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- 2026-04-17 16:27:21
- Company
- Kyowa Kirin Korea appoints Lee Sang Heon as next CEO
- by Eo, Yun-Ho Dec 26, 2019 06:30am
- 이상헌 신임 사장 On Dec. 20, Kyowa Kirin Korea announced the promotion of current Chief Operating Officer Lee Sang Heon (54) as a Chief Executive Officer from Jan. 2, 2020. Graduated from Seoul High School and Yonsei University majoring in bioengineering, soon-to-be CEO Lee Sang Heon had experience in marketing and business alliance in Boryung Pharmaceutical and JW Pharmaceutical. Since April of 2010, Lee joined Kyowa Kirin Korea as a director of management and planning and successfully served his role in business management, project development, and compliance. After being promoted as an executive managing director in 2017, CEO Lee was later appointed as COO and contributed Kyowa Kirin to secure its market leadership in the special disease treatment sector like hemato-oncology and nephrology in Korea. The current CEO Na Jong Cheon is to resign at the end of 2019.
- Policy
- Moon Care on new drug and generic pricing in 2019
- by Kim, Jung-Ju Dec 26, 2019 06:29am
- The Moon Jae-in administration’s ambitious Moon Jae-in Care has directly affected the drug pricing system, essential to the insurance coverage. The healthcare coverage enhancement policy lowered the threshold of new drug listing standard, but further complicated the post-marketing drug pricing system. Also Ministry of Health and Welfare’s (MOHW) had its pharmaceutical benefit sector to concentrate their drug pricing capability on the designing of the technicalities of the healthcare policy. Lowered threshold, but complicated post-marketing evaluation for all-around management of generic and new drug The impact of the groundbreaking insurance coverage enhancement program by the Moon Care has struck down on the general drug pricing system this year. In the beginning of the year, the government, as previously notified, presented generic pricing and new drug listing system revision, listed drug reevaluation and pharmaceutical expense management all at once. For the bigger frame of enhancing healthcare coverage and reducing the people’s medical bills, the government has decided to progressively reinforce coverage on new drug while strictly managing already-listed new drugs and generics. To better manage quality of generic after the valsartan contamination issue, the government has decided to link approval and drug pricing system under the name of ‘3+1 System.’ Ministry of Food and Drug Safety (MFDS) revised the generic approval system and pricing system to gradually lower pricing of items depending on the number of listed items. In July, MOHW issued an administrative notice on partially revised regulation of ‘Pharmaceutical Affairs Decision Making and Approval Criteria’ with the said changes, and plans to finalize it by the end of the year. On the other hand, the barrier of new drug listing has been alleviated. The RSA eligibility and scope have been expanded for high-cost new drugs as constantly demanded by the industry. But for an item to choose the option, it has to pass the three following conditions; a drug used for treating cancer or disease either recognized by ‘Special Case Standard for Partial Copayment Benefit’ or ‘Special Case Benefit for Patients with Rare Disease and Chronic Disease’; drug with clinical efficacy proven to improve quality of life or recognized so by a related committee; drug recognized as Breakthrough Therapy Designation (BTD) or Priority Medicines (PRIME) by the US Food and Drug Administration (FDA) or European Medicines Agency (EMA), respectively, or recognized as equivalent by Drug Reimbursement Evaluation Committee (DREC). But some have raised an issue about the regulator turning Health Insurance Policy Deliberation Committee (HIPDC) on-paper reimbursement listing review into a face-to-face review for new drug exempted from negotiation. They claimed it would cripple the system’s effectiveness and accessibility. Meanwhile, the government plans to establish a listed drug reevaluation standard and to elaborate the post-marketing evaluation procedure. The three reevaluation types—external reference pricing, listing contract expired drug, and performance-based post-marketing evaluation—would be categorized by literature-based reevaluation and real world evidence (RWE)-based reevaluation. But the industry is firmly opposing on the notion of reevaluation, as the result of the reevaluations would eventually either reduce reimbursed price or adjust the general pricing lower. Reevaluation procedure on reimbursed drugs (summarized by Daily Pharm) The government also finalized the ‘7.7 Pricing System’, which raised both Korean and global pharmaceutical companies’ eyebrows, as its initial version and enforced it from this year. First it started from the KORUS FTA renegotiation agenda, but technically the government dropped both benefit for Korean-made new drug exporting to global markets and the U.S.