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- Policy
- More rare diseases designated for special case NHI benefit
- by Lee, Hye-Kyung Jan 13, 2020 06:22am
- From Jan. 1 this year, the government expanded list of designated rare diseases and healthcare institutes examining rare disease eligible for the special case healthcare benefit. To reduce medical expense and to improve medical access for patients with ultra rare and unknown diseases, National Health Insurance Service (NHIS, President Kim Yong-ik) announced the extended list of rare disease and healthcare institute examining rare disease for special case National Health Insurance (NHI) benefit that came in effect from Jan. 1. The objective of the special case benefit system is to reduce patient’s copayment rate on expensive rare and severe disease treatment, which makes a rare disease patient to be responsible for 10 percent of inpatient and outpatient medical expense. Accordingly, the list of designated rare disease receiving special case benefit has been expanded to include 1,014 rare diseases, applying the benefit to around 270,000 patients. Before the change, it used to be approximately 265,000 patients receiving the benefit. Constantly listening to patients, their family, patient groups and related academic societies, NHIS increased the number of designated rare disease for the benefit after a series of deliberation by Rare Disease Management Committee (Korea Centers for Disease Control and Prevention) and Special Case Benefit Committee (NHIS). From last year, the government agency has opened a separate disease group dedicated for unspecified chromosome abnormalities, as patients with the condition could not receive any special benefit without a specific name of diagnosed disease. Rare disease patients with the designated special case disease are expected to access treatment with lessened financial burden, as supported by special case NHI benefit and Rare Disease Patient Medical Aid program. Also the NHIS has added more healthcare institutes to examine and diagnose rare disease. Since 2016, NHIS has appointed qualified healthcare institute to exam ultra rare disease and unspecified chromosome abnormalities to promptly but accurately provide special case benefit to the patients. In December, the agency called for a bidder among tertiary hospitals offering rare disease or genetics clinic, and selected seven more hospitals, making total of 28 hospitals available for rare disease examination from this year. The new appointment was to expedite examination procedure to diagnose increasing number of rare disease eligible for NHI special case benefit, and to resolve inconvenience of patients in regions without the designated institute, such as Jeonnam, Jeonbuk and Chungbuk. A NHIS official stated, “The agency would continue to improve rare disease patient’s access to treatment by providing special case benefit to growing number of newly diagnosed rare diseases found with fast-advancing technology, and by appointing more healthcare institutes capable of examining the diseases for the patients to receive adequate treatment.”
- Company
- “RSA expansion, a foundation to expedite new drug listing"
- by Eo, Yun-Ho Jan 10, 2020 06:26am
- A ‘new drug’ holds the foremost value of the pharmaceutical industry. And global pharmaceutical companies’ eyes are currently fixated on the ‘adequate value of new drug’ than ever before. As the era of high-cost drug has come, government and pharmaceutical industry’s gap in views of drug pricing has never been so apart. Korea Research-based Pharmaceutical Industry Association (KRPIA), representing the voices of global pharmaceutical companies in Korea, is stepping forward seeking the middle ground of the two. A consensus between them does exist. For an instance in last year, the Korean health authority expanded scope for risk sharing agreement (RSA) and announced a plan to apply RSA on follow-on drug and to expand pharmacoeconomic evaluation (PE) exemption system. The year 2020, the time of changes and expectations, marks Chair Avi Benshoshan’s third year serving KRPIA. And Daily Pharm interviewed him for this year’s plan of the organization. Chair Avi Benshoshan#- New Year’s greetings and message for the member companies. As you may be aware, this year would be another year of economic recession and sluggish growth as predicted by major economic indicators. However, we hope to create a regulatory environment that recognizes value of innovation to maintain the growth engine of pharmaceutical and bio industry this year as well. And I wish everyone has a year full of keen wisdom to seek an opportunity in crisis, like a small but bright mouse. - KRPIA member companies share a common theme of ‘new drug.’ But each of them has diverse field of expertise in anticancer, rare disease, chronic disease and off-patent treatments, which comes with different interest groups. Respective member companies have their own specialized field, but in a bigger frame, they are all heading for the same goal of improving patient’s health. In the same sense, KRPIA is planning to present more concrete basis for new drug to strengthen the ‘patient-centered healthcare policy,’ and to reinforce the organization’s role as a communicator between government and healthcare sector stakeholders. The organization ultimately aims for a mutual growth through raising awareness of social value in new drug and improving policy. We think the government, global pharmaceutical companies and the organization also share a same goal of adequately providing new drug to patients in urgent need and lowering barrier of new drug access to prevent disheartening catastrophe of patients giving up on treatment for financial reasons. - It could be considered quite limited, but the organization’s long-awaited drug pricing system revision is in process. The organization sees it as a positive change as RSA scope expansion and PE-exemption system amendment are all part of regulatory reform to improve patient’s access to new drug. We fully understand the government’s contemplation on soaring medical expense. However, considering on how ‘Korea Passing’ phenomenon was a prevalent issue throughout the pharmaceutical industry, decision on new drug reimbursement has reached a difficult point in time as it has to take account of other countries as well. We have a great anticipation on the government’s decision to expand scope of RSA as it was their solution balancing between stable National Health Insurance (NHI) finance and patient’s access to new drug. And also it could be a starting point of regulatory reform to adopt fast-track listing. Although the government has not unveiled any specifics, yet, the organization plans to cooperate with the government to deliver the complete effect of regulatory change to the patients. -Last year, the government presented a research outcome on new drug review period. What do you suggest is needed to enhance the review system? The last year’s research holds a significant meaning to it as it investigated, for the first time in Korea, the actual time taken for new drugs to be reviewed and approved in Korea.” The average time taken for review and approval on 115 investigational new drugs in Korea was approximately 300 days, similar to that in other advanced countries. Unlike other countries with already set predictability of the review system, however, Korea’s approval period showed large gaps between different items and in different years. Predictability is a crucial factor for a business, therefore, the government should consider including additional supplementary material submission period as part of the review processing period to raise regulatory predictability like the other countries. And for rare disease treatment with urgent and highly unmet medical need, the government should activate preferential review system, differentiated from general approval procedure and implement practical policies for better effectiveness. - Regarding regulations, in which part does KRPIA try to improve or recommend? To enhance Korea’s medical and bio companies’ capacity and support their global market expansion, KRPIA has been operating ‘Global Pharmaceutical Company-Startup Co-incubating Platform’ with KOTRA since March 2018, targeting about 100 medical and bio startups. And in 2019, we have organized ‘Global Open Innovation Korea’ with KOTRA, Ministry of SMEs and Startups and Korea Institute of Startups & Entrepreneurship Development (KISED) as an effort to meet the government’s biohealth industry fostering policy. We highly appreciate the government's commitment designating the biohealth industry as one of top key emerging industries and also their aggressive investment on the industry. Nevertheless, it is unfortunate to see multiple government bodies executing different biohealth industry fostering policies resulting in overlapped actions and inefficient communication in between the policies. Based on other cases in overseas, the massive scale of government’s investment, determined to assertively support the bio industry, is as important, but also we believe focusing investment efficiently among various government policies would bring a success to the policy. As Korea already has an outstanding infrastructure in basic science, life science and clinical study for development of biohealth industry, it would be wise to fine tune policies between government bodies to maximize the investment effect. –How about a word of determination and ambition for the New Year’s? For the year 2020, KRPIA plans to provide even more concrete basis for new drug to strengthen ‘patient-centered healthcare policy’, and to raise awareness of social value in new drug. Also, the organization would engage with government and healthcare sector interest groups better to improve existing policies. And we would endeavor to grow deeper mutual relationship between Korean and global pharmaceutical companies in various fields like technology co-development and overseas market co-marketing. Last but not least, the organization would fully support Korea to become a pharmaceutical powerhouse by hosting more clinical trials and increasing R&D investment. We hope the pharmaceutical industry could bring better health to the people and result in fruitful outcome to contribute improving the people’s happiness.
