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- 2025-12-25 19:22:24
- Policy
- Vildagliptin generic preferential sales date may get delayed
- by Lee, Tak-Sun Oct 30, 2020 05:55am
- A diabetic treatment ‘Galvus’ by Novartis The preferential sales rights Ahn-gook Pharmaceutical has earned for the Galvus (vildagliptin) generic could be cut as a higher court trial has overturned the patent litigation decision. Accordingly, the South Korea’s Ministry of Food and Drug Safety (MFDS) is internally reviewing the matter. On Oct. 29, the Patent Court has partially ruled in favor of Novartis that filed litigation against Ahn-gook Pharmaceutical and Hanmi Pharmaceutical to cancel the decision made to nullify the extended term of Galvus substance patent term. Previously, the Intellectual Property Trial and Appeal Board stated 187 days out of 26 months and 23 days of the extended Galvus patent term would be nullified. The deducted number of days (MFDS approval review supplementary evidence submission period) delayed the patent term coming in effect due to the patentee’s liability. Hence the Board stated the extended term was unjust. Based on the Board’s decision, Ahn-gook Pharmaceutical was able to nab the preferential sales rights over the Galvus generic ‘Ahngook Vildagliptin tablet.’ The preferential sales rights would be effective from Aug. 30 2021 through May 29 2022, or from 187 days prior to the patent expiration (Mar. 4, 2022). Regardless, the Patent Court said otherwise and stood on the side of Novartis unlike the Board. Although the specifics were not disclosed as the full decision is not yet opened to the public, the sources report the nullified period would be significantly less than 187 days. Now that the higher court has overturned the decision, some claim the effective term of the preferential sales rights Ahn-gook Pharmaceutical won should be shortened in accordance to the Patent Court’s decision. An industry insider commented, “For a precedent of the court accepting the litigation against the extended patent term nullification, there was an interpretation that the preferential sales rights was only effective for the period deducted due to the partially nullified extended patent term. So it would make sense to deduct the number of effective days as well.” Another industry insider said, “They just need to change the effective dates of preferential sales rights stated on the indication. Nevertheless, the change in number of effective days would not impact the industry greatly, as only Ahn-gook Pharmaceutical’s subsidiary Ahngook Newpharm won the preferential sales rights, and the number of deducted days was insignificant.” However, MFDS is contemplating about the situation; so far, since the system was implemented from 2015, the number of effective preferential sales rights days has never been changed. But if the number of days is changed, the same substance sales ban period would also get affected and create an inevitable ripple effect on the follow-on drug market. A MFDS official said, “When either one of the patentee or the preferential sales right holder reports the final outcome to MFDS, the ministry would need to have an extensive internal discussion. We cannot provide any clear answer immediately.” Depending on Ahn-gook Pharmaceutical’s preferential sales rights period, the fate of other companies with the follow-on drugs would be decided as well. Hanmi Pharmaceutical, although it did not win the preferential sales rights, can release its incrementally modified drug (IMD) along with Ahn-gook Pharmacetuical as the IMD has a different salt base.
- Policy
- Roche approved to release a new drug treating lymphoma
- by Lee, Tak-Sun Oct 30, 2020 05:55am
- A new drug by Roche, Polivy injection (polatuzumab vedotin), is released to the South Korean market to treat patients with lymphoma, a type of blood cancer. The injection, used in combination with bendamustine and rituximab, is expected to be a new option for patients not responsive to the existing treatment. On Oct. 27, the Ministry of Food and Drug Safety (MFDS) green lit Roche Korea’s Polivy injection for the Korean market. The injection, in combination with bendamustine and rituximab, is indicated to treat adult patients, who are not suitable to take a hematopoietic stem cell transplant, but have relapsed or refractory diffuse large B-cell lymphoma (DLBCL), after at least two prior therapies. Eisai’s Symbenda injection is the original bendamustine, and Roche’s Mabthera injection is the original rituximab. Both injections are prevalently used as first-line treatments in patients with DLBCL. Apparently, however, 30 percent of the patients who have used the drugs did not demonstrate satisfying response rate. Polivy injection is an antibody-drug conjugate (ADC) that targets CD79b, a surface immunoglobulin of B lymphocyte antigen receptor. Its clinical studies have confirmed the efficacy in combination with bendamustine and rituximab. The polatuzumab vedotin plus bendamustine plus rituximab combination therapy and bendamustine plus rituximab combination therapy as a reference drug, were administered to 40 patients each to observe their results for 42 months. The Polivy group showed a significantly better complete reaction (CR) of 42.5 percent than the reference drug group reaching 15 percent. The new drug is highly anticipated by a group of patients who could not respond to the existing option of bendamustine plus rituximab combination therapy. Polivy injection has been approved by the U.S. Food and Drug Administration (FDS) in June last year. As the injection was approved as a biological drug that has to submit evidences in-development, MFDS plans to manage the drug with the risk management plan (RMP) even after its market launch.
