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- 2025-12-23 20:01:58
- Policy
- Generic exclusivity of Alicoxib has been extended by one mon
- by Lee, Tak-Sun May 18, 2021 05:52am
- Korea Arlico PharmArlico Pharm's "Alicoxib," which acquired generic exclusivity, has been extended for one month. The MFDS allowed the application for extension in consideration of the listing period. According to the MFDS on the 17th, Alicoxib will be guaranteed exclusive rights until January 30 next year. It was extended by about a month from December 25. The entry period for the same ingredient was postponed by one month. This is because when generic exclusivity is acquired, products of the same active ingredient are not allowed to enter within 9 months. The MFDS grants a nine-month effective period, but if sales are delayed within the effective period due to registration, it is extending the period at the request of pharmaceutical companies. Alicoxib has been effective since March 26, but it was not until May 1. However, the generic exclusivity item has a registration period of two months after the application month, which is shorter than 3 months. Arlico Pharm also produces three other ingredients in addition to Alicoxib. They also acquired a generic exclusivity. In addition, six other pharmaceutical products also received generic exclusivity. They are also expected to extend the generic exclusivity period. Alicoxib (Etoricoxib) is a COX-2 inhibitor that, unlike non-selective NSAID (COX-1), selectively inhibits COX-2 induced by inflammatory reactions to relieve pain, and does not inhibit COX-1, which is associated with GIl complications. The original is MSD's Arcoxia, and recorded ₩1.7 billion (based on UBIST) in sales of outpatient Rx last year.
- Policy
- No. of clinical trials rise despite COVID-19
- by Lee, Tak-Sun May 18, 2021 05:51am
- Despite the COVID-19 outbreak last year, the number of clinical trials conducted in Korea had increased, which raised Korea’s global clinical trial rank by two steps. In particular, this was the first time the proportion of early clinical trials (Phase I, II) had exceeded the Phase III trials. Such positive results were possible with the Ministry of Food and Drug Safety (MFDS) and clinical research institutions’ quick response to the COVID-19 variable. A joint analysis by MFDS and Korea National Enterprise for Clinical Trials (KoNECT) of clinical trials aproved in 2020 showed that despite the COVID-19 crisis, the total number of trials approved last year was 799, an 11.9% point increase from the 714 in 2019. The number of approve trials had increased for 3 consecutive years to reach 799 trials last year. Among the trials, company-sponsored trials by pharmaceutical companies drove the growth, accounting for 611 (76.5%) trials, a 13.6% point increase from the 538 conducted in 2019. Looking at the 611 company-sponsored trials by each phase, the increase was focused around early clinical trials (Phase I and II). The number of Phase I and II trials among the 611 trials last year was 400, an increase from 309 in 2018 and 322 in 2019. In the past, over half of the multinational clinical trials conducted in Korea used to be Phase III trials, however, for the first time last year, the number of early clinical trials (Phase I and II) exceeded the proportion of Phase III trials. The proportion of Phase III trials among multinational clinical trials (355) rose from 55.7% in 2018 to 55.2% in 2019, then fell under 50% to mark 45.1% last year. On the other hand, among multinational clinical trials (355), the proportion of Phase I and II trials were 43.9% in 2018 and 43.8% in 2019, which then surged in 2020 to 53.5%. By efficacy, early clinical trials on anticancer drugs and infectious diseases (antibiotics etc.) had increased greatly. This is in line with the global trend, where the development of anticancer drugs and COVID-19 treatments/vaccines are being actively progressed. Phase I and II clinical trials for anticancer drugs had increased greatly from 81 in 2019 to 160 last year. The number of Phase I and II clinical trials for infectious diseases approved last year was 42. According to the clinical trial registration website developed by the National Institute of Health (NIH), the number of clinical trials increased globally last year, and Korea’s global clinical trial ranking rose two steps from the 8th in 2019 to 6th, the highest-ever rank to be recorded by Korea. The analysis is that the increase of domestic clinical trials and multinational clinical trials in Korea are a result of Korea’s rapid response to the change in clinical trial environment caused by COVID-19, and the global recognition of Korea's clinical trial competency. In particular, the increase of early clinical trials for anticancer treatment is expected to provide new opportunities to patients suffering from late-stage cancer, etc. who have no other available treatment options. “Through the operation of the ‘National infectious disease clinical trial center and the National clinical trial participant platform, we plan to establish a COVID-19 clinical trial success model and actively foster Korea's clinical trial competency." The MFDS also plans to actively support the rapid development of COVID-19 treatments and vaccines by actively resolving difficulties in clinical trial sites and operating the Institutional Review Board (IRB) while further strengthening the protection of rights and interests of clinical trial participants and reinforcing safety management of clinical trials.
