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- 2025-12-23 19:20:19
- Policy
- Chong Kun Dang faces Hanmi due to Rivaroxaban 2.5mg
- by Lee, Tak-Sun May 29, 2022 05:14pm
- Riroxia 10mg, which was released five months before the expiration of the original material patent by Chong Kun Dang, dominated the generic market. Next month, capsule-type 2.5mg products will be listed, and it is expected to face off with Hanmi over the generic marketChong Kun Dang anticoagulant Rivaroxaban 2.5mg will be listed as the second generic drug after Hanmi. Since Chong Kun Dang has shown extraordinary affection for anti-coagulation oral new drugs, it is expected that it will also focus its efforts on low dose Rivaroxaban products. According to the industry on the 22nd, Riroxia capsules 2.5mg will be listed next month. The original Rivaroxaban product is Bayer's Xarelto. However, 2.5mg product could not be released because it still has a patent for its product and a patent for its use, and Hanmi Pharmaceutical and SK Chemical acquired generic for exclusivity. There is also a difference in adaptation of the low dose (2.5 mg) and other doses. If 10, 15, and 20 mg are also used for treatment such as treatment of cardiac venous thrombosis and pulmonary embolism, 2.5 mg prodcut is used for the prevention of cardiovascular disease like aspirin. Studies show that using Xarelto 2.5 mg with Aspirin relatively reduced the risk of death from stroke, myocardial infarction, and cardiovascular disease in adult patients with coronary artery disease or symptoms than Aspirin alone. Accordingly, Bayer, which owns Xarelto, also paid more attention to generic blocking than other doses, such as registering 2.5 mg patent and use patent separately in Korea. Hanmi Pharmaceutical and SK Chemical succeeded in invalidating and avoiding 2.5mg of patents, respectively, and through this, they obtained generic for exclusivity. When the material patent was terminated in October last year, other pharmaceutical companies were not able to release 2.5mg products, but Hanmi, which acquired generic for exclusivity, was able to release the product. Currently, Original Bayer and Hanmi Pharmaceutical are the only pharmaceutical companies that have registered Rivaroxaban 2.5mg products. Chong Kun Dang could have been released in October last year if it had solved the original patent. Chong Kun Dang products are capsule formulations and are different from those of Korea. It seems that the registration was belatedly promoted because the patent for use was still in existence at the time. Currently, the Korean Supreme Court has ruled that the patent is invalid due to the request from Hanmi, and the final registration is about to be invalidated. The patent for use also expires on the 7th of next month. Although Chong Kun Dang belatedly releases 2.5mg products, they are faster than other post-refining drugs. This is because Rivaroxaban 2.5mg tablets can be released only on July 4 when the generic for exclusivity period between Hanmi and SK ends. Chong Kun Dang is working harder than any other pharmaceutical company in Korea on anticoagulant oral medicine generics. Rivaroxaban's other products, excluding 2.5 mg, also reduced some of the indications related to prolongation of life and pushed ahead with the launch five months before the expiration of the material patent. Chong Kun Dang requested a trial to confirm the scope of rights to avoid material patents. The request for the trial was dismissed in July last year, and Chong Kun Dang appealed to the Patent Court. However, Chong Kun Dang explained that Bayer's application for an injunction against patent infringement requested by the Seoul Central District Court has been rejected based on the judgment that it does not infringe material patents due to reduced indications. Chong Kun Dang ranks first in the Rivaroxaban market. Chong Kun Dang is conducting marketing under the plan to expand the original anticoagulant drugs to local clinics as they remain only in prescriptions for hospitals. Riroxia 2.5mg, which is listed at this time, is also expected to launch a large-scale marketing by Chong Kun Dang. It is expected that they will make desperate efforts to fight against Hanmi, which dominated the late drug market. The drug price was also set at 700 won, the same as 2.5 mg of Riroxban in Korea and Hanmi. As it is a showdown between the Chong Kun Dang, which has the strongest sales power in Clinics, and Hanmi, fierce competition is expected.
