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- 2026-05-18 13:59:02
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- Expansion of non-face-to-face tx little by little
- by Nov 18, 2021 05:54am
- Despite opposition from the KMA to expand non-face-to-face treatment using regulatory sandboxes, it is judged that the satisfaction of overseas Koreans is high and it will help resolve medical blind spots. However, concerns about allowing regulatory special cases are also expected to increase, taking advantage of regulatory sandboxes. Ministry of trade, industry and energy deliberated and resolved a total of 14 cases such as on-face-to-face overseas Koreans' care services including digital switching of tasks and tasks, such as carbon neutral through the 5th Industrial Convergence Regulation Special Deliberation Committee. Temporary permission for the non-face-to-face overseas Koreans' care and counseling is a major medical foundation Myongji. Myongji Hospital provides services such as medical counseling and medical treatment to overseas Koreans through telephone and video using an online platform, and medical staff judges and issues prescriptions when requested by patients. This is the same as the approval agenda for Life Semantics Corp. and Inha University Hospital from 20 to 2021. There are many people who have difficulty using medical services due to language and medical accessibility problems or are excluded from access to local hospitals due to their citizens' priority policy abroad. In particular, temporary permission was granted through sandboxes with the aim of "protecting the Korean people to the end," saying that SOS is lined up from overseas workers in the Middle East, where the number of COVID-19 confirmed cases is soaring. This year, Ministry of trade, industry and energy said, "Under the current medical law, telemedicine is only allowed for doctor-medical people, and medical practices such as doctor-patient diagnosis and prescription are prohibited in principle. The Special Regulatory Committee approved additional temporary permits." However, to prevent diplomatic and trade problems, services were provided to the extent that they did not violate local laws, and the same conditions as the existing approval agenda, such as medical mediation, were added. Ministry of trade, industry and energy "non-face-to-face overseas Koreans ' care services, currently on projects on the table is high user satisfaction." said. The Ministry expected that in the future, overseas Koreans will be able to use various non-face-to-face medical services at more domestic medical institutions, which will increase their medical options. Last year, the KMA pointed out in a statement that telemedicine for overseas Koreans is ineffective. At the time, the KMA argued, "Telemedicine is likely to trigger competition between companies and industries that provide platforms and increase unnecessary demand, abandoning the basis of face-to-face treatment and the people's right to health."
- Policy
- Will impurities again in losartan trigger full recalls?
- by Lee, Tak-Sun Nov 17, 2021 05:45am
- Once again, impurity was detected in ‘losartan,’ an ingredient used in hypertension treatments. The impurity in issue was detected during self-inspections conducted by the individual pharmaceutical companies under the direction of the Ministry of Food and Drug Safety, upon which some companies have been discontinuing the lot release of their products. In particular, the companies are concerned that a large number of the drugs will be subject to recall, as they believe the raw materials imported from India and China that are used by most generic companies may be the cause of the problem. The MFDS plans to take additional measures after receiving the companys’ test results by the end of this month. According to the industry on the 16th, azido impurities were detected in their hypertension drugs containing losartan. The azido impurity detected this time is known to be a different substance from the AZBT(5-(4'-(azidomethyl)-[1,1'-biphenyl]-2yl)-1H-tetrazole) that was detected in losartan last September. At the time, excessive amounts of AZBT were found, and 22 lot numbers of 12 products in 11 companies were recalled. The ministry's measures then were applied not only to losartan but also to other sartan drugs such as valsartan and irbesartan that were used to treat hypertension. However, the impurity detected this time was only found in losartan. Based on information overseas in late September, the MFDS ordered companies producing ingredients and finished products containing losartan to conduct individual tests for azido impurities, and submit their inspection results by the 30th of this month. Pharmaceutical companies that detected excess impurities before submitting the results to the Ministry of Food and Drug Safety had stopped lot releases of their products as a precautionary measure. A pharmaceutical company official said, “We have CMO agreements with 3 places, and all 3 places have told us that they will stop supplying their products due to impurity detection. The word is that the ingredients from India and China that most generic companies use may be the cause of the problem.” Another company official said, “The impurity is presumed to be caused in the course of synthesizing raw materials. Pharmaceutical companies that finished inspections reported their results to the Ministry of Food and Drug Safety last week and are preparing voluntary recalls." However, the MFDS has not made any statements yet. The industry expects the ministry to make an official statement in early December after all the test results are submitted and the authorities prepare measures based on the results. The industry has also requested an extension of the deadline for data submission, claiming that there was not enough time to derive results. If the ministry accepts the deadline extension, the MFDS announcement is also expected to be delayed further. Upon news of the impurities, the pharmaceutical sales market has been intent on finding alternatives. The companies have been encouraging healthcare professionals to prescribe alternatives with a list of other sartan drugs that could replace losartan. Currently, 376 drugs containing losartan are approved by the MFDS. Depending on the magnitude of the recall, the impact on the pharmaceutical industry may also be significant. Depending on the situation, there is also the possibility that pharmacies will also suffer from conducting the recalls.
