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- 2025-12-26 15:39:16
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- General hospitals to prescribe Dupixent for adolescents
- by Eo, Yun-Ho Mar 17, 2021 06:10am
- An atopic dermatitis treatment for children and adolescents Dupixent is to be prescribed at general hospitals in South Korea. A related industry source reported Sanofi Genzyme’s atopic dermatitis treatment Dupixent (dupilumab) 200 mg has been passed by drug committees at Seoul National University Hospital, National Medical Center, Korea University Ansan Hospital, Ulsan University Hospital, Chonnam National University Hospital, and Kangdong Sacred Heart Hospital. Other Big Five tertiary healthcare institutes are also currently reviewing the drug for prescription. The low-dose (200 mg) Dupixent is indicated to treat adolescents aged over 12 weighing less than 60 kg with severe atopic dermatitis. After administering an initial load of 400 mg, the maintenance load of 200 mg can be injected every other week. The injection also expanded its indication to treat pediatric patients at age six through 11 with severe case of atopic dermatitis. The 200 mg dose is also applicable for the expanded indication. However, the 200-mg dose of Dupixent is not covered by the National Health Insurance (NHI). NHI-covered Dupixent is eligible for treating adult patient over the age of 18 with severe chronic atopic dermatitis apparent for over three years, who has uncontrolled condition after four-week topical treatment as first-line treatment, and not showing more than 50 percent improvement in Eczema Area Severity Index (EASI) score after three-month systemic immunosuppressant therapy; has EASI score over 23 before administrating the treatment. The coverage is, however, only applicable for 300 mg dose. The LIBERTY AD ADOL trial has confirmed the efficacy and safety profile of Dupixent 200 mg. The trial, participated by 251 adolescent patients with severe atopic dermatitis, found the drug improved the size and severity of the skin lesion by 66 percent at week 16 in patient groups administered with 200 mg and 300 mg, who also demonstrated statically significant improvement in quality of life. And a Phase III LIBERTY AD PEDS study conducted on 367 pediatric patients age six through 11 observed Dupixent improving the skin lesion, itchiness and quality of life in pediatric patients with severe atopic dermatitis. About 75 percent of the patient group administered with a combination of Dupixent and topical corticosteroids scored EASI 75, which was far better improved than 26.8 percent among the placebo group. From January 2021, Dupixent was applied with a special case reimbursement for the patients with severe case of atopic dermatitis, dropping their copayment rate from 60 percent to 10 percent. Initially, the patients had to pay about 12 million won for administering 27 loads annually at a tertiary healthcare institute, but now they can pay only 2 million won annually with the special case coverage.
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- Yuhan to sell Samsung’s biosimilar for Humira in Korea
- by An, Kyung-Jin Mar 17, 2021 06:09am
- AdalloceSamsung Bioepis announced on the 15th that it has signed a marketing partnership with Yuhan for domestic sales of Adalloce, biosimilar for Humira. Adalloce is a biosimilar of Adalimuma with the largest global sales. It was the first in Korea to be approved for sale among the biosimilars for Adalimuma. It treats autoimmune diseases such as rheumatoid arthritis, ankylosing spondylitis, and Crohn's disease through a mechanism that suppresses the expression of tumor necrosis factor (TNF-α) in the body. Samsung Bioepis obtained a marketing license for Adalloce from the MFDS in September 2017, and has been preparing for domestic release through a licensing agreement with AbbVie, an original developer. Adalloce was released in Europe under the product name Imraldi in October 2018. Since then, it has recorded cumulative sales of $417 million (about ₩450 billion) until the end of last year. In May 2019, it was approved for sale by the FDA under the product name Hadlima. According to the licensing agreement with AbbVie, it is planned for July 2023. Adalloce's domestic release is expected in the first half of this year. After Adalloce is released in the domestic market, Samsung Bioepis will release all three biosimilars of blockbuster products in the field of TNF-α inhibitors in Korea. The market size is about ₩200 billion. Yuhan is in charge of sales of Etoloce, biosimilar for Enbrel and Remaloce, biosimilar for Remicade, previously released by Samsung Bioepis in the domestic market. Through this contract, Samsung Bioepis is in charge of the domestic sales of three autoimmune disease treatments, further strengthening the partnership between the two companies. Samsung Bioepis President Han-Seung Koh said, "We are pleased to be able to introduce biosimilar products of the world's most widely used drugs in Korea. We will continue to strive to expand treatment opportunities through high-quality medicines to patients."
