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- 2025-12-23 19:11:00
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- Verzenio prescribing guideline recommendations
- by Eo, Yun-Ho May 31, 2023 05:36am
- Verzenio is expected to be used in early breast cancer patients with a high risk of recurrence even after surgery. Looking at the recently published domestic and international breast cancer treatment guidelines, the CDK4/6 inhibitor Verzenio was recommended based on a high level of evidence as adjuvant therapy after surgery for patients with high-risk recurrence of early breast cancer with HR+/HER2- positive lymph nodes. In the 10th breast cancer treatment recommendation of the Korean Breast Cancer Society revised in April this year, patients who underwent surgery for HR+/HER2- breast cancer had 4 or more lymph node involvement, 1-3 benign lymph nodes, and tumor size of 5 cm or more or a high-risk tumor of grade 3 In order to reduce the recurrence rate of patients with factors, endocrine therapy and Verzenio combination treatment after breast cancer surgery were recommended as 'evidence level 1' and 'recommendation grade A'. Prior to the Korean Breast Cancer Society, the treatment guidelines of the National Comprehensive Cancer Network in the US were also revised in March. NCCN changed the level of evidence for 2 years of Verzenio + endocrine therapy as adjuvant therapy after surgery in HR+/HER2- high-risk breast cancer patients (the details are the same as in Korea) from category 2A to category 1, the highest grade. Verzenio's most recent data is the results of a 4-year follow-up study of monarchE, presented at the San Antonio Breast Cancer Symposium annual conference in December 2022 and published in The Lancet Oncology in January 2023. In the paper, the patient group treated with Verzenio + endocrine therapy had a reduced risk of recurrence and death compared to the control group until the 4th year after completing 2 years of postoperative adjuvant therapy, and the gap with the control group continued to increase until the 4th year. These results suggest the possibility that the risk of recurrence can be continuously reduced by maintaining endocrine therapy after completing Verzenio + endocrine therapy for 2 years. The monarchE study was a phase 3 study that confirmed the clinical efficacy and safety profile of Verzenio + endocrine therapy as adjuvant therapy after surgery for HR+/ HER2- lymph node-positive early breast cancer patients (N=5,637) at high risk of recurrence, compared to the existing standard endocrine therapy. a clinical study The monarchE cohort 1, which served as the basis for domestic approval, included 5120 patients (91%). The primary evaluation index was Invasive Disease-Free Survival (IDFS), and the secondary evaluation index was DRFS and OS. Looking closely at the results, Verzenio + endocrine therapy in monarchE cohort 1 reduced the risk of recurrence and death by about 35% at 4 years compared to endocrine therapy alone. The absolute difference of Verzenio gradually increased from 3.1% in the second year to 5.0% in the third year and 6.9% in the fourth year. The risk of distant recurrence and death was also reduced by approximately 35%, and OS has not yet been derived. Early breast cancer patients are treated with the goal of a complete cure, but in the case of recurrent or metastatic breast cancer patients, the goal is changed to treatment to prolong life and improve quality of life. Since the risk of recurrence is highest in the first 1 to 2 years after diagnosis, treatment to prevent recurrence after surgery is essential. About 14% to 23% of hormone receptor-positive (HR+) early breast cancer patients still experience recurrence even after surgery and endocrine therapy as an adjuvant treatment after surgery. In particular, according to a real-world study conducted in the United States, patients with recurrence risk factors defined in the IDFS, monarchE study showed about three times greater recurrence risk than breast cancer patients who did not. Among the risk factors for recurrence defined by monarchE, Cohort 1, the domestic approval standard, is ▲4 or more pALN, ▲1 to 3 positive axillary lymph nodes, and ▲ a tumor size of 5cm or more, ▲histological grade 3. While there was an unmet demand for more effective treatment options for the high-risk group for recurrence in the early stage of breast cancer, Verzenio obtained significant results in HR+/HER2- lymph node-positive high-risk early breast cancer with high-risk recurrence through the phase 3 trial of monarchE in 2020. And based on this, in November 2022, for the first time as a CDK4/6 inhibitor, it obtained approval from the Ministry of Food and Drug Safety in Korea as a combination therapy with endocrine therapy as an adjuvant treatment for adult patients with high-risk early breast cancer with HR+/HER2- positive lymph node recurrence. Jihyung Kim, Professor of Oncology at Gangnam Severance Hospital, said, “As a strategy to lower the risk of recurrence in early breast cancer patients, the introduction of new adjuvant drug therapy after surgery can improve the patient’s long-term treatment prognosis as well as reduce the possibility of recurrence or metastatic breast cancer. There are also benefits from the national fiscal perspective,” Kim said. Kim emphasized, “We hope that more domestic early breast cancer patients at high risk of recurrence can enjoy the treatment benefits of Verzenio through the application of domestic health insurance benefits for Verzenio, which has shown clinical usefulness for early breast cancer patients at high risk of recurrence.”