-based multinational pharmaceutical companies’ demand for new drug pricing benefit. Considering the government had its agenda behind it, the industry reprehended the government last year for its concerning and unfair action. The Drug Pricing Benefit for companies states the manufacturer and suppliers of WHO-recommended essential drug or National Essential Drug as designated by Article 2 of the Pharmaceutical Affairs Act should be confirmed to manufacture and supply without an issue. And the government would strip the pricing benefit of the companies, if they have issues supplying drugs on the Reimbursed Drug List, or were imposed with administrative penalty or convicted by a court for providing illegal rebate, according to Paragraph 2 of Article 47 of the Pharmaceutical Affairs Act. But there are exceptions. A company that suspends the supply of the drug with following reasons would be exempted from the penalty; in case manufacturing plant is shut down or closed; manufacturing, import or sales approval is suspended or canceled; new issue of safety or effectiveness arises; manufactured or imported supply shortage occurs due to surged demand (except when the demanded amount is within the predicted billing amount); when the company is faced with inevitable natural disaster. The government is also continuing on with the rebate prevention policy. The so-called ‘K-Sunshine Act’ was enforced and required pharmaceutical companies to file, archive and submit financial profit provision record (within the allowed amount by Pharmaceutical Affairs Act), or the expenditure report. At the moment, the government is reviewing the submitted expenditure reports. The government is focusing on analyzing and investigating expenditure types to set the system down. However, the companies may undergo investigation by prosecution when correlation between their expenditure and rebate are clearly found. The insurance coverage enhancement policy implemented this year constructed with substance-by-substance reimbursement, expanded listing of high-cost drug, and listed drug reevaluation would base even more specified drug pricing policy for next year. The industry is expected to see the effect in the field. Moon Care ploughs on with coverage enhancement with selective reimbursement This year was the first year for the first National Health Insurance Comprehensive Plan. Last year the government was sketching out the technicality of the Moon Care, and this year it was busy executing the detailed policy actions in the set order. Starting from the first pilot program of primary healthcare-based chronic disease management (initiated from December 2018), the government gradually increased healthcare coverage on ultrasound scan, essential check up and treatment for lower abdomen (rectums and anal passage) and urinary system (kidney and bladder). Moreover, coverage on cavity treatment for children under 12, thoracoabdominal MRI scan and Korean medicine treatment has been granted this year. In addition, the government started the pilot program for Community Care that integrated healthcare and welfare, providing customized benefit by each region across the country. On July 2, President Moon Jae-In presented the importance of National Health Insurance, performance of coverage enhancement and prospective plan at the ‘Second Anniversary Briefing of NHI Coverage Enhancement Initiative Implementation’ convened at NHIS Ilsan Hospital. The healthcare coverage statistics presented by the government in July found the coverage rate in general hospital was increased from 62.6 percent in 2016 to 67.2 percent in 2018. But with the figure, the public is skeptical about the government raising the National Health Insurance premium by 3.2 percent. The skepticism is not only about the premium increase, but also about ultimately reducing the people’s medical bills by fixing insurance income source and increasing rate of the government funding. Both industrial organizations and civic groups are urging the National Assembly to push up the government funding rate up to 20 percent to keep the moderate balance of medical service fee and coverage rate. Currently, Ministry of Economy and Finance has promised MOHW to provide the government insurance funding of 14 percent for next year, which MOHW would utilize on reinforcing insurance coverage programs.