- Policy
- RSA isn't enough to evaluate the benefit of first in class
- by Lee, Jeong-Hwan May 18, 2021 05:51am
- It was pointed out that in order to enhance patient accessibility of first-in-class, which costs tens of millions to billions of won per dose, and maintain national health insurance financial soundness, the first-in-class customized reimbursement model should be found. They argue that a system should be created that combines risk-sharing drugs (RSA), economic evaluation exemption, and separate fund (FUND) methods to review benefits for expensive anticancer drugs or rare genetic diseases that do not have alternative drugs. Kang Sun-woo, a member of the Democratic Party of Korea, held a parliamentary debate to strengthen access to the first-in-class of rare genetic diseases on the 13th. Kang Hye-young, a professor at Yonsei University of Pharmacy, announced the successful overseas cases of first-in-clas and the implications of the new system. Currently, the market for treatments for rare incurable diseases has proven to be effective, but the rapid development of first-in-class drugs, which cost tens of millions to billions of won, is affecting the finances of each country's health insurance. The limited health insurance budget has increased the burden that should guarantee access to drugs for a small number of patients suffering from rare diseases. Professor Kang Hye-young pointed out that the problem is that Korea has not applied or added ICER thresholds in relation to the first-in-class at the stage of evaluating benefit of drugs and drug pricing. First-in-class, which has excellent drug effectiveness and safety, requires a customized benefit model to flexibly evaluate drugs that satisfy clinical and technical innovation and social needs. Professor Kang said that RSA is also limited to anti-cancer drugs and rare disease treatments, undermining the benefit equity of various incurable disease treatments. It was suggested that the system should be created to increase patient accessibility rather than financial risk sharing based on the introduction of a suitable type of RSA for first-in-class. It is pointed out that Korea has not used the fund yet in expanding its benefit using the fund. Professor Kang said that when considering the benefit through funds, it is necessary to determine the subjects of funding, the scope of medicines eligible for support, and the scope of benefits. "Our first-in-class customized the benefit policy should recognize drug innovation and ensure patient access to unmet medical needs," Professor Kang said. "We need to prepare the system not only for quick approval of new drugs but also for smooth patient benefits."
- Policy
- Will Moderna’s COVID-19 vaccine be introduced in H1?
