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- 2025-12-24 04:49:17
- Policy
- Pantoprazole, shouldn’t be exceed 20mg per day
- by Lee, Tak-Sun Oct 29, 2020 05:52am
- Pantoloc, brand for Pantoprazole For Pantoprazole, one of the anti-ulcer PPI, the MFDS is pursuing a change in the approval so that it does not exceed 20 mg per day for patients with severe hepatic impairment. Previously, it was supposed to take 40mg once every other day, but it was not to exceed 20mg per day. The MFDS recently prepared a proposal for amendment of the permission matters and requested related companies to submit their opinions by November 11. The original for Pantoprazole is Takeda's Pantoloc. Pantoloc is a blockbuster drug that recorded ₩14.5 billion in outpatient prescriptions last year. The proposed amendment to this permit applies only to a single drug of Pantoprazole Sodium Hydrate 40mg. A total of 19 pharmaceutical companies and 20 items are licensed. The main changes are the indication and dosage for patients with severe hepatic impairment such as Zollinger–Ellison syndrome and other pathological conditions of gastric acid hypersecretion. It was supposed to take 40mg once every other day, but from now on, it will not exceed 20mg once a day. The MFDS said that, as a result of an additional review on the safety and effectiveness of the update application data, it was determined that changes to the permission matters were necessary, and that a change proposal was prepared. With this change, patients with severe liver impairment cannot take 40 mg tablets at once. Instead, you should take 20mg or 40mg in half. Currently, Pantoprazole’s indication does not exceed 20mg per day for patients with severe hepatic impairment. There was a difference from the 40mg tablet. Accordingly, it is interpreted that the MFDS has devised a plan to change this permission to reduce confusion in taking patients. An official from the MFDS explained that the existing indication doesn’t have safety issues. Pantoprazole 40mg was first approved in 2004.
- Policy
- The MFDS begins preliminary screening for COVID-19 vaccine
- by Lee, Tak-Sun Oct 29, 2020 05:52am
- It was revealed that the domestic health authorities have begun a preliminary review of the COVID-19 vaccine that AstraZeneca is developing. It is explained that applications for domestic approval are expected after three months as soon as possible. Among vaccines currently being developed at home and abroad, it is the fastest for domestic product approval. The MFDS announced on the 27th that AstraZeneca formed a dedicated approval review team for the COVID-19 vaccine being developed and began preliminary review of non-clinical test data. The COVID-19 vaccine being developed by AstraZeneca is a vaccine jointly developed with The Jenner Institute in the UK, and is currently being evaluated for its rapid commercialization. In Korea, SK Bioscience has signed a contract to consign the vaccine. The MFDS is operating one of ‘Go’ Expedited Programs for rapid approval of COVID-19 treatment and vaccine. For products that are expected to apply for permission, 'permission exclusive review team' was formed 90 days before the scheduled application date. And it has a system to proceed with the preliminary examination. Accordingly, the data will be reviewed in advance under the assumption that the AstraZeneca-developed COVID-19 vaccine is applied for approval after 3 months. It plans to review not only non-clinical data but also clinical data in progress overseas. An official from the MFDS said, "AstraZeneca has the only COVID-19 vaccine that is undergoing pre-examination by the approval team." And he added that it plans to review the data before applying for permission. Meanwhile, in Korea, 'INO-4800' of the International Vaccine Institute and 'GX-19' of Genexine are currently in phase I/IIa as a vaccine for COVID-19. The MFDS said that it will continue to monitor development trends, such as clinical trials of COVID-19 treatments and vaccines, and provide support for items such as product approvals, special manufacturing, and imports necessary for domestic introduction. In addition, the MFDS said it will do its best to ensure that the Korean people receive treatment opportunities.