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- 2 K-biosimilars are approved in the US and Europe per year
- by Chon, Seung-Hyun May 31, 2023 05:36am
- Biosimilar drugs that were developed in Korea are accelerating entry into the global market. Over the past decade, 13 and 10 biosimilars developed by Celltrion and Samsung Bioepis have been approved in Europe and the US, respectively. After Celltrion's Remsima received EMA approval in 2013, an average of 2 biosimilars have passed European and US review every year. According to industry sources on the 31st, Samsung Bioepis has obtained approval from the European Commission (EC) for 'Epysqli', a biosimilar of the rare disease treatment 'Soliris.’ Epysqli is the first biological drug developed by Samsung Bioepis in the field of hematology. Soliris is an ultra-high-priced drug developed by Alexion in the U.S. that is used for intractable rare diseases such as nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. Last year, its global sales amounted to about KRW 5 trillion. With Epysqli’s approval, Samsung Bioepis has now been approved for 7 biosimilars in the European market. Samsung Bioepis started entry into the global market in earnest after receiving approval for its Enbrel biosimilar Benepali in Europe in January 2016. Then, in May 2016, the company also received approval for Flixabi, its biosimilar of the autoimmune disease treatment Remicade, in Europe. Also, the company received approval for biosimilars of the anticancer drug Herceptin and autoimmune disease treatment Humira in Europe in 2017. In 2020, it also acquired marketing authorization for its Avastin biosimilar, and then for the biosimilar of the eye disease treatment Lucentis in Europe in 2021. K-Biosimilars approved in the US and Euope Celltrion has acquired approval for 6 biosimilars in Europe. In August 2013, Celltrion first received approval for Remsima, the ‘world’s first biosimilar monoclonal antibody.’ Then, Celltrion received approval for Truxima and Herzuma in Europe in 2017 and 2018, respectively. Truxima and Herzuma are biosimilars of the anticancer drugs Mabthera and Herceptin. In November 2019, Celltrion received approval for its subcutaneous injection type of Remicade biosimilar Remsima SC in Europe and started market entry in earnest. Remsima SC is a biological drug developed by Celltrion. The company changed the intravenous formulation of its currently marketed Remsima into a subcutaneous injection (SC). In February 2021, Celltrion obtained European marketing authorization for Uplima, a biosimilar of Humira. In August of last year, Celltrion succeeded in obtaining European sales approval for Humira's biosimilar, Yuflyma. In 10 years since Celltrion received the approval for Remsima in Europe in 2013, a total of 13 biosimilars from Celltrion and Samsung Bioepis have been approved in Europe. Celltrion and Samsung Bioepis each received approval for 5 biosimilars in the US. In 2016, Celltrion’s Remicade biosimilar Inflectra became the first to pass the US barriers of approval. The company also received marketing authorization from the FDA for its Truxima and Herzuma in 2018. Celltrion received FDA approval for its Avastin biosimilar Vegzelma in September last year, and then for its Humira biosimilar Yuflyma on the 24th of this month. At Samsung Bioepis, its Remicade biosimilar ‘Renflexis’ became the first to receive FDA approval in April 2017. Since then, the company received approval for its Herceptin, Enbrel, and Humira biosimilars in 2019 from the FDA. In January 2019, its Herceptin biosimilar Ontruzant was approved in the U.S., followed by the approvals of Eticovo and Hadlima in April and July of the same year. The original products of the biosimilars Eticovo and Hadlima are Enbrel and Humira. Samsun Bioepis also received approval for its Lucentis biosimilar Byooviz in September 2021.
