung cancer (NSCLC). JIN-A02, a fourth-generation EGFR tyrosine kinase inhibitor (TKI), has a mechanism of action that selectively binds to the C797S mutation that causes resistance to third-generation treatments for non-small cell lung cancer. In clinical trials, high doses (300 mg) of JIN-A02 did not cause any serious adverse reactions or dose-limiting toxicity. To date, JIN-A02 has shown partial response (PR) in 1 patient and stable disease (SD) in 3 patients in clinical trials. J INTS BIO explained that this is the first case of a PR in a patient with the C797S mutation among the fourth-generation EGFR-TKI treatments currently being developed in Korea and abroad. Currently, the first-generation EGFR-positive lung cancer drugs on the market include AstraZeneca's Iressa (gefitinib) and Roche's Tarceva (erlotinib), the second-generation drugs include Boehringer Ingelheim's Giotrif and Pfizer's Vizimpro (dacomitinib), and third-generation drugs, Yuhan Corp’s Leclaza (lasertinib) and AstraZeneca's Tagrisso (osimertinib). However, resistance inevitably develops even with the use of effective targeted therapies. A typical mutation that occurs with EGFR-positive targeted therapies is C797S. In addition, patients lack treatment options to use after targeted therapies. Platinum-based chemotherapy, docetaxel, and immune checkpoint inhibitors are available for patients who develop resistance to targeted therapies. Still, there has been no significant improvement in their response rates with their subsequent use. To address the need, latecomers such as J INTS BIO, have set a goal of confirming the possibility of commercialization by targeting the C797S mutation that occurs after patients develop resistance to existing 1st- to 3rd-generation targeted therapies. Voronoi will present the early clinical results of VRN11 at the American Association for Cancer Research (AACR) Annual Meeting 2025, which will be held next month. According to Voronoi, VRN11 is effective not only against EGFR C797S acquired resistance mutations, but also against common mutations such as EGFR Del19 and L858R, and atypical mutations such as EGFR G719X, L861Q, and S768I. Voronoi recently changed the clinical protocol for VRN11. The company has received approval from the Ministry of Food and Drug Safety to change the clinical trial protocol expand the size of the Phase I clinical trial from 50 to 103 patients and significantly increase the dose escalation rate and target. BridgeBio is exploring the safety and efficacy of BBT-207, which is being developed as a 4th-generation EGFR-positive non-small cell lung cancer treatment, in a Phase I dose-escalation trial. At the recent meeting of the Safety Monitoring Committee, the efficacy and safety of the drug were evaluated by analyzing data from 6 patients enrolled in the fifth dose group of the BBT-207 Phase 1 clinical trial. In the above, BBT-207 did not cause any serious adverse drug reactions, and 3 cases of partial response (PR) and several stable disease (SD) cases were observed. Therapex recently announced the clinical design and interim results of the first cohort of ‘TRX-221,’ a 4th-generation EGFR-targeted anticancer drug for non-small cell lung cancer. TRX-221 is a 4th-generation EGFR tyrosine kinase inhibitor that selectively inhibits EGFR C797S as well as EGFR activating mutations and T790M mutations. Currently, Therapex is conducting a Phase Ia clinical trial on TRX-221 at 6 university hospitals in Korea, including Asan Medical Center, Severance Hospital, and Samsung Medical Center. The company has been administering the drug to patients in the second cohort since early September. Therapex plans to conduct global clinical trials, including in the United States, to expand patient recruitment during the dose development phase. Black Diamond makes the most progress in development... Boehringer also shows its candidate’s potential in preclinical trials Black Diamond Therapeutics has made the most progress in the global pharmaceutical industry. Black Diamond Therapeutics has observed the most PRs with its 4th generation EGFR TKI candidate in the Phase I/II trial. Black Diamond Therapeutics is developing BDTX-1535, which had been developed as a treatment for brain tumors, as a 4th generation lung cancer targeted therapy. According to the results of the Phase II clinical trial that have been disclosed so far, 8 out of 19 patients (42%) treated with the 200 mg dose of BDTX-1535 showed an objective response rate (ORR). Five of the responding patients showed a confirmed partial response (PR), one of whom converted from a PR to an unconfirmed complete response (CR) at the 8-month time point. The safety assessment showed that the 200 mg dose was well tolerated, consistent with previous clinical results. The majority of adverse events were mild or moderate, with rash (70%) and diarrhea (35%) being the most common adverse reactions. There were two cases of Grade 3 rashes, but no Grade 4 rash or Grade 3/4 diarrhea were observed. In particular, Black Diamond explained that its candidate showed promising therapeutic effects in patients who developed resistance after treatment with Tagrisso. Black Diamond plans to update the Phase II clinical trial data within the second quarter of this year. Boehringer Ingelheim is developing BI-4732 as a 4th generation-targeted therapy. It is currently in the preclinical stage. Domestic researchers, including Byoung Chul Cho, director of the Lung Cancer Center at Yonsei Cancer Center, are participating in this clinical trial. In clinical trials that have been disclosed so far, BI-4732 has recorded a cancer cell growth inhibition rate of up to 183% in animal models transplanted with cell lines derived from patients with the triple mutations of exon 19 deletion, T790M, and C797S. This was up to 2.6 times higher than that of Tagrisso. The development of 4th generation lung cancer-targeted therapies is also underway in China. Chinese companies Betta Pharmaceuticals and Chia Tai Tianqing are conducting Phase I clinical trials of BPI-361175 and TQB-3804, respectively.