- Opinion
- [FOCUS] There is no reliability of cluless government policy
- by Chon, Seung-Hyun Dec 26, 2019 06:29am
- The impurity issues that started in Valsartan last summer led to Ranitidine and Nizatidine, and many drug products were discontinued. This year, the domestic pharmaceutical industry suffered greatly due to impurity risk all year round. Using a stigma called "carcinogen", a huge amount of medicines were recovered, and pharmaceutical companies suffered huge losses. So far, the government's follow-up on impurity drugs has been a fear to pharmaceutical companies. From the Valsartan to Nizatidine, the pharmaceutical industry continued to report that the domestic measures were strong. Valsartan immediately suspended the sale of products using the company's drug substance when recalls were received in Europe. Since January 2015, the Ministry of Food and Drug Safety has stopped selling all drug products that used the ingredients in question. It has been criticized that losses have increased and confusion has increased as the problem-free products have been recovered. It has been concluded that impurity-containing Valsartan medicines are not harmful to humans in both Korea and the United States. In Korea, Ranitidine has been inspected for the collection of finished drugs and drug substances, and all products of Ranitidine have been suspended. Not all Ranitidine has been removed from abroad. In the United States and Europe, companies made their own recovery. The US Food and Drug Administration (FDA) issued an official statement last month stating that "the hazards of NDMA detected in Ranitidine are comparable to those exposed when eating roasted or smoked meat". 13 products of Nizatidine was discontinued. No products have been issued a recall order in the US and Europe. Mainly older products were classified as subjects of recovery, and pharmaceutical companies complained that they were forced to sacrifice while stopping the sale of trouble-free products. The MFDS is currently investigating the presence of impurities in Metformin. Singapore's Ministry of Health (HSA) recently retrieved 46 items of Metformin sold locally and recovered three. N-nitrosodimethylamine (NDMA) was detected above the daily allowance. Unlike Valsartan, Ranitidine, and Nizatidine, Metformin investigations are cautious. The MFDS said they are investigating an Metformin, but has not yet conducted a collection test. The MFDS set out to conduct collection tests after Metformin's NDMA test was established this year. In this situation, the MFDS ordered pharmaceutical companies to submit data on the production of pharmaceuticals containing Metformin hydrochloride and the system of active drug substance investigation. Pharmaceutical companies are questioning whether “products using raw materials recovered from Singapore have been brought into the country”. Metformin's drug product recovered from Singapore has never been imported into Korea. However, the MFDS has not yet made an official position on whether the drug substance used in the product is imported into Korea. In the case of Valsartan, products that use the same raw material pharmaceuticals as those recovered as impurities from overseas must be discontinued in Korea. If it is confirmed that the same drug substance as Metformin recovered in Singapore is imported into Korea, it may be decided whether to discontinue the sale. In fact, it is reasonable to take follow-up measures through collection inspection even if the drug substance and the same manufactory that were recovered overseas are imported into Korea. It is reasonable to recover only the serial number in question even for the same product. This is a lesson already learned from the Valsartan issue. Rather, the bold policy to relieve the anxiety of the people encouraged anxiety. It caused a lot of social cost waste. It would be even more frustrating if they were reluctant to disclose transparent information because they were afraid of criticism that the MFDS would be in conflict with public insecurity or past policies. If they have experienced trial and error in the past, it is the government's role to honestly admit and implement an evolved policy. Then they should ask for understanding why it should have been. Only then they can gain trust. We want a "cool" government that can reflect on their mistakes.
- Company
- Roche sets sail for more trials on Xofluza
- by Eo, Yun-Ho Dec 24, 2019 06:13am
- Following the two decade-long heritage of Tamiflu, next generation flu treatment Xofluza is quickly taking next steps to secure its market position. According to the related industry source on Dec. 24, Roche is to soon present two Phase 3 trial results of Korean health regulator-approved Xofluza (baloxavir), and the company also is prepping for three other clinical trials. The completed trials have tested efficacy of the treatment in a post-exposure prophylaxis study and on high-risk children. The post-exposure prophylaxis study tested the rate of virus transmission from an influenza virus-infected household member to Xofluza-treated household. The result found an arm treated with Xofluza significantly reduced the risk of people developing flu by 86 percent. Clinical trial MINISTONE confirmed positive effect of Xofluza, evaluating virus titer and the time to alleviation of symptoms on pediatric patients aged one to 12 with treatment of the flu treatment. Moreover, Xofluza is also currently calling for clinical trial participants for three other trials. One of the three trials is to study the treatment effect on infant patients under the age of one, whereas the second one titled FLAGSTONE is to observe arms treated with either Xofluza only or Xofluza and the standard of care Tamiflu together as a combination on hospitalized patients. The FLAGSTONE trial is designed to administer Xofluza once on day 1, day 4, and day 7, respectively, for three times total. CENTERSTONE, the last one out of the three trials, is to evaluate preventive effect of Xofluza on patient’s virus transmission. Unlike the post-exposure prophylaxis study, the third trial is to administer the treatment on the patient only and observe not only the patient’s time to alleviation of symptoms, but also the virus transmission among the patient’s household members. When the three trials complete with satisfying results, indications for Xofluza would expand remarkably. Professor Lee Jae-gab of Hallym University Medical Center Infectious Disease Department commented, “Besides the advantage of convenient one-dose oral administration, Xofluza is expected to be used for various indications as it has a different mechanism of action compared to other existing options”. Xofluza has been approved by Korea’s Ministry of Food and Drug Safety (MFDS) in November for treating adult and pediatric patients aged over 12 with Type A and B influenza infections.