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- Sales of Keytruda rose 117%
- by Chon, Seung-Hyun May 30, 2023 06:59pm
- Immuno-oncology drug Keytruda continued its high-altitude march in the domestic pharmaceutical market. Last year, Health Insurance 2 sales more than doubled as the number of recipients of the leading water-based benefits expanded for 13 consecutive quarters since the first quarter of 2020. Keytruda further strengthened its solo system by more than doubling the gap with second place. According to IQVIA, a drug research agency on the 22nd, Keytruda took the lead with sales of 87.8 billion won in the first quarter. Sales increased by 117.1% in one year from 40.4 billion won in the first quarter of last year. Released in Korea in 2015, Keytruda is an immune checkpoint inhibitor that inhibits the PD-1 protein on the surface of T-cells of immune cells to prevent binding to the PD-L1 receptor and activates immune cells to treat cancer. In Korea, 24 indications were approved for 16 cancer types, including melanoma, lung cancer, and head and neck cancer. Currently, the cancers for which Keytruda can be used are ▲lung cancer ▲head and neck cancer ▲Hodgkin's lymphoma ▲urothelial cancer (bladder cancer) ▲esophageal cancer ▲melanoma ▲renal cell cancer (kidney cancer) ▲endometrial cancer ▲stomach cancer ▲small intestine cancer ▲ovarian cancer ▲ Pancreatic cancer, biliary tract cancer, colorectal cancer (colorectal cancer), triple-negative breast cancer, and cervical cancer reached 16 cases. It can be used in the largest number of cancer types among immuno-anticancer drugs approved in Korea. Keytruda showed high growth last year thanks to the favorable news of salary expansion. In March of last year, the scope of health insurance coverage for Keytruda was expanded as the first treatment for non-small cell lung cancer. As Keytruda's first-line treatment benefit application effect began in earnest, the growth rate accelerated. Sales increased by 33.4% from 40.4 billion won in the first quarter of last year to 53.9 billion won in the second quarter. In the third and fourth quarters of last year, sales were 67.2 billion won and 78 billion won, respectively, raising more than 10 billion won in sales each quarter. Considering Keytruda's drug price cut, the increase in prescriptions is analyzed to be even greater. In March of last year, Keytruda's insurance cap was lowered by 25.6% as the benefits range expanded. In the aftermath of drug price cuts, sales in the first quarter of last year decreased by 26.0% compared to the previous quarter. However, despite the drug price cut, and the upward trends, Keytrua increased since the second quarter of last year. It is calculated that the amount used has more than doubled in one year since the first treatment benefit was applied. It has maintained its lead position for 13 consecutive quarters since taking first place overall in the first quarter of 2020. The gap with 2nd place Lipitor widened more than twice, establishing a solid solo system. New drug products recently introduced by multinational pharmaceutical companies continued to be strong at the top of pharmaceutical sales. Amgen's Prolia recorded sales of 35.5 billion won in the first quarter, up 41.6% from the same period last year, ranking third overall. Released in Korea in November 2016, Prolia is a biopharmaceutical osteoporosis treatment that targets RANKL, an essential protein for the formation, activation, and survival of osteoclasts that destroy the bone. Since 2017, Prolia began to enjoy an upward trend in sales after benefits were applied only to secondary treatment. From April 2019, sales of Prolia soared even more as insurance benefits were recognized for primary treatment. Prolia surpassed 100 billion won in annual sales last year, six years after entering the country. Prolia is jointly sold by Chong Kun Dang. Ono Pharmaceutical's immuno-oncology drug Opdivo recorded sales of KRW 33.9 billion in the first quarter, up 35.4% from the previous year. Opdivo, which was licensed in 2015, stayed in the 10 billion won range until the second quarter of 2021. It exceeded 20 billion won in the third quarter of 2021 and exceeded 30 billion won in the fourth quarter of last year. Opdivo recorded a high growth rate of 64.7% in two years from 66.7 billion won in 2020, and stepped on the 100 billion won mark in annual sales for the first time last year. Sanofi's atopic dermatitis treatment Dupixent recorded sales of 30.9 billion won in the first quarter, up 29.4% from the previous year. Dupixent is the first targeted biological agent developed for the treatment of moderate to severe atopic dermatitis where topical treatments are not recommended or symptoms are not adequately controlled. .Dupixent, which received domestic approval in March 2018, received coverage for severe atopic dermatitis from January 2020, and sales expanded rapidly.