- by Lee, Tak-Sun May 17, 2021 05:53am
- The process for the rollout of Moderna COVID-19 vaccine in the first half of this year is gaining momentum. As the possibility obtaining marketing authorization for the imported vaccines on Friday(21st) is high, its rollout in the first half of the year is promising due to the Korea-US Summit event. In addition, the overall inspection of the distribution channels that were conducted prior to the introduction of the vaccine, including the simulation vaccine delivery training and safety inspection of GC Pharma’s logistics center in Ochang, have added strength to the possibility of Moderna’s vaccine being introduced in the first half of this year On April 12th, GC Pharma had submitted an application for the approval of Moderna’s COVID-19 vaccine. On May 13th, the Central Pharmaceutical Affairs Council (CPAC) concluded that it was reasonable to grant approval of Moderna’s vaccine for use in adults 18 years or older as a two-dose schedule. CPAC is a legal advisory board of the Ministry of Food and Drug Safety (MFDS), and the ministry is known to generally follow CPAC’s recommendations. However, in the case of COVID-19 treatments and vaccines, the MFDS receives three separate independent evaluations before granting final approval. The last expert meeting, by the ‘Final inspection Committee,' is scheduled to be held on the 21st next month. Considering that the Final Inspection Committee followed CPAC’s decision for AstraZeneca, Pfizer, and Janssen COVID-19 vaccines as well as Celltrion’s COVID-19 treatment, unless a major issue comes up, the Moderna vaccine is also likely to be granted approval. The MFDS will hold a meeting with the Final Inspection Committee to finalize the labeling details and decide whether to approve the marketing authorization of the vaccine. As the Korea-U.S Summit is scheduled on the same day, industry officials predict that the government will use the summit as an opportunity to approve the Moderna vaccine and announce its rollout schedule in Korea. Also, there have been media reports that 50,000 doses of the vaccine will arrive in Korea in the last week of May. If the vaccine is imported this month, the government’s announcement of releasing the vaccine in Korea in the 2nd half of this year will come true. In the case of the Moderna vaccine, as the company prioritized its U.S. supply, the rollout schedules in other countries were expected to be delayed by one quarter. This was why there had been strong expectations that the vaccine will be introduced in the third quarter rather than the second quarter. However, the mock delivery training for Moderna vaccines and the joint safety inspection conducted at GC Pharma’s logistics center in Ochang have supported the possibility that the introduction of the Moderna vaccine may be more imminent in Korea. In the case of these imported Moderna vaccines, the drug substance of the Moderna vaccine was first produced at the Lonza plant in Switzerland, then filled and finished by a Spanish pharmaceutical company. After its arrival in Korea, GC Pharma will take over its distribution as the license holder. Apart from the imported vaccines, the CMO deal for producing the Moderna vaccine in Korea is expected to be announced during the Korea-U.S. Summit period. The popular prospect is that Samsung Biologics will be the CMO that fills and finishes the solution in Korea. On such expectations, Samsung Biologics had publicly stated that “nothing has been finalized.” However, considering that the company drew a firm line on the rumors of a CMO deal for the Pfizer vaccine stating that “it is not true,” the rather unclear position of Samsung Biologics has added fuel to the rumor. Also, as John Rim, the CEO of Samsung Biologics will be at the South Korea-U.S. Summit, this also had added strength on the possibility of the company being the CMO for Moderna. However, even after a CMO deal, it would take some time for the CMO to actually produce the vaccines, as pharmaceuticals manufactured in Korea are required to receive a separate approval from the MFDS. The vaccines that passed the CPAC review this month were imported vaccines, therefore a separate approval is required for domestically manufactured products. AstraZeneca had also submitted two applications for its vaccine; one for the manufacture and marketing authorization of its products manufactured by its CMO SK Bioscience, and the other for the import authorization of products manufactured outside of Korea, including those from Italy.
- Policy
- Off-label use of Olumiant and Botox denied
- by Lee, Hye-Kyung May 17, 2021 05:53am
- An application for the use ‘Olumiant(baricitinib) in patients with alopecia areata was rejected by the health authorities in Korea. In addition, the application to administer Botox injections for the primary suture of facial lacerations and recurrent pancreatitis was also disapproved due to lack of medical evidence. The Health Insurance Review and Assessment Service (HIRA) reviews applications in advance for the off-label use of drugs beyond the scope approved by the Ministry of Food and Drug Safety (MFDS) to prevent the use of medicines that lack medical evidence or have potential safety concerns. According to the cases of off-label use disapprovals recently disclosed by HIRA, 8 cases of disapprovals including Olumiant and Botox were added this month, to make the cumulative number of disapproved cases to 209 in total. In the case of Olumiant, a medical institution had applied to prescribe the 2mg or 4mg Olumiant tablet to a patient with alopecia areata for 12 months, but the application was turned down due to lack of medical evidence. The application for the off-label use of Botox was for its use in patients who receive primary suture for facial lacerations and avulsions at emergency centers or outpatient clinics, and for patients with recurrent pancreatitis that have been excluded from all causes of acute pancreatitis such as gallstone, alcohol, hereditary, and autoimmune manifestations and is at high risk of pancreatitis due to ERCP procedures. The application was also denied approval. Also, applications to administer ‘Carmine Injection 0.8%’ to women in the childbearing age who were diagnosed with infertility, or is suspected of infertility due to tubal factors (fallopian tubes, fallopian tube adhesions, paratubal cyst, fallopian tube plastic surgery subjects) to check the bilateral tubal patency of the fallopian tubes during laparoscopic surgery; and to administer ‘Antiroid tablet’ to patients in need of taste tests whose information on their PROP phenotype is deemed clinically useful, were also disapproved. In addition, applications for the off-label use of 'Mabthera injection', 'Eglandin injection', and 'Valcyte 450mg' on RPGN patients, hospitalized patients after kidney transplant, and patients with glioblastoma without kidney failure, respectively, were rejected on the grounds of lacking medical evidence.