- Company
- Hugel's toxin has been approved for national lot release
- by Nho, Byung Chul Nov 17, 2021 05:44am
- Status of approval for national lot release of Hugel toxin drugs published in the MFDS. As Hugel recently obtained approval from the Ministry of Food and Drug Safety for three types of botulinum toxin products, administrative measures such as "cancellation of permission" and "suspension of product sales" on the 10th proved once again that there was a difference in legal interpretation of indirect exports, not quality and safety issues. According to the status of national lot release approval for botulinum toxin posted on the website of the MFDS, Hugel received approval for 50 units of botulinum toxin formulation Botulax and 200 units of Botulax on the 15th. A day later, on the 16th, domestic sales of three Botulax products resumed as additional approval for 100 units of Botulax was obtained. Including the number of national lot releases, Hugel has obtained 156 cumulative approvals this year. It is the largest number of botulinum toxin companies in Korea. Competitors Daewoong Pharmaceutical, Medy Tox, and Huons have obtained national lot release approval for 84, 80, and 44 cases, respectively. Earlier on the 10th, the MFDS announced that it would start administrative disposition, collection, and disposal procedures for the company's products against Hugel for violating the national lot release. Hugel immediately announced its position and applied for cancellation and suspension of execution, including an order to suspend manufacturing and sales, to the Seoul Administrative Court on the same day. On the morning of the 11th, the next day, it submitted a provisional application for suspension of execution of the Ministry of Food and Drug Safety's disposition, and the court cited it, enabling the sale of four types of Botulax in Korea. An official from Hugel said, "This disposition by the MFDS is only a problem caused by differences in legal interpretation of indirect exports to the Pharmaceutical Affairs Act, and has nothing to do with the product quality of Botulax manufactured and produced by Hugel." He said, "Hugel has received the national lot release without any problems in terms of quality such as effectiveness and safety in compliance with the Pharmaceutical Affairs Act." Biological agents such as botulinum toxin must be approved for lot release to be sold in Korea.
- Company
- Rinvoq combo rises as optimal option in rheumatoid arthritis
- by Nov 17, 2021 05:44am
- AbbVie’s JAK inhibitor ‘Rinvoq (upadacitinib)’ in combination with MTX was found to improve the clinical remission achievement rate over the TNF-α inhibitor ‘Humira (adalimumab)’ combination therapy in rheumatoid arthritis. The Rinvoq combination therapy achieved a 20% range remission rate in the most commonly used DAS28 index as well as the strictest Boolean index. In the SELECT-COMPARE trial that was conducted on patients who had an inadequate response to MTX, 29% of the patients treated with Rinvoq+MTX achieved clinical remission per DAS28 at Week 12, which is a higher rate than the 18% in those treated with the adalimumab combination. Such results were consistent under other evaluation indexes such as the SDAI, CDAI, Boolean index. The differences were also consistent in the evaluations made at Week 26 and Week 48. At Week 48, Rinvoq’s remission achievement rate was 38% per DAS28, 25% per CDAI, and 21% per Boolean. Achievement of clinical remission in SELECT-COMPARE trial by disease activity evaluation index ◆Rinvoq maintained a 20% range remission rate with the Boolean index, a more stringent index than DAS28 DAS28 is the most widely used index to measure the achievement of clinical remission in rheumatoid arthritis, but Boolean is considered the most stringent index. First, DAS28 is evaluated using three thresholds in 28 joints - tender joint count (TJC), swollen joint count (SJC), and patient pain score on a visual analog scale (VAS). DAS28-CRP, which adds the C reactive protein (CRP) that is related to the progression of rheumatoid arthritis to DAS28, is most widely used. With the Boolean index, the ▲number of tender joints (TJC)≤1 ▲number of swollen joints (SJC)≤1 ▲CRP≤1mg/dL ▲Patient Comprehensive Assessment (PGA)≤1 (on a scale of 0-10) needs to all be satisfied to be considered to be in remission, therefore the range considered and accepted as remission is narrower with the Boolean index. This is why a study that analyzed the remission achievement rate of 3,209 rheumatoid arthritis patients in Korea with five disease activity indexes showed that the Boolean index had the lowest patient remission rate. ◆Remission achievement rate low for existing treatments when measured by various indexes…”We should consider new treatment options to meet new treatment goals” Based on data from the Korean College of Rheumatology Biologics Registry (KOBIO), the KCR Clinical Research Committee had previously presented the reemission achievement rate of rheumatoid arthritis patients who have been treated with biologics and oral targeted therapies during the past 5 years. Treatments included in the analysis were TNF-α inhibitors such as Humira, etc.; ‘Actemra (tocilizumab),’ ‘Orencia (abatacept),’ and ‘Xeljanx (tofacitinib).’ The KCR analyzed the remission achievement rate of the treatments above with five disease activity assessment indexes - DAS28-CRP, DAS28-ESR, CDAI, SDAI, Boolean - and the result showed that the achievement rate differed greatly by index. At week 48 after starting treatment, the remission achievement rate was near 56.0% per DAS28-CRP, but the dropped greatly to 10.4%, 12.7%, and 12.9% per more stringent indexes such as CDAI, SDAI, and Boolean, respectively. The rate of patients that maintained remission for 2 or more years, or ‘continuous remission,' was 62% per DAS28-CRP, but 8%, 11%, 13% per CDAI, SDAI, Boolean, respectively. With the remission rate of existing treatments falling to a 10% range in indexes that are relatively stringent compared to DAS28, the analysis was that a more detailed consideration is needed in setting a treatment strategy. Young-Il Seo, professor of Rheumatology at Hallym University Sacred Heart Hospital Pyeongchon, said, “the low remission achievement rate observed with CDAI, SDAI, and Boolean index suggests that patients experience greater difficulties in reality and that improvements are needed to increase treatment satisfaction. In this sense, we would need to more actively consider using treatment options that meet various indexes.”
- Company
- Exports of Botulinum drugs to the U.S. doubled
- by Kim, Jin-Gu Nov 17, 2021 05:44am
- The cumulative exports of domestic botulinum toxin drugs amounted to 220 billion won this year, the report showed. Exports to China, which had consistently accounted for a high proportion, have decreased, but exports to the U.S. and other countries have increased. According to the Korea Customs Service on the 15th, the cumulative exports of domestic botulinum toxin drugs amounted to $190.28 million between January and October this year. Compared to $161.09 million during the same period last year, it increased 18%. Looking at major exporters, dependence on China has decreased significantly compared to last year. Instead, exports to the U.S. and Brazil increased. Between January and October this year, domestic botulinum toxin exports to China amounted to $78.11 million, down 13% from $89.97 million during the same period last year. During the period, China's share of total botulinum toxin exports decreased by 15%p from 57% to 42%. Exports to the United States increased 110% from $12.2 million to $25.61 million. The share of U.S. exports increased from 8% to 13%. It is analyzed that exports to the U.S. more than doubled due to the end of the Nabota-related dispute. Earlier this year, Daewoong Pharmaceutical's U.S. partner Evolus concluded the dispute with Medy Tox and Allergan by agreement. Since then, Nabota's monthly exports to the U.S. have been around $2.5 million to $3 million. This is in contrast to exports from the second half of 2019 to the beginning of last year, when the dispute was in full swing. In addition to the U.S., exports to Brazil and Japan have increased. In Brazil, it increased 59% from $10.5 million between January and October last year to $16.74 million between January and October this year. In the case of Japan, it increased 39% from $6.54 million to $9.11 million during the period. Thailand, a major exporter, fell 16% from $13.83 million to $11.58 million. As exports to Brazil increased significantly during the same period, the third-largest exporter of domestic Botulinum toxin changed from Thailand to Brazil.
- Company
- Celltrion's COVID-19 tx is approved for sale in Europe
- by Chon, Seung-Hyun Nov 17, 2021 05:44am
- Regkirona, a COVID-19 antibody treatment developed by Celltrion, has been approved in Europe. Celltrion announced on the 15th that the EC approved Regkirona on the 12th (local time) for the final sale for the purpose of treating COVID-19. Regkirona has been approved for the treatment of adult patients aged 18 or older who have been confirmed with COVID-19 who do not require oxygen supply and are likely to be severely transmitted. It is a single administration of 60 minutes intravenously, the same as domestic item permission. Regkirona officially received an item license from the EC a day after obtaining an approval recommendation from the CHMP under the European Medicines Agency (EMA) on the 11th. Celltrion said, "If CHMP usually recommends approval for new drug approval, EC's final item approval will be completed 1-2 months later, but in this case, official item approval continued in a day," and explained, "It can be interpreted as an EC-level effort to quickly cope with the surge in the number of COVID-19 confirmed cases in Europe." Regkirona is the first new antibody drug developed in Korea to obtain an official item license in Europe. Regkirona obtained emergency approval from the BPOM and the ANVISA in July and August, and in September, it obtained a formal item license from the MFDS in Korea. Regkirona is administered to 22,587 patients in 129 hospitals as of the announcement of Central Disaster and Safety Counters Headquaters (CDSCHQ) on the 12th and is actively used to treat COVID-19 patients in Korea. Regkirona confirmed the safety and effectiveness of the global phase 3 clinical results conducted on 1,315 mild and moderate COVID-19 patients in 13 countries around the world, including Korea, the United States, Spain, and Romania. In the high-risk group of patients administered Regkirona, the incidence of severe patients decreased by 72% compared to the placebo group, and the clinical symptom improvement time was also reduced by more than 4.7 days compared to the placebo group in the high-risk group. An official from Celltrion said, "We will do our best to help many COVID-19 patients in Europe benefit from Regkirona's proven safety and effectiveness, and to contribute to the end of the global COVID-19 crisis."