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- Praluent is in the process of listing insurance benefits
- by Eo, Yun-Ho Mar 17, 2021 06:09am
- Sanofi-Aventis' PCSK inhibitor Praluent is belatedly in the process of registering insurance benefits. It is slow compared to the rival drug Amgen's Repatha. According to the industry on the 12th, Praluent (Alirocumab) was recently judged appropriate for benefit from the HIRA's Pharmaceutical Benefits Advisory Committee. It is a PCSK9 inhibitor and was first approved in Korea in January 2017. Since April of the same year, Repatha(Evolocumab) was approved and was first listed as an indication of HOFH (Homozygous Familial Hypercholesterolemia) in August 2018. In January 2020 Repatha succeeded in expanding the benefit criteria to patients with ASCVD, atherosclerotic cardiovascular disease, HeFH, Heterozygous Familial Hypercholesterolemia, and statin intolerance. The PCSK9 inhibitor is a drug that has excellent efficacy but has a price issue. There were problems both at home and abroad, and Amgen cut the prices of their drugs by 60% in October 2018 and Sanofi in February 2019. Sanofi voluntarily withdrew Praluent's listing in October 2018, before the drug price cut, and passed the Pharmaceutical Benefits Advisory Committee, about two years later. Interest is focused on what changes Prarent will bring to the market after 4 years. Domestic treatment guidelines recommend that patients with ASCVD (AtheroSclerotic CardioVascular Disease) be adjusted to less than 70mg/dL LDL-C to prevent recurrence of cardiovascular disease. In 2019, the European Society of Cardiology lowered the target LDL-C level for ultra-high-risk groups to less than 55 mg/dL. Accordingly, there is increasing interest in the clinical field about PCSK9 inhibitors, which are useful for ultra-high-risk patients who cannot reach the target level with existing treatment regimens. Praluent has a tendency to reduce the risk of all-cause death, and there are Praluent 75mg and Praluent 150mg available. It is possible to select a dose for each patient based on the patient's condition and LDL-C level.
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- Takeda to chase Roche in ALK targeted therapy market
- by Mar 16, 2021 06:22am
- Product images of ALK-positive treatment. Clockwise from left: Xalkori, Zykadia, Alunbrig and Alecensa The follow-on drug competition within the anaplastic lymphoma kinase (ALK)-positive lung cancer treatment market is intensifying with more competitors joining the race. From next month, Alunbrig (brigatinib), receiving the National Health Insurance (NHI) reimbursement for the first-line therapy for lung cancer, and the market leader Alecensa (alectinib) are to engage in a fierce competition. On top of everything else, a third-generation new drug following after Xalkori (crizotinib) is to be introduced. The ALK-targeting treatment market has been dominated by Pfizer Pharmaceutical Korea’s Xalkori so far. As a first-generation ALK tyrosine kinase inhibitor (TKI), it has been generating 50 billion won annually in sales. Like the epidermal growth factor receptor (EGFR) targeted therapy market, ALK TKI market has been reshuffled since second generation drugs were released to the market. Particularly, Roche’s Alecensa has been strongly asserting its market presence as soon as it entered the market. Alecensa, approved as a third ALK targeted therapy in South Korea in 2016, has expanded its indication to treat ALK-positive patients with non-small cell lung cancer (NSCLC) as a first-line therapy in April 2018, and requested for the reimbursement listing in December of the year. Immediately after getting listed for the first-line therapy indication, Alecensa sales exceeded Xalkori’s. In 2018, Alecensa sales hit 10.4 billion won, or a quarter of Xalkori’s at 49.6 billion won, but after the listing in 2019, the drug generated 22.1 billion and surpassed Xalcori making 20.3 billion won. Technically, Alecensa took over a half of Xalkori’s market share. Even last year, Alecensa made 29.3 billion won and topped the ALK treatment market. Regardless, even Alecensa is to face another new comer. Takeda Pharmaceuticals’ Alunbrig is swiftly prepping to overtake Alecensa’s place. As a fourth ALK TKI drug in South Korea, Alunbrig was authorized in December 2018. In the following year, the drug was released in the second quarter and raised 1.2 billion won. Takeda Pharmaceuticals is speeding up the drug’s marketing procedure as it started late as a second generation drug. The multinational company has immediately requested for the reimbursement as soon as Alunbrig’s expanded indication for the first-line therapy was cleared