- Policy
- Choline alfoscerates, 82 generics were approved last year
- by Lee, Tak-Sun Jan 10, 2020 06:26am
- The most representative of choline alfosceratesDespite the controversy over last year's efficacy, choline alfoscerate formulations were found to have received 82 new licenses last year. Only 267 cumulative licensed items are available. On the 9th of last year, an investigation into the approved items of the same ingredient was conducted through MFDS' website. The choline alfoscerate formulation was found to have a validity issue during a national audit last October. In response, the Ministry of Health and Welfare announced plans to conduct a pay reevaluation by June this year, and the MFDS began validating in November. The industry believes that choline alfoscerate's reimbursement restrictions are strong. Nevertheless, pharmaceutical companies considered the high marketability of the formulation and continued to produce the product. Choline alfoscerate formulations form a large market with insurance claims amounting to about ₩300 billion. Irrespective of the size of hospitals and majors, the elderly are indiscriminately prescribed for the prevention of dementia. It is a perfect market for domestic pharmaceutical companies that do generic sales in the parliamentary market. In addition, consignment items poured out last year as new formulations such as liquid In hard capsules and syrups, which can be bottled, were released. Choline alfoscerate formulations, despite no original patent expiration issues last year, recorded a number of licensed items following Pregabalin (93) and Oseltamivir (87). Major generic drug licenses in 2019 Pregabalin and Oseltamivir formulations have recently expired. However, Pregabalin has three doses, and Oseltamivir is difficult to make an indirect comparison in that there are three capsule dosage forms and a suspension formulation. The MFDS is currently validating Choline alfoscerate preparations, but it is difficult to draw conclusions. Since it has already been validated through the 2018 update, it is difficult to conduct clinical reevaluation due to lack of literature data. However, the industry reports that reimbursement revaluation may result in reimbursement restrictions in order to reduce consumption.
- Company
- The controversy of Eliquis' fluctuating price
- by Jung, Hye-Jin Jan 10, 2020 06:25am
- The price of Eliquis, an anticoagulant drug, Apixaban, has fluctuated several times. Wholesalers and pharmacies dealing with dispensing and distribution are also confused. In particular, as the most recent provisional disposal application that Korea BMS applied for was accepted earlier than expected, some pharmacies and wholesalers had to pay the difference, but Korea BMS showed a negative attitude toward settlement. Initially, the Ministry of Health and Welfare announced that as of January 1 this year, the Eliquis insurance price, which is ₩1185, will be reduced to ₩830 , a 30% reduction. Accordingly, Korea BMS has proceeded with the original lawsuit to prevent the price cut, and has defended the price cut right now by applying for suspension of execution. The BMS filed an application for disposition shortly after the suspension of drug price reduction was lifted after the first trial decision by the Ministry of Health and Welfare. As the court accepted it, the drug price, which was lowered on January 1, recovered to ₩1185 from two days later. The problem is that the provisional decision was unexpectedly fast and was shipped at a reduced price on the first two days of January. There was no time for wholesalers and pharmacies to cope. January 1 2020 was a public holiday, but during the two-day weekday, wholesalers and pharmacies nationwide charged Eliquis at ₩830. Even though pharmaceutical companies need to settle balances on shipments made during the day, Korea BMS has been controversial, stating that it will only settle for prescription quantities. Personal information such as the patient's prescription is required to check the quantity of the prescription. But, wholesalers or pharmacies cannot provide the personal information to pharmaceutical companies under the Personal Information Protection Act. A wholesaler said, “As the result of the application for disposable treatment on the afternoon of January 3, we had a hard time reprocessing all the shipments that were shipped on the morning of the day at the original medicine price, and if a drug company wants to settle the balance only for the prescription of a hospital, it is like evading settlement”. The official pointed out that BMS is the first Korean pharmaceutical company to announce such a settlement method. A BMS official explained, “The company anticipates the problems that may arise as the price of medicines has been reduced, and has countermeasures, and will confirm the specific details and answer”.