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- Imfinzi for liver cancer is expected to land in Korea soon
- by Eo, Yun-Ho May 30, 2023 05:33am
- According to related industries, the Ministry of Food and Drug Safety is in the process of final review for approval of Imjudo, a CTLA-4 inhibitor. Final approval is expected in the second half of the year. The first indication for Imfinzi and Imjudo combination therapy is liver cancer. The combination therapy is the only dual immunotherapy that has been approved for the first-line treatment of liver cancer and was approved by the US FDA in October last year as a treatment for unresectable hepatocellular carcinoma. In addition, it obtained marketing approval from Japan's Ministry of Health, Labor and Welfare in December last year and EMA in Europe in February. The combination therapy is a STRIDE (Single Tremelimumab Regular Interval Durvalumab) strategy in which Imfinzi is additionally administered at regular intervals every 4 weeks after administering 1500 mg of Imfinzi and 300 mg of Imjudo once. In the HIMALAYA study, a phase 3 clinical trial, the combination therapy reduced the risk of death by 22% compared to the control group, Nexavar monotherapy, and demonstrated OS benefit. The 3-year overall survival rate was 31% in the Imfinzi and Imjudo combination therapy group and 20% in the sorafenib monotherapy group. Imjudo combination therapy recently added indications for lung cancer in the United States. In the phase 3 clinical POSEIDON study, which served as the basis for approval, the patient group who received the Imfinzi/Imjudo/platinum-based chemotherapy combination showed a 23% lower risk of death compared to the various chemotherapy control groups. The 2-year overall survival rate was 33% in the combination group and 22% in the control group. Imjudo is conducting a phase 3 study of combination therapy with Imfinzi in several types of carcinoma, including the EMERALD-3 study, the ADRIATIC study, and the VOLGA and NILE studies.
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- Reimb in progress for 1st endometrial cancer immunotherapy
- by Jung, Sae-Im May 30, 2023 05:33am
- Pic of Jemperli Will the latecomer cancer immunotherapy ‘Jemperli (dostarlimab)’ from GSK be reimbursed as the first cancer immunotherapy in endometrial cancer? With cancer immunotherapies changing the treatment paradigm for the first time in decades, the demand in the field to speed up the reimbursement progress has also been increasing. in the field. According to industry sources on the 30th, GSK has applied for the reimbursement of Jemperli to the Health Insurance Review and Assessment Service and is awaiting the application to be deliberated by the Cancer Disease Deliberation Committee. Therefore, whether the agenda will be deliberated by the CDDC is receiving attention. Jemperli is the 7th approved cancer immunotherapy in Korea. The drug received marketing authorization from the Ministry of Food and Drug Safety in December last year. The drug is a PD-1 inhibitor like Keytruda and Opdivo. Unlike the other PD-1 immunotherapies, Jemperli was first approved for use as a second-line treatment in patients with recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing chemotherapy regimen who have a specific biomarker. The biomarker approved in the indication is ‘microsatellite instability-high or mismatch repair deficient (dMMR).' As a latecomer in the cancer immunotherapy market, Jemperli sought to clearly distinguish itself from the other drugs. Its strategy was to solidify its position in endometrial cancer, an area that has almost no existing immuno-oncology drugs in the market. In fact, only Keytruda among the existing cancer immunotherapy has indications for endometrial cancer. Jemperli entered as the second immuno-oncology drug in the field and started a one-on-one competition with Keytruda. Endometrial cancer is a cancer that occurs in the endometrium, which constitutes the inner wall of the uterus and accounts for the majority of cervical cancers. Approximately 1 out of 4 endometrial cancer patients are diagnosed in the advanced stage or experience recurrence, and there is no effective treatment available if the condition recurs after platinum-based chemotherapy. When using chemotherapy in the second line, the known average survival rate is less than 1 year, and the 5-year survival rate is only 10%. No new treatment has been introduced for relapsed or advanced endometrial cancer for around 30 years. The immunotherapies that have been introduced after decades have been evaluated to have transformed the endometrial cancer treatment paradigm. MSI-H/dMMR, which is considered a major biomarker for endometrial cancer treatment, is known to be present in up to 26% of patients. This is the highest among solid cancers. This means that the use of cancer immunotherapies can be relatively large in the area. Jemperli’s approval was based on the cohort A1 analysis results of Phase I multicohort GARNET trial that included a cohort of patients with relapsed or advanced dMMR/MSI-H endometrial cancer who progressed on or following prior treatment with a platinum-containing regimen. In particular, this study had the largest cohort among PD-1 inhibitor monotherapy studies for dMMR/MSI-H endometrial cancer patients among those that have been conducted so far. As a result of analyzing a total of 108 patients with a median follow-up of 16.3 months, Jemperli demonstrated durable antitumor activity with a manageable safety profile. In the cohort, the ORR was 43.5% (95% CI, 34.0-53.4) and the median DOR was not yet reached. 