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- 2026-04-12 02:53:19
- Policy
- Abbott has filed a suspension of execution with the court
- by Kim, Jung-Ju Jul 18, 2022 06:06am
- Abbott Korea, which has been in a dispute with the Ministry of Health and Welfare, immediately filed an appeal against the administrative court ruling by raising the issue of lowering the additional revaluation of the Rytmonorm SR series. Leo Pharma, which raised the issue together last year, decided to avoid legal confrontation with the government and abandoned the appeal. As a result, the drug price of Leo Pharma's seven items has been lowered as planned by the government from the 15th, and the drug price of Abbott's three items will be temporarily maintained due to the suspension of execution. Abbott appealed to the High Court for a total of three products containing Rytmonorm SR 225mg, 325mg and 425mg, and applied for a suspension of execution of the government's drug reduction plan (Notice No. 202-223), which the court accepted. Earlier in September 2021, the MOHW decided to conduct an additional revaluation by extensively overhauling the additional system that adds to the drugs listed on the list and conducting the first drug reduction according to the results. Products from these companies were included in the target. The lawsuit began as companies that were hit by the weak cut immediately protested. However, as the Seoul Administrative Court recently ruled in favor of the government, the first lawsuit ended, and at the same time, the suspension of execution, which temporarily maintained the price until the ruling, ended. But Abbott immediately appealed. Accordingly, the High Court decided to maintain the original price until the ruling, citing the suspension of execution applied by the company. Once the suspension of execution is maintained from the 15th to the 29th of this month, it is highly likely that the extension will be repeated again if the lawsuit is prolonged. Leo Pharma chose to give up the appeal and the drug price was immediately lowered. "We have decided not to proceed with the appeal process by persuading the Danish headquarters about the ongoing revaluation lawsuit," said Leo Pharma. The company added, "There is no way to recover from the decline in sales, but we decided to give up the appeal to do our best to meet social responsibility as a pharmaceutical company." Meanwhile, the ministry plans to guide further changes during the lawsuit.
- Company
- GC WellBeing transfers raw materials technology to Japan
- by Jul 18, 2022 06:06am
- GC Wellbeing (CEO Kim Sang-hyun) announced on the 15th that it has signed a technology transfer contract with Japan's Healthy Navi for the functional raw material Green-Cera F. Healthy Navi is a company in charge of product development and distribution of functional and general food ingredients in Japan. Green-Cera F is a raw material recognized by the Ministry of Food and Drug Safety for its functionality that can help stomach health by protecting the gastric mucosa. Through non-clinical tests, it has been confirmed that this raw material can help stomach health, such as antioxidant, anti-inflammatory, protecting the gastric mucosa, and increasing the amount of gastric mucus. In addition, through human application tests, statistically significant improvement was shown in the gastrointestinal liver symptom scale item. Through this contract, GC Wellbeing provides Green-Cera F to Healthy Navi and receives royalties for raw material sales in Japan. Healthy Navi will secure Green-Cera F's exclusive supply rights to Japan and the right to develop and launch products using this raw material. The company plans to further accelerate the overseas expansion of excellent functional materials held under this contract and expand markets such as Asia, the U.S., and Europe outside Japan. An official from GC Wellbeing said, "This contract is the first case of technology transfer of its functional raw materials overseas." "We plan to actively promote overseas expansion of our company's functional materials in the future," he said. GC Wellbeing is researching and developing functional raw materials derived from various natural products, which can help joint and cartilage health.