- Policy
- Godex continues to monopolize the market
- by Lee, Tak-Sun Oct 27, 2020 06:11am
- Annual sales of ₩60 billion in outpatient prescriptions Celltrion's liver disease treatment 'Godex capsule', which has grown to about ₩60 billion per year, was developed as tablet formulations rather than conventional capsule formulations and is pursuing product approval. Godex capsule has no competing generics, but as the patent expired in November last year. Accordingly, Celltrion has developed tablets preemptively to maintain its monopoly position and expand its market share. According to the industry on the 26th, Celltrion has completed the development of a so-called Godex tablet and has recently submitted the application to the MFDS. Godex capsule, licensed in 2000, is a complex improved drug combining Carnitine Orotate, Adenine HCl, Antitoxic Liver Ext, Biphenyl Dimethyl Dicarboxylate, Cyanocobalamin, Pyridoxine HCl, and Riboflavin. Transaminase (SGPT) is used in patients with elevated liver disease, and prescription results are steadily increasing in recent years. Together with Ursa, it is the most commonly prescribed drug for patients with liver disease, and the amount of outpatient prescription based on UBIST last year reached ₩59.3 billion. However, Godex capsule is also in a situation where it can compete for generics due to the expiration of its patent on November 8 last year. However, since it is a complex drug that combines seven main ingredients, it is difficult to prove the equivalence, so no pharmaceutical companies are developing generics. Accordingly, it will be able to achieve more than ₩60 billion, surpassing last year's performance. Celltrion has proactively developed IMD (Incrementally Modified Drugs) in line with the expiration of the patent for Godex capsule. In April of last year, CTP-JB02 was approved for Phase III clinical trials and went through a validation procedure. CTP-JB02 was known as 'Godex tablet'. Godex tablet, which is being promoted for commercialization, is slightly different in ingredients from the existing Godex capsule. Among the ingredients, the salts of Carnitine have changed. In Godex capsules, Orotate was used for Carnitine, while Godex tablets were known to use napadicylate for L-carnitine. Celltrion is said to have applied for a patent for such a pharmaceutical composition. Once a patent is registered, Godex's market monopoly is also guaranteed. Godex capsules should be taken 2-3 times a day, 2 capsules at a time. Therefore, it seems that Godex tablets will be an alternative to patients who do not prefer Godex capsules.
- Policy
- Kyongbo joins Galvus latecomer competition with IMD
- by Lee, Tak-Sun Oct 27, 2020 06:11am
- Kyongbo Pharmaceutical joined the competition among the dipeptidyl peptidase-4 (DPP-4) inhibitor Galvus (vildagliptin) latecomers. The South Korean company has reportedly applied for the authority’s approval on its new incrementally modified drug (IMD). According to the Ministry of Food and Drug Safety (MFDS) and the pharmaceutical industry sources on Oct. 23, Kyongbo Pharmaceutical submitted an approval application on three doses of vildagliptin hydrochloride plus metformin hydrochloride on Sept. 28. Unlike the original Galvus, the IMD has hydrochloride base attached to the original active ingredient vildagliptin. As a result, now three South Korean companies—Ahn-gook Pharmaceutical, Hanmi Pharmaceutical and Kyongbo Pharmaceutical—have either applied for the government approval or received the approval for a Galvus follow-on drug. In November 2019, Ahn-gook Pharmaceutical won the authority’s approval on a vildagliptin latecomer, ‘Ahngook Vildagliptin 50 mg tablet,’ and became the first company to take on the market. As for Hanmi Pharmaceutical, the company received the approval on ‘Vildagle 50 mg tablet (vildagliptin hydrochloride),’ but it soon dropped the license as it lost the patent challenge trial to enter the market by breaking off indications. However, Hanmi Pharmaceutical submitted the applications on a single agent drug, sharing the same substance as Vildagle, and a combination agent drug with vildagliptin hydrochloride-metformin hydrochloride on Sept. 29 and on Oct. 16, respectively. Ahn-gook and Hanmi would be able to release their products from August next year at earliest, as they have succeeded in nullifying 187 days of Galvus patent term to be terminated in March 2022. But