83.7% of the patients that showed response continued treatment for over 2 years. Overall survival (OS) estimates at 12 months and 24 months were 73.3% and 60.5%, respectively. Patients did not reach the median OS even with a long-term follow-up of more than 2 years. Recently, a possibility had risen for expanding the use of cancer immunotherapies as a first-line treatment for recurrent and advanced endometrial cancer. In the first quarter of this year, Jemperli and Keytruda each announced clinical results showing that the drugs were effective when used in combination with chemotherapy in the first line. In the Phase III RUBY study, Jemperli lowered the risk of disease progression and death by 36% compared to the placebo group. This is significant as the trial included patients without MSI-H/dMMR biomarkers. In the MSI-H/dMMR patient group, the risk of disease progression and death decreased by 72%. Keytruda reduced the risk of disease progression and death by 70% in patients with MSI-H/dMMR in a clinical trial. With the performance of cancer immunotherapies gaining prominence and data to change the standard treatment, and chemotherapy, increasing, the demand for the reimbursement of cancer immunotherapies in clinical settings has also been rising. No cancer immunotherapy is currently approved for reimbursement in endometrial cancer yet. In the global market, cancer immunotherapy is already being reimbursed in five of the major A8 countries - the US, Germany, the UK, Switzerland, and Italy. Currently, only Jemperli has applied for reimbursement for endometrial cancer. However, an unmet demand exists as the agenda has not been presented for CDDC review for some while. Seob Jeon, Director of the Insurance Committee at the Korean Society of Gynecologic Oncology (Gynecology, Soonchunhyang University Cheonan), said, “The introduction of a new cancer immunotherapy option that can be used as monotherapy in recurrent endometrial cancer, an area that had a 5-year survival rate below 10%, has brought new hope to the patients. However, we need collaborative efforts from the government and pharmaceutical companies for the patients who are waiting for reimbursement for cancer immunotherapy because they have no other alternative than cytotoxic chemotherapy. I hope that the policy grounds will be laid so that the benefits of the treatment can be applied in the field."
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- Ebixa 20mg may be prescribed at general hospitals in Korea
- by Eo, Yun-Ho May 26, 2023 06:47am
- The high-dose formulation of the Alzheimer’s treatment ‘Ebixa’ has landed at general hospitals in Korea. According to industry sources, Lundbeck Korea’s ‘Ebixa (memantine) tablet 20mg’ passed the drug committees of medical institutions in Korea, including Seoul National University Hospital, Seoul Asan Medical Center, Sinchon Severance Hospital, and Seoul National University Bundang Hospital. The drug has stably established a prescription environment in Korea since its launch in August last year. Ebixa is an NMDA receptor antagonist approved for the treatment of moderate-to-severe Alzheimer’s disease. It blocks glutamate, a neurotransmitter involved in learning and memory, to prevent or slow down the progression of the disease. It is used to treat Alzheimer’s disease in patients with an MMSE total score of 20 or lower and CDR2-3 or GDS 4-7 accompanied by cerebrovascular disease. Ebixa 20mg is a new formulation that increased the dose by 2 times from the existing 10mg dose. If the original Ebixate 10mg had to be administered twice a day based on the maintenance dose for healthy adults, the 20mg can be orally administered once a day, improving the patient's medication compliance through simplification of the regimen. However, the 20mg dose should be administered at the same time every day and can be administered up to twice a day if necessary. Pharmacokinetic tests and comparative trials that administered Ebixa 20mg once a day showed that its safety and efficacy were similar to the twice-a-day oral administration of the existing Ebixa 10mg formulation. As a result, Ebixa 20mg reduces the burden of dementia patients having to remember the time and frequency of taking medications and reduces the possibility of them taking incorrect medications. Ebixa 20mg’s safety and efficacy have been confirmed through pharmacokinetic tests and comparative clinical trials. In May 2008, the drug was approved for once-daily use by the EMA and approved for use as once-daily use in 30 European countries, Argentina, Mexico, Turkey, Singapore, Japan, and Australia.