- Opinion
- [Reporter’s View] Postponing clinical reevaluations by 1 yr
- by Lee, Tak-Sun Jul 18, 2022 06:05am
- The National Health Insurance Service’s Drug Reimbursement Evaluation Committee conducted its first reevaluation to assess the reimbursement adequacy on the anti-inflammatory streptokinase/streptodornase combo and decided that the combination is inadequate for insurance benefit. The drug has been used to ▲relieve acute inflammatory edema exacerbation due to ankle surgery or trauma, and ▲ to address the expectoration of sputum difficulties that accompany respiratory disorders. However, as the drug is not listed for reimbursement in any of the A8 reference countries (the US, the UK, France, Italy, Japan, Germany, Switzerland, and Canada), the combination was highly likely to receive negative results during reevaluation. The issue that arises here is that Korean pharmaceutical companies are conducting domestic clinical trials to supplement the lacking evidence on its use overseas. The Ministry of Food and Drug Safety ordered companies to conduct a clinical reevaluation for the drug, under which companies have been investing their own resourcesinceom 2017 to demonstrate the efficacy of the combination. SK Chemical, which owns the original Varidase Tab, is taking lead in demonstrating the drug’s efficacy in the first indication, and Hanmi Pharmaceutical, which has made the highest performance in the market with its Mucolase Tab, is leading the clinical trials for the second indication. With patient recruitment complete for both trials, the companies only have final analysis reports left. The companies are required to submit the final result report to the MFDS in 1H next year. In line with this progress, the companies subject to reimbursement cancellation requested that the reimbursement reevaluation be pushed back one year, to after the final report for the clinical reevaluation is submitted. However, on the 7th, DREC turned down the companies’ requests. It could seem harsh, as the companies were only asking for a 1-year grace period rather than avoiding the reevaluation in its entirety. However, HIRA’s reasons for the refusal, such as maintaining equity with other ingredients and the differences that exist in their purpose and method was also reasonable. However still, the streptokinase/streptodornase combination is the only drug that will submit clinical reevaluation results next year among drugs subject to reimbursement reevaluations this year. The result report for drugs such as acetyl L carnitine and oxiracetam that will receive reimbursement reevaluations next year are scheduled to submit results this year. Also, the differences in purpose and method that HIRA pointed out can be addressed by HIRA’s postponement of the reimbursement reevaluations. If streptokinase/streptodornase receives a non-reimbursement decision during reimbursement reevaluations, the drive and momentum to conduct its clinical re-evaluations will dissolve into thin air. The company would see no reason to verify the efficacy of a drug that lost marketability due to non-reimbursement. If its efficacy is demonstrated through the clinical trial next year, this would then bring more serious problems, as it would be difficult to reverse the non-reimbursement judgment even though there is evidence to prove reimbursement adequacy. HIRA needs to stop drawing a line between clinical re-evaluations and reimbursement re-evaluations and rationally adjust the order of drugs subject to reevaluations by period. Then no objections will arise regarding the procedure or results. The drugs that had received non-reimbursement decisions last year are still being sold in the market after 1 year. The companies had filed a suspension of execution to the court to suspend the disposition. In this sense, 1 year is not that long a delay. The companies will be proposing 1-year grace period again in the 30-day objection submission period. Upon receiving the request, I ask HIRA and DREC to seriously consider what s more reasonable.
- Company
- SK’s epilepsy drug makes over ₩400 billion in 3 years
- by Chon, Seung-Hyun Jul 15, 2022 05:57am
