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- 2026-04-15 22:52:05
- Policy
- Transferred drugs exempted from stepped pricing reduction
- by Kim, Jung-Ju Dec 23, 2020 06:10am
- The South Korean government is to enforce an amendment in the ‘stepped drug pricing system’ from next year to remove the issue regarding the drugs reapplying for listin6g due to corporate transfer. The government created a new legal basis to solve the problem raised by the pharmaceutical and bio industry that the new generic pricing system neglected an original drug and stipulated it to reapply for listing with reduced pricing. On Dec. 21, the Ministry of Health and Welfare (MOHW) announced the said changes would be reflected in the ‘Pharmaceutical Decision and Adjustment Criteria’ affecting all drugs and Korean herbal medicine from Jan. 1 next year. The stepped drug pricing matches the reimbursed pricing of a drug with the Ministry of Food and Drug Safety’s (MFDS) joint bioequivalence test 1+3 policy, and sets the upper limit pricing, regardless of qualifying two criteria for top-level pricing, at 85 percent of the lowest pricing of the first-in-class drug, if the number of listed same-substance drugs exceeds 20. Initially, the government designed the system for a drug transferred to other company to reapply for the listing with lowered pricing, when seeking for reimbursement again after removing itself from the listing. However, the industry criticized the forced pricing reduction is unfair as product transfer between companies are actively executed within the industry. And the government made an exception for the case in the system to accept the industry’s request. The types of drug that fall under the pricing reduction exemption are a drug inheriting the status of the manufacturer according to the Pharmaceutical Affairs Act Article 89; a company switching the manufacturing and sales license into an import license or vice versa; a product dropping the license due to a revision in the Pharmaceutical Affairs Act and MFDS notice or change in business type, and seeking for new license as a same product. MOHW official said the amendment, effective from Jan. 1 next year, would be enforced from applicant drugs with incomplete evaluation by the Health Insurance Review and Assessment Service (HIRA) or reevaluation.
- Policy
- MOHW nominee to “Expand coverage on expensive new drug”
- by Lee, Jeong-Hwan Dec 23, 2020 06:09am
- The Minister of Health and Welfare nominee Kwon Deok-cheol expressed his determination to analyze the financial impact that immunotherapy and other high-priced new drugs would have on the National Health Insurance, and to expand reimbursement centering drugs with high social demand. He also answered enhancing the patients’ access to pharmaceuticals by implementing a cancer fund, referring to foreign government system, has to be reviewed thoroughly. On December 21, Kwon provided his answers for the on-paper National Assembly Health and Welfare Committee hearing for the minister nomination. People Power Party Lawmaker Lee Jongseong and Democratic Party Ko Youngin asked the nominee about the decreased healthcare coverage in severe disease drug, the need for applying reimbursement on high-priced new drugs like immunotherapy and cancer drug fund. The nominee said he agrees with the need of expanding reimbursement to lessen the cancer patients’ medical expense and to improve access to treatments. He explained the government has set down a National Health Insurance coverage enhancement initiative since 2017 and continued to expand coverage on severe disease treatment like anticancer drugs. However, Kwon explained the number reimbursement application is increasing with more new drugs being developed, but he claimed the government should consider drug’s clinical efficacy and cost-effectiveness, financial impact on the insurance and reasonable drug pricing adjustment, when deciding the feasibility of the reimbursement listing, to well manage pharmaceutical expense. He added a pricing adjustment on immunotherapies should be considered with an analysis on those factors. Kwon also reserved any clear answer on the need for the cancer management fund. Regarding the suggestion to open a cancer drug fund, independent from the National Health Insurance providing financial support on high-priced anticancer treatment, he said factors like the National Health Insurance system varying from other countries’, an efficient use of government budget, and fairness among all types of diseases should be comprehensively taken account of.