- Company
- The NHIS again urged to pay Valsartan damages by this month
- by Chon, Seung-Hyun Dec 24, 2019 06:10am
- Health authorities urged pharmaceutical companies to pay Valsartan claims. 36 pharmaceutical companies have already filed a lawsuit that they are not liable to pay preemptively, but have reaffirmed their willingness to collect the money. According to the industry on the 20th, the National Health Insurance Service recently issued a reminder to pharmaceutical companies to pay Valsartan compensation claims. The National Health Insurance Service requested to pay ₩2.03 billion in compensation to 69 pharmaceutical companies. After last year's outbreak of the impurity Valsartan’s issue, it is follow up by the Ministry of Health and Welfare that they will get back the amount of money invested in the drug to the patients for the remainder of the existing prescription. The National Health Insurance Service sent out a notice to pharmacy companies that did not pay the compensation and urged them to pay by October 31. But the payment rate was low, so they sent a second reminder this time. In fact, most large companies have refused to pay. According to the data submitted to In-sun Nam, a member of the Democratic Party of Korea, 26 pharmaceutical companies paid ₩440 million in compensation. The payment rate was only 21.5%. The drugmakers refused to pay about 80% of the recourse amount. The industry believes that companies that have not paid the bill so far are unlikely to pay. A legal battle with the health authorities has already become a reality. Pharmaceutical companies filed a debt existence verification lawsuit against the National Health Insurance Service in Seoul Central District Court on Nov 27th. It preemptively filed a lawsuit stating that it was not responsible for the Valsartan damages claimed by the National Health Insurance Service. Thirty-six pharmaceuticlas of the claims were filed. Originally, pharmaceutical companies considered ways to co-operate if the National Health Insurance Service filed a lawsuit for damages. However, they agreed to take a hard-line response by preemptively bringing up class action. Pharmaceutical companies are claiming that they are not responsible for Valsartan damages claimed by the government. Pharmaceutical companies stress that there are no manufacturing and design flaws with impurity Valsartan. Carcinogen N-nitrosodimethylamine (NDMA), detected in Valsartan issue, is a hazardous substance that has no standard in the Valsartan raw material. Neither governments nor pharmaceutical companies were aware of the risks of NDMA detection in Valsartan. According to the Product Liability Act, it is clear that if the manufacturer proves that the defect was not found at the level of science and technology at the time the manufacturer supplied the product, he would be liable for damages. After the Valsartan issue, the MFDS derived a test method for detecting NDMA from Valsartan raw materials and set new standards. The MFDS reviewed the guidelines recommended by the International Pharmaceutical Regulatory Harmonization Committee (ICH M7), domestic and international data, and expert advice to set the NDMA standard for Valsartan to 0.3 ppm or less. Pharmaceutical companies also hold the position that compensation claims made by the National Health Insurance Service are not included in liability. Pharmaceutical companies insist that there is no liability under the Product Liability Act for Valsartan consultation fee or dispensing fee.