- Policy
- Xarelto's generic 15 items have been revoked
- by Lee, Hye-Kyung May 25, 2022 05:47am
- The MFDS canceled the item license of Rivaroxaban-based products, which were sold before the expiration date of the registered patent right as of the 27th. The cancelled product is Rixa 10mg, 15mg, 20mg, Wirelto 10mg, 15mg, 20mg, Jabaroxa 10mg, 15mg, 20mg Xarel-Q 10mg, 15mg, 20mg Xarelivan 10mg, 15mg, 20mg. The composition patent of the original Bayer Xarelto is until November 2024, and the material patent ended in October last year. However, it was confirmed that five pharmaceutical companies distributed generics to wholesalers before Xarelto's patent expired on October 3 last year, and the cancellation of the item license was decided this time. The reason was that generic products were distributed to wholesalers before the expiration of Xarelto's patent (October 3, 2021). According to Article 76(1)5-8 of the Pharmaceutical Affairs Act, "If a person who applied for an item permit or permission to change a registered patent right to sell it after the expiration of the period sells the drug" is subject to cancellation and suspension. The items that were decided to cancel the item license were reportedly distributed to some wholesalers first for distribution purposes after October 13 last year. Xarelto's outpatient prescription (UBIST) performance reached 59.6 billion won last year.
- Policy
- GSK meningococcal vaccine Bexero PFS was approved in Korea
- by Lee, Hye-Kyung May 25, 2022 05:47am
- The MFDS recently approved the item permission of Bexero PFS applied by GlaxoSmithKline (GSK). Bexero PFS is used to prevent invasive meningitis disease by Neisseria meningitidis B group at least 2 months of age. The safety and effectiveness of this vaccine in infants under 8 weeks of age have not been established. This vaccine injects deeply into the muscles. It is recommended to inoculate infants under 12 months of age to the outside of the thigh and to the upper arm deltoid area for those older than that. If inoculated at the same time as other vaccines, the injection site is different. Bexero PFS should not be intravenously, subcutaneous, or intradermally injected, nor should it be mixed in the same syringe as other vaccines. Bexero PFS is the only vaccine approved in Europe in 2016 to prevent type B meningitis and is a drug obtained by GSK through asset exchange with Novartis in 2015. The vaccination purpose of this vaccine is to prevent invasive meningococcal disease (IMD) by promoting antibody production that recognizes the vaccine antigens NHBA, NadA, fHbp, and PorAP1.4 (immune dominant antigen present in OMV components). In approximately 1000 meningococcal B group isolates collected in 5 European countries from 2007 to 2008, between 73 and 87% of meningococcal B group isolates, depending on the country of origin, showed MATS antigen profiles prevented by this vaccine. Phase 3 clinical trials showed that the vaccine was inoculated twice every two months for complement deficiencies (40 patients) aged 2 to 17, asymptomatic or spleen impaired patients (107), and healthy subjects (85) of the same age, with 87% and 97% for fHbp antigens, 95% and 100% for PorA P1.4 antigens, and 73% and 94% for NHBA. In the UK in September 2015, Bexsero PFS was introduced as NIP with a schedule of two additional inoculations (two months of age and four months of age) to infants.
- Policy
- Atopic Dupixent Pen will be available in Korea
- by Lee, Hye-Kyung May 24, 2022 05:54am
- Dupixent, an atopic treatment that is expected to improve convenience when self-injecting at home with easy operation, will be available in Korea. The MFDS recently approved 200mg and 300mg of Dupixent PF Pen applied by Sanofi Aventis. Dupixent PF Pen formulation, which was approved by the U.S. FDA in June 2020, secured adaptations to atopic dermatitis and asthma among the existing Dupixent PFS-approved indications. Existing Dupixent was approved in Korea as a treatment for atopic dermatitis that was ineffective with existing treatment in January 2018, and additional indications were approved as a severe or intractable bronchial asthma treatment that cannot control asthma symptoms with existing treatment in March 2019. Dupixent PF Pentype has the advantage of being able to inject drugs with simple operation. It consists of a visual and auditory feedback device that shows visual indications and sounds when the administration function is executed, as well as a pre-filled pen with hidden need or syringe with need shield. Existing PF pen is used for self-administration after being administered at hospitals and clinics or trained by medical personnel on how to administer it.