- Policy
- Benefit standards of Zometa Ready & Xgeva are expanded
- by Lee, Hye-Kyung Dec 23, 2020 06:09am
- The administration conditions for Zometa Ready (Zoledronic acid) of SciGen Korea and Xgeva (Denosumab) of Amgen Korea, which are used to treat patients with multiple myeloma and solid cancer bone metastasis, will be changed. Previously, both drugs were reimbursed only when they showed lytic findings on plain X-rays, normal on X-rays, or when bone destruction was clearly demonstrated by CT or MRI. Reimbursement was not recognized when abnormal findings were confirmed only by bone scan. However, from January 1 of next year, Zometa Ready will be able to reimbursed if bone metastases and bone lesions are clearly demonstrated through radiological examinations, and Xgeva is clearly proven through radiological examinations. The HIRA publishes a revision of the announcement regarding drugs prescribed/administered to cancer patients containing such contents and receives an inquiry until the 24th. In the breast and prostate cancer guidelines, Zometa Ready and Xgeva are recommended for patients with bone metastasis regardless of osteolytic and osteoblastic lesions, and the approved clinical trial did not limit the subject to osteolytic lesions. It includes all imaging tests such as X-ray, CT, and MRI. The HIRA said, "As many guidelines such as multiple myeloma related guidelines recommend drug administration regardless of osteolysis and osteoblastic sarcoma, it is reasonable not to limit it to lytic lesions. Bone metastasis and bone lesions must be clearly demonstrated in radiology to enable reimbursement." The recommendation that bone metastasis is not recognized only by bone scan results, which was set as the ASCO breast cancer guidelines, has been deleted. In addition, the multiple myeloma NCCN guideline recommended Zometa Ready and Panorin (Pamidronate) as Category 1 for all patients receiving myeloma treatment equally. In a randomized clinical trial, the two drugs had the same effect on reducing the risk of skeletal symptoms, and the benefits of Zometa Ready were lowered than at the time of the HIRA's review. In the case of Xgeva, it was confirmed that only the bone metastasis of castration-resistant prostate cancer was evaluated for its clinical usefulness and feeding adequacy. Therefore, among the criteria applied for each cancer type, the standard for prostate cancer has been changed from being recognized when properly administered as necessary within the scope of the approval requirements to be recognized when properly administered to castration-resistant prostate cancer.
- Company
- Domestic companies won the first trial of 12 patents
- by Kim, Jin-Gu Dec 23, 2020 06:09am
- This year, domestic pharmaceutical companies have challenged 12 new patents. In 4 out of 12 patent disputes, generic companies have won all of them, and the remaining 8 cases have yet to be tried. According to the pharmaceutical industry on the 21st, a total of 12 patent disputes pending from January this year to this day. Daewoong and Chong Kun Dang were the most active companies to attack original patents. Each requested 4 patent trials. Subsequently, it was found that Dongkoo Bio&Pharma, Dong-A ST, Mothers Pharm, CTC Bio, Aju, Chodang, Cosmax pharma, Penmix, and Huons requested two patent trials. In addition, JW-Pharma, Kwang Dong, Daehan, Dongkwang, Myungin, Boryung, Arlico, Wooridul, Ildong, Choa, Taejoon, Theragenetex, Hana, Kolmar Korea, Hyundai, Whanin, and Huvist filed a patent trial one by one. 10 of 12 patents were owned by Global Pharmaceuticals. The remaining two were one patent for Chong Kun Dang's GERD treatment Eso Duo. Chong Kun Dang is a challenger in four other patent disputes and is defending two Eso Duo patent disputes. A total of 4 cases were concluded of the 12 patent trials filed this year. Generic companies won all four patent disputes (first trial). In February of this year, the first patent dispute began this year when JW Life Sciences requested a trial to confirm the scope of passive rights to Pfizer's Precedex (Dexmedetomidine) formulation patent. Daehan joined, too. The KIPO took the side of JW Life Sciences in the first trial. Currently, Pfizer has filed a suit to cancel the trial in the Patent Court of Korea in objection. Subsequently, on the 20th of the same month, CTC Bio filed a trial to confirm the scope of passive rights to the patent for the formulation of Chong Kun Dang's GERD treatment,Eso Duo. Aju and Chodang joined. The three companies also challenged another formulation patent for Eso Duo in September. However, Daewon and Sinil, which had challenged Eso Duo’s patent with them, voluntarily