in last August. The drug has been passed by Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation convened last January. The drug is expected to win the coverage for the first-line therapy within the first half of the year at earliest. Alunbrig is the first solid cancer treatment Takeda Pharmaceuticals launched. Backed by the company’s big ambition, the drug sales generated 3.9 billion won in 2020, which fell short of Alecensa and Xalkori’s, but it is looking forward to rapidly grow in the market with the first-line therapy expansion. Moreover, the market is going to open a door to a third generation ALK TKI new drug this year as well. Pfizer Pharmaceutical that developed Xalkori is preparing to launch Lorbrena (lorlatinib). Submitting the approval application last year, Pfizer is currently in process of reviewing Lorbrena with South Korea’s Ministry of Food and Drug Safety (MFDS). Lorbrena is also to accelerate the expansion to the first-line therapy. Already in the U.S., the drug successfully won the first-line therapy indication as of Mar. 8. Categorized as a third generation drug, Lorbrena can reportedly cover more resistance gene mutations. Meanwhile, Novartis’ Zykadia (ceritinib) was quickly introduced to the market, the prescription market seems to be disinterested in the drug. Zykadia has raised 800 million won in sales, which was lower than Alunbrig’s that entered the market last.
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- Binex is likely to be removed from the KPBMA member list
- by Nho, Byung Chul Mar 16, 2021 06:22am
- The KPBMA It is observed that Binex, which is suspected of changing the manufacturing of active pharmaceutical ingredients, has a strong expulsion from the KPBMA membership. The KPBMA is expected to hold a meeting of the board of directors on the 16th and refer the agenda on the Binex situation to the ethics committee. In a statement on the 11th, the KPBMA is highly likely to convene an ethics committee with the unanimous opinion of 14 directors and presidents in order to degrade K-Bio status and protect the right to public health. If the board of directors' opinion is gathered on this day, the ethics committee will convene within 3 days at the latest, and it is expected that a prompt decision will be made. Since the establishment of the KPBMA in 1945, Wales Korea has the only precedent for the withdrawal of regular members. Wales Korea was expelled from the KPBMA by changing the date of manufacture of the drug that expired in 2013. Pharmaking was prosecuted by the prosecution for a rebate in 2016 and voluntarily withdrew after being suspended from qualification by the association's ethics committee. If Binex is subject to disqualification, it will be the second expulsion case ever. However, the Ethics Committee may consider the pharmacy precedent as much as possible and refine it to suspension of qualifications rather than expulsion or forced withdrawal. Binex joined the association in 1957 under the name of the former Suncheondang and has been active as a member for 65 years. The ethics committee is chaired by Yun Sung-tae, vice-chairman of Huons Global, and consists of 7 members, including President Oh Heung-ju, DongKook (Vice Chairman) and Lee Won-beom, CEO of Whanin (a member). Looking at the membership management regulations of the association,'The chairman may request a deliberation by the ethics committee when it is recognized that a member has a reason for disciplinary action in the articles of association. The association shall notify the member in writing of the fact of the claim and the grounds for disciplinary action recognized, and give them an opportunity to clarify.' Therefore, Binex of the Ethics Committee, a member of the Pharmaceutical Association, has the strongest force. The meeting of the chairman and the directors on the 16th, deciding whether to refer to the ethics committee 2013 Wales Korea Pharm's first expulsion precedent, likely to follow the procedure of suspension of qualification → voluntary withdrawal. Immediate decision after convening of ethics committee within a few days, unanimous public opinion rises. It is observed that Binex, which is suspicious of a change in the manufacture of the main ingredient of pharmaceuticals, is likely to be expelled from The KPBMA as a full member. The KPBMA is expected to hold a meeting of the board of directors on the 16th and refer to the Binex situation to the ethics committee. In a statement on the 11th, the KPBMA is highly likely to convene an ethics committee with the unanimous opinion of 14 directors and presidents in order to degrade K-Bio status and protect the right to public health. If the board of directors' opinion