- Policy
- Fexclu priced at 90% of the weighted average of K-CAB+PPIs
- by Lee, Tak-Sun May 20, 2022 06:12am
- The price of ‘Fexclu Tab (fexuprazan), the potassium-competitive acid blocker (P-CAB) class gastroesophageal reflux disease (GERD) treatment developed by Daewoong Pharmaceutical was set at 90% of the weighted average price of the same class drug ‘K-CAB (tegoprazan, HK Inno.N) and PPI (proton-pump inhibitors) drugs. On the 12th, the Drug Reimbursement Evaluation Committee of the Health Insurance Review and Assessment Service had deemed that reimbursement for the drug was adequate if the company accepts a price below the appraised amount. The appraised amount was set at 90% of the price of ‘K-CAB+PPI’ after classifying the alternative of Fexuclu as 'K-Cap + PPI’ in the calculation formula. According to industry sources on the 19th, HIRA delivered its appraised amount to Daewoong Pharmaceutical. Daewoong Pharmaceutical, which had been hoping to be appraised using only K-CAB’s price, received the results with some disappointment. The price of K-CAB had been set at a more expensive level than others, being applied the 'preferential treatment for new drugs that entered the global market’ system that does not exist anymore. The current price ceiling for K-CAB is set at ₩1,300, but as most PPIs are now off-patent and have received significant price discounts, the weighted average price that includes PPIs as alternatives will widen the price gap between Fexclu and K-Cab. The current ceiling price of major PPIs are Nexium 40mg (esomeprazole) ₩1,015, Lanston LFDT tab 30mg (lansoprazole) ₩829, Noltec tab 10mg (ilaprazole) ₩1,131. If a drug’s price is set low in Korea, other countries that reference Korea’s price would also set a lower price for the drug, ultimately creating an unfavorable environment for overseas expansion of drugs. This is why the domestic pharmaceutical industry had requested a preferential clause be added for new homegrown drugs. An industry official pointed out, "In some cases, domestic prices are what impedes overseas penetration of the drugs, and the current drug price calculation standards do not properly reflect the efforts invested by the companies in developing new drugs." However, it is expected that Daewoong Pharmaceutical will accept the given price and proceed to conduct pricing negotiations with the NHIS, as the company has been conducting pre-marketing activities with the aim to release the drug in July, and the low possibility that the decision will be overturned even if the company raises an objection to HIRA’s appraised price. Therefore, Fexclu is expected to engage in a one-on-one competition with K-CAB in Korea with its lower price. K-CAB had raised ₩109.6 billion in outpatient prescriptions (source:UBSIT) last year.
- Policy
- The MFDS will gradually disclose the results of GMP survey
- by Lee, Hye-Kyung May 20, 2022 06:11am
- The MFDS has decided to disclose the results of the drug GMP survey on its website in the future. The MFDS has prepared a plan to disclose information on the results of the drug GMP survey based on the discussions discussed through the Public-Private Consultative Body on the Results of the GMP Survey. As a PIC/S member country, the results of the survey will be disclosed at the level of the U.S. and Europe, but in consideration of the need to prepare legal grounds, it will gradually disclose detailed information after the revision of the Pharmaceutical Affairs Act in the first stage. Subject to the disclosure are pharmaceuticals and herbal medicines under the jurisdiction of the Drug Safety Bureau, and the results of a survey on the status of the licensing stage, regular monitoring, and overseas manufacturing plants. Advanced biopharmaceuticals such as biological drugs are excluded. As a result of the fact-finding survey, the disclosure time is within 6 months after the approval and report of the item, the regular monitoring of the post-authorization stage is within 6 months after the issuance of the GMP conformity report, and the overseas manufacturing plant survey is within 6 months after the report. The MFDS will go through the process of inquiring opinions of the company and disclose it on the website only for summary information. If the company does not agree to disclose the results of the survey, the survey related to the company among the disclosure contents will be shaded. The scope of disclosure is a level that summarizes the outline and points of the fact-finding survey by referring to the current status of the United States and Europe, and is limited to item information in the case of the fact-finding survey. The MFDS is planning to expedite the disclosure of the results of the GMP test in May in line with the current evaluation for WLA registration.
