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- 2026-04-13 21:57:45
- Policy
- The Committee discusses the permission for Mifegymiso
- by Lee, Tak-Sun Sep 05, 2021 08:25pm
- Mifegymiso, which Hyundai has applied for permission, will be discussed at the Central Pharmaceutical Advisory Committee, the MFDS' legal advisory body. The Central Pharmaceutical Advisory Committee's consultation is expected to determine whether Mifegymiso will conduct a bridging study in Korea. The MFDS will hold a meeting at the Central Pharmaceutical Advisory Committee on the 2nd to ask whether Mifegymiso-related safety and validity are reasonable. The meeting is expected to receive comments on the current controversial Bridging Study. "We will discuss Mifegymiso's Bridging Study at the Central Pharmaceutical Advisory Committee," said an official at the MFDS. "Based on the results of the consultation, we will review the direction of the item permit review." If Mifegymiso is granted, it will be the first for the medical termination of a regency in Korea. The MFDS has changed its registration to allow abortion to be introduced in accordance. Since there have been no medications for termination of pregnancy, other medications have been used for termination of pregnancy. In July, Hyundai applied for permission from Mifegymiso (Mifepristone and Misoprostol), an oral medication. The drug is supplied by British pharmaceutical company Linepharma International and will be supplied exclusively by Hyundai. The MFDS has also begun a full-fledged review. It is heard that screening such as safety, validity, quality, and GMP is currently underway. Some in the medical community argue that bridging study should be carried out to secure safety for Koreans before using the drug. The women's community argues that Mifegymiso's Bridging Study should be omitted and approved quickly because Bridging Study has no substitute and can be exempted if necessary. As a result of social controversy, the MFDS has formed an expert to ask whether it is bridging study. If the Central Pharmaceutical Advisory Committee decides on the pros and cons of Bridging Study, the MFDS is likely to accept it. If bridging study is carried out, the item permit is expected to be delayed due to a period of about a year. Attention is focusing on what scientific conclusions the MFDS will reach amid controversy.
- Company
- Boryung released Avastin Biosimilar for the first time
- by An, Kyung-Jin Sep 05, 2021 08:24pm
- View of Boryung headquarters buildingBoryung announced that it will sell its anti-cancer biosimilar "Onbevezy" introduced by Samsung Bioepis in the domestic market from the 1st. Onbevezy is a biosimilar product of the blockbuster anti-cancer drug Avastin (Bevacizumab) developed by Roche. Samsung Bioepis proved the equivalent effect and safety of its original product Avastin through Phase 1 and Phase 3, and received approval for domestic items as the first biosimilar of Bevacizumab in March. It has indications such as metastatic direct colon cancer, metastatic breast cancer, non-small cell lung cancer, progressive or metastatic neoplasm, glioblastoma, epithelial ovarian cancer, ovarian cancer, primary peritoneal cancer, and cervical cancer. In May, Boryung signed an exclusive contract with Samsung Bioepis for Onbevezy 100mg and 400mg. It plans to expand its influence in the anti-cancer drug market by releasing products simultaneously with the listing of drug benefits on September 1. By adding biosimilar anti-cancer drugs to its portfolio, it is also expected to increase its competitiveness in the anti-cancer drug sector. As of 2019, Avastin recorded about ₩8.8 trillion in sales in the global market. In South Korea, it formed a market worth ₩118 billion (IQVIA) based on accumulated sales last year. Onbevezy is 37 % cheaper than the original Avastin. It has a longer expiration date from 24 months to 36 months. "Onbevezy is cheaper than Avastin," said Kim Young-seok, head of the Boryung anti-cancer drug division. It will be an alternative to ease the financial burden of patients and increase the performance of treatment. "We will actively try to settle in the market quickly through synergy between Samsung Bioepis' product power and Boryung's sales competitiveness."