is gathered on this day, the ethics committee will convene within 3 days at the latest, and it is expected that a prompt decision will be made. Since the establishment of The KPBMA in 1945, Wales Korea Pharm has the only precedent for the withdrawal (dismissal) of regular members. Wales Korea Pharm was expelled from the Association by changing the date of manufacture of the drug that expired in 2013. Afterwards, Pharmaking, who was prosecuted by the prosecution for a rebate in 2016, voluntarily withdrew after being suspended from qualification by the association's ethics committee. If Binex is subject to disqualification, it will be the second expulsion case ever. However, the Ethics Committee may consider the pharmacy precedent as much as possible and refine it to suspension of qualifications rather than expulsion or forced withdrawal. Binex joined the association in 1957 under the name of the former Suncheondang Pharmaceutical Company and has been active as a member for 65 years. Meanwhile, the ethics committee is chaired by Yun Sung-tae, vice-chairman of Huons Global, and consists of 7 members, including President Oh Heung-ju, DongKook (Vice Chairman) and Lee Won-beom, Whanin President (Committee). Looking at the membership management regulations of the association,'The chairman may request a deliberation by the ethics committee when it is recognized that a member has a reason for disciplinary action in the articles of association. The association shall notify the member in writing of the fact of the claim and the grounds for disciplinary action recognized, and give them an opportunity to clarify.' Therefore, when or after the convocation of the Ethics Committee this time, attention is also being paid to whether Binex's executives will appear in person to explain the overall situation or replace them in writing.
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- SGLT-2 inhibitor Jardiance to expand HF indication
- by Eo, Yun-Ho Mar 15, 2021 06:28am
- Following after Forxiga, Jardiance is also preparing to introduce the heart failure indication in South Korea. According to a pharmaceutical industry insider, Boehringer Ingelheim Korea is waiting for the health authority’s review result in its sodium-glucose cotransporter 2 (SGLT-2) inhibitor Jardiance’ request to expand indication in treating adult patients with heart failure with reduced ejection fraction (HFrEF) regardless of diabetic status. The South Korean authority has approved the same indication in competing Forxiga (dapagliflozin) in last December. The U.S. Food and Drug Administration (FDA) has reportedly granted a fast-track status on Jardiance’ indication, which is also under review in other countries like Japan. The drug’s efficacy in heart failure treatment has been statistically confirmed by a Phase III EMPEROR-Reduced trial. The study verified Jardiance met the primary endpoint by demonstrating 25 percent lower risk in cardiovascular related death or hospitalization by a heart failure, compared against placebo. Evaluating the secondary endpoint, Jardiance lowered the risk of a first hospitalization by a heart failure and repeated hospitalization by 30 percent. And for a new indicator, the decrease in estimated glomerular filtration rate (eGFR) by the drug was significantly delayed compared to the placebo. In last year, American Society of Nephrology (ASN) also disclosed the result of sub-analysis on EMPEROR-Reduced trial at 'Kidney Week 2020.' The analysis studied various subgroups of patients, including groups with severe renal impairment, experienced the drug’s benefit regardless of the chronic renal disease. The president of the Korean Society of Heart Failure and a cardiology professor at Seoul National University Bundang Hospital, Dr. Choi Dong-ju noted, “The size of heart failure patients in South Korea has almost doubled within last decade. The prevalence in heart failure will increase continuously in the future due to the aging society. But it is satisfying to see the EMPEROR-Reduced trial showing a positive outcome in treating heart failure.” Meanwhile, the FDA has designated the fast-track review status on EMPEROR program, which consists of EMPEROR-Preserved and EMPEROR-Reduced trials on evaluating Jardiance’ efficacy in lowering the risk of cardiovascular related death and hospitalization by heart failure. The EMPEROR-Preserved trial aims to assess Jardiance’ effect on cardiovascular related death and hospitalization by heart failure in patients with Heart failure with preserved ejection fraction (HFpEF). Currently, the health condition does not have any specific treatment for it, and the trial result would be disclosed within this year.