- Policy
- 23 new drugs approved last year with no Korean-made
- by Lee, Tak-Sun Jan 10, 2020 06:25am
- Apparently, total 23 investigational new drugs have been approved in Korea last year. Compared to 2018, the number was increased by 14 but not one of them was made in Korea. Moreover, two incrementally modified drugs (IMDs) and three biosimilars have been cleared. According to Ministry of Food and Drug Safety (MFDS)’s pharmaceutical information website on Jan. 8, updated information of newly approved investigational drugs in 2019 found that total 23 drugs have been passed by MFDS last year. All of them were developed outside of Korea. Korean pharmaceutical companies JW Pharmaceutical, Jeil Pharm and SK Chemicals had their Hemlibra subcutaneous injection, Lonsurf tablet and Ongentis capsule approved, respectively, but all of them were developed from abroad. K-CAB tablet (tegoprazan, CJ Health Care), approved on July 5, 2018, is still the latest Korean-made new drug. 2019 new drugs Out of all drugs approved last year, five were biological drugs and 17 were synthetic drugs. MFDS has approved two IMDs last year, including; an amlodipine besylate-chlorthalidone-telmisartan triple combination drug, True Set tablet (Yuhan), and eight items of multiple combination drugs with pitavastatin calcium and fenobirate. Besides, three biosimilars—Samsung Bioepis’ Etolce 50 mg prefilled syringe (etanercept), Daewon Pharmaceutical’s Terosa cartridge injection and Pangen’s Panpotin prefilled syringe injection—were approved last year as well. Meanwhile, total 4,793 finished pharmaceutical products (661 OTC, 4,132 prescription drugs) have been approved last year. Compared to 2,056 products approved in 2018, year 2019 had significantly more finished products cleared. The surge in approved finished products could have been because of surge in number of CMO-manufactured generics with cosigned bioequivalence test. 4,207 generics have been cleared in 2019, which the number doubled from 1,754 in 2018. Sources analyze it was because many of the generics have applied for approval in a hurry before the cosigned bioequivalence test limiting policy came into effect.
- Policy
- Ibrutinib's Asian Standard Therapy Strategy Revealed
- by Lee, Jeong-Hwan Jan 10, 2020 06:24am
- A domestic study shows that allogeneic hematopoietic stem cell transplantation is the ultimate treatment strategy for patients who do not have treatment effect after 3 months after taking Imbruvica (Ibrutinib/Janssen), a kind of hematologic cancer. The researchers also found that the initial prognostic factors of mantle cell lymphoma and the failure to treat early Ibrutinib were a poor risk factor for refractory and recurrent mantle lymphoma. The Korean researchers have suggested a standardized treatment strategy for applying target anticancer drugs in mantle cell lymphoma disease. On the 8th, the research team of Professor Seok-gu Cho and Young-woo Jeon of the Lymphoma Center, Yeouido St. Mary's Hospital, Catholic University, Korea, released the findings. The new drug Ibrutinib is an oral capsule and is a special anticancer drug that kills only cancer cells. It is effective in some patients with lymphoma and attracts attention as a new treatment. Therapeutic research has been difficult for 'relapsed and non-refractory mantle cell lymphoma', which accounts for 6% of non-Hodgkin's lymphoma patients. In particular, the price of new drugs, such as Imbrica, was so expensive that accessibility to patients was low. This is why it is meaningful that a team of professors Seok-gu Cho and Young-woo Jeon at the Yeouido St. Mary's Hospital Lymphoma Center of Catholic University apply a single treatment at a single institution and analyze the Ibrutinib treatment response in the same patient. For four years (2013-2018), the researchers collected patient groups from the Lymphoma-myeloma center of the Seoul St. Mary's Hospital, and the Lymphoma Center of the Yeouido St. Mary's Hospital. Thirty-three patients who were prescribed Ibrutinib for recurrence of disease during the use of R-CHOP, a representative primary treatment, after the diagnosis of mantle cell lymphoma. The team analyzed the effects of Ibrutinib treatment and predictive outcomes. The disease-free survival of patients with refractory and recurrent mantle lymphoma with Ibrutinib was about 35 months, longer than the control group, 12 months. Based on the response for 3 months after taking Ibrutinib, the disease-free survival rate was also classified into ▲ early treatment response group and early treatment failure group. The disease-free survival rate was 82% in the early treatment responders with complete or partial remission and 18% in the early failure groups. The early treatment response group was found to maintain long-term survival while maintaining remission, but the