- SK Biopharmaceuticals’s new anti-epileptic drug ‘Xcopri’ has brought in a total of ₩400 billion in upfront payments and milestone payments over the past 3 years. This is the largest amount of cash secured by a new drug that was licensed out by Korean pharmaceutical companies. According to the Financial Supervisory Service on the 14th, SK Biopharmaceuticals signed a licensing deal with the Brazilian pharmaceutical company Eurofarma Laboratorios SA for its anti-epileptic drug Xcopri. Under the agreement, SK Biopharmaceuticals will receive an upfront payments of $15 million and up to $47 million in milestone payments which are paid when each phase of development, approval, etc. is completed. The company will also separately collect royalties proportional to net sales upon Xcopri’s commercialization. Under the licensing agreement, Eurofarma will sell cenobamate in 17 Latin American countries including Brazil and Mexico. Eurofarma, which owns expertise in the sales and marketing of central nervous system (CNS) disorder treatments owns a sales network throughout Latin America. Cenobamate is a new anti-epileptic developed solely by SK Biopharmaceuticals from its initial development to US FDA approval as a treatment for partial-onset seizures in adults. It simultaneously regulates 2 targets related to excitatory/inhibitory signaling that is known to cause epilepsy to reduce seizure frequency. SK Biopharmaceutical received approval for cenobamate under the brand name ‘Xcopri’ from the US FDA in November 2019 and has been directly selling the drug through its US subsidiary SK Life Science ever since. SK Biopharmaceutical has been entering overseas countries other than the US by licensing out cenobamate to its local partners. SK Biopharmaceutical entered into a licensing agreement last February with the Swiss pharmaceutical company Arvelle Therapeutics to transfer technology on cenobamate for up to $530 million. At the time, SK Biopharmaceutical received an upfront payment of $100 million with no obligation of return. In October 2020, the company entered into an exclusive licensing agreement with Ono Pharmaceutical for Ono to develop and commercialize Xcopri in Japan. Under the agreement, SK Biopharmaceutical received an upfront payment of ¥5 billion with no obligation of return, and will also be eligible to receive up to ¥48.1 billion based on the achievement of certain regulatory and commercial milestones, as well as double-digit royalties on net sales generated in Japan. In November last year, SK Biopharmaceutical licensed out 6 new central nervous systems (CNS) drugs including cenobamate to Ignis Therapeutics. Under the deal, SK Biopharmaceutical received an upfront payment of $20 million, a milestone payment of $15 million, and royalties on net sales in the future. Through the technology export, SK Biopharmaceutical acquired 150 million shares of Ignis (share amounts to 44.9% including common stock). And in December last year, SK Biopharmaceutical signed a licensing deal with Endo Group for the commercialization of its epilepsy drug cenobamate across Canada. Under the deal, SK Biopharmaceutical received an upfront payment of $20 million in USD. The company will also be able to receive up to $21 million in Canadian dollars based on the achievement of certain regulatory and commercial milestones in the future. Paladin Labs Inc., a Canada-based operating subsidiary of Endo, will be responsible for all commercial activities related to cenobamate in the region, including its release. Endo is a global healthcare company headquartered in Ireland. In addition to upfront payments, the company has also received milestone payments upon cenobamate’s approval abroad. SK Biopharmaceutical received $123.22 million from its European partner Angelini Pharma as milestone payments last year. Angelini Pharma (formerly Arvelle Therapeutics UK) has collected additional milestone payments after receiving marketing authorization from the European Commission in March last year. SK Biopharmaceutical’s cash inflow from upfront payments and further milestones from the technology transfer of cenobamate is $278.22 million and ¥5 billion. Based on the recent exchange rates, the company had secured about ₩400 billion through upfront and milestone payments through technology transfer with cenobamate. This is estimated to be the largest amount earned from the technology transfer of a single new drug developed in Korea. In 2015, Hanmi Pharmaceutical received the largest amount as an upfront payment, €240 million (approximately ₩260 billion, to transfer the license of its 3 new diabetes drugs to Sanofi. No additional milestone occurred and all rights were returned to Hanmi Pharmaceutical. Yuhan Corp’s new anticancer drug ‘Leclaza (lasertinib)’ received $150 million (approximately ₩190 billion) in upfront and milestone payments. Yuhan Corp has made a licensing deal with Janssen biotech in November 2018. At the time, the company received an upfront payment of $50 million with no obligation of return. Yuhan Corp received a milestone payment of $35 million from Janssen in April 2020 for lasertinib. At the time, Janssen had paid an additional milestone to Yuhan Corp when it started a clinical trial for combination therapy using amivantamab and lasertinib. Yuhan Corp had collected an additional $65 million in milestone payments when Janssen started recruiting subjects for the Phase III trial of its self-developed anticancer drug amivantamab and lasertinib combination.