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- HER2 targeted therapy market exceeds KRW 200 billion
- by An, Kyung-Jin Mar 15, 2021 06:28am
- The South Korean market for targeted therapy prescribed to treat human epidermal growth factor receptor 2 (HER2)-positive breast cancer has exceeded 200 billion won in sales last year. Two domestically developed biosimilars increased the market influence and made up for the sale revenue void in the original by the original maker’s follow-on drugs, such as Kadcyla and Perjeta, breaking the market sales record. On Mar. 11, a pharmaceutical market research firm IQVIA reported the trastuzumab drug market size last year dropped to 99 billion won by year-on-year 4.8 percent. The market size increased for two consecutive years since it plummeted from 103.4 billion won in 2016 to 83.6 billion won in 2017, and recovered up to annual sales of 100 billion in 2019. But it took a slight fall after a year. Trastuzumab is the key substance in a targeted therapy Herceptin by Roche. The drug is prescribed to HER2-positive patients with metastatic breast cancer and stomach cancer. In South Korea, two biosimilars of the original Herceptin—Celltrion’s Herzuma and Samsung Bioepis’ Samfenet—were released to the market after the original’s patent expired. The original generated sales of 69.9 billion won last year. Compared against the year before, it was dropped by 11.2 percent. And compared against 103.4 billion won raised in 2016, before the biosimilars were released, one-third of the sales were evaporated. Herceptin’s pricing was brought down by 20 percent, from 517,628 won to 414,103 won per 150 mg injection, two months after Celltrion’s Herzuma was listed for National Health Insurance (NHI) reimbursement in April 2017. And with another pricing drop, the original drug is currently maintaining the pricing at 362,340 won since April last year. By principle of the South Korean drug pricing system, a biosimilar can be priced at 70 percent of the original’s pricing before the patent expiration. And from October 2016, an item ‘developed by a company recognized as an innovative pharmaceutical company or a company with collaborative deal between South Korean and global companies, released first time internationally in South Korea, or manufactured in South Korea’ can be priced up to 80 percent of the original. Meanwhile, an off-patent original’s pricing is reduced to 70 percent to 80 percent of the initial pricing when a biosimilar is launched. The trastuzumab drug market shrunk down to 83.6 billion won due the pricing reduction in Herceptin in 2017. But as biosimilars developed with South Korean technology pushed the sales, the market growth is catching up with the original’s gap. Celltrion’s Herzuma sales last year grew by 10.4 percent from the year before and generated 25.4 billion won. The Ministry of Food and Drug Safety (MFDS) authorized the sales of Herzuma in January 2014 and the drug started making sales revenue from the third quarter of 2017. The 2018 sales was stale with 7.7 billion won, but the sales surged to 23 billion won in 2019 and it is keeping the growth ever since. However, the domestic market share of Samsung Bioepis’ Samfenet is still insignificant. Samfenet generated 3.6 billion won last year. Although the sales grew by 65.8 percent compared to the year before, the gap with the competitor is rather substantial. Currently, Daewoong Pharmaceutical is in charge of Samfenet sales. Within three years of releasing the biosimilars, their market share in the trastuzumab drug market grew exponentially. The two biosimilars took 29.3 percent of the last year’s trastuzumab drug market sales. Herzuma’s share is at 25.7 percent, when Samfenet took up 3.6 percent. Basically, Herzuma led the biosimilar market expansion. And the targeted therapy market for the HER2-positive breast cancer patients expanded vastly as Herceptin developer Roche released follow-on drugs Kadcyla (trastuzumab emtansine) and