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- New ADC for breast cancer 'Trodelvy' at the final reimb step
- by Eo, Yun-Ho Mar 12, 2025 05:57am
- A new antibody-drug conjugate (ADC) for breast cancer, 'Trodelvy,' will enter the last stage toward being added to the insurance reimbursement list. The Ministry of Health and Welfare (MOHW) ordered the National Health Insurance Service (NHIS) to begin drug pricing negotiations for Gilead Sciences Korea's triple-negative breast cancer (TNBC) treatment Trodelvy (sacituzumab govitecan). Consequently, negotiations are expected to begin this month (March). Trodelvy has already been listed in about 30 countries worldwide. Since last year, Taiwan has offered health insurance coverage for Trodelvy, which has a national health system like South Korea. Many countries are focusing on quickly improving patient access to Trodelvy due to poor treatment availability for mTNBC and the clinical value of Trodelvy. TNBC is an aggressive form among breast cancer types that is more likely to recur and metastasize. Patients with TNBC who have progressed metastasis despite undergoing chemotherapy have a life expectancy of several months. However, chemotherapy has been used as the standard therapy for a long time because an effective method to target cancer cells has not been discovered. Trodelvy is the first Trop-2 targeted ADC and is the only treatment for mTNBC that is used as second-line treatment or above with a demonstrated survival extension effect compared to chemotherapy. Since its introduction, it has become the standard therapy globally. The current guidelines in the United States and Europe recommend Trodelvy as a priority treatment for patients with mTNBC who have a treatment history. According to the Phase 3 study, patients treated with Trodelvy had an overall survival of 11.8 months, which is close to a year, whereas patients undergoing chemotherapy had 6.9 months. Furthermore, Trodelvy has been shown to be effective in regulating symptoms and pains associated with cancer and improving overall well-being, thereby improving patients' quality of life. Trodelvy received the highest score of 5 on the ESMO-MCBS, a value-evaluation tool for anticancer medicines rated by the European Society for Medical Oncology (ESMO). Drugs with Score of 5 are indicated to not only extend patient survival but also be effective in improving quality of life. Trodelvy is the only drug to receive a Score of 5 among TNBC treatments. Meanwhile, the clinical effectiveness of Trodelvy was demonstrated through the Phase 3 ASCENT study. It has shown a 49% reduction in the risk of death and a 57% improvement in progression-free survival (PFS) in adult patients with unresectable locally advanced or mTNBC who have received two or more prior systemic therapies, including at least one for metastatic disease, compared to patients who received single-agent chemotherapy (TPC, Treatment of Physician’s Choice). These effects were observed regardless of the presence of brain metastasis.