- Policy
- No companies have won suits on Gov's price cut dispositions
- by Lee, Hye-Kyung Nov 16, 2021 05:53am
- The National Health Insurance Service said it needs to be granted the authority to urge or dispose of arrears in order to efficiently collect the losses that were caused by the non-price cuts that occurred during the stay of execution when preparing a bill to recover and refund the drug price cut amount. The NHIS delivered its opinion on modifying and accepting the ‘Partial Amendment of the National Health Insurance Act (bill No.12727) that NA member Woni Kim presented as representative for the recovery and refund of drug price cuts after adding the request stated above. The bill allows the NHIS to collect the loss incurred due to the drug price not being discounted during the suspended period if the company loses the original case after the suspension of execution is applied in the administrative suit. On the other hand, if the pharmaceutical company wins the trial regarding the disposition of drug price reduction, the bill allows the pharmaceutical company to compensate for its loss. According to the analysis data disclosed by NHIS on the status of drug price cut lawsuits filed by pharmaceutical companies, 40 out of the total 58 cases have been ruled upon in the first or subsequent trials since 2011. Among these, pharmaceutical companies have partially won 17 cases (42.5%). The NHIS said, “One thing to note is that there had been no cases in which the pharmaceutical company won the suits regarding price cut dispositions of original drugs. The stay of execution has only become a means of delaying the price cuts by pharmaceutical companies.” Data on the suspension of execution of drug price cuts and the status its original lawsuits since 2018 showed that the court accepted the suspension of execution in 38 out of 39 administrative lawsuits. The court’s acceptance rate of the stay in execution is 100% as the pharmaceutical company did not apply for suspension of execution for the 1 remaining case. On the other hand, the government won 15 of the 20 cases (75%) that have been ruled upon in the first or subsequent trials after the suspension of execution was applied. The NHIS explained, “Pharmaceutical companies have only won 25% of the suits filed regarding the price cut dispositions. However, as the suspension of execution on the price cut dispositions is accepted 100%, this has been causing losses in NHI finances. In this context, we fully agree with the purpose of the proposed bill.” The reimbursement expense is the actual transaction price of a drug that does not exceed the price cap (as notified by the MOHW). However, in reality, drug transactions are being made at the set upper limit, so the decision to suspend execution of the disposition that lowers this upper limit allows the companies to maintain the previous drug price during the period set by the decision. The NHIS said, “ It may seem excessive that the company needs to bear the loss when the court decides on the stay of execution. However, on the other hand, the NHIS will also be allowing pharmaceutical companies to preserve their loss if the companies win. In this sense, the bill is not disadvantageous to any parties and can be implemented." However, the NHIS added that the scope of the legal provisions, the location of the provisions, and the accepted provisions need to be more specifically stipulated.
- Company
- Drug price negotiations for Xospata began
- by Eo, Yun-Ho Nov 16, 2021 05:53am
- The new leukemia drug Xospata is in the final procedure for insurance benefit registration. According to related industries, Astellas recently entered into drug price negotiations with the NHIS for Xospata(Gilteritinib), a treatment for Acute Myeloid Leukemia (AML). The negotiation deadline is until the 20th of next month. After receiving a conditional benefit decision at the HIRA's Drug Reimbursement Evaluation Committee in September, the drug accepted the proposed valuation amount and went through a drug price negotiation process. It remains to be seen whether Xospata will be able to complete negotiations with the government until the end and be listed. Xospata is the first FLT3 targeted anticancer drug in Korea to be approved by the MFDS as a target treatment for FLT3 mutation positive (FLT3mut+) recurrence or refractory (R/R) AML. This drug targets both FLT3-ITD and FLT3-TKD, which are divided into two mutant forms, and is a monotherapy that is taken once a day and can be treated on its own at home without frequent hospital visits. It also showed higher effectiveness and safety than conventional chemotherapy. In addition, Xospata has been classified as 'Category 1', the highest recommended grade for the treatment of patients with recurrent or refractory AML with positive FLT3 mutation in the latest guidelines of NCCN. Kim Hee-je, a professor of hematology at Seoul St. Mary's Hospital, said, "With the approval of Xospata in Korea, patients can relieve anxiety. Of course, there are still cost issues, but we expect it to become a standardized treatment as soon as possible after registering benefit, the professor said.