Perjeta (pertuzumab). Around 15 percent to 20 percent of the total breast cancer patients are confirmed positively with HER2, which has fast relapse and short survival period. Roche’s Kadcyla generated 43.5 billion won last year, growing 22.7 percent from the year before. Kadcyla is the first antibody drug conjugate (ADC) Roche first show cased for the breast cancer sector. The drug can be prescribed to treat unresectable locally advanced or metastatic breast cancer in patients previously treated with trastuzumab and taxane. During the same time, Roche’s Perjeta generated 74.1 billion won. Growing 33.1 percent compared to the year before, the sales surpassed Herceptin for the first time. The drug, in combination with docetaxel and trastuzamab, can be prescribed to patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous HER2 targeted therapy or chemotherapy. As it was listed for selective reimbursement in May 2019, the combination therapy with trastuzumab became the standard adjuvant treatment before a surgery. Five drugs including the three trastuzumab drugs, Kadcyla and Perjeta, have raised 216.6 billion last year together and increased the market by 11.0 percent from the year before. Compared to 116.1 billion won in 2016, the market sales have almost doubled in four years and broke the record. The industry evaluates Roche has overcome off-patent Herceptin’s sales drop with the follow-on drugs. Also the HER2-positive breast cancer patients would benefit from the expanded treatment options.
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- 3 companies have abandoned Pelubi's patent challenge
- by Kim, Jin-Gu Mar 12, 2021 06:22am
- Pelubi Pharmaceutical companies that were trying to overcome the patent of Daewon's anti-inflammatory pain reliever Pelubi (Pelubiprofen) gave up. After Mother's and Hutecs voluntarily withdrew the request for a referee last year, Nexpharm was recently added, leaving only three of the six challengers. Some of the companies that voluntarily withdrew are said to have failed to develop the formulation. According to the pharmaceutical industry on the 10th, Nexpharm withdrew the trial to confirm the passive scope of rights for the Pelubi recently filed against Daewon. The third step after Mother's and Hutecs. Hutecs gave up its patent challenge in September of last year and in October of the same year. As a result, only three companies are left to challenge the Pelubi patent. Youngjin Pharm, Huons, and Chong Kun Dang, who first requested a patent trial, are planning to continue the patent challenge. Pelubi is a Korean new drug No. 12 developed by Daewon. After launching in 2008, the initial sales did not meet expectations. Until 2014, Pelubi's outpatient prescription was less than ₩5 billion. Then, as Daewon released the Sustained Release type as a generic, sales increased as additional indications were secured through follow-up clinical trials. Daewon launched the Pelubi SR in June 2015. In 2017, Pelubi's prescription amount surged with the addition of an indication of antipyretic action. Since 2019, it has produced more than ₩30 billion in prescriptions. Then the patent challenge continued. Starting with Youngjin Pharmaceutical in December 2019, Huons, Chong Kun Dang, Nexpharm, Hutecs, Mother's, etc., challenged the drug patents that expire in November 2028. At the same time, it started to develop generic for Pelubi. Excluding Chong Kun Dang, the remaining five companies were approved for generic for Pelubi bioequivalence test. The bioequivalence test was recently completed. However, it is confirmed that some companies have failed to prove bioequivalence. An official in the pharmaceutical industry said, "Pelubi ( Pelubiprofen) is a product with improved dissolution rate and stability, and development is difficult due to the nature of the formulation." He said, "I know that some of the companies that gave up the patent challenge have failed to develop the formulation they were aiming for."