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- 12 Korean biosimilars globally approved in 3 months
- by Chon, Seung-Hyun Mar 12, 2025 05:56am
- Domestic pharma and biotech companies have achieved 12 biosimilar approvals in the U.S. and Europe this year. Celltrion and Samsung Bioepis have surpassed last year's record of 11 approvals in three months due to their rapid global expansion. Together, Celltrion and Samsung Bioepis have received over 20 biosimilar approvals in Europe and the United States. Celltrion received the U.S. Food and Drug Administration (FDA) approval for Xolair’s biosimilar Omlyclo on the. 10, according to industry sources. Xolair is an antibody biologic drug used to treat allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic idiopathic urticaria. Xolair generated global sales of approximately KRW 6 trillion last year. Omlyclo is the first Xolair biosimilar to be approved in the U.S. and was also the first to be approved in other major global markets including the European Commission (EC), South Korea, the United Kingdom, and Canada. Celltrion has now received approval for a total of 4 biosimilars in the U.S. this year. In January, Celltrion received FDA approval for Avtozma, a biosimilar version of the autoimmune disease treatment Actemra. Actemra is indicated for rheumatoid arthritis (RA), giant cell arteritis (GCA), systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA), and COVID-19. On April 4, Celltrion received FDA approval for the biosimilars Stoboclo and Osenvelt, which are biosimilar versions of Prolia and Xgeva. Prolia and Xgeva are biologics developed by Amgen that differ in the dose and dosing schedule of denosumab. Prolia is approved for the treatment of osteoporosis and Xgeva is approved for the prevention of skeletal-related events in patients with bone metastases and the treatment of giant cell tumors of bone. Number of biosimilars approved by domestic pharmaceutical and biotechnology companies in Europe and the United States by year (Unit: number of items, Source: each company, Financial Supervisory Service) Celltrion has also received 4 biosimilar approvals in Europe this year. Last month, Celltrion received biosimilar approvals for 4 original drugs: Eylea, Actemra, Prolia, and Xgeva. Eylea is indicated for the treatment of ophthalmic conditions including wet macular degeneration, retinal vein occlusion macular edema, and diabetic macular edema. Celltrion received a recommendation for approval of the 4 biosimilars from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in December of last year and cleared the final approval hurdle within 2 months. This brings the total number of biosimilar approvals Celltrion has received in the U.S. and Europe in the first 3 months of this year to 8, the most ever. This more than doubles the 3 approvals it has received in 2018 and last year in just 3 months. Samsung Bioepis has received a total of 4 biosimilar approvals in the U.S. and Europe this year. Last month, Samsung Bioepis received approvals for 2 biosimilar products Prolia and Xgeva in the U.S. and Europe, respectively. The Prolia biosimilar was approved under the brand name Ospomyv in the U.S. and Obodence in Europe. The Xgeva biosimilar was approved under the brand name Xbryk in both the U.S. and Europe. Celltrion and Samsung Bioepis have received approvals for a total of 12 biosimilars in the U.S. and Europe this year. This surpassed the previous record of 11 approved in a year last year in just 3 months. Last year, 4 domestic pharma and biotech firms achieved 11 biosimilar approvals in the U.S. and Europe. Samsung Bioepis won 3 and 2 biosimilar approvals in the U.S. and Europe, respectively, last year. Samsung Bioepis received U.S. approval for its Eylea biosimilar Opuviz in May last year. In June and July last year, the company received FDA approval for its Stelara biosimilar Pyzchiva and Soliris biosimilar Epysqli, respectively. Samsung Bioepis' Stelara biosimilar Pyzchiva and Eylea biosimilar Opuviz passed through the European gateway in April and November last year. Celltrion received a total of 3 biosimilar approvals in the U.S. and Europe last year. Celltrion's biosimilar to Stelara received FDA approval last year, and biosimilars of Xolair and Stelara reached the commercialization stage in Europe. Dong-A ST won back-to-back FDA approvals in the U.S. and Europe for its biosimilar Imuldosa last year. Korean biopharmaceutical company Prestige Biopharma obtained marketing authorization for its Herceptin biosimilar Tuznue in Europe in September last year. In 2019, Celltrion and Samsung Bioepis received a total of 5 biosimilar approvals in the U.S. and Europe. In November 2019, Celltrion received approval in Europe for Remsima SC, a subcutaneous formulation of Remicade. Remsima SC is a subcutaneous (SC) version of the original intravenous (IV) formulation of Celltrion's proprietary biological drug, Remsima. In 2019, Samsung Bioepis received FDA approval for biosimilars of four products: Herceptin, Enbrel, Humira, and Lucentis. In January 2019, the company received U.S. marketing approval for Herceptin biosimilar Ontruzant, followed by Ethicobo and Hadlima in April and July. The original versions of Ethicobo and Hadlima are Enbrel and Humira, respectively. In September 2021, Samsung Bioepis received U.S. approval for Lucentis' biosimilar Byooviz. In August 2013, Celltrion's Remsima was approved for sale in Europe as the world's first antibody biosimilar, marking the beginning of domestic biosimilars' push into the global market. Since 2016, domestic pharma and biotech companies have continued to achieve new biosimilar approvals in the U.S. or Europe every year. Celltrion and Samsung Bioepis received 24 and 21 approvals in the U.S. and Europe, respectively. Celltrion received 12 and 12 approvals in Europe and the U.S., respectively. Samsung Bioepis' biosimilars received 11 approvals in Europe and 10 in the US.