- Policy
- 1+3 restrictions bill for generics & IMDs was passed
- by Lee, Jeong-Hwan May 17, 2021 05:53am
- The number of joint biological equivalence tests and joint clinical trials of generic and data IMDs is expected to be limited to three consignment companies per manufacturer. Only three additional medicines can be licensed for biological equivalence tests or clinical trials. However, biological drugs such as high-tech new drugs and vaccines and medicines designated by the head of the MFDS may be exempted from regulations on "Common Biological Equivalence Testing and Clinical 1+3 Restriction." On the 28th, the National Assembly's Health and Welfare Committee passed the 1+3 restrictions bill on drug co-development. The first bill subcommittee of the Welfare Committee voted to revise the bill of Seo Young-seok and Seo Jung-sook. Only three additional medicines can be licensed for biological equivalence tests or clinical trials. The first bill subcommittee of the National Assembly's Health and Welfare Committee on the 28th passed some revisions to the Pharmaceutical Affairs Law proposed by Seo Young-seok and Seo Jung-sook, respectively, reflecting the MFDS' amendment. The bill subcommittee's resolution will succeed in legislation if it passes the procedures of the Welfare Committee, the Legislation and Judiciary Committee and the plenary session. It was designed to establish a sound pharmaceutical industry by limiting the number of items in the pharmaceutical market. In particular, recent GMP violations by the domestic companies such as Binex, Vivozon, and Chong Kun Dang have increased the feasibility of legislating regulations on generic and IMD regulations. The MFDS, which had previously considered IMD regulations carefully, also expressed its support for regulations on IMDs after the GMP crisis, helping pass both bills. Specifically, if the same manufacturing process is manufactured by the same manufacturer with the same manufacturing method as the pharmaceutical company's drug that directly conducted the BA test, the use of biological equality data will be limited to three times. In short, the number of consent to use biological equivalence test data for one drug is up to three items. Clinical trial data can also be used for up to three items other than drugs from pharmaceutical companies. However, non-Rx drugs, biological preparations such as advanced biopharmaceuticals and vaccines, and other medicines determined by the head of the MFDS are not subject to the 1+3 restriction.