- Company
- Keytruda adds neoadjuvant/adjuvant therapy indication
- by Jul 15, 2022 05:57am
- Keytruda MSD’s anti-PD-1 immunotherapy drug ‘Keytruda (pembrolizumab)’ received approval to extend its indication as neoadjuvant/adjuvant therapy in triple-negative breast cancer (TNBC). From the 13th, the Ministry of Food and Drug Safety has extended Keytruda’s indication▲ as neoadjuvant therapy in combination with chemotherapy (carboplatin+paclitaxel, followed by doxorubicin or epirubicin+cyclophosphamide), and ▲ as adjuvant monotherapy in patients with previously untreated Stage II or III TNBC. The company expects the recent approval to benefit more patients as a PD-L1 expression test is not required for the use of Keytruda as neoadjuvant/adjuvant therapy. Also, its convenience of administration has been improved with the allowance of its administration every three weeks and every six weeks. As a result, in addition to being approved as a treatment for locally advanced recurrent or metastatic TNBC in July, the drug has established its position as a treatment in early TNBC. The recent approval as neoadjuvant and adjuvant therapy was based on the Phase III KEYNOTE-522 trial conducted in 1,174 TNBC patients. In the trial, neoadjuvant administration of the Keytruda+chemotherapy combination reduced the risk of disease progression that precluded definitive surgery, local/distant recurrence, second primary cancer, or death from any cause by 37%, and significantly prolonged event-free survival (EFS). The 36-month EFS of the Keytruda group was 84.5%, significantly higher than the 76.8% in the control group. In the median follow-up period of 15.5 months, the pathological complete response (pCR) of Keytruda as neoadjuvant/adjuvant therapy was 64.8%, a statistically significant difference from the 51.2% of the chemotherapy monotherapy group. The safety profile of the Keytruda regimen was consistent with the profile of chemotherapy or Keytruda monotherapy that is used in high-risk early TNBC patients, and no new safety concerns were identified. Most of the immune-mediated adverse events (AEs) occurred in the neoadjuvant phase. The immune-mediated AEs as adjuvant monotherapy were low-grade and at a manageable level. Sungphil Kim, Business Unit Head of the Oncology Franchise of MSD Korea, said, “We are pleased to be able to introduce Keytruda as a new therapy option for TNBC in only one year since we received approval for the first breast cancer indication. Keytruda will offer new hope to high-risk TNBC patients who are in dire need of a new treatment option by reducing tumor size as adjuvant therapy and preventing recurrence and metastasis as neoadjuvant therapy in TNBC as a single, integrated regimen."
- Company
- Daewoong expects sales of 4 new drugs to rise
- by Lee, Tak-Sun Jul 15, 2022 05:57am
- Daewoong Pharmaceutical expects sales to rise through its new drug introduced along with the new drug Fexuclue, a new drug for gastroesophageal reflux disease. This includes biosimilars such as Lexapro, Ogivri, and Alymsys, the No. 1 items in the antidepressant market. According to industries on the 14th, Daewoong Pharmaceutical is planning to continue its performance increase through its new drug introduced this year. Last year, Daewoong Pharmaceutical recorded its highest-ever performance with sales of 1.1530 trillion won and operating profit of 88.9 billion won. The driving force behind the rise in sales is P-CAB gastroesophageal reflux disease, which was released this month. Fexuclu is expecting sales of 100 billion won. Although it is not known to the media, it is analyzed that the pipeline of new drugs will also contribute to the rise in sales. Daewoong Pharmaceutical signed four drug sales contracts with other companies last year, all of which are expected to have high sales in a short period of time. Lundbeck signed a joint sales contract with Lexapro last December. Lexapro is the number one item in the antidepressant market. Based on last year's UBIST, it is a large product with an out-patient prescription of 22.2 billion won. Daewoong signed a contract with Ebixa Corporation for dementia treatment in 2019 and is expanding cooperation with Lundbeck by jointly selling Lexapro. It is also worth paying attention to the contract, an exclusive license in Korea, for Viatris and Herceptin biosimilar Ogivri in September last year. Ogivri was approved by Alvogen Korea in August 2020. However, since then, the license holder has been changed to Daewoong Pharmaceutical. It is also being released with a salary in November 2020. Ogivri is the third Herceptin biosimilar to compete with Celltrion Herzuma and Samsung Bioepis Sampenet. Competition for the three items is expected to intensify as Daewoong Pharmaceutical holds domestic copyrights. Alymsys, an Avastin biosimilar waiting to be reimbursed, is also a rising star. Alymsys is an item authorized by Alvogen Korea earlier this year. Prior to this, in October last year, Daewoong signed an exclusive distribution and sales contract with Alvogen for Alymsys in Korea. As a result, when the salary is released, Daewoo will be in charge of domestic sales. Currently, Avastin biosimilar has been released only in Korea by Samsung Bioepis. Given that the original Avastin has a market worth 120 billion won in Korea, high sales are expected if it settles down well as a biosimilar. The last contract signed last year was signed with LG Chem. Currently, LG Chem has a joint sales contract with DPP-4 diabetes treatments Zemiglo and Zemimet, and in addition, a license contract was added in November last year to develop Gemigliptin and Enavogliflozin complex. Enavogliflozin is an SGLT-2 diabetes drug developed by Daewoong. It is analyzed that it is an attempt to increase its grip on the diabetes market by developing a complex that combines Zemiglo.