early treatment failure group died within six months. The team found a risk factor that predicted a poor prognosis for patients with refractory and recurrent mantle cell lymphoma. ▲The initial prognostic factors of mantle cell lymphoma at first visit were poor, or ▲The initial treatment failed after taking Ibrutinib. It was also confirmed that allogeneic hematopoietic stem cell transplantation was the ultimate treatment for patients who had no therapeutic effect on Iburitinib. Professor Seok-gu Cho (corresponding author) said, "Cortic cell lymphoma is a disease with a very low incidence and a poor recurrence, and the new drug-targeted anticancer drug study is meaningful to patients who relapse during treatment with established and consistent treatments". Professor Cho added, "It also means that the analysis of prognostic factors and prognostic factors for the new drug-targeted anticancer drug is the initial analysis data published for Asians". Professor Jeon Young-woo, the first author, said, “New drug Ibrutinib is not a perfect treatment. Rapidity is most important in treating lymphoma when deciding and switching treatment, and the prognosis is extremely poor. A strategy to improve survival by allogeneic hematopoietic stem cell transplantation is important, and the study was published in the September 2019 issue of Cancer Medicin (IF = 3.35)”.
- Company
- Valsartan's third payment deadline has expired
- by Chon, Seung-Hyun Jan 10, 2020 06:24am
- The third payment deadline for the Valsartan damages claim urged by health authorities has ended. Most of the companies that did not pay the compensation were refused to pay. The health authorities say they will continue to incentivize payments, but a lawsuit filed by pharmaceutical companies will conclude the legitimacy of government action. According to the industry on the 7th, the third payment deadline for the Valsartan indemnity claims by the National Health Insurance service has expired on December 31 last year. In October last year, the NHIS asked for 69 drug companies to pay ₩2030 million in compensation. It is a follow-up in accordance with the Ministry of Health and Welfare's decision to return the amount of money invested in pharmacies since the outbreak of the impurity Valsartan issue in 2018 for the remainder of the prescription. The NHIS sent the first reminder to the pharmaceutical companies that did not pay the compensation, by last October 31. Again, due to low payment rates, the NHIS sent a second reminder last December. In order to increase the collection rate, three payment deadlines were given. However, most companies that did not pay the initial deadline were reportedly refused to pay. According to data submitted to the Democratic Party's lawmakers by In-soon Nam last November, 26 pharmaceutical companies paid ₩440 million in compensation. The payment rate was only 21.5%. Pharmaceutical companies refused to pay about 80% of the proceeds. The company has already entered a lawsuit with the NHIS, especially those with large amounts of compensation. Pharmaceutical companies filed a lawsuit to confirm the absence of debt against the National Health Insurance Service on November 27 of last year. It preemptively filed a lawsuit stating that it was not responsible for Valsartan damages claimed by the NHIS. Companies involved in litigation include JW PHARMACEUTICAL CORPORATION , JW SHINYAK CORPORATION, SK Chemicals, Khunil Pharmaceutical, Kwang Dong Pharmaceutical , Guju Pharmaceutical, Kukje Pharmaceutical, Nexpharm Korea, Dasan Pharmaceutical, Daewoo Pharmaceutical, Daewon Pharmaceutical, DAE HWA Pharmaceutical Co., Ltd., DongKoo Bio Pharmaceutical, Mother's Pharmaceutical, MyungMoon Pharm. Co., Ltd., BINEX.CO.LTD, Samik Pharmaceutical Co., Ltd., SAMIL PHARMACEUTICAL CO.,LTD , CMG Pharm, Ajou Pharm, Unimed Pharm, Inist Bio Pharm, Eden Pharma, Reyon Pharm, Chong Kun Dang, Jinyang Pharm, Terragen Etex, Hana Pharm, Korea Kolmar, Hutecs, Hanlim Pharmaceuticals, Hanwha Pharmaceuticals, Whanin Pharmaceuticals, Huons, Huons Medicare, etc. Most companies with large amounts of compensation were involved in litigation. LG Chemical did not participate in the lawsuit among six companies, including Daewon Pharm, Hutecs, LG Chemical, Hanlim Pharm, JW SHINYAK CORPORATION, and Korea Kolmar. Pharmaceutical companies are claiming that they are not responsible for Valsartan claims 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 in the Valsartan raw material that has no standard. Neither governments nor pharmaceutical companies were aware of the risk of NDMA detection in Valsartan. According to the Product Liability Act, it is clear that if the manufacturer proves that a defect was not found at the level of science and technology at the time the manufacturer supplied the product, it would be liable for damages.