- Policy
- Combination of Epidiolex & Clobazam are reimbursed
- by Lee, Hye-Kyung May 17, 2021 05:52am
- Starting this month, detailed standards for the health insurance application of "Epidiolex (Cannabidiol)," used to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex, have been unveiled. The HIRA recently released 'Question and Answer on Applying Benefit Standards to Epidiolex' and guided details on targets and methods of evaluation. Epidiolex was Emergency Use Medication by the MFDS for the use of "the treatment of Lennox-Gastaut syndrome and seizure related to Dravet syndrome" in patients over the age of two. It was supplied to Korea through the Korea Organ & Essential Drug Center from April 1st. Epidiolex can be reimbursed if ▲ the requirements for not showing a reduction in seizure frequency with other antiepileptic drugs are met or ▲ has a history of administration of antiepileptic drugs before Epidiolex. However, the history of administration of antiepileptic drugs before administration of the drug means "the history of more than five of the 11 antiepileptic drugs prescribed in the detailed recognition criteria for care benefits being administered at sufficient internal medicine capacity." The administration history should be checked by detailed medical records. The requirement for patients who have not shown a decrease in seizure frequency with other antiepileptic drugs refers to "the frequency of seizures did not decrease by more than 50% compared to the time of initial antiepileptic drugs even though more than five of the 11 drugs were administered with sufficient internal medicine." Patients who administer Epidiolex only can be reimbursed in combination with Clobazam. If Clobazam cannot be administered, Epidiolex will be reimbursed if detailed medical records confirm it. The HIRA also detailed the 'methods of assessment for sustainable investment'. It explained that for an additional 3 months after the first 3 months of Epidiolex administration, the seizure frequency should be reduced by more than 50% for the first 3 months of the drug, and for continuous additional administration after the first 6 months of the drug, the seizure frequency should be reduced by 50% or more. In order to evaluate the appropriateness of continued administration of Epidiolex and prevent drug abuse, patients or guardians should fill out the seizure log with frequency of seizures and whether Epidiolex is administered, and medical institutions should manage it. As for patients who have already been administered Epidiolex since April 1st, it is considered to meet the requirements for the benefit ▲if the criteria for detailed recognition of medical benefits at the time of initial administration of the drug, ▲if the 'subject to administration' requirements are met and can be verified through the details of the medical records, and ▲ five or more of the 11 types of antiepileptic drugs can be checked in detail in the medical records, and the necessity and appropriateness of the drug launch are considered to meet the requirements of the benefit unit if confirmed by a specialist. It can be administered continuously if the assessment method for patients three months after Epidiolex administration for non-reimbursement meets Da-1 of the criteria for detailed recognition of medical benefits at the time of initial effectiveness assessment (three months after administration of the drug), or if the seizure frequency is maintained by more than 50% compared to the initial dose of the drug, or if it is confirmed by experts that treatment effects and continuous administration are necessary after the drug is started.
- Policy
- Will vaccination gather pace? MFDS approves 2.6 M doses
- by Lee, Tak-Sun May 14, 2021 05:50am
- Vaccination in Korea is expected to speed up as a large number of COVID-19 vaccines have been approved national lot release. Through the fast track review and approval system, the Ministry of Food and Drug Safety also (MFDS) approved the national lot release of AstraZeneca’s vaccine earlier than expected. Since the 12th, as many as 2,640,000 doses were approved for lot release. According to the MFDS on the 13th, 2,203,000 doses of AstraZeneca’s COVID-19 vaccine manufactured by SK Bioscience were approved national lot release on the 12th. This is even more than the 1,574,000 doses that were granted last February. The approved vaccines will be used as booster shots and as first shots for older adults aged 65 to 75 who will start inoculations on the 27th. As of 12:00 a.m. on the 13th, the vaccination reservation rate of seniors aged 70 to 74 was 51.6%. The 438,000 doses of the Pfizer vaccine that arrived on the 12th were also immediately granted lot release on the 13th the next day. The Pfizer vaccines are being given to seniors aged 75 or older. Currently, only booster shots are being administered but the government will resume administration of the first dose from the end of this month. The COVID-19 vaccines approved on the 12th and 13th are in total, 2,640,000 doses, which makes up about 40% of all the doses that were released until now. In addition, 835,000 doses of the AstraZeneca vaccine arrived in Korea through the COVAX facility on the 13th. These vaccines, which were imported vaccines manufactured in Italy, were granted emergency use as it was not yet approved in Korea. These vaccines will be swiftly supplied as products approved for emergency use do not need to be reviewed for national lot release, Vaccinations in Korea are expected to speed up with improved procurement. By the first half of the year, the government plans to inoculate a total of 13 million people, mainly those in their 60s or older. A total of 18.32 million doses will be brought to Korea during the first half of the year, which is sufficient for achieving the target. As of 12:00 a.m. on the 13th, the cumulative number of people who received their first shots was 3.71 million. To enable faster vaccination, the MFDS has expedited the national lot release approval for vaccines. For example, for initial approval, the first three lots manufactured are approved within 20 days, and those manufactured thereafter within 10 days, and products with the same lot number are approved within a day. Through the national lot release system, the MFDS conducts one final quality test before biologics like vaccines are marketed.