- Company
- Besremi demonstrates effects in polycythemia vera
- by Whang, byung-woo Mar 11, 2025 05:54am
- "In polycythemia vera, 10–20% of patients develop resistance or intolerance to hydroxyurea treatment. Since no other treatment option is available, reimbursement for the new treatment option must be considered." Although the average survival for polycythemia vera is around 14.1 years, typically considered a comparatively lower mortality risk than other blood cancers, the abnormal overproduction of blood cells in the bone marrow can lead to severe cardiovascular complications such as thrombosis and embolism. Currently, the disease cannot be completely cured, and long-term management of complications is of utmost importance. However, treating the disease with the standard therapy hydroxyurea is limited because of its non-responsiveness or intolerance. Dr. Seong Yoon Yi, Professor of the Division of Hematology-Oncology in the Department of Internal Medicinea at Inje University Ilsan Paik HospitalDr. Seong Yoon Yi, Professor of the Division of Hematology-Oncology in the Department of Internal Medicinea at Inje University Ilsan Paik Hospital, emphasized the critical need to secure reimbursement for new treatment options that target the underlying pathology of polycythemia vera. Polycythemia vera is caused by somatic mutations in the bone marrow that abnormally activate hematopoiesis, resulting in excessive production of red blood cells, white blood cells, and platelets. Approximately 90% of patients with polycythemia vera have been found to harbor a mutation in the JAK2 gene. Dr. Lee explained, "Because polycythemia vera is a rare blood cancer, it is uncommon for patients to seek medical attention in its early stages. Most patients are diagnosed only after presenting with vague symptoms, followed by blood tests, bone marrow examinations, and genetic tests." Dr. Lee said treatment strategies are typically divided into low-risk and high-risk groups. Patients aged 60 or older or those with a history of thrombosis are classified as high-risk. Low-risk patients are generally treated with aspirin and phlebotomy, whereas high-risk patients receive these interventions in combination with hydroxyurea to help control excessive blood cell production. The problem with polycythemia vera, being an incurable condition requiring prolonged treatment, is the emergence of drug tolerance and adverse effects. Dr. Lee explained, "Polycythemia vera, like diabetes and hypertension, is a chronic condition that requires lifelong management, which means treatment lasts indefinitely," adding, "Over the long term, there are instances when blood counts are not stably controlled with hydroxyurea, and the disease can progress rapidly." "In some cases, patients develop tolerance to hydroxyurea so that it no longer provides therapeutic benefits, or they experience intolerable side effects that force them to discontinue treatment," He added. "Typical side effects include skin ulcers, a decrease in white blood cell counts leading to compromised immunity, and a decline in cardiac function, especially in older patients." Patient Lee Deok-hee, who joined the meeting with Dr. Lee, shared, "Since my diagnosis in 2010, I have been receiving both hydroxyurea and phlebotomy for 13 years. Initially, having hydroxyurea prescribed every three months was enough to maintain stable blood counts. However, since 2023, as I've developed resistance, I've had to visit the emergency room more frequently, and my daily life has become so restricted that I can no longer maintain my work." "Polycythemia vera's second-line treatment option poses a cost problem" According to research from the Myeloproliferative Neoplasms Research Group under the Korean Society of Hematology, approximately 10–20% of polycythemia vera patients develop resistance or intolerance to hydroxyurea treatment. Regarding this, Dr. Lee emphasized, "Although polycythemia vera is considered a rare blood cancer and may appear to affect only a small patient population, the number of cases continues to accumulate over time. As the disease progresses, low-risk patients often transition to a high-risk category, thereby increasing the likelihood of developing resistance or intolerance, presenting a challenge that cannot be overlooked." Following hydroxyurea treatment, two treatment options are considered: Besremi (ropeginterferon alfa-2b) and Jakavi (ruxolitinib). Besremi is a next-generation interferon that selectively targets and