- Company
- PPC signs co-marketing partnership with Biosuntek
- by Eo, Yun-Ho Jan 10, 2020 06:23am
- From left; CEO Kim Sanghee, CEO Michael Stibilj, President Cho Joon-sang and Senior Director Suh Young-hwan PPC Korea and Biosuntek Laboratory (“Biosuntek”) have agreed to co-market pharmaceutical clinical development. PPC Korea, a contract research organization (CRO) providing service in Asian region, has invested in a bioequivalence test analyst institute, Biosuntek Laboratory and signed a strategic partnership agreement on Jan. 8. The signing event had PPC Group CEO Michael Stibilj, PPC Korea CEO Kim Sanghee, President of Biosuntek Cho Joon-sang and many other related company personnel. With the partnership agreement, Biosuntek and PPC Korea would offer one-stop service covering early clinical development to last phase clinical trial by respectively providing bioequivalence test analysis and early clinical trial services and post-clinical trial service. Together, two companies are now able to provide services ranging from project management, regulatory affairs, clinical monitoring, data management, biostatistics, medical writing, pharmacovigilance, and also bioequivalence study based on pharmacokinetic analysis and protein analysis. Established in 2010, PPC Korea is PPC Group’s offshoot in Korea and it has been a leading CRO conducting clinical trials not only for synthetic drug, but also for innovative investigation medicine like cell therapy, biosimilars and anticancer treatments for global and Korean companies. The parent company, PPC Group has conducted over 600 clinical trials for investigation drugs and over 2,000 bioequivalence studies in Korea, China and Taiwan since 1997. In China and Taiwan, the company owns four clinical pharmacology units to conduct Phase I study, three bioanalytical labs and a central lab. In 2019, the company was listed as APAC Top 10 CROs by Pharma Tech Outlook with its leading position in Asian CRO market. Founded in 2008, Biosuntek has been offering services, such as analytic methodology development, analytic validation and sample analysis, biosimilars and proteins including antibody protein analysis, bioequivalence test, PK, DDI and related clinical trial. And as of 2019, the laboratory has been an industry leader with over 200 ingredient analytic methodologies. PPC Korea CEO Kim Sanghee stated, “We are very pleased to now provide more valuable service to clients by investing on an outstanding analytic laboratory, Biosuntek, and agreeing on strategic partnership and co-marketed clinical study.” President of Biosuntek Cho Joon-sang commented, “As PPC Korea became a shareholder of Biosuntek, we have constructed a strong foundation to offer global-level one-stop new drug development solution based on the optimal synergy created from two companies’ technology and capacity.”