- Policy
- Eyes on approval of ‘acetaminophen+ ibuprofen’ combo OTCs
- by Lee, Tak-Sun May 14, 2021 05:50am
- 미국에서 OTC로 발매된 최초의 아세트아미노펜+이부프로펜 복합제 The Ministry of Food and Drug Safety (MFDS) is reviewing the approval of an acetaminophen and ibuprofen combination therapy as an over-the-counter drug (OTC). The two ingredients are well-known antipyretic-analgesics, however, the combination of only these two ingredients was not commonly used as the two have different mechanisms of actions. However, with the U.S Food and Drug Administration (FDA) approving the first acetaminophen and ibuprofen combination drug as an OTC, the possibility of seeing the combination in Korea is also rising. According to the MFDS on the 13th, the members of the Central Pharmaceutical Affairs Council will be discussing whether to classify the acetaminophen and ibuprofen combination as an OTC and the appropriateness of its approval at the meeting on the 17th. No combination drug with only the acetaminophen and ibuprofen ingredients has been approved in Korea yet. However, the combination has been approved overseas. In March last year, the U.S. FDA approved GSK’s ‘Advil Dual Action,’ which contains acetaminophen and ibuprofen. This was the first case where an ibuprofen and acetaminophen combination drug was approved as OTC in the U.S. Advil Dual Action contains 250 mg of ibuprofen and 500 mg of acetaminophen. In clinical trials, a fixed-dose combination of the two components demonstrated a superior effect compared to the individual components alone. The drug was officially released as an OTC in the U.S market in September last year. There had been attempts to receive approval of the ibuprofen and acetaminophen combination as an OTC in Korea as well. In 2017, Hanmi Pharmaceutical submitted an application for the approval of the combination as an OTC but was rejected. The Central Pharmaceutical Affairs Council that discussed the OTC designation of the combination then did not approve the product due to concerns about drug abuse. The product contained 500 mg acetaminophen and 200 mg ibuprofen. The members of the council were concerned that people would be taking the drug regardless of their pain intensity, and that the approval will unintentionally increase the maximum dose intake of the two ingredients. As a result, only 3 of the 8 members of the council agreed to the OTC permit, and the others opposed the decision. The MFDS also expressed concerns over its safety. MFDS opposed the OTC designation saying that the adverse reactions that occur from the two ingredients were similar and that there was a risk of gastrointestinal bleeding. However, with the U.S FDA's approval of the drug as an OTC last year, the situation may change this time. The MFDS and the experts usually refer to approvals abroad, especially those from the U.S FDA when making decisions. Therefore, the possibility exists for the combination to see different results this time around at the Central Pharmaceutical Affairs Council meeting that will be held on the 17th. An MFDS official confirmed that “It is true that a relevant product has applied for approval.”
- Policy
- MFDS has begun testing the second supply of AZ vaccine
- by Lee, Tak-Sun May 14, 2021 05:50am
- The MFDS has begun a national test on the second supply of AZ COVID-19 vaccines produced by SK Bioscience. The vaccine will be supplied 7.23 million doses from the 14th to early June. According to the MFDS on the 12th, SK Bioscience recently applied for a lot release for the second supply of AZ vaccine. The MFDS plans to approve the lot release within 10 days through a quick test. The MFDS approves shipments of 3 lots produced after the approval within 20 days, production within 10 days, and the same lot number volume immediately after the supply. In the case of the AZ COVID-19 vaccine produced by SK Bioscience, more than 1,574,000 doses were lot released on February 17 after being approved on January 29. Lot release completed within 20 days. In the case of the Pfizer vaccine, more than 501,000 doses were lot released on the 28th of the same month. Since the second supply of the AZ vaccine, which will be distributed this time, is produced after the initial 3 lots, it aims to release the lot within 10 days of the test. The vaccine, which will be distributed this time, is expected to be used for vaccination for senior citizens aged 60 to 74, which will begin on the 27th. 83.5 million doses of the COVAX AZ vaccine, which will arrive tomorrow, will be introduced in Korea without going through a national lot release process as it has received Emergency Use Authorization as an unlicensed Italian product.