withdrew the judgment. On the 28th of the same month, Myungin challenged Eisai's Crystalline Form Patent for'Fycompa film coated tab', a treatment for epilepsy. A trial was filed with Whanin to confirm the scope of rights, and at the first trial, generic companies won. In March, Theragenetex filed an invalidation trial for a patent for the use of Handok's osteoporosis treatment Bonviva. The treatment is sold by Handok in Korea, but the patent right is in Roche. Following Theragenetex, Choa, Wooridul, Arlico, Kolmar Korea, Huvist, Ildong, Hana, Hyundai, Dongkwang joined. In the same month, Daewoong challenged two patents for the formulation of Belkyra, an injection drug for improving allergan's jaw fat. When Allergan splits the existing formulation patents and registers two new patents for patent defense, it also filed a negative trial for confirmation of the scope of rights. The dispute ended with the victory of Daewoong and Penmix. On July 22, Taejun filed a trial to confirm the scope of passive rights to a patent for the formulation of Novartis' glaucoma treatment Simbrinza (Brimonidine tartrate/Brinzolamide). The first trial is still in progress. On the 31st of the same month, Boryung filed a trial for a passive confirmation of the scope of rights against Celgene's Pomalyst. Kwang Dong joined, and the results of the first trial have not yet come out. On September 29, Daewoong challenged the formulation and use patents of Amgen's psoriasis treatment Otezla (Apremilast) at the same time. A trial for invalidation was requested for the use patent, and a trial to confirm the passive scope of rights was requested for the formulation patent. When Daewoong challenged patent of Otezla, Dong-A ST, Chong Kun Dang, Dongkoo Bio&Pharma, Mothers, Huons, and Cosmax pharma joined. The first trial is still in progress. For the last time this year, Chong Kun Dang filed a judgment for passively confirming the scope of rights to material patent of Bayer's NOAC (new oral anticoagulant) Xarelto. In the case of Xarelto, SK Chemicals and Hanmi overcame the formulation patent and received generic for exclusivity. If Chong Kun Dang succeeds in material patent, it can release generics before SK Chemicals and Hanmi.
- Company
- “30-year presence of antihypertensive Novarsc to continue"
- by Eo, Yun-Ho Dec 22, 2020 06:13am
- Dr. Kim Cheol-ho Norvasc (amlodipine) is not the world’s first calcium channel blocker (CCB). However, it is undisputedly the most famous CCB. Launched in 1990s, Norvasc was not the first-in-class but it instigated a notable change in the market with the first once-daily administration. Some say the drug marked the early beginning of the current day convenient administration marketing. A star of hypertension drug market Novarsc is now celebrating its 30 year anniversary of marketing approval in South Korea. Surely it is an old drug, but it still has its high reputation firmly built around ceaseless evolution. In 2017, Norvasc T was released to the market for the patients, who need amlodipine and telmisartan simultaneously. The company also introduced an improved bottle packaging to enhance the convenience of patients and healthcare providers storing and managing Norvasc T and to absorb the moisture of telmisartan. And besides the existing line of 5 mg and 10 mg tablets, the brand also launched 2.5 mg tablet for children from age six to 17, which was the first among all CCB original drugs for hypertension. From then on, Novarsc has been offering necessary dosage options to effectively bring down blood pressure in patients ranging from six years of age to elderly. Daily Pharm interviewed Dr. Kim Cheol-ho, a professor at Seoul National University Bundang Hospital Department of Internal Medicine to hear more about the value of Novarsc. -This year marks the 30th year for Novarsc. What was your first impression on the drug? And how was the hypertension treatment scene back then? Around 1989, I discovered Norvasc from an international journal. Back then the drug had not been introduced to South Korea, yet. During that time, only diuretics, beta-blockers and first and second generation CCBs with short duration of action were available. As amlodipine, or Norvac, was introduced, the South Korean market welcomed a once-daily calcium blocker. -How did it improve the treatment scene particularly, other than administration convenience or adherence? The drug’s coercion effect was groundbreaking. First, we used nifedipine three times a day, and then Perdipine twice a day. But when we switched to once-daily Novarsc, we found the blood pressure went down significantly. It was a shocking experience. -Since the release of Novarsc, how