eliminates the JAK2 mutation, the primary cause of polycythemia vera. It was developed to improve the purity and tolerability compared to existing interferons, allowing for administration every two weeks for the initial 1.5 years and once every four weeks thereafter. Currently, Besremi is recommended as a polycythemia vera treatment in the National Comprehensive Cancer Network (NCCN) and European Leukemia Network (ELN) guidelines, regardless of a patient's prior treatment history. "Notably, the extent to which the allelic burden, which is the fundamental driver of the disease, is reduced," Dr. Lee said. "Clinical trials have demonstrated that Besremi significantly lowers the JAK2 mutation allelic burden. This means that Besremi alleviates symptoms and addresses the underlying cause of polycythemia vera." However, Besremi and Jakavi are currently not reimbursed, posing substantial cost hurdles. In practical terms, hydroxyurea remains the only treatment that patients can use without an economic burden. Consequently, there is growing attention on Besremi's multiple attempts to be considered for the Economic Evaluation Committee of Health Insurance Review and Assessment Service (HIRA). Given the apparent demand for new treatment options in clinical practice, industry observers are closely watching whether Besremi can pass through the subcommittee review and ultimately reach the final stage at the Drug Reimbursement Evaluation Committee (DREC). Dr. Lee said, "We know that patients with polycythemia vera want new treatment options to be reimbursed. In particular, Besremi has shown stable clinical data across risk groups and offers the potential for a fundamentally transformative approach, which has greatly raised patient expectations." He added, "While it would be ideal for every patient to access treatment without any economic burden, the realities of the National Health Insurance budget mean that securing reimbursement is especially urgent for patients who develop resistance or intolerance to hydroxyurea. These patients have no other treatment options once hydroxyurea becomes ineffective." Finally, Dr. Lee stressed that, given the unique characteristics of polycythemia vera as a rare blood cancer, reimbursement reviews should consider not only the number of patients and drug costs but also the broader societal burden. "Costs related to treating side effects of hydroxyurea, such as myocardial infarction or stroke, and the social costs when caregivers have to quit their jobs for patient care are often overlooked. I hope these factors will be partially reflected in the drug reimbursement decision-making process," Dr. Lee added.
- Company
- Celltrion’s Xolair biosimilar Omlyclo is approved in the US
- by Chon, Seung-Hyun Mar 11, 2025 05:54am
- Celltrion announced on the 10th that ‘Omlyclo,’ its biosimilar version of ‘Xolair’ has was approved by the US Food and Drug Administration (FDA). Xolair is an antibody biologic used for allergic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and chronic spontaneous urticaria (CSU). Xolair posted global sales of approximately KRW 6 trillion and over KRW 3 trillion in the US market alone. Celltrion applied for Omlyclo’s marketing authorization to the FDA based on the results of a global Phase III trial last year and was approved for all indications the original drug was approved for, including allergic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), chronic spontaneous urticaria (CSU), and Immunoglobulin E (IgE)-mediated food allergy. Omlyclo was approved as the first Xolair biosimilar in the United States, following approvals in major global countries such as Europe (EC), South Korea, the United Kingdom, and Canada. As Omlyclo’s interchangeability was recognized in the United States, pharmacies will be able to substitute the original product with Omlyclo without the healthcare professional’s prescription change. Celltrion will sell Omlyclo through its local subsidiary in the US. With the approval, Celltrion has received approval for 4 products in the United States in the first quarter of this year alone – Omlyclo; the autoimmune disease treatment Avtozma; and biosimilar versions of the bone disease treatment Prolia-Xgeva. “Omlyclo has not only been approved as a first mover in the United States, the world's largest pharmaceutical market, but also secured an interchangeability designation, enabling it to take an advantageous position in the market upon its initial launch,” said a Celltrion official.