- Policy
- Green light to Sprycel's reimb with indication expansion
- by Lee, Tak-Sun May 20, 2022 06:11am
- The chronic myeloid leukemia treatment ‘Sprycel tab (dasatinib, BMS Korea)’ has received the green light to expand its reimbursement. The Health Insurance Review and Assessment Service announced that it had set the reimbursement standards for Sprycel in pediatric patients with acute lymphoblastic leukemia (ALL) at the 5th Cancer Disease Deliberation Committee meeting that was held on the 18th. Based on the set standards, Sprycel can now progress to the next step in expanding its reimbursement to the indication set above. The drug will now undergo Drug Reimbursement Evaluation Committee review, drug pricing negotiation with the National Health Insurance Service, then receive final deliberations for reimbursement. The specific indication for Sprycel that was approved in the reimbursement standard is for ‘the treatment of pediatric patients 1 year of age and older with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in combination with chemotherapy.’ Deliberation results of HIRA CDDC that was held on the 18th The other 3 drugs failed to establish reimbursement standards on the same day. Lilly Korea’s ‘Retevmo capsule (selpercatinib)’ that is gaining attention as a tumor-agnostic anticancer drug, Pfizer Korea's ‘Mylotarg injection (gemtuzumab ozogamicin),’ and Novartis Korea's ‘Jakabi tablet (ruxolitinib) all failed to establish reimbursement standards. Retvmo’s reimbursement standards were failed to be set for all its indications: ▲treatment of advanced or metastatic RET-mutated medullary thyroid cancer who require systemic therapy; ▲ treatment of patients who are refractory to radioactive iodine therapy and who have prior sorafenib and/or Lenvatinib treatment experience, with advanced or metastatic RET-fusion benign thyroid cancer who require systemic therapy; and ▲ treatment of metastatic RET fusion-positive non-small cell lung cancer (NSCLC). In the case of Mylotarg, which had failed to expand reimbursement to newly diagnosed CD33-positive acute myeloid leukemia (AML) in adults, and Jakabi which failed to expand its reimbursement standard to the treatment of patients with intermediate or high-risk myelofibrosis, the drugs are now left to reattempt reimbursement expansions at this stage.
- Policy
- HIRA plans to improve the overall management system
- by Lee, Tak-Sun May 20, 2022 06:11am
- Lee Jin-soo, chairman of HIRAWith the launch of Zolgensma, the HIRA plans to improve the overall management system of the pre-approval system. Accordingly, it has been confirmed that internal research is being carried out. The HIRA allows benefits for ultra-high-priced drugs such as Soliris and Spinraza or some medical procedures through a pre-approval system. However, some items have been pre-approved for a long time, and as ultra-high-priced drugs subject to pre-approval are expected to increase in the future, they are reportedly considering adjusting the target items. Lee Jin-soo, chairman of the HIRA Medical Review and Assessment Committee, made the announcement at a meeting with the Korea Special Press Association on the 17th. Chairman Lee explained, "Recently, demands for higher-priced drugs have continued to increase, and medical institutions are also expected to actively use the pre-approval system," adding, "We will improve the overall management system of the pre-approval system." Currently, hematopoietic stem cell transplantation, Soliris (subject to PNH, aHUS diseases) 'ICD&CRT, VAD, and Spinraza are allowed to administer or perform pre-approval systems. Among them, hematopoietic stem cell transplantation is under consideration. Chairman Lee said, "In the case of hematopoietic stem cell transplantation, the pre-approval system has been applied since 1992. At the beginning, it was a high-risk and high-cost act, but now it is cheaper than other expensive drugs, so I think we can go to a post-examination." However, in the medical community, there is a high opinion that it should be maintained. Hematopoietic stem cell transplantation benefited 3,323 people through preliminary screening last year, costing a total of 127.6 billion won. This is a much higher cost than other items. Soliris, an ultra-high-priced drug, cost 36.7 billion won and Spinraza 41.6 billion won last year. The number of people subject to approval is also higher. Chairman Lee said, "Hematopoietic stem cell transplantation has been a learning training for medical institutions since pre-examination was introduced for 30 years, so the approval rate is far higher than other items. However, we are considering withdrawing internally in consideration of manpower and screening capacity." The new drug to which the pre-approval system will be applied is Zolgensma, a treatment for spinal muscular dystrophy. Zolgensma was recognized of benefits on the condition of prior approval of medical care benefits at a review of the Drug Benefit Evaluation Committee held on the 12th. The Medical Review and Assessment Committee is currently considering coordinating the Spinraza review division with the same indication if Zolgensma is confirmed to be subject to the pre-approval system. "In order to improve the system, the review and evaluation laboratory is conducting internal research on the systematic operation of the pre-approval system," Chairman Lee said. "We will analyze the operation status and collect domestic and foreign cases to come up with specific improvement measures." The preliminary review department of the Medical Review and Assessment Committee plans to expand the application of the pre-approval system for severely incurable diseases who need high-risk and high-cost medical services and strengthen management. Chairman Lee said, "Last year, the number of pre-approval items increased from eight to nine, and we received about 280 billion won in medical expenses."