Novartis filed an appeal to cancel the Intellectual Property Trial and Appeal Board’s decision, which is expected to conclude on Oct. 29. If the two South Korean companies were to win the case at the Patent Court as well, their products would be available in the market by August next year. But the release date could be pushed to March 2022, if they were to lose the case. Ironically, Kyongbo Pharmaceutical is rooting for Ahn-gook and Hanmi, because it wants to release its product alongside the two companies after confirming the nullification of the Galvus patent extension term. When the original’s company loses the patent challenge, other follow-on drug companies are also allowed to take an action. Although Ahn-gook Pharmaceutical owns the preferential sales rights effective from August next year, Hanmi and Kyongbo can enter the market without sales ban as their products have different salt base from Ahn-gook’s. At the moment, Kyongbo is in process of seeking negative confirmation of Galvusmet substance patent (Sept. 25, 2026) scope filed in last January to evade the patent. As Ahn-gook Pharmaceutical, Hanmi Pharmaceutical and Korea United Pharm have already won the cases, Kyongbo is confident it would also evade the patent. As a Phase I clinical trial to confirm the equivalence with the original from last March was successful, Kyongbo Pharmaceutical was cleared to apply for approval with the third latecomer drug in the market. Only time would tell if Kyongbo Pharmaceutical can take over the vildagliptin market valued at 20 billion won in South Korea.
- Policy
- Continued administration of Remdesivir was recommended
- by Lee, Tak-Sun Oct 27, 2020 06:11am
- COVID-19 treatment Domestic health authorities recommended that patients continue to administer 'Remdesivir', a treatment for COVID-19. Although the WHO announced that it was not effective, it was not the final clinical trial result, and the US clinical trial reliability, which was the basis for the approval, was highly regarded. The MFDS and the Korea Disease Control and Prevention Agency announced on the 23rd that it is recommended to continue administration under the judgment of medical staff in accordance with the approval of the product in relation to the results of the clinical trial of Remdesivir recently announced by the WHO. The WHO announced on the 15th that there was no difference between the control group and the test group of Remdesivir clinical trial results, mortality, and treatment duration. The research results have not gone through a peer review process in the academic paper publication procedure. The MFDS and the Korea Disease Control and Prevention Agency determined that additional data reviews such as review of the presentation contents, expert consultation results, administration timing, and subgroup analysis by severity were necessary. When the final results of The MFDS clinical trial are announced, the test methods and results such as the target patients registered for the trial and the local medical situation where the trial was conducted will be carefully reviewed, and discussions will be conducted with overseas regulatory authorities including expert advice. The MFDS approved Remdesivir on July 24 to use Remdesivir only for severe hospitalized patients who need supplemental oxygen based on the results of a clinical trial led by the NIAID for the treatment of Korean COVID-19 patients. In particular, the result that Remdesivir shortened the treatment period by 5 days in COVID-19 patients was judged to be clinically meaningful. Remdesivir has been approved and used in the United States, Europe, Japan, Taiwan, and Singapore. In addition, the MFDS’ COVID-19 Expert Committee and the Central Clinical Committee of Novel Infectious Diseases said that the U.S. NIAID used a highly reliable research method, and it was judged that there was a scientific basis for the effectiveness of the drug, so the use of Remdesivir as a treatment for COVID-19 should be maintained. Accordingly, the MFDS and the Korea Disease Control and Prevention Agency continue to monitor clinical trials and abnormal cases for COVID-19 treatments and vaccines, while introducing safe and effective drugs in Korea, so that Koreans can receive treatment opportunities. Remdesivir was approved by the U.S. Food and Drug Administration (FDA) as an official treatment for COVID-19 on the 22nd local time in the United States.