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- Lucentis sales fell 34%
- by Chon, Seung-Hyun May 26, 2023 06:47am
- Humira, Avastin, Herceptin, and Mabthera also saw drug prices cut after entering the market for similar drugs. Domestic sales of Lucentis, an eye disease treatment, fell by more than 30%. As Chong Kun Dang and Samsung Bioepis launched biosimilars, drug prices went down and sales took a direct hit. New drugs from multinational pharmaceutical companies, such as Remicade, Enbrel, Herceptin, Mabthera, Humira, and Avastin, are experiencing repeated sales declines due to drug price cuts after the introduction of domestically developed biosimilars. It is evaluated that a virtuous cycle structure in which domestic companies' R&D achievements generate hundreds of billions of won in health insurance financial savings is being established. According to IQVIA, a drug research agency on the 26th, sales of Lucentis in the first quarter were 5 billion won, down 34.2% from the same period last year. It decreased by 20.1% in one quarter from 6.2 billion won in the fourth quarter of last year. Lucentis, sold by Roche and Novartis, is a drug used to treat eye diseases such as macular degeneration and diabetic macular edema. This drug is used for ▲ the treatment of neovascular (wet) age-related macular degeneration, ▲ treatment of visual impairment due to diabetic macular edema, ▲ treatment of proliferative diabetic retinopathy, ▲ treatment of visual impairment due to retinal vein occlusive macular edema, ▲ It is used for treatment of visual impairment due to the formation of choroidal neovascularization. A direct factor behind the decline in Lucentis' sales was drug price cuts following the entry into biosimilars. Samsung Bioepis and Chong Kun Dang received permission for Lucentis' biosimilar products. Samsung Bioepis obtained approval for Lucentis biosimilar Ameliebou in May last year, and Chong Kun Dang got approval for Lusenbier in October last year. Ameliebou and Lusenbies have been listed on the health insurance benefit list since January. Lucentis has lowered its insurance cap by 30% since February. The insurance price of Lucentis 10mg (3mg/0.3mL) went down from 820,636 won to 574,445 won, and Lucentis 10mg (2.3mg/0.23mL) went down from 828,166 won to 579,716 won. The drug price of Lucentis PFS (826,231 won → 578,362 won) was also cut by 30%. In principle, when a biosimilar appears in the domestic drug price system, the upper price standard for original drugs is lowered by 30% compared to before the patent expiration. 'Items developed by a company that signed a joint contract with an innovative pharmaceutical company, a company equivalent to it, a domestic pharmaceutical company, or a foreign company, or items for which Korea was the first licensed country or items produced in Korea' Guaranteed up to 80% of the original product. With the advent of a biosimilar developed by a domestic company, Lucentis saw a 30 percent drop in drug prices, and a drop in sales equal to the rate of drug price cut became a reality at once. Recently, sales of global blockbuster products Humira and Avastin also plummeted due to drug price cuts following the entry of biosimilars. Autoimmune disease treatment Humira saw its sales drop 24.7% in the first quarter from 27.5 billion won in the first quarter of 2021 to 20.7 billion won in the second quarter. Humira is a TNF-alpha inhibitor that treats autoimmune diseases by suppressing the expression of tumor necrosis factor (TNF-α). As of June 7, 2021, Humira's insurance cap has been reduced by 30%. The price of Humira Pen 40mg/0.4mL, Humira PFS 40mg/0.4mL, and Humira 40mg vial fell 30% from 411,558 won to 288,091 won, and Humira PFS 20mg/0.2mL from 224,002 won to 156,801 won. When Samsung Bioepis registered Humira biosimilar Adalloce for reimbursement in May 2021, Humira's upper limit fell a month later. Humira posted sales of 104 billion won in 2020, but decreased by 12.3% to 91.2 billion won in 2021. Last year, it was 85.8 billion won, down 17.5% from two years ago. In just two years after the introduction of biosimilars, sales decreased by about 30 billion won. Roche’s anti-cancer drug Avastin recorded sales of 19.4 billion won in the first quarter, down 32.4 percent in two years from 28.7 billion won in the first quarter of 2021. Avastin is an anticancer drug used for metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer, advanced or metastatic renal cell carcinoma, glioblastoma, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and cervical cancer. Avastin showed a stable growth flow, such as 28.7 billion won, 30.2 billion won, and 30.8 billion won, from the first quarter of 2021 to the third quarter, but in the fourth quarter, it decreased by 28.6% from the previous quarter to 22 billion won. The drop in sales was inevitable due to drug price cuts following the introduction of biosimilars. Samsung Bioepis received permission for Avastin's first biosimilar, Onbevezy, in March 2021, and was listed on the health insurance list in September of the same year. With the listing of Onbevezy, the upper limit of Avastin 0.1g/4mL in October 2021 was reduced by 30% from 33,387 won to 231,271 won. Avastin 0.4g/16mL fell 30% from 1,077,531 won to 752,746 won.