- Company
- Academia supports 1st-line reimbursement of Tagrisso
- by Eo, Yun-Ho Sep 03, 2021 06:03am
- The lung cancer societies are supporting the need to extend insurance benefits for ‘Tagrisso’ to 1st line treatment in lung cancer. In July, AstraZeneca Korea had reduced the standards and reapplied to extend reimbursement to the reduced scope for its 3rd generation EGFR TKI Tagrisso (osimertinib). However, the Health Insurance Review and Assessment Service had decided not to deliberate Tagrisso’s reimbursement as an agenda at the Cancer Disease Deliberation Committee meeting in September. However, still, HIRA had sought opinions from relevant societies, including the Korean Association for Lung Cancer, the Korean Society of Medical Oncology, and the Korean Cancer Study Group. All the societies have expressed support for Tagrisso’s 1st-line indication and submitted opinion statements that a reimbursement extension is necessary, even for the reduced standard. The key strategy for approval of the insurance benefit this time is in the reduced benefit standards. In its application, AstraZeneca reduced the scope of its reimbursement to ‘1st-line treatment of patients with EGFR exon 19 deletion or those with brain metastasis’ rather than in line with its indication of ‘NSCLC patients whose tumors have EGFR mutations, with exon 19 deletions or exon 21 (L858R) mutations.’ In other words, the company adopted the strategy to increases the justification of Tagrisso’s efficacy and treatment benefits. Narrowing the scope of reimbursement would naturally allow for a broader discussion on its fiscal impact. So HIRA decided to collect the society’s opinion on the proposal for the reduced scope of reimbursement. On this, the lung cancer societies have submitted an opinion statement that states “Tagrisso needs to be reimbursed for 1st line NSCLC according to its indication. Therefore, the society sees no problem reimbursing the drug for the reduced scope of standards, and support its coverage extension.” An official from one lung cancer society said, “The drug has already demonstrated statistically significant benefit through a Phase III study and should be reimbursed according to this indication. However, as the agenda continues to be unable to pass the CDDC review stage, we submitted an opinion statement that reimbursement should be first approved for patients in urgent need of such prescriptions.” Tagrisso had added the indication for 1st-line treatment of lung cancer in Korea in December 2018 and aimed to expand its reimbursement to the indication in 2019. However, at the Cancer Disease Review Committee meeting in October, the committee decided to defer the decision until the full data from the Phase 3 FLAURA trial that studied the overall survival (OS) of NSCLC patients in 1st line is disclosed. Although AstraZeneca had submitted the full FLAURA data and expressed their will to accept most of the cost-sharing plan proposed by the government, the reimbursement fell through due to opposition from committee members (specialists) due to issues on the drug’s clinical efficacy. AstraZeneca had attempted to reverse the decision by submitting the OS evidence confirming Tagrisso’s OS benefit in Asian patients from the FLAURA China study, but the committee’s response was, once again, a ‘No.’ After Tagrisso failed to receive reimbursement in April, 1,713 lung cancer patients and their families sent an appeal to the government, the Korean Association for Lung Cancer, and AstraZeneca, “imploring approval for the 1st-line reimbursement of Tagrisso.”.
- Policy
- GOV to bring 1.5 mil COVID-19 vaccines from Romania
- by Kim, Jung-Ju Sep 03, 2021 06:03am
- The Korean government has secured 1,503,000 doses of Pfizer and Modena’s COVID-19 vaccines from Romania and will bring the vaccines to Korea in two shipments this week and next week. The swap was made in line with cooperation for preventive measures against the pandemic that was discussed between the two countries from last month to exchange vaccines with medical supplies. Presided by Vice Head 2 Hae-Cheol Jeon, The COVID-19 Central Disaster and Safety Countermeasures Headquarters (Head: Prime Minister Boo-Kyum Kim) today reported on the progress made for the ‘KOR-RO vaccine cooperation’ to central ministries and 17 metropolitan councils at the Central Government Complex’s virtual meeting room. According to the CDSCH, a total of 1,503,000 doses - 1,053,000 doses