- Company
- EUSA Pharma is entering the Korean market
- by Jul 15, 2022 05:57am
- EUSA Pharma, a British pharmaceutical company specializing in rare diseases, announced its full-fledged entry into the Korean market. EUSA Pharma plans to directly supply the existing domestic approved Castlemans disease treatment, Sylvant (Siltuximab), while also accelerating the introduction of new rare disease treatments. EUSA Pharma held a press conference at The Plaza in Seoul on the 13th and announced its ambition to improve its recognition of Castlemans danger and enter the Korean market. EUSA Pharma is a pharmaceutical company specializing in rare diseases established in the UK in 2015. It was established as EW Healthcare Partners Funding, an investment company specializing in life science. As of June last year, global sales were recorded at 130 million euros. The number of employees around the world is about 250. In the first half of last year, the Asia-Pacific regional headquarters was established in Korea and the Korean subsidiary EUSA Pharma was launched in the second half of last year. Korea is the first region outside Europe and the U.S. where EUSA Pharma has entered. The Korean corporation consists of a total of seven executives and employees. Lee Yeon-jae, CEO of EUSA Pharma CEO Lee Yeon-jae (46) was appointed as the integrated general manager of the EUSA Pharma Asia-Pacific headquarters and the Korean subsidiary. CEO Lee has worked as CEO of UCB Pharmaceutical Korea and executive director of Sanofi-Aventis Korea's rare blood disease business division through Novartis Korea and Daewoong Pharmaceutical. The representative item of EUSA Pharma is Silvant, a Castlemans disease treatment that was approved in Korea in 2015 and is being applied to benefits. EUSA Pharma acquired Sylvant from Jansen in 2020 and has global copyright. In Korea, Samoh is the right to import and sell, and EUSA Pharma will be in charge of supplying and marketing Sylvant. Regarding the background of EUSA Pharma's entry into Korea, CEO Lee said, "The Asia-Pacific region, especially Korea, is considered an important market for the company as multiple Castlemans disease diagnosis and treatment are actively conducted." He explained, "Korea is not a country with a large number of patients compared to the population, but thanks to the medical staff's efforts to find and diagnose patients, it is considered the best country to diagnose and treat multiple Castleman disease after the United States and Italy." EUSA Pharma's first activity is to create an environment where patients can be diagnosed faster by raising awareness of multiple Castleman disease. Multiple Castlemans disease is a rare blood disease that causes organs such as lymph nodes, liver with lymphatic tissue, and spleen to enlarge due to excessive proliferation of lymphocytes. According to Jeon Young-woo, a professor of blood medicine at Yeouido St. Mary's Hospital, it takes about 27.5 months for patients to be diagnosed with multiple Castlemans disease. Due to the low awareness of the disease and low specific symptoms, it is often diagnosed only after the disease has progressed considerably. There are about 150 annual patients in Korea, but it is speculated that there will be more hidden patients who have not yet been diagnosed. If you do not receive proper treatment early, there is a high risk of developing lymphoma. 27% of patients are diagnosed with cancer within 2 to 5 years after diagnosis of multiple Castlemans disease. In the case of idiopathic multiple Castlemans disease, 35% of patients died within 5 years. Professor Jeon said, "Even within the medical staff, the recognition of multiple Castlemans disease is not very high, so diagnosis is very difficult unless it is tested for a purpose." After the lymph nodes become enlarged, it can be said that the disease has already progressed to seriousness," he explained. Professor Jeon said, "As long as early diagnosis is done well, various drugs such as Sylvant can be used to treat it. In particular, if Sylvant is used for more than six months, symptoms improve dramatically, and permits and benefits are applied as the first treatment in Korea. We can suspect Castlemans disease as an early test, and we should try to raise the awareness of medical staff and patients," he said. EUSA Pharma plans to make efforts to introduce the treatment Dinutuximab beta, which targets another rare disease, high-risk neuroblastoma, in Korea. CEO Lee said, "We are currently preparing screening data for Dinutuximab beta permission." Meanwhile, as Global EUSA Pharma was acquired by Recordati at the end of last year, changes are expected in its Korean subsidiary. CEO Lee said, "We are discussing organizational charts and development strategies for each country, and major commercial organizations have been reorganized." CEO Lee added, "There is a possibility that the name of the company will be changed, and it is expected to be finalized at the end of this year."