- Company
- Big Pharmas butting heads over Faslodex combination
- by Eo, Yun-Ho Jan 09, 2020 09:06am
- Three investigational drugs are busy preparing for applying reimbursement on a combination therapy with Faslodex. The competing three investigational drugs are cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor treatment—Pfzier’s Ibrance (palbociclib), Lilly’s Verzenio (abemaciclib), and Novartis’ Kisqali (ribociclib). The three global pharmaceutical companies are expected to intensely compete against each other over reimbursement on an indication of second-line combination therapy with AstraZeneca’s Faslodex (fulvestrant) to treat patients with hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2) breast cancers. According to industry sources, Ibrance and Verzenio have simultaneously entered a negotiation with Risk Sharing Agreement Subcommittee in the end of last year, and Kisqali, approved for marketing in Korea the last in November, would be deliberated by Cancer Disease Deliberation Committee soon. The close race may continue with only Ibrance and Verzenio starting a Drug Reimbursement Evaluation Committee (DREC) deliberation first, or all three of them undergoing reimbursement feasibility review at the same time. Nevertheless, the three drugs have different circumstances. Ibrance, as first-line therapy (combination with letrozole), has already been listed for reimbursement through refund type risk sharing agreement, but it is now applying for reimbursement on the additional indication. Ibrance had applied for reimbursement on the expanded indication several times before, but the talks fell through as Faslodex as a monotherapy was not listed for reimbursement at the time. Meanwhile, Verzenio was approved for the Korean market in May, when monotherapy Faslodex was listed for reimbursement, and applied for reimbursement immediately. So far, the drug could take the RSA procedure as no other drug has received reimbursement for a combination therapy with Faslodex, yet. As for Kisqali, speed would unlock the door to the final race. Regardless of the Cancer Disease Deliberation Committee passing the drug in January, Kisqali can be deliberated by DREC only after getting passed by Pharmacoeconomic Evaluation Subcommittee and RSA Subcommittee.
- Policy
- Exclusive rights such as Betmiga and Olosta expire
- by Lee, Tak-Sun Jan 09, 2020 06:43am
- In 2020, the generics market is likely to be generally calm, with a small number of large-scale items whose exclusive rights expire. Nevertheless,the exclusive right of blockbuster products like hypersensitivity bladder treatment ‘Betmiga’ (Mirabegron/Astellas), hypertension-hyperlipidemia treatment ‘Duowell’(Telmisartan, Rosuvastatin/Yuhan), anti-smoking ‘Champix’(Varenicline/Pfizer) is scheduled to expire, and fierce competition for the generic market is expected. On the 6th, after expiration of PMS and patent expiration items, a number of original items such as Duowell and Champix were captured. Generic drugs cannot be released until the original drug expires and the reexamination expires. Moreover, because there are many kinds of patents like substances, uses, and compositions, just because one patent is terminated doesn't mean you can make generic drugs. 'Duowell', a hypertension-hyperlipidemic drug, is not listed on the MFDS patent list. Generic applications can be applied after the re-examination expiration date which is October 30th. However, it is not attractive to the first generics because more than 10 drugs similar to Duowell have already been approved for sale as data submission drugs. Among the items whose PMS has expired, the substance patent of the anti-smoking drug 'Champix' expires in July. Dozens of companies have already obtained approval through salt-modified drugs, and have sold them for a limited time. But last month, the Patent Court raised the hands of the original drug, which prevented the sale of salt-modified drugs. However, sales will be possible after July. Although there is a follow-up patent, domestic pharmaceutical companies have already succeeded in avoiding patents. On May 3, the overactive bladder drug 'Betmiga' will expire. Although there is a follow-up patent like Champix, domestic pharmaceutical companies have been incapacitated through aggressive patent challenge, which is likely to release generic drugs within the year. The anti-depressant drug 'Pristiq' (Desvenlafaxine/Pfizer) is also likely to release generics this year. Pristiq's expiration date on February 5 has raised the possibility of early launch, with five domestic pharmaceuticals successfully evading patents last year. In addition, the patents on birth control pills 'Yaz', 'Yasmine' (Drospirenone/Ethinyl estradiol/Bayer) and Parkinson's treatment drug 'Stalevo'( Levodopa/Carbidopa/Entacapone) are completely expired. However, Stalevo has been selling products since 2015, with three companies including Jeil Pharmaceutical Co., Ltd, Myung In Pharmaceutical Co., Ltd., and Ilhwa gaining generic exclusivity permission through patent challenge. In addition, the hypertension-hyperlipidemia treatment drug 'Olostar' (Rosuvastatin Olmesatanmedoxomil/Daewoong Pharm. Co., Ltd) will be released this year based on the patent challenge of latecomers.
