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- 2026-05-04 06:32:13
- Policy
- Ponesimod's Domestic Item License
- by Lee, Hye-Kyung Oct 12, 2022 05:50am
- Ponesimod of Janssen Korea, a rare drug for treating multiple sclerosis, has been approved for domestic items. The Ministry of Food and Drug Safety (Director Oh Yoo-kyung) announced on the 11th that it has approved Ponesimo for the treatment of recurrent dysplasia in adults. The drug has been shown to reduce inflammatory reactions by blocking lymphocytes from being separated from lymphatic organs and inducing the number of lymphocytes in peripheral blood to decrease rapidly. Ponesimo is expected to reduce the occurrence of new diseases in patients with multiple sclerosis and prevent additional disorders from occurring and accumulating due to repeated and continuous symptoms. Ponesimo was designated as a rare drug in Korea on October 1 last year after being approved by the U.S. FDA in March last year as a treatment for adult patients with recurrent multiple sclerosis, including clinical solitary syndrome, recurrence-relaxation disease, and active secondary progressive disease. The Ministry of Food and Drug Safety said, "We expect that this rare drug license will contribute to improving the quality of life of patients by expanding their treatment opportunities and options." The Ministry of Food and Drug Safety said, "We will do our best to expand treatment opportunities to patients such as rare and incurable diseases by quickly supplying treatments that have been sufficiently confirmed in safety and effectiveness based on regulatory science expertise."
- Policy
- Alvogen’s Alymsys reimbursed...compete with Avastin similar
- by Lee, Tak-Sun Oct 12, 2022 05:50am
- Samsung Bioepis’s Avastin biosimilar Competition for biosimilars of the anticancer drug Avastin (bevacizumab) is intensifying in the domestic market. Alvogen’s ‘Alymsys’ is making a bid against Samsung Bioepis’s ‘Onbevzi,' which had been dominating the Avastin biosimilar market. With the entry of Alymsys, the original Avastin and its two biosimilars will be competing in the market. According to industry sources on the 11th, Alvogen Korea’s ‘Alymsys inj.’ will be included on the NHI reimbursement list starting this month. The maximum reimbursement price for the 0.1g dose will be KRW 208,144 per vial, the same as Samsung Bioepis’s ‘Onbevzi inj.’ The price of the 0.4g dose was also set at KRW 677,471, the same as Onbevzi. The price of its original, Roche’s Avastin inj is set at KRW 218,782 for the 0.1g dose and KRW 712,098 for the 0.4g, which is slightly higher than its biosimilars. Onbevzi enjoyed a monopoly in the biosimilar market for 1 year after being approved for reimbursement in September last year, and enjoyed a significant preoccupation effect in the market. Its sales, which reached KRW 0.5 billion in Q4 last year based on IQVIA, had continued rising to KRW 1.8 billion in Q1, and then KRW 4.1 billion in Q2. At this rate, its sales is expected to exceed KRW 10 billion only one year since its launch. With the launch of Onbevzi, Avastin’s price was also discounted. With the price reduction, its sales also dropped by KRW 20 billion from the KRW 58.9 billion in 1H of the previous year to KRW 38.1 billion in the 1H this year. Avastin is a targeted therapy monoclonal antibody that is widely indicated for the treatment of various cancers including ▲metastatic colorectal cancer, ▲metastatic breast cancer ▲non-small-cell lung cancer ▲advanced or metastatic renal cell carcinoma, ▲glioblastoma, ▲epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, ▲uterine cervical cancer, etc. Its market size exceeds KRW 100 billion in Korea. Due to its potential, biosimilar companies that had mainly stayed abroad have been launching large-scale marketing activities in the Korean market. However, Avastin’s patent emerged as a variable. Due to the patent, biosimilars were restricted from being used like the original drug, in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin for the ovarian cancer indication. Samsung’s Onbevzi was also unable to obtain this indication due to unresolved patent issues earlier in its release. On the other hand, Alvogen’s Alymsys was approved with the said indication. This is why the release of Alymsys was expected to weaken the competitiveness of Onbevzi in the market. But the situation was once again reversed with Samsung reaching an agreement on patent issues with the original developer Genentech, and Alvogen failing to do so. Samsung recently reached an agreement with Genentech for the patent suit on Avastin, which had been ongoing since June 2020. As a result, the company was able to obtain an additional indication for epithelial ovarian cancer last month. Alvogen, on the other hand, had to delete the indication in August due to a patent dispute and received reimbursement approval for the remaining indications. This is why the reimbursement approval period was delayed by one month. Despite some indication-related issues, many experts expect biosimilars to succeed in the domestic market, considering the high usage rate of bevacizumab in various other cancers as well. Samsung Bioepis entrusted sales of its product to Boryung Pharmaceutical, which is showing prominence in the anticancer drug market, and Alvogen to the large domestic pharmaceutical company Daewoong Pharmaceuticals for its early settlement in the market. In addition, Celltrion also received approval for its ‘Vegzelma inj’ on September 28th and is working to release the drug with reimbursement within the year. Celltrion also reached an agreement on Avastin’s patent with Genetech in May and was approved for the same indication as the original, including ovarian cancer related indication. Until now, Remsima was the only product that showed a good performance in the domestic biosimilar market. It is analyzed that the domestic biosimilar market is also entering full-fledged growth, starting with the Avastin biosimilar.