of the Pfizer vaccine and 450,000 doses of the Moderna vaccine – will arrive on the 2nd and 8th at the Incheon International Airport through the KOR-Romania vaccine cooperation, 526,500 doses of the Pfizer vaccine will first arrive on the 2nd, then the 526,500 doses of the remaining Pfizer vaccine as well as 450,000 doses of the Moderna vaccine will arrive via DBI at 3:00 p.m. on the 8th next week. The two governments had started discussions on the 10th last month to exchange vaccines and medical supplies to cooperate in areas needed to prevent and control the pandemic, at a time when the world was suffering vaccine shortages. As a result, Korea was able to purchase 1,053,000 doses of Pfizer’s vaccine and receive a contribution of 450,000 doses of the Moderna vaccine from Romania in exchange for a contribution of needed medical supplies from Korea. The two countries have been strengthening healthcare cooperation as strategic partners since the COVID-19 crisis. Romania had expressed gratitude to Korea for providing diagnostic kits to Romania in the early stages of the COVID-19 outbreak, which was the 60th year since establishing diplomatic ties with Romania. This vaccine cooperation is part of the country’s efforts to boost global solidarity and efficiency in cooperation to overcome the pandemic. The government expected the vaccine cooperation to further strengthen the ties between the two countries. The 1,053,000 doses of Pfizer’s vaccine supplied are from Pfizer Belgium and are set to expire on the 30th of this month. The 450,000 doses of the Moderna vaccine are from Rovi in Spain and are set to expire from November 12th to December 5th. The 1,503,000 doses of the Pfizer and Moderna vaccines will be used to inoculate those aged from 18 to 49 as soon as it arrives in Korea. The government also announced its plans to continue various efforts to ensure a stable supply of vaccines in Korea. Also, as global exchange, donation, and repurchase of vaccines are actively being implemented to make up for the gap in vaccine procurement between countries, the Korean government also plans to contribute to the efficient use of vaccines and international cooperation to respond to COVID-19.
- Company
- Kymriah was virtually pending at the Committee
- by Eo, Yun-Ho Sep 02, 2021 05:59am
- It wasn't easy: the listing of the super expensive one-shot treatment 'Kymriah's insurance benefits was discussed but put on hold. According to related industries, Novartis Korea's world's first CAR-T treatment, Kymriah(Tisagenlecleucel), was virtually pending at the HIRA Cancer Drugs Benefit Appraisal Committee on the 1st. However, based on the amendments mentioned in the commission, it is said that the discussion will proceed quickly. Kymriah's indications are Diffuse Large B-Cell Lymphoma (DLBCL) and B-cell Acute Lymphocytic Leukaemia (ALL) in children and young adults. Both are subject to terminal patients who are not effective in treating more than one or who have recurred after re-occurrence or transplantation. The Cancer Drugs Benefit Appraisal Committee reportedly responded positively to ALL, especially to children with high life expectancy, and skeptical responses to lymphoma. Kymriah, which was licensed in March, quickly submitted the benefit using the "Medicine Approval-Patent Linkage System." However, the Korea Leukemia patients organization criticized the government and Novartis after the Cancer Drugs Benefit Appraisal Committee failed to be presented in July. However, it is hard to predict whether ALL indications will be registered. The drug costs about ₩500 million per dose, and variables such as the NHIS negotiation can occur. Yoo Chul-joo, a professor of pediatric blood oncology at Severance Hospital, said, "Although recurrence and non-responsiveness ALL patients in Korea are extremely rare, we expect similar cases in Korea as the government, pharmaceutical companies, and medical community work together to treat them quickly with Kymriah." If Kymriah is listed, it is likely to be linked quickly to actual prescriptions. Currently, Big 5 general hospitals such as Seoul National University Hospital, Asan Medical Center, Seoul St. Mary's Hospital and Sinchon Severance Hospital are undergoing management procedures, including human cells, and Samsung Medical Center has already completed approval. In the case of Seoul National University Hospital, Kymriah passed the DC in April, and passed at SMC in May .