did the trend in hypertension treatment or cardiovascular disease prevention shift? Simply put, the paradigm had changed. Although previously we had diuretics, beta-blockers and first generation angiotensin-converting enzyme (ACE) inhibitors, their antihypertensive effects were not strong enough. But with Novarsc’s remarkable coercion effect, more patients were able to reach the target blood pressure level. Especially from 2000, when the Separation of Prescription and Dispensing (SPD) System was implemented, patients had to get prescription for drugs and the hypertension control in South Korea has gotten much better. From early 2000 to mid-2000s, the hypertension control rate in South Korea was increased from approximately 10 percent to 40 percent. CCB was an integral factor to the improvement, and Novarsc’s part in CCB was huge. -What is the latest topics addressed about hypertension control? There are two major questions—‘is the blood pressure the lower the better?’ and ‘is the treatment the earlier the better? We have not found a clear answer to the question of ‘is the blood pressure the lower the better?’ It is an issue of how much antihypertensive effect is good.’ And it relates to a definition of how high is high. Although we do not have accurate data to support how early the hypertension treatment should start, I personally advise discovering the hypertension patient in their 30s to 40s is better. Recent studies claim high blood pressure is related to a cause of dementia, so treating it from early on would help patients maintain their cognitive function as well. -Would you say the significant influence of Novarsc in hypertension management would be maintained in the future? For a long time, its presence would continue to be noticeable. It is true that the drug has contributed immensely in protecting the Korean people from cardiovascular diseases for three decades. In last decade, the improvement rate in hypertensive control in South Korea has been growing sluggishly. Almost to the point there is no growth. Both the people and the healthcare providers should pay more attention, and the government and relevant organizations should also raise awareness of the condition.
- Policy
- “Just worrying about new pricing system gets you nowhere”
- by Eo, Yun-Ho Dec 22, 2020 06:12am
- Professor Suh Dong-churl A vast number of patients are suffering in vain and pain as more drugs are available without the healthcare insurance benefit. Now, the coverage on new drug is developing into an issue for the general South Korean public. Although the South Korean government tried to expand the scope of risk sharing agreement (RSA) and pharmacoeconomic evaluation (PE) exemption system, the government and pharmaceutical industry are not seeing eye-to-eye in the age of the high-priced drug. To seek the breakthrough point, the industry claims the government has to implement post-listing evaluation, adjusted incremental cost-effectiveness ratio (ICER), and indication-specific pricing, but the government, who needs to count every penny cannot easily be convinced by the industry’s suggestions. Daily Pharm interviewed Dr. Suh Dong-churl, a professor at Chung-ang University College of Pharmacy and a pharmacoeconomic scholar, for his opinion on the effectiveness and implementation strategy of the above mentioned policy recommendations. -First, what is your opinion on the need to implement the post-listing evaluation? Personally, the government’s concern on listing a drug first and evaluating it later seems to be on the difficulty in setting the drug pricing. But a recent study comparing the drug pricing in South Korea to A7 countries using the latest currency rates and purchasing power parities (PPP) found the drug pricing in South Korea was on par with the lowest pricing among the A7 member countries. So that’s a start. It cannot be said there is no financial impact at all, but limiting the post-listing evaluation to rare disease treatment would not create threatening level of financial impact. I see about less than 1 percent and maximum under 10 billion won. Like how the health authority stipulated various conditions and limitation when implementing the RSA, the authority can also set out restrictions for the pre-listing evaluation. Did RSA push up the financial burden in the National Health Insurance (NHI)? I don’t think so. I assume the same for the pre-listing evaluation. -There are concerns of possible reimbursement suspension, when a company refuses to accept the adjusted pricing after the post-listing evaluation. Such situation could be avoided if the contract term preemptively requires at least a few years of drug supply or