- Policy
- Two companies' Ticagrelor can be reimbursed
- by Lee, Tak-Sun Oct 07, 2022 06:04am
- Brilinta was released last monthAs Kukje and Korea United Pharmaceutical newly entered the anti-thrombotic Ticagrelor market, it was reorganized into a competitive system for nine companies. Although the original Brilinta's material patent expired in November last year, only six pharmaceutical companies' products entered the market due to high manufacturing costs and lack of marketability. And although generics for exclusivity ended last August, no news of generics' benefit was heard that month. According to the industry on the 6th, Kukjel has obtained benefits for Ticagrelor since September and Korea United Pharmaceutical from this month. Kukje is competing in the market with Brilor and Korea United Pharmaceutical with Tiglor. Competition, which had been stagnant due to their participation, has resumed. Currently, Hutex Pharmaceutical Korea, Alboven Korea, Hana Pharmaceutical, Samjin Pharmaceutical, Korea United Pharmaceutical, Kukjel, Genuonesciences, and Chong Kun Dang are competing in the market. Among them, Samjin, Korea United Pharm, Kukje Pharma, Genuonescience, and Chong Kun Dang are their own manufactured products, and the rest of the products are all entrusted to Genuonescience for consignment production. There are 41 licensed generics for Ticagrelor companies, but many consigned items are believed to have given up the market due to high raw material prices. Kukje and United Pharm, which have additionally been challenged, are analyzed to have solved the cost problem through their manufacturing. However, it is not a good situation for generic companies to succeed in the market. First of all, the Ticagrelor formulation market is gradually decreasing. Original Brilinta's outpatient prescription performance is gradually decreasing, with 10.8 billion won in 2019, 9.8 billion won in 2020 and 9.7 billion won in 2021. United is also seeking to expand its market by adding Tiglor to Clopidogrel-based Clavixin and Clavixin Duo. In the medical field, Ticagrelor does not have drug resistance due to existing clopidogrel CYP2C19 gene mutation It is believed that generics can sufficiently succeed in the market because it has the advantage of fast drug expression time.
- Policy
- Innovative pharmaceutical companies' new drug tx
- by Lee, Jeong-Hwan Oct 07, 2022 06:03am
- It was also pointed out that the government is delaying the preparation of a sub-law of a clause that favors the price of new drugs developed by innovative pharmaceutical companies in the Special Act on the Promotion of the Pharmaceutical Industry. Critics say that it has not been active in subsequent legislation such as enforcement ordinances and enforcement rules for the fourth year of legislation. On the 5th, Rep. Nam In-soon of the Democratic Party of Korea claimed, "We need to come up with a policy of preferential treatment for new drugs made by innovative pharmaceutical companies as soon as possible." Nam is criticizing the government for being indifferent to follow-up legislation even though the law on the addition of the upper limit on health insurance medical care benefits was implemented in December 2018 for new innovative pharmaceutical companies unrelated to the Korea-U.S. FTA trade issue. In particular, considering that improving the self-sufficiency rate of raw materials is an important task, it was also suggested that it is necessary to consider preferential treatment for related raw materials such as infectious disease vaccines such as COVID-19 and innovative new drugs. Rep. Nam In-soon said, "The government has designated bio-health as the so-called Big3 industry and has been pushing for a plan to promote bio-digital health as a major export industry and improve public health by spreading digital healthcare and big data-based advanced and precision medical care." Representative Nam said, "There are only generic drug preferential regulations for innovative pharmaceutical companies, but there are no drug preferential regulations for new drugs, so the contradictory situation of encouraging generic development over new drugs continues." She then said, "We are also implementing a policy that favors drug prices for the first approved new drugs in Japan and Taiwan and new drugs from companies that have conducted clinical trials in Korea." She added, "To become a global hub of bio and digital health, not only support such as preferential drug prices for innovative pharmaceutical companies, but also various support measures such as training R&D and manpower, financial support, overseas expansion support, and reduction of levies."