- Policy
- Chong Kun Dang is approved for its Jardiance Duo latecomer
- by Lee, Tak-Sun Nov 16, 2021 05:52am
- Chong Kun Dang became the first to receive approval for its latecomer of the SGLT-2 inhibitor combination drug for diabetes, ‘Jardiance Duo (empagliflozin-metformin hydrochloride). In addition, the company received the first generic exclusivity provided to companies that succeed challenging the original patent and be the first to apply for approval. On the 12th, the Ministry of Food and Drug Safety approved three doses of the ‘Chong Kun Dang Empagliflozin Metformin Tablet.’ The product is a combination of metformin hydrochloride and empagliflozin L-proline. Unlike the existing Jardiance Duo, Chong Kun Dang’s product has added an amino acid, L-proline to its Empagliflozin. Chong Kun Dang has also used empagliflozin L-proline in its single-agent Jardiance latecomer, ‘Chong Kun Dang Empagliflozin Tablet.’ The company received generic exclusivity for both its combination and single-agent drug. Chong Kun Dang succeeded in challenging the crystalline form patent of Jardiance and Jardiance Duo that is set to expire on December 14th, 2026. The company was the first to file a negative patent scope declaration trial in January 2018, and a partially valid decision in May, and the court confirmed the decision in June. Like for the single agent, the company was the first to apply for approval of the combination. However, the company’s acquisition of the first generic exclusivity does not mean that the company monopolized the market, as many domestic companies are seeking to enter the first latecomer market for Jardiance and Jardiance Duo. Jardiance DuoMany other companies have also succeeded in avoiding the original’s patent through salt modification. 94 products were approved for generic exclusivity with latecomers of the single-agent Jardiance. The generic exclusivity for Chong Kun Dang’s Empagliflozin Metformin Tablet applies only to products that use the same ingredient, empagliflozin L-proline, and therefore the drugs subject to sales prohibition are limited. However, the possibility that the company may enter the market before other companies through patent strategies remains. Jardiance and Jardiance Duo’s substance patient will expire on March 11th, 2025. Therefore, the companies may release their latecomers from March 12th, 2025 when the patent expires. Jardiance and Jardiance Duo sold 35.4 billion and 15.8 billion each in outpatient prescription sales last year (UBIST).
- Company
- Somavert can be prescribed at general hospitals
- by Eo, Yun-Ho Nov 16, 2021 05:52am
- According to related industries, Pfizer Korea's Somavert (Pegvisomant) has currently passed the Drug Committee (DC) of medical institutions such as Seoul National University Hospital and Sinchon Severance Hospital, and is also undergoing procedures at medical institutions such as Seoul National University Bundang Hospital, Wonju Severance Hospital, and Samsung Medical Center. In the case of terminal hypertrophy, Sinchon Severance Hospital is taking care of the largest number of patients, so it is expected to lead to prescription fast. Somavert has been listed on the insurance benefit list since September. Somavert demonstrated its validity through a 12-week randomized, double-blind study of 12 patients with terminal hypertrophy. The study found that the median serum IGF-I concentration at 12 weeks of study compared to the baseline was 4.0±16.8%, 26.7±27.9%, 50.1±26.7%, and 62.5±21.3%, respectively, in the placebo group, Pegvisomant 10 mg group, Pegvisomant 15 mg group, and Pegvisomant 20 mg group. The proportion of patients whose serum IFG-I concentration returned to normal compared to baseline was also found to be significantly higher than that of placebo, Pegvisomant 10 mg/day administration group, Pegvisomant 15 mg/day administration group, and Pegvisomant 20 mg/day administration group, respectively, indicating that Pegvisomant was significantly higher than placebo. Meanwhile, Somavert was approved in Korea in September last year for the treatment of adult terminal hypertrophy patients who do not respond appropriately to surgery and radiation therapy, or whose IGF-I (Insulin-like growth factor I) concentration is not normalized by somatostatin analog therapy, and was designated as a rare drug in 2018.