- Company
- Multinational companies leaving the Korean market
- by Jul 15, 2022 05:57am
- New drugs from multinational pharmaceutical companies such as Otezla, Cotellic, and Erievedge, which were not properly introduced in the domestic market, left the Korean market one after another this year. It is believed that it has made significant sales overseas but has decided to withdraw due to lack of marketability in Korea. According to the MFDS on the 7th, Roche voluntarily dropped two types of anticancer drugs, Cotellic and Erievedge, in the first half of the year. The licenses for Cotellic and Erievedge were revoked as of June 23 and April 7. Erivedge is a skin cancer treatment approved by the MFDS in 2013. It is used to treat metastatic basal cell cancer that cannot be operated or radiated. It is the first target anticancer drug for skin cancer and a rare drug that raised global annual sales of 380 billion won. Although Erivedge was a non-reimbursed drug in Korea, it was selected as the government's "disaster medical expenses support project" in 2015 as a treatment for rare diseases and provided medical expenses. However, as severe skin abnormalities were reported and it was pointed out that the drug price was higher than its clinical usefulness, In 2017, the UK removed Erivedge from the list of anti-cancer drug support funds. Even in Korea, Erivedge has not been imported since 2019. Cotellic is a melanoma treatment approved in Korea in 2015. Although it was conditionally approved as a new drug for MEK inhibitors, it was pointed out in the 2017 parliamentary audit because it was not supplied to Korea after approval. It seems that he did not enter the domestic market after that. Since it has never been supplied, no application for salary has been made. Due to the cancellation of the Cotellic, Roche's immuno-cancer drug Tecentriq and combination therapy are not expected to be used in Korea. Roche obtained an indication of progressive melanoma treatment in the United States with Tecentriq+Cotellic+Zelboraf 3 drug therapy in 2020. Amgen's psoriasis drug Otezla has left the market. Otezla is the first PDE-4 inhibitor that Amgen acquired from Celgene. In the global market, they performed so well that they were ranked as blockbusters. Otezla's annual sales reached 2.9 trillion won last year. Korea also showed high expectations for Otezla, which obtained permission in 2017. However, Otezla was not even released in Korea. It is believed that negotiations were not smooth because Celgene, the first permit holder, was merged with BMS, and Amgen changed one after another in the process of acquiring Otezla. In addition, as the expiration date of Otezla's patent approaches, Amgen seems to have decided that it has lost marketability in Korea. Amgen dropped Otezla's permission on June 9.