- Company
- AbbVie’s Rinvoq to benefit most from changes in KOR
- by Whang, byung-woo Mar 10, 2025 06:05am
- Expansion has been growing on the expansion of related prescription markets with the government approving reimbursement for switching between atopic dermatitis treatments, which has been in high demand in the field. The industry expects an increased number of treatment options and an expanded scope of reimbursement to enable more effective treatment for patients. In particular, the presence of Rinvoq (upadacitinib) has been growing with its indication expansion to moderate to severe atopic dermatitis in adolescents aged 12 and older, and the grant for switching between JAK inhibitors. On the 7th, AbbVie Korea held a press conference on the latest clinical research of Rinvoq and changes in the treatment environment due to changes in the atopic dermatitis reimbursement coverage standards. Tae Young Han, Professor of Dermatology, Nowon Eulji Medical Center According to the Korean Atopic Dermatitis Association guidelines, patients with moderate-to-severe atopic dermatitis are highly recommended to consider switching to another biological agent or oral JAK inhibitor if they do not respond sufficiently to the biological agent or oral JAK inhibitor or if they cannot use them due to side effects. Until now, there have been limitations to treatment due to the fact that reimbursement coverage was not applied when the patient wanted to switch from biological agents to JAK inhibitors. However, from the 1st of this month, ▲if a patient is not responding to a biological agent or a JAK inhibitor, or ▲if the patient cannot continue taking the medication due to side effects (recommended to continue taking the replaced medication for at least 6 months), the patient will be eligible for reimbursement even if the patient has switched to a JAK inhibitor or biological agent. However, switching between the same class of drugs is not allowed. Professor Tae Young Han of the Department of Dermatology at Nowon Eulji Medical Center who made a presentation on this day, said, “Atopic dermatitis is a disease that has symptoms and manifestations depending on the characteristics of the patient, and a personalized treatment strategy is needed for each patient to receive appropriate treatment. The recognition of reimbursement coverage for switching has opened up new treatment opportunities for patients who have not seen sufficient treatment effects so far.” Han added, “Patients who have had side effects or showed an inadequate response to biological agents can be switched to a JAK inhibitor such as Rinvoq to achieve an appropriate treatment response. In addition, with the availability of reimbursement coverage, it is now possible to prioritize the use of treatments that are expected to be highly effective for each patient, from his or her initial treatment.” The reason why the expansion of Rinvoq’s influence is drawing attention is because of the Heads Up trial, which is a head-to-head trial between Dupixent (dupilumab), the biological agent with the most prescriptions, and Rinvoq. The results showed that 90% of patients who switched to Rinvoq (30 mg) after 24 weeks of dupilumab (300 mg) achieved EASI 90 (an almost clear skin condition) at Week 16 of Rinvoq treatment (40 weeks in total), and 56.1% achieved WP-NRS 0/1 (no or almost no itching). Yong Hyun Jang, Professor of Dermatology at Kyungpook National University said, “For moderate or more severe atopic dermatitis, the use of drugs that have quick and high efficacy in the early stages needs to be prioritized to quickly suppress severe itching. With switching between different classes of drugs granted reimbursement in Korea, the burden of choosing Rinvoq as the initial treatment option will be reduced as its long-term safety has been confirmed in clinical trials.” According to the results of the approximately 4-year follow-up of the extension study of Phase III clinical study on Rinvoq (Measure Up 1, Measure Up 2), among patients who received 15 mg and 30 mg Rinvoq, 69.8% and 72.9% of patients maintained EASI 90 and 44.9% and 47.2% of the patients maintained WP-NRS 0/1, respectively. Yong Hyun Jang, Professor of Dermatology at Kyungpook National University The indication expansion to adolescents aged 12 and older and the reimbursement expansion for Rinvoq also received positive evaluations. Professor Jang said, “Adolescents require sufficient sleep for growth and development, and lesions on visible areas such as the face and neck are especially stressful at that age. This is a very important period to prevent exacerbation of atopic dermatitis in adulthood, so the importance of early treatment is even greater. I expect the changes in the approval environment in Korea will help establish a flexible treatment strategy.” Jiho Kang, Country Medical Director of AbbVie Korea, added, “With the approval of switching and the approval for adolescents and the expanded insurance reimbursement coverage, we hope that the flexible dose strategy of Rinvoq will help improve the quality of life and enable patients to enjoy daily life that is no different from that of the general public through Rinvoq’s fast and strong treatment effect.” Meanwhile, due to the approval of switching, Rinvoq’s insurance price has been cut due to expected additional claims, based on the calculation formula. Due to this expansion of the scope of use, the insurance price ceiling of Rinvoq will be reduced from the previous KRW 18,740 to KRW 18,328 for the 15 mg product and from the previous KRW 29,850 to KRW 29,193 for the 30 mg product starting next month.