- Policy
- Can the ICER value increase the range of GDP?
- by Kim, Jung-Ju Oct 30, 2020 05:55am
- The National Assembly is calling for an increase in the incremental cost effectiveness ratio (ICER), which is used as the basis for price determination, for reimbursement of expensive drugs, which is the key to strengthening the coverage of Moon Jae In Care pharmaceutical sector. This is because the price of breakthrough new drugs used for serious diseases is getting higher and higher, and it seems difficult for insurers who manage finances to diagnose as the cause of excessive spending and exceed the current maximum of ICER. The NHIS and The HIRA's recent written responses to the National Assembly's Health and Welfare Committee are summarized, and the position on this is consistent. As of 2018, Korea's health insurance coverage rate was 63.8%, the highest level since 2010. Although it appears to be in the early 60% of the figures, it is interpreted that the driving effect of'Moon Jae-in Care' is significant when considering the rapid change in population diseases, the expansion of expensive drug reimbursement, the increase in natural increase and the balloon effect. The NHIS (left) and The HIRA Severe treatments, anticancer drugs, and drugs for treating rare diseases are the key to strengthening the coverage of the drug sector. As these new drugs become more expensive, the ICER range, which determines the benefit price (insurance ceiling) of these drugs, is also required to be expanded. In fact, on the 22nd, at the general government audit of the Welfare Committee, Minister of Health and Welfare Park Neung-hoo was struggling with a question from Rep. Lee Yong-ho, who raised the need for an upward adjustment of the first-line treatment for the new lung cancer drug Tagriso. At the time, Minister Park explained, "Tagriso's drug price is not a very expensive drug, because new drugs are released every day and there are a lot of very expensive drugs. There are some super expensive drugs that cost 100 million won per administration." Kim Yong-ik, chairman of the NHIS, also said at the NHIS·the HIRA on the 20th, "The listing of new drugs is inevitable. If negotiated, the NHIS or the government, which has to set the drug price, will be in a difficult position." "If this is set up, it can be difficult for patients." Kim Sun-min, Chief of the HIRA was in the same position. He said, "The value of ISR should be effective when you inject additional costs. Recently listed anticancer drugs require as much as 1 billion won or more to extend the average one-year lifespan." also he added, "We need to consider patients with other diseases and discuss with social consensus." Accordingly, Rep. Kang Ki-yoon of the Welfare Committee made a written inquiry to the HIRA, saying that GDP applied to the ICER value should be realized. ICER is a key tool that compares the effects and costs of life extension after one year of taking drugs belonging to the comparative group when evaluating the economics of drugs for which insurance benefits are applied. Korea has dualized drug reimbursement work, and the HIRA is conducting economic evaluation and the NHIS is conducting drug price negotiations. Most of the world's advanced insurance countries that are evaluating the economic feasibility of new drug benefits use the ICER tool to evaluate and deliberate just before drug price negotiations. Usually, the country's GDP level is the reference range. It is threatening the reinforcement of guarantees as there is a growing tendency to derive a price range that is far beyond. Regarding this, the HIRA said, "There is no explicit ICER threshold for determining whether to pay benefits. GDP per capita is based on the 2013 level of 25 million won (1ICER)." We are considering it and evaluating it.” In order to overcome these difficulties and strengthen the security of new drugs, Korea has already established the ICER threshold for new drugs for treatment of severe and rare diseases in the case of new drugs for the treatment of severe and rare diseases, which is 50 million won (2ICER) in GDP. It is applying elasticity to the level. Accordingly, there is a need to further increase the ICER threshold with'Moon Jae-in Care' pursuing a breakthrough strengthening of security. However, it is difficult for the insurer. This is because Moon Jae In Care is being continuously promoted by taking steps as a long-term plan at the government level, so enormous finances are being invested, and in particular, it is self-determining that financial overspending has resulted in increased access to new drugs. The NHIS responded to a written inquiry from Rep. Nam In-soon asking for a reinforcement explanation of Moon Jae-in Care. "The area that needs to be improved" answered. It is said that the ICER threshold expansion is not realistic given the fact that an increase in the ICER threshold will lead to an increase in fiscal expenditure. The HIRA also said, "The ISR threshold adjustment can contribute to strengthening accessibility to new drugs, but it is necessary to collect sufficient social opinions as it is accompanied by additional financial requirements such as an increase in drug prices.
- 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.