- Policy
- Samsung reigns over Avastin biosimilar market in Korea
- by Lee, Tak-Sun Jul 14, 2022 05:54am
- No new biosimilars of ‘Avastin (Roche, bevacizumab)' are being introduced to the market after Samsung Bioepis’s biosimilar. The Avastin biosimilar market is estimated to have a ₩120 billion market in Korea. In terms of approvals, Pfizer Korea and Alvogen Korea had also received approval for their biosimilars after Samsung Bioepis, but only Samsung Bioepis received reimbursement approval for its biosimilar in September last year. The industry analysis is that the supply amount and results of patent challenges have risen as a variable, delaying reimbursement and release of the other biosimilars. According to industry sources on the 13th, Alvogen Korea withdrew its reimbursement application for ‘Alymsis inj’ that was approved in January this year. With the withdrawal, Alymsis’s reimbursed release in Korea is expected to be further delayed. The industry had previously expected Alymsis to be released with reimbursement in September this year. Alymsys is an Avastin biosimilar developed by the Spanish pharmaceutical company mAbxience that received US FDA approval in April through Amneal Pharmaceuticals. In Korea, the drug will be supplied by Alvogen Korea and marketed by Daewoong Pharmaceutical. The two companies signed an agreement in October last year under which Daewoong Pharmaceutical owns the rights to exclusively distribute and sell Alymsis in Korea. However, a variable - the patent challenge - arose with only reimbursement approval left for its release. Two of Alvogen’s three patent invalidation trials filed by the company were accepted by the court, but one was rejected. The rejected patent is known to be a combined therapy use patent set to expire in 2033. The industry believes that patent challenge results may have affected Alvogen’s reimbursement application withdrawal. However, no news on the reimbursement of Pfizer’s ‘Zirabev inj,’ which was approved before Alymsis, is arising either. Zirabev was approved in May last year. Therefore, speculations are rising that the release date of Zirabev is not being set due to insufficient domestic supply. With the release dates of Alvogen and Pfizer’s Avastin biosimilar unclear, the market preoccupation effect of Samsung Bioepis’s ‘Onbevzi inj,’ the first biosimilar that was released in September last year, has doubled. Onbevzi, which is sold in Korea through Boryung Pharmaceutical, has already passed the review of drug committees at 58 hospitals in Korea. This includes the ‘Big 4’ hospitals in Korea - Samsung Medical Center, Seoul Asan Medical Center, Seoul National University Hospital, and Sinchon Severance Hospital. Based on IQVIA, Onbevzi accounted for 9% of the market in the first quarter of this year. Onbevzi 0.1g/4mL is listed at ₩208,144 in Korea. This is slightly cheaper than Avastin 0.1g/4mL, which costs ₩218.782. Samsung Bioepis has also been emphasizing the economical price of its drug. A company official said, “We will continue to make efforts to provide more treatment options for patients with Onbevzi while contributing to the NHI fiscal-saving effort made by the health authorities in Korea.” Meanwhile, Celltrion had also applied for the approval of its Avastin biosimilar 'CT-P16' in September last year but had not received marketing authorization yet.
- Company
- Tabrecta can be prescribed at hospitals
- by Eo, Yun-Ho Jul 14, 2022 05:54am
- According to related industries, Tabrecta of Novartis Korea passed the D.C. of medical institutions such as the National Cancer Center, Pusan National University Hospital, Samsung Seoul Hospital, and Sinchon Severance Hospital. Tabrecta, which is currently undergoing the insurance benefit registration process, was approved in Korea in November last year. MET mutations are rare types that account for about 3% to 4% of metastatic non-small cell lung cancer, and as there have been no treatments, interest in these new drugs is increasing. Tabrecta targets c-Met and was first approved in the United States as a non-small cell Lung Cancer treatment in May 2020. The drug was validated by a phase 2 GEOMETRY mono-1 study of 97 patients with METex14. As a result of the study, the overall response rate was 68% in patients who had never been treated and 41% in patients who had previously been treated. Among patients who took Tabrecta, patients who had not previously been treated (DoR was 12.6 months and those who had been treated were 9.7 months. Tabrecta is also stepping up research for future combination therapy. In particular, it is expected to solve the resistance problem of EGFR TKI in lung cancer. Tabrecta is conducting clinical trials in combination with AstraZeneca's third-generation EGFR TKI Tagrisso. Specifically, combination therapy of Tabrecta and Tagrisso is compared with platinum-based chemotherapy for EGFR mutated non-small cell lung cancer patients with T790M negative and amplified MET genes during treatment with first and second generations EGFR TKI or Tagrisso. Han Ji-yeon, a professor of hematology and oncology at the National Cancer Center, said, "The prognosis of patients with MET amplification is also very poor. At a time when it is very important for MET inhibitors to enter the market quickly, it is significant that drugs such as Tabrecta, which proved a clear effect only on MET Exxon 14 deficit mutations, were approved."