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- Shingles vaccine Shingrix occupies 29% of market in 3 months
- by Jung, Sae-Im May 26, 2023 06:47am
- GSK’s shingles vaccine ‘Shingrix’ occupied 29% of the market in Q1 this year. In only 3 months of its release, it beat MSD’s ‘Zostavax’ and ranked 2nd in the market. The company has made a smooth start by actively conducting marketing activities in partnership with a domestic pharmaceutical company. According to the market research institution IQVIA on the 25th, the shingles vaccine market in Korea in Q1 reached KRW 21.9 billion, a 147% increase from the KRW 8.9 billion in Q1 of the previous year. The shingles vaccine market, which had been on a downward curve due to COVID-19, has started rising again this year. In Korea, three shingles vaccines are currently available in the market - SKYZoster, Zostavax, and Shingrix. In particular, Shingrix made rapid advances after generating full-fledged sales for the first time this year. Shingrix's sales in Q1 were KRW 6.3 billion. Sales of Shingrix were recorded from Q4 last year, but considering that it started sales in mid-December, full-fledged sales occurred for the first time in Q1 this year. Data: IQVIA Shingrix recorded higher sales than MSD's Zostavax in Q1 and rose to 2nd place. Its share in the domestic shingles vaccine market also reached 29%. On the other hand, Zostavax’s only raised KRW 6 billion, similar to Q1 of the previous year. Although Zostavax sold more products, Shingrix quickly surpassed sales with its high-price strategy. SK Bioscience’s ‘SKYZoster’ also posted KRW 9.5 billion in sales in Q1 this year, which is a 152% increase from the same period in the previous year, contributing to the market expansion. Shingrix is a shingles vaccine that GSK ambitiously released in December last year. Last year, GSK selected GC Biopharma and Kwangdong Pharmaceutical as domestic marketing partners and set out to occupy the market. Expectations were high that Shingrix’s release will rebound the shingles vaccine market that had been on a downward trend due to COVID-19. In only six months of its launch, Shingrix has landed in more than 7,000 clinics and 200 general hospitals in Korea and greatly expanded its market. The company’s Q1 sales were KRW 6.3 billion, which exceeded the company’s initial target. The greatest benefit of Shignrix is its strong shingles prevention effect. In a Phase III clinical trial (ZOE-50) that was conducted on adults aged over 50 years of age, Shingrix showed a 97.2% efficacy compared to the non-vaccinated group at 3.2 years of follow-up. In another Phase III clinical trial (ZOE-70) conducted on adults aged 70 years and above, Shingrix showed an 89.8% efficacy at 3.7 years of follow-up. This is superior to the 5% protection in adults aged over 50 years of age and 41% in adults aged 70 years and above demonstrated with the use of Zostavax. The prevention rate of SKYZoster is also known to be similar to Zostavax. Also, Shingrix’s safety profile was confirmed through 5 clinical trials that were conducted on immunocompromised patients aged 18 years and older. Based on such evidence, patients who received autologous hematopoietic stem cell transplantation or those with solid cancer, blood cancer, or solid organ transplant patients who have an increased risk of shingles are also eligible to receive vaccination with Shingrix. Shingrix's rapid growth was analyzed to have been driven by its overwhelmingly high preventive effect and the distinction that it is the only inactivated vaccine that can be vaccinated to immunocompromised people. In the early days of Shingrix's release, there were concerns in the market due to its higher price than existing vaccines. The price of Shingrix, which is administered two times in total, is set at around KRW 500,000 to 600,000. This is more than twice as high as the existing vaccine, which costs KRW 150,000 to 200,000. For this reason, the vaccine is more used in general hospitals than in clinics. Vaccination with Shingrix is expected to become more active in front-line hospitals and clinics as the price burden felt by consumers gradually decreases. A GSK official said, "Shingrix showed superior results in clinical trials. Based on this, Shingrix is maintaining a high market share in the markets where live vaccines have already been released, such as the US, Canada, and Belgium. We will continue to make efforts to reduce the disease burden of shingles for healthcare professionals and those at risk by stably settling in the Korean market.”