- Policy
- Eligibility for adjustment applications improved
- by Lee, Hye-Kyung Sep 02, 2021 05:59am
- The criteria for adjustment applications that affect drugs subject to pricing calculations will be improved. On the 2nd, the Health Insurance Review and Assessment Service (HIRA) will present the ‘proposal to improve the assessment criteria for drugs that apply for drug pricing adjustments’ as an agenda for deliberation for its Drug Reimbursement Evaluation Committee (DREC). For drugs whose price changes after listing, a pharmaceutical company can request adjustments, upon which HIRA’s Drug Pricing Calculation Department adjusts the price. However, the drugs that may request adjustments were limited to single-brand drugs that are medically essential and have no alternatives, etc. An official from HIRA said, “Until now, not many adjustment applications were filed, so we applied the criteria to DREC’s deliberation for operation. However, with the increase in applications for adjustments that will arise after the reassessment for premium-priced drugs are complete and the complaints from the industry, we presented the agenda on easing the criteria for adjustment applications for DREC’s deliberation.” Companies that have items subject to reassessments of premium pricing had written an agreement regarding their supply obligations etc. after negotiations with HIRA. Since the reassessments were announced, the companies have been ardently awaiting the day to apply for adjustments. In the process, the pharmaceutical industry had requested the government to expand the scope of eligibility for adjustment applications to single brand drugs or drugs that occupy over 90% of its market, national essential medicines or rare diseases, and drugs that are cheaper than other drugs of the same class or cheaper than other countries. A HIRA official said, “Not all the requests made by the pharmaceutical companies were reflected due to concerns over its fiscal impact or rise of other side effects, but we have sent the draft to a public-private consultative body and collected opinions.” If the measures to ease the adjustment criteria pass the DREC meeting, the authorities plan to apply the changes to applications for adjustments filed from September without collecting opinions from pharmaceutical companies. The official added, “The adjustment criteria are currently operated based on an undisclosed internal guideline applied on DREC’s deliberation cases. We plan to reorganize the existing standards to set as operation regulations, then disclose and revise them continuously. Unlike new drugs that undergo the reimbursement listing application process, incrementally modified drugs (IMDs), combination drugs, and generics are listed for reimbursement in 45-75 days after receiving pricing according to a set calculation criteria (a fixed rate of the original’s price) and evaluation for appropriateness of reimbursement. These drugs are subject to the drug premium system, which allows a drug to be sold with a premium at a specific rate for a specific period of time (unlike price increases) for the following purposes: to mitigate the shock of price cuts experienced by original products; to ensure a stable supply of generics (3 or fewer companies); to encourage the entry of generics while providing preferential treatment for technology development, among others. However, the premium pricing criteria was adjusted last year, faced with criticism the system has fallen to become a system that prevents drug price reductions (for originals) and raises drug prices (for generics), as well as the existence of so many products that have maintained their premium long-term. According to the adjusted criteria, the base premium period for all drugs regardless of whether it is a small molecule drug or a biologic is set at 1 year, with a 2-year extension approved for drugs produced with identical ingredients by 3 or fewer companies. Accordingly, 416 generics that exceeded the premium pricing period by over 3 years had undergone price cuts starting September 1st.
- Company
- First IV acetaminophen+ibuprofen combo lands in Korea
- by An, Kyung-Jin Sep 02, 2021 05:59am
- Product picture of Maxigesic IV being sold abroadAn acetaminophen+ibuprofen solution for infusion will soon be released in the Korean pharmaceutical market. Whether the introduction of a new combination therapy option in the single drug-oriented nonopioid analgesic infusion space is gaining attention. According to industry sources on the 1st, Kyongbo Pharmaceutical had received marketing authorization for ‘Maxigesic IV’ from the Ministry of Food and Drug Safety on the 30th of last month. ‘Maxigesic IV’ solution’ is a unique solution combining two nonopioid analgesics- 1000mg acetaminophen with 300mg ibuprofen - for intravenous infusion. Recently, a different pharmaceutical company had applied for an oral drug that contains the same ingredients as an OTD drug but failed. Maxigesic IV was first developed in a tablet form by AFT, a New Zealand pharmaceutical company, to be sold as an OTC, but had switched formulations to be used to manage moderate-to-severe post-operative pain. In November 2018, Kyongbo Pharmaceutical had signed an exclusive development and sales agreement for ‘Maxigesic’ with AFT. The company will be importing the finished product from AFT to sell domestically. The agreement is valid for 15 years from the date of the product release. The two ingredients contained in ‘Maxigesic' -acetaminophen and ibuprofen- are the most widely used antipyretic analgesics. A Phase III clinical trial conducted by AFP on 276 adult patients with at least moderate pain following bunion surgery demonstrated that Maxigesic IV significantly relieved pain within 10 minutes after IV infusion. As a combination solution for infusion, the drug offers higher pain relief than acetaminophen or ibuprofen alone and develops fewer cardiovascular or gastrointestinal side effects. The drug has been received as a potential option that may reduce the use of opioid analgesics that even may replace the market for such drugs. With those strengths, AFP has finished submitting applications for drug approval in 21 countries worldwide, including in major European countries and Australia. The Belgian pharmaceutical company Hyloris Pharmaceuticals, which signed a licensing agreement with AFP for ‘Maxigesic,’ has also been taking steps to receive approval for the drug by the U.S. FDA. Analgesic effect of Maxigesic IV solution(Source: AFP, Hyloris Pharmaceuticals) With the domestic approval, Kyongbo Pharmaceutical is planning to hasten the release of the first IV solution that combines acetaminophen and ibuprofen. An official from Kyongbo Pharmaceutical said, “With a high unmet need remaining in the nonopioid analgesic market, an IV solution that combines two of the most commonly used analgesic ingredients may have the potential to exert and expand its influence in the field of analgesics.