- Policy
- Stribild was withdrawn in Korea
- by Lee, Tak-Sun Oct 26, 2020 06:15am
- Stribild, which once ran the No. 1 HIV treatment market with an annual sales of ₩20 billion, withdrew from the domestic market. It has been 7 years and 8 months since the approval in February 2013. Stribild has been on a roll as a drug that enhances the convenience of AIDS patients by containing four ingredients in one pill, but it was naturally replaced Genvoya with less side effects. According to the MFDS on the 25th, Gilead voluntarily withdrew Stribild's domestic license on the 23rd. It is a drug that competes with GSK’s Triumeq. Stribild is a combination of Cobicistat/Elvitegravir/Emtricitabine/Tenofovir disoproxil fumarate in the treatment of adult HIV-1 infection in one pill. It was released in February of the following year with domestic approval in February 2013. As soon as the sale started, it dominated the HIV market with its strong effect and convenience of taking it once a day. In 2016, sales based on IQVIA were ₩20 billion. In the second half of that year, it was overwhelmingly ranked first. However, with the release of 'Genboya', which improved the side effects of Stribild in 2017, sales began to gradually decline. Genvoya is a drug that uses Tenofovir alafenamide fumarate (TAF) instead of Stribild's Tenofovir disoproxyl fumarate (TDF). TAF shows equivalent viral suppression at a tenth dose compared to TDF, and improves side effects such as kidney toxicity and bone marrow toxicity. Genboya has replaced Stribild and is now the best item. Zenboya recorded ₩9.9 billion in sales in the first half of this year based on IQVIA, and Stribild has not been able to capture sales since the third quarter of last year. Stribild was completely replaced by Zenboya. There is no need to maintain licenses since Stribild has no track record. Gilead withdrew from the domestic market voluntarily.
- Policy
- Tagrisso is not an expensive drug
- by Kim, Jung-Ju Oct 26, 2020 06:15am
- While Tagrisso, a new lung cancer drug, is currently being paid for as a second-line treatment, the government responded that it was difficult to claim that it should further increase its coverage as a first-line treatment. This is because the government should apply the principle by reasonably setting the economic evaluation and ICER standard values for the government that needs to continue to release ultra-high-priced new drugs and improve patient access evenly, so there is a gap with the needs of the people. Minister of Health and Welfare Park Neung-hoo made such a statement on the arguments of Lee Yong-ho at the National Assembly Health and Welfare Committee's comprehensive national audit, which is being held from the morning of the 22nd. He pointed out the fact that Tagrisso, which costs ₩200,000 per tablet, is being given as a second-line treatment in Korea, which shows a remarkably effective drug when taken daily among patients. Lee said, "Even though Tagrisso is a priority in the international standard for cancer treatment, the price is very high because it is paid as a secondary treatment in Korea." He stressed that the ICER threshold for the economic evaluation of severe and rare diseases should be realized at a GDP of ₩20,000 and asked the minister for an answer. In response, Minister Park said, "From the government point of view, the price of Tagrisso is not as a very expensive drug." He added that the reason is that new drugs are released every day and there are a lot of very expensive drugs, but we will actively review Tagrisso.