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- BMS’s oHCM drug Camzyos approved in Korea
- by Jung, Sae-Im May 25, 2023 05:46am
- BMS Korea (Country Manager: Hye Young Lee) announced on the 24th that the Ministry of Food and Drug Safety has approved the company’s obstructive hypertrophic cardiomyopathy (oHCM) treatment ‘Camzyos (mavacamten)’ to treat adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (oHCM) to improve exercise capacity and symptoms. Camzyos is the first and only FDA-approved cardiac myosin inhibitor that specifically targets excess myosin actin cross-bridge formation, which is the main cause of oHCM. Camzyos can improve left ventricular hypertrophy and left ventricular outflow tract obstruction by separating myosin from actin and relaxing the over-contracted heart muscle. oHCM is a rare disease that occurs when the left ventricular muscle of the heart becomes abnormally thick, obstructing blood flow through the aorta to the rest of the body. Its main symptoms are shortness of breath, dizziness, chest pain, fainting, etc., which appear in various ways and can increase the risk of various cardiovascular complications such as heart failure and atrial fibrillation. It can cause sudden cardiac death during exercise, especially in young adults and children aged 10 to 35 years. There had remained a high unmet need for the treatment oHCM as its treatment focused more on symptom relief than fundamental cure. Treatment options such as beta-blockers and non-dihydropyridine calcium channel blockers can reduce the heart rate and myocardial contractility, but it is difficult to expect long-term improvement with these existing drug treatment options alone. In addition to this, other available options involve surgically removing the enlarged myocardium or injecting alcohol to cause necrosis of the muscle area, but such procedures are performed to a limited extent due to high risk. Sang-Chol Lee, Professor of Cardiology at Samsung Medical Center, said, “oHCM is a serious and rare condition that can even cause sudden cardiac death without warning. We had much difficulty with its treatment as no effective method of treatment had been available for the non-invasive treatment of the enlarged heart structure, which led to patients experiencing worsening symptoms. Camzyos is the first cardiac myosin inhibitor that specifically targets the source of oHCM. The drug, which only needs to be administered orally once a day, showed excellent symptom improvement effect from the beginning of treatment, and is expected to help restore the quality of life for our patients.” The Phase III EXPLORER-HCM trial, which served as the basis for approval, Camzyos demonstrated statistically significant improvements in heart function and exercise capacity compared to placebo. In the trial, the composite primary endpoint was set as the proportion of patients who achieved either an improvement of mixed venous oxygen tension (pVO2) plus maintenance or improvement in NYHA class. Trial results showed twice more patients receiving Camzyos achieved the primary endpoint compared to the placebo. In particular, 20% of the patients that received treatment with Camzyos achieved both primary endpoints, pVO2 improvement, and the NYHA class requirement, and the heart function of half of those patients treated with Camzyos had improved to Class I, the mildest stage. The treatment effects of Camzyos remained consistent throughout the study for 30 weeks. Also, the left ventricular outflow tract (LVOT) gradient improved to the extent that 70% of the patients would not consider surgery. The proportion of patients who improved below the LVOT pressure difference of 50mmHg, which is the standard considered for surgery, showed a large difference of more than 50%, with 74% in the Camzyos arm and 21% in the placebo arm. The proportion of patients who improved to less than 30 mmHg, which is even lower, was also 57% in the Camzyos group, which was higher than the 7% in the placebo group. BMS Korea’s Country Manager Hye Young Lee, said “We are pleased to be able to provide a fundamental treatment benefit with Camzyos for Korean patients with oHCM who have been experiencing worsening symptoms, to the extent that patients had difficulty continuing on their daily life and were at risk of sudden death. We hope that the approval of Camzyos will be able to contribute not only to the treatment of domestic oHCM patients but also to restore their normal daily life," he said.
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- Latecomer new CML drug Bosulif attempts reimb in Korea
- by Eo, Yun-Ho May 25, 2023 05:46am
- The latecomer leukemia treatment ‘Bosulif’ is attempting to receive reimbursement in Korea. According to industry sources, Pfizer Korea submitted an application for its Chronic Myelogenous Leukemia (CML) treatment Bosulif (bosutinib), and is receiving a review for its reimbursement. The drug, which was approved in January in Korea, was rather late in entering Korea after it was approved by the U.S. FDA in 2012. Bosulif is a 2nd generation targeted anticancer therapy like Novartis Kroea’s ’ ‘Tasigna (nilotinib),’ BMS Korea’s ‘Sprycel (dasatinib),’ Il-Yang Pharamceutical’s ‘Supect (radotinib)’. With so many drugs already on the market, no major difficulties are expected in Bosulif’s reimbursement process. Bosulif’s safety and efficacy were verified through a Phase III trial (NCT02130557) that was conducted on patients with newly-diagnosed Ph+ CML. The major efficacy outcome measure was the major molecular response (MMR) at 12 months. Results showed that MMR at 12 months was 47% in the Bosulif arm. The MMR in the comparator arm, which administered the 1st generation drug Glivec (imatinib), was 36%. MMR at 60 months was 74% in the Bosulif arm and 66% in the Glivec arm. The median time to MMR in respondents after 60 weeks of follow-up was 9.0 months in the Bosulif arm and 11.9 months in the Glivec arm In the market, next-generation CML-targeted anticancer drugs are already entering the market. Otsuka Pharmaceutical Korea’s Iclusig (ponatinib)’ is a 3rd generation treatment, and Novartis Korea’s Scemblix (asciminib) is available as a 4th generation treatment. Iclusig was listed for reimbursement in Korea in 2018, and Scemblix passed the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee in April and the company is conducting drug pricing negotiations with the National Health Insurance Service.