continuous supply to the patients using the drug. In the U.S., for instance, a pharmaceutical company signs a contract in the beginning of the year with their requested pricing, and the company refunds back the difference at the end of the year, if there were a gap between the actual transaction prices by the pharmaceutical company and hospital and insurance company. On the other hand, the South Korean government is trying to do everything. We don’t need to worry too much now. The concern of reimbursement suspension was also there when RSA was reevaluated. But have you heard of any case reported so? -The need of adjusting ICER is constantly addressed. Some say it should be applied flexibly, and some say it should be raised completely. ICER should not be fixed, but should rather reflect the reality. But current system is going backwards. Personally, I advise adjusting it in ranges. At the moment the ICER for anticancer treatment is at around 70 million won, which doubles the GDP, but it is actually fixed at around below 50 million won. However, adjusting the ICER should seek for national consensus, before the actual enforcement of the change, by discussing it with the healthcare providers, patient groups and consumer groups. It is not an easy one to solve. -How about the frequently addressed indication-specific pricing? Some are worried about various issues like confusion in disease code or an abuse. First, there is an opinion that the NHI data cannot fathom the figures, but the Health Insurance Review and Assessment Service’s (HIRA) data can clearly confirm which drug was prescribed for which indication. And I heard some are criticizing the indication-specific pricing goes against the fundamental principle of the NHI that gives a single pricing on a single drug. But it would make more sense for policies to constantly change as there are new drugs released with various indications. The government is concerned of the surging financial burden. The pharmaceutical expense budget may be raised, but the number of patients receiving medical service and admitted to hospital would be lessened. Ultimately, the increased pharmaceutical expense would balance out with the decreased medical service expense. -But a string of expensive new drugs are preparing for the South Korean market, and surely the financial burden on NHI would get heavier. What would be your advice on the financial issue? Securing a certain level of finance would be needed. Reducing the generic pricing would save somewhat of the expenditure, and expanding tax benefit would be good as well. And to improve the listing process speed, I would like to recommend pharmaceutical companies to directly pay for the administrative cost. The U.S. Food and Drug Administration (FDA) offers a system called, ‘User Fee Program,’ which lets an applicant company to cover for the cost of human resource to reduce the review period. Using the program, FDA was able to significantly shorten the review time. Patients with rare disease or cancer have short life expectancy, and that is why swiftly granting access to new drug is crucial. The efforts to expedite the review process would not go unnoticed.
- Company
- Boryung's FAH is expected to be released soon
- by Kim, Jin-Gu Dec 22, 2020 06:10am
- (From left) Dukarb, Tuvero, and Kanarb Boryung's hypertension combination drug is expected to be released in the second half of next year. If FAH is released next year as planned by Boryung, it will be the 7th 'Kanarb Family'. Interest is focused on whether to continue the Ducaro and Archave successes as the 5th and 6th Kanarb family this year. According to the pharmaceutical industry on the 21st, phase III clinical trial of Boryeong's three-drug hypertension drug based on Kanarb is in the final stage. Product release is possible as early as the second half of next year. Boryung is developing under the name 'FAH', a combination of Fimasartan, Amlodipine, and a diuretic (HCTZ) for high blood pressure. Boryung has conducted Phase III clinical trial on 250 hypertensive patients at 32 domestic hospitals since May 2019. Boryung released its own Fimasartan-based hypertension drug Kanarb in 2010, and has added five combinations so far. Boryung It started with Lacor (Fimasartan potassium/HCTZ) in 2013, Dukarb (Fimasartan potassium/Amlodipine) and Tuvero (Fimasartan + Rosuvastatin) in 2016. In February of this year, Dukaro (Amlodipine Besylate/ Fimasartan Potassium Trihydrate Granule/ Rosuvastatin Calcium (Micronized)) was released, and in September, Akarb (Atorvastatin Calcium Trihydrate/ Fimasartan Potassium Trihydrate Granule) was released, expanding the Kanarb family lineup. The Kanarb family