- Policy
- Korea’s Drug expense management to settle on ‘trade-off’
- by Lee, Hye-Kyung Dec 24, 2019 06:10am
- Apparently, the government is to redirect finance saved by dropping drug with unproven clinical efficacy from reimbursement listing and adjusting drug price to provide coverage on new drugs for treating severe and rare disease. It would mean that the ‘trade-off’ strategy kept mentioned by Korea’s Ministry of Health and Welfare (MOHW), as a part of the National Health Insurance Comprehensive Plan, would be implemented soon. The technicality of the trade-off strategy and the tentatively named ‘Severe Disease Drug Expense Account’ would be included in the ‘Pharmaceutical Listing and Adjustment Standard’ MOHW is to publicly notify soon after the pre-announcement period started from September. Deputy Director Choi Kyung-ho of Pharmaceutical Benefit Division at MOHW reiterated the notion of ‘money pot’ when describing the trade-off strategy at a policy seminar convened on Dec. 19 about insurance coverage on immunotherapy by Lawmaker Kim Kwang-soo. The deputy director pointed out, “England has Cancer Drugs Fund (CDF) that sets a road map to manage National Health Service (NHS)-covered drug and its annual action plan, but it has a limitation on the ‘money pot’”. The government official indirectly mentioned of the Korean ministry planning to reallocate saved drug reimbursement to cover severe disease drug expense as a trade-off. Deputy Director Choi stated, “Whether it be a household or a state, they need to get an access to money when need be. But there are not many pots of money available, realistically. We need to reevaluate drugs to sort out drug underperforming and ineffective than expected and even considered valueless in other countries”. Recently, Health Insurance Review and Assessment Service (HIRA) held a public hearing on pharmaceutical reimbursement reevaluation standard and procedure, and stated it would conduct a post-marketing review on high-cost anticancer and rare disease treatments with uncertainty in clinical efficacy based on foreign government insurance listing status, usage frequency, and ratio of claimed reimbursement. In short, the government is to revisit pharmaceutical expense increase rate and reimbursement claim cost. Deputy Director Choi stressed, “The ministry is trying to create a pot of money, or an account, by reevaluating listed drugs and reusing saved finance on anticancer or rare disease treatment. Only when we save money from the reevaluation, we would be able to use it as resource to cover anticancer or rare disease treatment”. A so-called trade-off or money pot is a tentatively named Severe Disease Pharmaceutical Expense Account as stated the National Health Insurance (NHI) action plan. The action plan aims to generate an account from adjusted and saved NHI expense according to pharmaceutical reevaluation to utilize it on enhancing coverage over high-cost severe disease treatments. The government is considering various means to operate the Severe Disease Pharmaceutical Expense Account without revising statute, but by having National Health Insurance Service (NHIS) to manage the account separately like the National Health Promotion Fund. In September, Song Young-Jin from the Pharmaceutical Benefits Division published an article in the September issue of HIRA Policy Report and also stated “The government plans to differentiate evaluation style or gradually apply evaluation model, taking in account of unique pharmaceutical quality, on selectively reimbursed drug, high-cost severe disease treatment, conditionally approved drug, evaluation-exempted drug or drug underperforming than expected.” The government official also has mentioned of establishing future reevaluation initiative by reviewing past pharmaceutical reevaluation cases and similar cosigned research, and also set pilot program for year 2020 to expand reevaluation system gradually.