- Policy
- Hanmi’s generic for Galvus is aiming for release next year
- by Lee, Tak-Sun Oct 23, 2020 09:44am
- Galvus by NovartisHanmi applied for item approval again three months after withdrawal of the DPP-4 inhibitory diabetes treatment 'Galvus' (Novartis, Vildagliptin) salt-modifying drug. Indications were not removed unlike existing products, and combination drugs were applied for permission. According to the MFDS and pharmaceutical industry on the 21st, Hanmi applied for item approval for a single drug for Vildagliptin HCl on the 29th of last month and a combination drug for Vildagliptin HCl /Metformin HCl on the 16th of this month. In January, Hanmi obtained an item license for Vildagliptin HCl. At the time, it was licensed to exclude two of the original drug uses. The company tried to obtain insurance benefits, but the Intellectual Property Trial and Appeal Board dismissed the request from Hanmi. Accordingly, as of July 6, Hanmi voluntarily withdrew the item. The item applied for permission this time contains the same six original uses unlike the previous case. It seems that it is now aiming for release on August 30th next year. Although it failed to split the indications, Hanmi and Ahn-Gook succeeded in invalidating Galvus' material patent duration extension period of 187 days. Accordingly, the product can be released on August 30 next year. However, in response to the Intellectual Property Trial and Appeal Board trial decision, Novartis has filed a lawsuit to cancel the trial decision to the Patent Court of Korea. The judgment of this lawsuit is scheduled for the 29th this month. It will be difficult to launch in August next year if the court takes the side of Novartis, then, it will be available only in March 2022, a year later. Hanmi applied for permission for the Metformin combination drugs at this time. Currently, Hanmi is the only generic company that has applied for a combination drug. Although it failed to launch this year, it can dominate the market with Ahn-Gook even if it is released next year. However, Ahn-Gook did not apply for a combination drug. It is analyzed that if Hanmi introduces a single drug and a combination drug at the same time, it will be more advantageous in the competition for market share of generic companies. According to UBIST in the first half of this year, the outpatient prescription sales of the original, Galvus and the combination drug, Galvusmet were ₩4 billion and ₩17.9 billion, four times larger in the combination drug market.
- Policy
- Saxenda must be prescribed thru outpatient Rx
- by Lee, Jeong-Hwan Oct 23, 2020 09:44am
- The MFDS stated that the principle is to issue outpatient Rx by applying the principle of separation of prescribing and dispensing drugs for self-injectable medicines such as obesity drug, Saxenda. Unless a doctor directly injects, according to the purpose of separation of prescribing and dispensing drugs, medical institutions such as hospitals and clinics should not directly prescribe or dispense self-injection drugs, but rather must dispense them at a pharmacy. On the 20th, the MFDS unveiled an agreement with the MOHW regarding self-injectable medicines in a written inquiry by Nam In-soon, a member of Democratic Party of Korea. She inquired about the need for safety management and prevention of drug abuse for self-injectable medicines. It was pointed out that self-injectable medicines should be reinforced during the national audit last year that the safe use measures for patients should be strengthened due to side effects such as bleeding, infection, and pain. In particular, she asked about the results of consulting the MFDS’ Central Pharmaceutical Affairs Review Committee in January this year to support measures to support the safe use of self-injectable medicines and the contents of consultations with the MOHW regarding the mandatory outpatient Rx. She clarified that self-injectable medicines is subject to separation of prescribing and dispensing drugs, and urged that the outpatient Rx be made mandatory and consulted with the MOHW so that the public can use it safely. The MFDS stated that based on the discussion of the MOHW, self-injectable medicines should be prescribed through outpatient Rx, unless the doctor injects directly. She said that she would discuss the details of outpatient Rx with the MOHW. The MFDS said, "To support the safe use of self-injectable medicines, we have created patient-participated information and planned patient education with experts." Saxenda has improved the packaging unit from the current 5 packaging to unit packaging." She added, “I confirmed the position of the MOHW that Issuing outpatient Rx for self-injectable medicines is a principle unless the doctor injects directly.” And she also said that outpatient Rx for self-injectable medicines is a task under the jurisdiction of the MOHW, and I will discuss the details in the future."