- Company
- Sputnik V's lot release is imminent
- by Kim, Jin-Gu Sep 02, 2021 05:59am
- The Russian COVID vaccine Sputnik V is about to be released, Korus Pharm said on Tuesday. According to Korus Pharm, local administrative procedures for Sputnik V's lot release are being finalized. The production of finished products with a capacity of 1000L has already been completed, and it is expected that the product will be released in earnest once the quality check is completed at the Gamaleya Institute in Russia. In late July, Korus Pharm completed quality verification of Sputnik V's validation badge from the Gamaleya Institute in Russia. Production of 1000L DS was completed in mid-August. Korus Pharm has maintained production of 4 million doz per share, and is expected to increase production to 6 million doz per share starting this month. If bio-reactor is added, it will have a production capacity of more than 10 million doz per week. In addition, Korus Pharm explained that Kirill Alexandrovich Dmitriev, CEO of Russia's RDEF, will visit Korea to commemorate the full-fledged lot release, and is currently discussing his visit to Korea. Kirill Alexandrovich Dmitriev will visit to discuss contracts for additional supplies under the lot release of commercial supplies. "As soon as Russia's local administrative procedures are completed, we will start mass production and establish a shipping process," "As soon as the Russian administrative process is completed, we will mass-produce and establish a shipping process," a Korus Pharm company official said. "We hope that more vaccines will be supplied around the world to help with collective immunity of COVID-19."
- Company
- SK Bioscience has started clinical trial of GBP510
- by Chon, Seung-Hyun Sep 02, 2021 05:59am
- Phase 3 of COVID vaccine developed in Korea have begun in earnest. SK Bioscience announced on the 30th that it has started administering the first subjects of phase 3 clinical trials of GBP510, jointly developed by the Institute for Protein Design (IPD) at the University of Washington. This is the first phase 3 clinical trial of a candidate substance for COVID vaccine developed in Korea. Previously, SK Bioscience received approval from the MFDS on the 10th for clinical trial of GBP510. Phase 3 of GBP510 will be held in 14 domestic institutions, including Korea University and Guro Hospital, and 4,000 domestic and foreign adults over the age of 18 in Europe and Southeast Asia. GBP510 is mixed with GSK's Pandemic Immunostimulator (Adjuvant) and is injected twice every 28 days. SK Bioscience, along with the International Vaccine Institute (IVI), a non-profit international organization in East Europe and Southeast Asia, is applying for approval of each country's Phase 3 clinical trial plan. It is planning to start clinical trials overseas as early as next month. SK Bioscience plans to secure interim data in the first half of next year by evaluating the immunogenicity and safety of GBP510 through Phase 3 clinical trial conducted at home and abroad. With prompt permission from Korean health authorities, it will also begin preparation for the WHO certification and acquisition of Emergency Use Authorization by each country. SK Bioscience confirmed that as a result of Phase 1/2, Phase 1 clinical trial conducted on 80 healthy adults, 100% of neutral antibodies that neutralize COVID were formed in the dosing group that administered both GBP510 and immune enhancer. This is measured through international standard substances and evaluation methods established by the WHO and the NIBSC. In terms of safety, no significant adverse event has occurred that is related to the administration of GBP510. SK Bioscience is also monitoring safety of 247 participants in the second stage, which includes senior citizens. No particular safety issues have occurred so far. The company predicted, "When the development of the GBP510 is completed, the difficulty of supply and demand of COVID vaccine in Korea, which relies on imports, will be resolved." If GBP510 successfully enters the commercialization stage, it can establish and supply its own production and supply plan as it is a vaccine for domestic development. In the long term, it is expected that it will contribute to securing vaccines as it can quickly cope with mutant viruses based on platform technology. The synthetic antigen vaccine platform applied to GBP510 can be stored under refrigeration conditions of 2 to 8°C, so it can be distributed using the existing vaccine logistics network and can be stored for a long time, so it can easily secure accessibility globally. GBP510 was selected as the first target of the Wave 2 project, which CEPI operated last year to support differentiated COVID vaccine candidates, and hundreds of millions of vaccinations will be supplied to the world including South Korea through the COVAX facility once the development is completed. SK Bioscience' vaccine factory in Andong has the capacity to produce hundreds of millions of commercial products a year immediately after developing the vaccine and manufacturing various types of vaccines simultaneously through independent spaces in nine areas of the plant. "With the rapid and systematic cooperation of health authorities and clinical institutions, we have successfully started to administer subjects. We will thoroughly verify safety and effectiveness through clinical trials."