- Company
- BMS loses the trial to revoke Eliquis’ 30% price cut
- by Kim, Jin-Gu Dec 24, 2019 06:09am
- Bristol-Myers Squibb (BMS) filed an administrative litigation to appeal against the government’s decision to lower pricing of new oral anticoagulant (NOAC) Eliquis (apixaban), but lost the case regardless. At a trial to revoke the Maximum Drug Reimbursement Price Adjustment order by the Minister of Health and Welfare on Dec. 19, Seoul Administrative Court has decided to dismiss the plaintiff, BMS’ appeal. The court also ordered the plaintiff to pay for the litigation cost. According to the court ruling, the Eliquis price reduction already postponed twice would be enforced soon. However, BMS has not confirmed their intention to file another appeal. The legal dispute between BMS and MOHW over lowering price of Eliquis actually started from a patent dispute. The Eliquis patent dispute began since March of 2015. Huons and other companies challenged Eliquis’ patent to invalidate it. The Patent Court, as a first trial, had decided that the drug patent is invalidated in February, 2018. The Korean companies won preferential sales approval by Ministry of Food and Drug Safety (MFDS) based on the invalidation ruling. Accordingly, apixaban generic was launched this June. With the generic entering the market, MOHW notified it would lower the maximum reimbursement price of the original Eliquis by 30 percent. The administrative measure was made based on the regulation stating the original’s maximum reimbursement price should be lowered, due to commercialization of its generic, by 30 percent in the first year and to 53.55 percent of the initial price from the following year. Therefore, the price of Eliquis was supposed to be lowered by 30 percent from 1,185 won per tablet to 830 won per tablet. However, BMS requested the Administrative Court to suspend the execution urging the ministry’s decision to lower the price was unfair. Simultaneously, the company officially filed for litigation against the administrative action to drop the drug pricing. The Seoul Administrative Court allowed BMS’ request on suspending the execution. The court stated the patent dispute over Eliquis has not been settled, yet, and the litigation to revoke drug price reduction is still ongoing, so the drug pricing reduction should be deferred until the final decision is made. While the BMS’ litigation was in process, price reduction on Eliquis has been postponed twice. MOHW then has decided to maintain the original’s initial pricing until Dec. 31 this year. Finally the last decision on the litigation has been made. But the Seoul Administrative Court that previously accepted BMS’ request to suspend the execution made a contrasting decision during the litigation case. Experts see that the Supreme Court invalidating Elquis’ patent in October has played the key role in the decision. The Supreme Court reaffirmed the first and second trial ruling by the Intellectual Property Trial and Appeal Board and the Patent Court, respectively, and ruled for the generic manufacturers. A legal expert elaborated, “The judge made a polarizing decision for the litigation case than for the suspension of execution trial. Whether or not the judge would quote the suspension of execution trial is not to base on the legality of the plaintiff’s claim, but on the predicted loss and the grounds of litigation.”
- Company
- No more patent-evading IMD, needs new strategies
- by Kim, Jin-Gu Dec 23, 2019 06:29am
- Technically, the days of Korean pharmaceutical companies evading drug patent infringement by modifying the original’s salt base are over. The Supreme Court’s ruling on the solifenacin (trade name: Vesicare) case in the beginning of the year first showed the signs of ending drug patent infringement with incrementally modified drug (IMD). And it was reaffirmed on Dec. 20 with the Patent Court’s ruling for varenicline (trade name: Champix). As for Korean companies, the time has come to seek for other strategy to challenge patent. Experts say it would be more difficult than the old IMD strategy, but it is not say there isn’t any other way to challenge patent. The other feasible strategy is to file an invalidation trial for each item to challenge the accusation of patent infringement. Popular IMD strategy has become a thing of the past Pharmaceutical industry and legal experts say the Champix ruling was actually “expected”. The majority of the experts predicted the solifenacin case would set a new precedent. Only a handful of experts claimed the Supreme Court left a room for interpretation on the patent’s ‘practical equivalence’ and ‘technical obviousness of Person Having Ordinary Skill in the Art (PHOSITA)’. Ultimately, judges made same decisions on following Januvia, Pradaxa, and Champix cases and reaffirmed the Supreme Court’s decision. In August and September, the Patent Court ruled favorably for the original patentee of Pradaxa and Januvia, respectively, against IMDs. Even in last year, IMD with switch in saline base has been the most common strategy for Korean companies to evade patent infringement and launch their generic early. Hanmi Pharmaceutical’s Amodipin is a typical case. By incrementally modifying Pfizer’s Norvasc in 2004, Hanmi Pharmaceutical