- Company
- Genuone is licensed to manufacture Pariet
- by Kim, Jin-Gu Mar 11, 2021 06:07am
- Genuone received permission to change the manufacturer of Pariet (Rabeprazole) with an annual prescription amount of ₩15 billion. This is the first achievement since its independence from Kolmar Korea and officially launched earlier this year. Genuone announced on the 9th that it has received permission to change the manufacturer of Pariet 10mg/20mg from the MFDS. Pariet is a PPI (proton pump inhibitor)-based anti-ulcer drug developed by Japanese pharmaceutical company Eisai. According to the drug market research institute UBIST, the amount of outpatient prescriptions last year was ₩10 billion. Janssen Korea introduced it in 2000. However, when it decided to withdraw from the Hyangnam factory, the manufacturer had to change. Genuone has been pursuing the conversion of Pariet manufacturers before becoming independent from Kolmar Korea. In August 2019, the bioequivalence test was approved. This is to confirm the equivalence between the existing Pariet and the product to be produced by Genuone. Subsequently, manufacturing technology was transferred through collaboration with Eisai, and in April of last year, item approval for Pariet 10mg/20mg was acquired from Janssen Korea. Through this, the company has acquired ₩10 billion worth of items per year while obtaining approval for the relocation of the manufacturer. The first lot release is expected in April. Sales are jointly handled by Eisai and Yuhan as before. This is the first achievement since Genuone was officially launched in January of this year. Genuone is a corporation formed by the acquisition of Kolmar Korea's pharmaceutical division and Kolmar Pharma's CMO division by IMM Private Equity, a domestic private equity fund. After the acquisition of CJ Healthcare, Kolmar Korea promoted the sale of Kolmar with the pharmaceutical division, and the sale was completed last year. Kim Mi-yeon, CEO of Genuone, said, "Starting with the production of Pariet, we will further strengthen our partnership with Eisai and expand our partnership with global pharmaceutical companies."
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- Tecentriq as liver cancer first-line treatment green lit
- by Mar 11, 2021 06:07am
- The South Korean health authority is seemingly giving a green light to an immunotherapy Tecentriq for its combination therapy as a first-line treatment in liver cancer. A pharmaceutical industry source reported on Mar. 9 that the Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee approved of the clinical efficacy in Roche’s Tecentriq (atezolizumab) plus Avastin (bavacizumab) combination therapy for patients with unresectable hepatocellular carcinoma, who have not received prior systemic therapy. The first threshold for the reimbursement was passed at the committee meeting convened on Feb. 24. The Tecentriq combination therapy has won the first-line treatment indication for hepatocellular carcinoma from the Ministry of Food and Drug Safety (MFDS) on July 31, 2020. It is the first and only hepatocellular carcinoma indication for an immunotherapy in South Korea. Moreover, Tecentriq combination therapy has overcome the biggest impediment of the Cancer Deliberation Committee in last February. Apparently, the committee did not demand for specific condition. The rest of the process is HIRA Drug Reimbursement Evaluation Committee (DREC) and National Health Insurance Service (NHIS) drug pricing negotiation. Considering rarely any Cancer Committee-approved drug fails to pass DREC these days, the next big issue with listing the Tecentriq liver cancer indication would be the pricing negotiation with NHIS. Meanwhile, the efficacy of Avastin combination therapy treating patients with hepatocellular carcinoma was confirmed in the IMbrave150 study. The result found the patient group using Tecentriq in combination with Avastin reduced the risk of disease worsening or death by 42 percent, compared with Nexavar (sorafenib) patient group. The Tecentriq plus Avastin therapy was also confirmed superior than Nexavar therapy as the combination therapy group’s mPFS marked 6.8 months, which was significantly longer than Nexavar group’s 4.3 months. The combination therapy has not reached the mOS, but the median value during the monitoring phase was at 8.6 months. Nexavar had mOS of 13.2 months. Also the combination therapy’s response rate at 27 percent doubled Nexavar therapy’s at 12 percent. However, the Cancer Deliberation Committee rejected the indication expansion requests on a combination therapy with paclitaxel in treating patients with triple-negative breast cancer (TNBC) as a first-line treatment, and a combination of bevacizumab, paclitaxel and carboplatin in treating patients with non-squamous non-small cell lung cancer (NSCLC) as first-line treatment.