is promising to exceed ₩100 billion in outpatient prescriptions this year. According to the drug market research institute UBIST, the Kanarb family recorded a prescription record of ₩94.3 billion until November. This is because, while the prescription amount of the single drug Kanarb has slowed, the prescription amount of the combination drugs, led by Dukarb, has increased significantly. Dukaro and Akarb, launched this year, are considered successful. Dukaro produced ₩5.4 billion by November, and Akarb produced ₩700 million in two months of launch. If the 7th Kanarb family is released next year, attention is focused on whether it will continue to succeed. The key is the competition drugs. The market for a combination drug for hypertension with ARB + CCB + diuretics is already dominating the market. Daiichisankyo's Sevikar HCT (Amlodipine/Olmesartan medoxomil/HCTZ), Hanmi's Amosartan plus (Amlodipine/Losartan potassium/Chlorthalidone), Ildong's Twotops Plus (Telmisartan/Amlodipine/HCTZ), Yuhan's True Set (Amlodilate/Chlorthalidone) /Telmisartan) is in competition. Until the third quarter of this year, Sevikar HCT had sales of ₩24.6 billion, Amosartan plus ₩17.4 billion, True Set ₩7.4 billion, and Twotops Plus ₩4.7 billion 20 items have been released as generics for Sevikar HCT due to the expiration of the patent. An official from the pharmaceutical industry said, "Kanarb's material patent will expire in February 2023. Boryung will try to launch as much variety of Kanarb-based combination drugs as possible before the patent expires." He said, "How much synergy between Boryung and its existing products in the competitive high blood pressure triple-drug market will determine the performance of the 7th Kanarb family."
- Company
- First line therapy for NSNLC, starts of combination therapy
- by Eo, Yun-Ho Dec 22, 2020 06:09am
- Various combinations have been approved for NSNLC (non-small cell lung cancer), the most competitive field for new anticancer drugs. Competition is expected to intensify in the future as numerous studies are underway based on immuno-cancer drugs and targeted anti-cancer drugs. Lilly threw the hat into the ring in Korea. The company is in the process of expanding insurance benefits for primary prescriptions of NSCLC of VEGF receptor 2 antagonist Cyramza (Ramucirumab) and epithelial cell growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Tarceva (Erlotinib). Cyramza's combination therapy was approved in Korea in July. The new combination targeting VEGF and EGFR is attracting attention because it has shown efficacy in mutant patients such as EGFR exon 19 deletion and exon 21 (L858R), which have been relatively weak so far. The possibility of Cyramza+Tarceva combination therapy was confirmed through a phase III RELAY. The Cyramza+Tarceva combined group reduced the risk of death by 40% compared to the Tarceva alone group, and the combined group showed a difference of more than 7 months from the control group at 19.4 months. Overall survival (OS) has not yet been derived. The median follow-up was 20.7 months, and the objective response rate was 76.3% in the Cyramza combination group and 74.7% in the Erlotinib alone group, but the median response duration was 18.0 months and 11.1 months. It is also encouraging that about 70% of the patients who participated in the RELAY study included East Asians. The immune anticancer drug Opdivo((Nivolumab), which has suffered from wage issues in Korea, is also starting a new challenge. Ono and BMS added a first-line indication for non-small cell lung cancer in combination with PD-1 inhibitor Opdivo and CTLA4 inhibitor Yervoy (Ipilimumab) on the 16th. The effectiveness of Opdivo-Yervoy combination therapy in the first line of NSNLC was confirmed through a Phase 3 CheckMate-9LA study. CheckMate 9LA (NCT03215706) is a phase III randomized study evaluating NIVO + IPI + 2 cycles chemo vs chemo in 1L stage IV/recurrent NSCLC A statistically significant improvement in OS was observed with NIVO + NSCLC-optimized IPI + a limited course of chemo vs chemo (4 cycles) in 1L advanced NSCLC. No new safety signals were reported. In addition, the results of extended follow-up for 12.7 months showed that the median OS of the two cycles of Opdivo+Yervoy chemotherapy was 15.6 months, which was consistently improved compared to 10.9 months of chemotherapy. Meanwhile, Opdivo+Yervoy combination therapy was approved as an indication for renal cell carcinoma in Korea, and it is in the process of registration after passing the Cancer Disease Review Committee in June. Cyramza was listed as a refund-type risk sharing agreement (RSA) in second-line gastric cancer therapy in May 2018.