- Policy
- The incidence of adverse effects in Alecensa is 80%
- by Lee, Hye-Kyung Oct 06, 2022 06:05am
- A five-year post-marketing survey (PMS) of the Anaplastic Lymphoma Kinase (ALK) mutant non-small cell lung cancer treatment Alecensa 150mg showed 1012 significant drug abnormalities that could not rule out causality. The permit will be changed with 20 and 122 cases of serious drug adverse reactions and unexpected drug adverse reactions that cannot be excluded from causal relationships, respectively. The Ministry of Food and Drug Safety announced that it will prepare an order (proposal) to change the permission based on the results of the investigation after marketing Alecensa in Roche Korea and conduct an opinion inquiry until the 19th. Eisai Korea obtained an item license for Fycompa film coated tab on July 10, 2015. Alecensa received a domestic item license in October 2016 for the treatment of ALK-positive local progressive and metastatic non-small cell lung cancer patients who had been treated with Xalkori. After expanding the indication to primary treatment in 2018, Alecensa sales exceeded Xalkori, which is 20.3 billion won, from 10.4 billion won in 2018 to 22.1 billion won in 2019. Since then, it has expanded to 29.3 billion won in 2020 and 32.7 billion won in 2021. As a result of a five-year post-marketing survey of 345 people under the patient registration program in Korea, the expression rate of abnormal cases was reported to be 80.29% (277/345 cases, a total of 1012 cases), regardless of causality. Among them, 4.64% (16/345 people, 20 cases) of serious drug abnormalities were reported, including mouth inflammation, increased blood bilirubin, increased blood creatine phosphorylase, increased blood creatinine, peripheral edema, fever, and death. Unexpected drug abnormalities such as decreased red blood cell volume rate decreased red blood cell count, joint pain, muscle weakness, dizziness, and nephropathy were found to be 24.06% (83/345 cases, 122 cases). The Ministry of Food and Drug Safety plans to change the permit after hearing opinions on the change order.
- Policy
- MFDS prepares clinical trial guidelines for COVID-19 drugs
- by Lee, Hye-Kyung Oct 06, 2022 06:05am
- The Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) published and distributed the ‘Clinical trial guideline on antiviral treatments for mild-to-moderate COVID-19 infections’ to support the rapid development of COVID-19 antivirals by guiding companies on the new clinical outcome parameters and methods for designing flexible clinical trials. The guideline was prepared to promote the preparation of a rapid clinical support platform to support the development of COVID-19 vaccines and treatments, which was part of the 100 Tasks for Food and Drug Regulatory Innovation that the MFDS had announced on August 11th. The guideline contains the additional new clinical outcome parameters required for clinical trials on mild-to-moderate COVID-19 patients and includes considerations that need to be made in selecting subjects, clinical treatment effect evaluation methods, efficacy evaluation, and in designing and performing clinical trials. The existing clinical outcome parameter was effective in preventing severe COVID-19, however, due to the decrease in severe COVID-19 patients, this parameter had made it difficult to perform clinical trials. Therefore, a new indicator had to be inevitably set in line with the COVID-19 situation, which is why the government added symptom improvement as a new parameter. The MFDS said, “the addition of the new clinical outcome parameter will aid rapid development of treatments by enabling easier progress of clinical trials, including faster recruitment of clinical trial subjects. We have improved the predictability and transparency of the trials by allowing companies to introduce an adaptive design in preparing clinical trial protocols so the number of test subjects can be appropriately changed based on the results of the interim analysis.” Also, if the company has received approval for a clinical trial plan in advance, the trial can be conducted without additional approval, which is also expected to help reduce the period. As the trial is conducted on infectious patients, the guideline also guides companies on the major considerations that require attention when conducting non-face-to-face clinical trials and case studies. More information can be accessed on the MFDS website (www.mfds.go.kr) > Legislative data > Resources > Guide/Guidelines.