- Policy
- NA audit talks about pre-listing coverage on anticancer
- by Lee, Hye-Kyung Oct 23, 2020 09:44am
- At the National Assembly annual audit, a healthcare provider suggested the ‘pre-listing reimbursement and post-evaluation’ should be implemented and ‘incremental cost-effectiveness ratio (ICER) threshold’ should be adjusted to practically improve access to new drugs. Professor Kang Jin-hyoung at the Catholic University of Korea Seoul St. Mary’s Hospital, treating cancer patients at the clinical treatment scene, elaborated about the patients struggling to receive treatment due the delayed new drug reimbursement listing. However, the insurer, or the National Health Insurance Service (NHIS) and Health Insurance Review and Assessment Service (HIRA) expressed a reserved view on the suggestion. At the NHIS-HIRA National Assembly annual audit session on Oct. 20, Professor Kang Jin-hyoung was summoned as a witness and stated, “A novel anticancer treatment takes a long time to receive NHI reimbursement even after getting approved for the market by the Ministry of Food and Drug Safety (MFDS),” and “Patients are in immense pain as an immunotherapy for lung cancer could not pass HIRA for three years.” Regardless of how greatly effective a new drug is, it is not easy for the patients to actually use those drugs without the reimbursement. Professor Kang explained, “MOHW and HIRA say the anticancer treatment listing takes 350 days, but it excludes the time for requesting and submitting supplementary evidence. The time should be shortened to within 180 days for the patients and healthcare providers to actually feel the improvement.” The professor also noted although the risk sharing agreement system (RSA) introduced in 2014 contributed in speeding up the new drug listing procedure initially, the effect of RSA implementation on shortening the time has been insignificant due to expensive anticancer treatment entering the market. The professor stressed, “The social controversy is that most of immunotherapies can hardly get to RSA signing. After RSA was implanted, a half of anticancer treatments were listed through RSA, but the actual effect of shortening the listing period was weak,” and “The new drug listing speed has slowed down due to scarce review meetings amid COVID-19. If RSA were the only supplementary boost for the positive listing system, we need to pursue new options from now on.” Professor Kang recommended the following agenda to improve the new drug accessibility; providing pre-listing reimbursement and post-evaluation option, adjusting ICER threshold, and seeking means to secure additional source of NHI income to enhance public-private access. Regarding the ICER threshold for severe and rare disease treatments, the professor noted the threshold should be flexibly adjusted in a ‘bracket’ range, instead of basing it on GDP per capita. An independent Lawmaker Lee Yongho, who summoned Professor Kang, commented that “The patients would be desperate to access those new drugs,” and “Only controlling the NHI finance would not grant a solution. We need a balanced approach.” NHIS President Kim Yong-ik (left) and HIRA President Kim Sun-min (Source: National Assembly Correspondent Organization) Instead of clearly giving their opinion, however, NHIS President Kim Yong-Ik and HIRA President Kim Sun-min both claimed implementing a new system should be approached, carefully.. President Kim stated, “We can only be cautious when listing a new drug. Negotiating with a pharmaceutical company from a disadvantageous position can put NHIS and the government at risk when setting the drug pricing. And higher drug price can then put the patients in a worse situation. This is why the problem is difficult to solve.” On introducing the pre-listing reimbursement and post-evaluation, President Kim said, “We would review the suggestion, but we would not make any hasty decision as with have imminent issues regarding drug pricing and NHI finance.” HIRA President Kim Sun-min also said the accessibility issue is regrettable from the point of patients, but the suggested agenda would be difficult to execute without a social consensus. President Kim explained, “ICER threshold has to be effective when adding more cost. Recently listed anticancer treatments require cost of over 1 billion won to extend life expectancy by average one year,” so “We need to consider other patients and pursue the social consensus through thorough discussions.” “Although we would further make efforts to expand access to new drugs for severe and rare disease patients, we are already providing pharmacoeconomic evaluation exemption system and pricing negotiation exemption system,” nevertheless, “We would continue to improve the access,” said President Kim. After hearing from Lawmaker Lee Yongho’s witness, People Power Party Lawmaker Lee Jongseong spoke to President Kim Yong-ik, “You sounded negative about providing support to access the novel immunotherapy, but the administration promised, with the Moon Care, that no one would be neglected from accessing treatments. The government needs more forward-looking review. It should consider making a cancer fund and other options.” President Kim then answered, “We are absolutely not negative about expanding access to new drugs. Surely the alternative options should be considered, but the previous answer was concerned more of the pricing negotiation.”