- Policy
- MFDS initiated a preliminary review of Pfizer's vaccine
- by Lee, Tak-Sun Dec 22, 2020 06:09am
- In Korea, the approval process for Pfizer's COVID-19 vaccine has also begun. The MFDS requested a preliminary review of non-clinical and clinical (Phase I, II, and III) data before Pfizer applied for a COVID-19 vaccine license on the 18th. On the same day, AstraZeneca also announced that it applied for an additional preliminary review of the quality data before applying for COVID-19 vaccine AstraZeneca vaccine requested a preliminary review of non-clinical data on October 6. The MFDS is operating two licensing exclusive review teams for rapid evaluation in preparation for domestic approval applications for COVID-19 vaccine. The virus vector vaccine team reviews AstraZeneca and Johnson & Johnson vaccines, and the nucleic acid vaccine team reviews Pfizer and Moderna vaccines. Vaccine developers can submit data such as quality, non-clinical, and clinical data to the MFDS for preliminary review before applying. The MFDS said that it expects to secure time to fully review the safety and effectiveness of the vaccine, and to shorten the review period after application for approval by up to 40 days. An official of the MFDS said, "We will do our best to quickly supply safe and effective vaccines to our people."
- Company
- CKD to outrun SK and Hanmi with Xarelto patent challenge
- by Kim, Jin-Gu Dec 22, 2020 06:09am
- 자렐토 제품사진 Chong Kun Dang is now the sole contender to challenge Bayer’s non-Vitamin K antagonist oral anticoagulants (NOAC) Xarelto (rivaroxaban) substance patent. As it overcame Xarelto’s formulation patent, Chong Kun Dang plans to enter the follow-on drug market faster than SK Chemicals and Hanmi Pharmaceutical, who won the preferential sales rights. According to a pharmaceutical industry source on Dec. 18, the South Korean company has requested the Patent Court to provide a negative scope confirmation on Xarelto’s substance patent. So far, Chong Kun Dang is the only one filed the suit. Xarelto own three patents; a formulation patent expiring in 2024, an indication patent expiring I 2022, and a substance patent expiring in 2021. A number of Korean companies have successfully evaded the formulation patent. Bayer registered the indication patent, after the court ruled favorable for the Korean companies on evading the formulation patent. In 2015, SK Chemicals and Hanmi Pharmaceutical jointly filed for the negative scope confirmation on Xarelto’s formulation patent and won the first and second cases. Since then, Hanlim Pharm, GC Pharma, Samjin Pharm and Yungjin Pharm were also able to evade the patent. Currently, Bayer’s appeal case is pending in the Supreme Court. SK Chemicals and Hanmi Pharmaceutical that evaded the formulation patent, were the first ones to receive the preferential sales rights. The two companies can sell the generic drugs exclusively for nine months from Oct. 3 next year, when the substance patent is expired. And now, Chong Kun Dang is intercepting by challenging the substance patent. If the company succeeds and overcomes the substance patent, Chong Kun Dang would be able to launch its product faster than SK Chemicals and Hanmi Pharmaceutical with the preferential sales rights. However, the feasibility of the substance patent would be the deciding factor. Unlike the formulation and indication patents, the substance patent challenge tends to be even more difficult. In 2015, Daewoong Pharmaceutical filed a substance patent challenge on Xarelto to nullify the patent, the court has dismissed the case and there has never been another substance patent challenge. At the moment, Chong Kun Dang has a generic named ‘Riroxia’ approved to market. Both the tablet and capsule forms have been approved. Capsule form option is only offered by Chong Kun Dang. Even if Chong Kun Dang fails to challenge the substance patent but succeeds in evading formulation and indication patents, Riroxia in a capsule form can be sold regardless of the preferential sales right. However, the company has not tapped on either formulation or indication patents, yet. A pharmaceutical market research firm UBIST found Xarelto has raised 50.8 billion won last year for outpatient prescription. Up until the last third quarter, the prescription volume of the drug reached 37.6 billion won.