- Company
- It is necessary to provide Kymriah treatment accessibility
- by Sep 02, 2021 05:59am
- Novartis Korea (CEO Kim Skafte Mortensen) announced on the 30th that the ICBMT released the results of a study that analyzed the treatment of DLBCL patients in Korea from August 26 at ICBMT. DLBCL is an aggressive lymphoma that accounts for about 40% of non-Hodgkin lymphoma. Although most standard treatments show abnormalities in part, it is known that 10 to 15% of patients do not respond to primary treatments and 20 to 35% experience recurrence. The study was conducted to identify the demographic characteristics and treatment patterns and prognosis of DLBCL patients in Korea. Led by Professor Park Mi-hye, College of Pharmacy, Sungkyunkwan University, a total of 4931 claims of the HIRA were analyzed from January 1, 2013 to July 31, 2019. The analysis found that the median of the overall survival of DLBCL patients who failed secondary treatment was 4.73 months. In addition, about 70% of patients who failed the second treatment were repeatedly undergoing salvage chemotherapy, and the duration of the second treatment to the third treatment was gradually shortened to 2.86 months (median) and 1.81 months (median) to the fourth treatment. "This study confirmed the poor treatment prognosis and limitations of current treatment of recurrence and non-responsiveness DLBCL patients in Korea," said Park Mi-hye, a professor at Sungkyunkwan University, who led the study. "There are no alternative treatments and poor prognosis. "This is the first study that has been analyzed for all patients in Korea using all data on claim data." She added, "In the end, the patients were repeating salvage chemotherapy, which is difficult to expect a life extension due to the absence of treatment options, and as the number of treatment increases, the length of failure will be shorter, so patients who are unable to expect further reactions need available treatment options." Poor prognosis and the need for effective treatment options in patients with recurrent and non-responsive DLBCL have already been confirmed through global research. According to the SCHOLAR-1 study, the first patient-level analysis result for non-responsive DLBCL patients, the complete response rate for non-responsive DLBCL patients was 7% and the median duration was only 6.3 months. Further analysis of the CORAL study, a multi-organ, randomized clinical trial, also showed that the expected survival rate for one or two years among patients with recurrent and non-responsive DLBCL, especially those who failed secondary relief chemotherapy, was 23% and 15.7%, respectively. "This analysis is encouraging in that we can see the treatment patterns or prognosis of most patients in the actual benefit care environment," said Yoon Duk-hyun, a professor of oncology at Asan Medical Center in Seoul who participated in clinical consultation and research on DLBCL disease and domestic treatment status. Professor Yoon said, "Even though patients with recurrent and non-responsive DLBCL use repeated salvage chemotherapy, the period until the next treatment period was very short, with a median of two to three months, showing very poor prognosis because there are no effective alternative treatments." The new option CAR-T treatment, Kymriah, was the only one in Korea in March to prove a high response rate and persistence in a single treatment in a recurrent and non-responsive DLBCL patient. "Fortunately, new targeted treatments and cell treatments, which are completely different from conventional anticancer drugs, are under development or approval," Professor Yoon said. "However, most new treatments require improvement due to the high cost of patients."