- Policy
- Data for reevaluation to be submitted from the 24th
- by Lee, Tak-Sun Oct 05, 2022 06:11am
- The data submission system for reevaluation of listed drugs that was set to be operated as of the 1st of this month will be operated from the 24th. The authorities plan to receive data submitted before then through the Health Insurance Review and Assessment Service’s e-mail. With the data submission system not being initiated in time, the industry has repeatedly been pointing to the administration's lack of preparation. Voices are continuing to rise in the industry to postpone the reevaluation of listed drugs in consideration of the circumstances, including the COVID-19 situation. According to the industry on the 3rd, HIRA has been notifying through associations that the data submission system for reevaluation of listed drugs that was set to be serviced from the 1st will be serviced from the 24th. Data submission is important to prove as the drugs subject to evaluations need to meet the reevaluation requirements or receive discounted ceiling prices depending on their degree of satisfaction. The health authorities have been requiring companies to submit data proving that the standard requirements were met to HIRA from the 1st of this month to February 28th next year. The standard requirements that need to be submitted are self-bioequivalence test data or evidence of clinical trial performance; and documents proving the use of APIs registered in the Drug Master File (DMF). If the subject drug satisfies both requirements, the ceiling price is maintained as is; however, if the drug satisfies only one of the two requirements, the price is reduced to 85%, and to 72.25% if both requirements are not met. As most listed drugs satisfy the DMF requirement, the self-bioequivalence test data will become the determining factor for the price discounts. The Ministry of Health and Welfare first applied the requirements to drugs that were newly listed from July 2020, and provide a grace period of 3 years for previously listed drugs. Therefore, the price adjustments for the listed drugs are planned on July 2023. To meet the self-bioequivalence test requirement, companies have switched their consigned products to in-house production and conducted self-bioequivalence tests. However, the COVID-19 outbreak in 2020 rendered the progress of the tests difficult, raising the suggestion that the entire revaluation schedule should be postponed. However, the MOHW decided to conduct the reevaluation of listed drugs as scheduled with some exceptions, with the goal of making price adjustments in July next year at the Health Insurance Policy Deliberative Committee meeting that was held on the 29th. However, the Ministry of Food and Drug Safety extended the data submission deadline for some oral preparations and sterile preparations among prescription drugs that were designated and subject to bioequivalence tests by 5 months, and the reports will be accepted if they are submitted by the end of May. Data on all other items will have to be submitted to HIRA by February 28th next year, as initially scheduled. Data submissions started on October 1st, but the authorities will have to wait another 20 days before the electronic window opens. Of course, the companies may submit their data via e-mail, but complaints about the delay in the industry are fierce as they are already pressed for schedule. An industry official said, “The government seems to not be ready to conduct the reviews that they have hurried the companies to prepare. With the 20-day delay in the data submission system, I wonder whether HIRA will be able to complete the review within the set period for the NHIS to complete pricing negotiations.
- Policy
- Pfizer Corona vaccine passed a verification advisory group
- by Lee, Hye-Kyung Oct 05, 2022 06:10am
- The Ministry of Food and Drug Safety (Director Oh Yoo-Kyung) announced on the 30th that Pfizer Pharmaceutical's COVID-19 vaccine "Comirnaty 2 0.1mg/mLP (Initial Virus of COVID-19, Omicron (BA.1)") passed the COVID-19 vaccine safety and effectiveness verification advisory group. The advisory group held a meeting on the 29th and proved its effectiveness in comparing the immune response of the neutralizing antibody with the existing vaccine after inoculating "Comirnaty 2 0.1 mg/mL", and judged safety to be similar to the existing vaccine. Seven people, including infectious medicine specialists and vaccine and pharmaceutical experts, attended the meeting of the verification advisory group. The Ministry of Food and Drug Safety will refer to the results of vaccine experts' consultation on the safety and effectiveness of the vaccine, including infectious medicine specialists, and quickly and closely review the submitted clinical, nonclinical, quality, and GMP data to decide whether to approve it. The Ministry of Food and Drug Safety said, "We will continue to do our best to supply safe and effective vaccines to our people."