- Policy
- 34 new global drugs, including Beleodaq, are urgently needed
- by Lee, Tak-Sun May 18, 2022 05:52am
- A study has been released that 34 new drugs, including the peripheral T-cell lymphoma treatment Beleodaq, are urgently needed to be introduced in Korea. These new drugs have not been introduced because they are judged to be insufficient in marketability due to domestic screening permits. KoNECT announced that it will select 34 new drugs that are urgently needed to be introduced in Korea and release them online on the 18th for the 2022 KoNECT Brief 1. KoNECT derived priorities through preliminary analysis of 244 in Korea. As a result, Beleodaq (peripheral T cell lymphoma treatment), Palynziq, Zinplava (lostridium difficile recurrence reduction effect), Artesunate (severe malaria treatment), and Xerava (complex abdominal infection treatment antibiotic) were the top drugs to be reviewed. Poteligeo (Fungi and Cezali Syndrome Treatment), Elzonris, Tecartus (CAR-T Cell Blood Cancer Treatment), Yescarta (CAR-T Cell Blood Cancer Treatment), Obizur (Instinctive Post-Cellular Blood Cancer Treatment), and Trumenba. The third-priority drugs mentioned by the association as urgent and unmet demand diseases were BEXSERO (menopausal bacteria serum type B vaccine), Alofisel (treatment of complex anal fistula of Crohn's disease patients), and Raxibacumab (first aid drug for anthrax). Top 4 drugs that need high introduction but require attention are Provenge (prostate cancer vaccine using cells from autologous choroid blood), Zanosar (treatment of malignant neoplasms of the pancreas), Cablivi (acquired thrombocytopenia), Audenz (immune cell-based influenza and anti-viral drugs), Audenz, Rukobia, Trogarzo, Krintafel, Nuplazid, and Apokyn. The last drugs appeared as Steboronine (BNCT), - Scenesse (erythrocytic protorphyria), Mepsevii, Ravicti, Lamzede, Myalept, Egaten (fascioliasis parasite infection treatment), Tpoxx (natural greenhead treatment), Solosec, Voraxaze, and Idenfirix. KoNECT analyzed that the main reason for the delay or non-introduction of global new drugs in Korea is to determine marketability such as whether to exempt ▲ bridge test, ▲ whether to register benefit, and ▲ product price, etc. In particular, whether to be exempted from PE system in the stage of determining drug prices is also important, and it was pointed out that blind spots exist in new drugs for rare diseases that are exempted from economic evaluation. For example, the MFDS' rare drugs and rare diseases of the KCDA are designated based on less than 20,000 people, but the HIRA's rare disease treatment system is limited to less than 200 people. KoNECT stressed the need for a specialized institution to introduce global new drugs in Korea along with the expansion of the "Expended Access Program (EAP)" and the national essential drug system, a program that provides drugs for clinical trials that have not yet been sold on humanitarian grounds. Bae Byung-joon, chairman of the National Clinical Trials Foundation, said, "Korea's drug price policy has been stingy in recognizing the innovative value of global new drugs, while generic prices are higher than the cost to protect domestic industries."
- Policy
- MFDS promotes RWD analysis of COVID-19 vaccines & txs
- by Lee, Hye-Kyung May 18, 2022 05:51am
- The MFDS (Director Kim Kang-rip) will push for a benefit and risk assessment study from May this year based on data actually used in medical sites after the COVID-19 vaccine and PO treatment were introduced in Korea. This study was prepared to analyze safety information such as the incidence of side effects, vaccine defense effects, and hospitalization/death change rates by using RWD and RWE of COVID-19 vaccines and eating treatments. The results of practical data studies will be used to examine the benefits and risks of drugs along with the results of clinical trials, and will be used to verify the causality of major adverse reactions or to establish a safety information monitoring system in the future. The main contents of the study include developing a technology to evaluate the mechanical relationship among ▲ vaccination and adverse reactions, ▲ vaccine developing criteria to evaluate the effectiveness and safety of vaccines, and ▲ therapeutic agent)analysis of domestic patients. Overseas regulatory agencies such as the United States, Europe, and Japan are also promoting various studies on COVID-19 vaccines and treatments using data actually used. The MFDS said, "We will continue to activate various studies to verify the safety and effectiveness of drugs based on scientific evidence and do our best to ensure that the public can use them with confidence based on regulatory science."