has been generating tens of billions of won annually after commercializing the antihypertensive amlodipine generic. The first alert went off when the original manufacturer, Astellas Pharma had requested litigation for cancellation of a trial decision on solifenacin IMD to the Patent Court in 2016. Korean companies switched out succinate of the original solifenacin drug with fumarate. The Patent Court recognized two combinations as different substances, and decided that solifenacin fumarate does not infringe the extended patent period. However, the Supreme Court said the otherwise. Following the court’s ruling, lower courts made a series of similar decisions and put the IMD strategy on shaky ground. Pipeline strategy to change inevitably, then how about the originals? Experts predict about 150 IMDs challenging respective patents would end up with similar ruling as the precedents. Accordingly, Korean companies now have no choice but to shift pipeline strategy. The time has come to let go of IMD, the relatively convenient option of evading patent infringement. Considering medium-sized pharmaceutical companies challenged patents with IMDs, the intangible loss for giving up on IMD is expected to be significant. Moreover, the original’s companies could start a domino of litigations. Based on the precedents, the original companies are highly likely to file damage suit against IMDs for infringing their patents. Since the overruling the previous solifenacin decision, Pfizer has requested for an injunction to ban sales of incrementally modified solifenacin, and the court has accepted the request. Other original companies have not been reported to have requested the injunction. The industry is keenly paying an attention on whether or not Pfizer would file the damage suit. The legal experts see that the case would probably be favorable to Pfizer quoting the Supreme and Patent Courts’ decisions and Seoul Central District Court’s injunction. Seeking for other options to challenge drug patent The industry-changing court ruling aside, it’s not to say Korean companies’ patent challenge is absolutely impossible from now on. The patent system can be bypassed. The Patent Court’s ruling on Betmiga (mirabegron) made a day before Champix case is a good example. At the Patent Court on Dec. 18, 11 Korean companies, including Hanmi Pharmaceutical, Chong Kun Dang Pharmaceutical, JW Pharmaceutical, Ildong Pharmaceutical, Intro Biopharma, Alvogen Korea, Kyung Dong Pharm, Shinil Pharmaceutical, Han Wha Pharma and Shin Poong Pharmaceutical won the patent dispute against original company Astellas Pharma. Meanwhile, Korean pharmaceutical companies are apparently trying new patent challenge strategies. The existing IMD strategy was based on defensive confirmation trial for scope of a patent, which means it was challenging a small part of a whole patent. Incremental modification of saline base was meant to challenge a part of extended period of drug patent. On the other hand, the Korean companies filed an invalidation trial instead to challenge the patent. If they win, the trial would nullify not partial, but the whole patent. However, the trial is not to challenge drug patent, but to challenge novel use patent. In other cases, some have challenged the extended period of drug patent with invalidation trial. Hanmi Pharmaceutical and Ahn-gook Pharmaceutical won the invalidation trial against Novartis’ DPP-4 class diabetic treatment Galvus in last February. The two companies have successfully revoked validity of the extend patent on Galvus. A legal expert commented, “More than the Champix’ case, Betmiga’s trial attracted more attention as it was unpredictable. Invalidation trial is surely complicated, but it is not impossible”. “Defensively confirming the scope of a patent is now useless only for IMD, but other option could be used to challenge drug patents”, the legal expert added.
- Policy
- Moon Jae-in Care needs speed control
- by Lee, Hye-Kyung Dec 23, 2019 06:29am
- There were voices of concern that the government's policy to strengthen health insurance guarantees could weaken domestic economic growth potential and national competitiveness. The Korea Employers Federation (Chairman of KEF, Kyung-sik Sohn) held a session on the 19th to evaluate the 1st National Health Insurance Comprehensive Plan (2019 ~ 2023) under the theme of 'National Health Insurance, Sustainable?'. The debate was held in the public's concern about the financial crisis of health insurance due to the overlap of policy factors such as increased measures to the medical use due to aging. In the past 10 years (2008 ~ 2018), Korea's medical expenses growth rate is 6.9% per year, three times the OECD average of 2.3%, and the fastest rate among 36 member countries. In the case of National Health Insurance, which accounts for the largest proportion of medical expenditures, which have increased by 8% every year for the past five years (2014 ~ 2018), are expected to increase by more than 13% this year. Yong-geun Kim, the Vice President of the KEF, said, “Recently, medical expenditures are rapidly increasing, which raises the public's concern about the financial crisis of health insurance, at the current rate of increase in medical expenses, it will soon