- Policy
- Post-marketing surveillance of breast cancer drug Kadcyla
- by Lee, Hye-Kyung Oct 04, 2022 06:07am
- A total of 31 serious adverse reactions (ADRs) whose causal relationship cannot be ruled out had been reported as results of the 8-year post-marketing surveillance (PMS) on Roche Korea’s second-line breast cancer treatment ‘Kadcyla (trastuzumab emtansine).’ With 163 additional cases of unexpected ADRs whose causal relationship cannot be ruled out also being reported in the same period, Kadcyla’s label will be changed. The Ministry of Food and Drug Safety announced it will change the label for Kadcyla inj. 100mg and 160mg according to the reevaluation results as of December 28th. Kadcyla received domestic marketing authorization in January 2014 to treat patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who had previously received trastuzumab and a taxane (separately or in combination). The drug has been approved for reimbursement since August 2017 in Korea. Also, the drug was also additionally approved by the MFDS as an adjuvant monotherapy for patients with early HER2-positive breast cancer who had residual invasive disease after completing neoadjuvant therapy containing trastuzumab and taxane in August 2019 and was listed for reimbursement in July this year. At the time of the Health Insurance Review and Assessment Service’s reimbursement evaluations, the committee deemed Kadcyla’s pharmacoeconomic evaluation results to be at an acceptable level compared to its competitor Herceptin and acknowledged that the drug was listed in all A7 countries. Through drug pricing negotiations with the National Health Insurance Service this year, the company agreed with the authorities on adopting the utilization cap type of the Risk Sharing Agreement and set the price at KRW 1,956,328 per vial for the 10mg dose and at KRW 2,930,920 per vial for the 160mg dose. Results of the post-marketing surveillance that was conducted on 520 patients over the past 8 years showed that the incidence rate of adverse events were 74.63% (338/520 patients, 1590 cases) regardless of causal relationships. Serious adverse events were reported in 12.69% (66/520 patients, 90 cases) of the patients. As a result of the 6-year post-marketing surveillance conducted in 307 patients for the reevaluation, pleural effusion will be deleted and erythema and infection in the catheter area, bacterial arthritis, COVID-19, infectious spondylitis, and mastitis added as serious adverse events. Among these, 4.23% were serious adverse drug reactions (22/520 patients, 31 cases), based on which vomiting, shortness of breath, and pulmonary edema will be added to the label. The MFDS said, “We plan to change the label according to the Pharmaceutical Affairs Act and the Regulation on Safety of Drugs, etc. We ask hospitals, clinics, and pharmacies to ensure proper use of the drug.”
- Policy
- The price of Zerbaxa is listed at 60,098 won
- by Kim, Jung-Ju Oct 04, 2022 06:07am
- Zerbaxa, called the next-generation antibiotic for MSD Korea, will be listed at 60,098 won per vial as of the 1st of next month. Yuhan Corporation's allergic rhinitis treatment Ryaltris nasal spray 18ml is listed at 6,197 won and Ryaltris nasal spray 31ml is listed at12,396 won, respectively. The Ministry of Health and Welfare held a health insurance policy review committee today (29th) and announced that it was approved for the revision of the "drug benefit list and upper limit table" for a total of three new drugs. These drugs will be listed on the drug benefit list as of October 1 and sold at insurance prices. ◆Zerbaxa = This drug is an antibacterial agent used to treat complex intra-abdominal infections and complex urinary tract infections and was approved by the Ministry of Food and Drug Safety as of April 7, 2017. The company applied for insurance registration in early November last year and applied for insurance registration with the HIRA in November of the same year. The HIRA submitted it to the Drug Benefit Evaluation Committee in June this year for deliberation. At the time, the committee confirmed that clinical usefulness was inferior to that of the control group, and judged that the company's price was more cost-effective than the Japanese drug price, which is the lowest A7. Among the A7 countries, it was listed in the U.S., Japan, Italy, and the U.K., and the average adjustment price was 108,383 won per bottle. Since then, the Ministry of Health and Welfare has negotiated drug prices with the NHIS from June to August this year and decided on the expected amount of claims. The NHIS and the company signed an Expenditure cap RSA contract to refund the amount to the NHIS if it exceeds a certain amount (cap). The price was agreed to be 60,098 won per bottle, down 6.44% from the price passed by the evaluation committee, considering the number of patients who are eligible for more PE drugs such as anticancer drugs and rare disease treatments. ◆Ryaltris nasal spray = This drug, a treatment for seasonal allergic rhinitis, was approved by the Ministry of Food and Drug Safety as of June 22, 2020. The company applied for the HIRA insurance registration more than a year later on July 30, 2021. The HIRA introduced the drug and conducted deliberation on January 13 this year. At the time, the evaluation committee judged that it was more effective in relieving symptoms than a single drug in terms of clinical needs and that it was cost-effective as the company accepted less than 90% of the weighted average price of alternative drugs. It is listed in the UK and Italy among the A7 countries, and the adjusted average price is 16,308 won per 240 doses. In February, the company moved to the industrial complex to negotiate the expected amount of claims. Initially, the two sides conducted and completed negotiations for two months, but the application for registration was made after confirming the possibility of normal supply due to delayed imports due to COVID-19. It predicted that no additional finances would be required because alternative drugs such as Motesone plus Nasal Spray or Dylastine existed. The insurance price is 6,197 won for Ryaltris 18mL and 12,396 won for Ryaltris 31mL.