become a factor that weakens growth potential and national competitiveness as excessive national resources are put into the medical sector”. Mr. Kim said, “Expansive radical guarantees will entail excessive insurance premiums, which will eventually lead to a vicious cycle of lowering private investment and consumption and reducing economic vitality, and it needed to adjust the speed of security measures”. The government plans to raise the rate of health insurance premiums by 3.2% annually to cover the cost of expanding the coverage, but this also means that in the era of low growth with an economic growth rate of around 2%, the burden on the people and businesses is beyond. Mr. Kim said, “Companies paying 43% of the total health insurance income cannot afford to pay premiums anymore due to the deteriorated business environment and poor performance, we need to focus on improving fiscal soundness by rationally improving health care spending while minimizing premium rate hikes”. He also called for a full reform of the health insurance system to make more efficient use of limited resources, and he cited the resolution of moral hazards in the medical field, revitalization of private insurance subscribers, the introduction of incentives for reducing medical expenses, the expansion of comprehensive budget system, the reduction of drug costs, and the introduction of the primary doctor's system. In addition, he urged a preemptive reform of the committee's operating system so that the opinions of companies (labor-management) and community members who are responsible for health insurance can be reflected in a greater proportion. Professor Hee-kyun Yang, Kyung Hee University, who was in charge of the first presentation, predicted that the burden of subscribers would increase because there is no way to solve the overuse of medical services due to the expansion of the guarantee coverage. Therefore, in case of excessive anticipated medical use (MRI, ultrasound, anticancer drugs, treatment materials, etc.) and services (elderly outpatient’s flat sum system, copayment limit, long-term hospitals, upper ward benefits) The government said that it is necessary to prepare a management plan for discounts and surcharges. As a plan to alleviate the phenomena of large hospitals, it was required to establish a four-stage medical delivery system (clinics-hospitals-advanced hospitals-nationalwide hospitals), including the establishment of a nationwide hospital using the total contract method. The second speaker, Seong-in Chang, a professor at Yonsei University, predicted that the cumulative reserves, which amounted to ₩20.8 trillion in 2017, will be exhausted in 2022. Professor Chang said, “To secure financial health of health insurance, we must break away from the stereotype of solving all things with one health insurance and establish a hybrid medical security system that properly connects social security and market economy principles, we need to consider introducing a lifetime health account that manages parts as an individual account”. Seok-yong Chang, a professor of Eulji University, the third speaker, pointed out that despite the establishment of the 1st National Health Insurance Comprehensive Plan, there is still no high-level health development plan. Professor Chang said, “As the rules of the game need to be carefully reviewed, we need a social consensus on strengthening the representation and professionalism of members and the formation of public interest committees in decision governance such as the Health Insurance Policy Review Committee and the Financial Steering Committee, and considering the enormous amount of financial operations, it is necessary to establish a pre-control mechanism of the National Assembly”.
- Company
- Ulcerative colitis added to Stelara's domestic indications
- by Eo, Yun-Ho Dec 23, 2019 06:29am
- Janssen's interleukin-12/23 (IL-12/23) inhibitor 'Stelara' can be prescribed for ulcerative colitis. According to the industry, the KFDS recently approved Janssen's Stelara (Ustekinumab) as a treatment for moderate to severe adult active ulcerative colitis. As a result, Stelara has acquired four indications in Korea, including ulcerative colitis, plaque psoriasis, psoriatic arthritis, and Crohn's disease. The expansion of Stelara's ulcerative colitis indications was based on the UNIFI program, Phase III. The program consisted of one maintenance therapy with subcutaneous injection every 8 weeks for 44 weeks after one initial induction study with a single intravenous injection of Stelara. The study found that 19% of Stellar dose groups reached clinical remission in 8 weeks and 58% of patients responded. In maintenance studies, 44% showed improved tissue endoscopic mucosal membranes after one year. Meanwhile, starting with Stelara in the interleukin therapeutic market, four items are approved including ▲IL-17's Cosentynx (Secukinumab) by Novartis, ▲Lilly's Taltz (Ixekizumab), ▲IL-23 Inhibitor, Tremfya (Guselkumab). In addition, Boehringer Ingelheim is conducting a global phase III study comparing the IL-23 inhibitor 'BI655066' with Stelara, and Brodalumab, developed by AstraZeneca, has also been shown to be effective in direct comparison with Stelara and has been approved in Europe.
