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- 2026-04-17 15:11:30
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- 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.
- Policy
- The MSI invests ₩420 billion to bio-based technologies
- by Lee, Jeong-Hwan Jan 09, 2020 06:42am
- The government will invest ₩420 billion to foster bio as a next-generation growth industry and invests ₩61.4 billion in finding and verifying new drugs. The budget increased by 10.1% compared to the previous year for the development of bio-based technologies. New drugs, medical devices, brain research, and bio-big data are the areas of intensive investment. On the 7th, the Ministry of Science and ICT said, "It will finalize the implementation plan of the original technology development project in the bio sector in 2020". The bio-innovation strategy established by the governmental department last year influenced the movement of the Ministry of Science and ICT. In particular, this year, we will strengthen our support to secure global technological competitiveness in bio-related core fields such as new drugs, medical devices, and brain research, while actively investing in future bio-convergence technologies such as biobig data, artificial intelligence drug development, and 3D biotissue chips. In accordance with the confirmed implementation plan, on the 8th, the government will announce new tasks in key areas such as new drugs and stem cells and start supporting them in earnest. The government selected the biohealth sector as one of the three new industries last year. Ministry of Science and ICT is fostering biotechnology by establishing an innovative strategy for the biohealth industry, and it is pointed out that SK Biopharm's epilepsy treatments are approved for marketing by the US Food and Drug Administration (FDA). First, the government plans to expand R&D investments to secure global technological competitiveness in biomedical core fields such as new drugs, medical devices, and precision medicine. In order to continue the performance of the new drug field, the government will invest ₩61.4 billion to secure new drug technologies, including new businesses to discover and verify new drug targets. In addition, AI and big data, which are the core engines of the Fourth Industrial Revolution, are expected to be used in the bio sector to transform the medical paradigm, thus supporting the convergence technology. Starting this year, the government plans to build a new 20,000 people scaled bio-data collection and utilization system for research with the relevant ministries (the Ministry of Science and ICT, the Ministry of Health and Welfare, Ministry of Trade and Industry). In addition, the government will continue to invest in the development of new drug technologies using artificial intelligence to drastically reduce the cost and time required for new drug development. New investments will also be made this year in building a next-generation drug evaluation platform. It also invests in the development of treatment technology to overcome diseases directly related to national health, such as dementia caused by aging and infectious diseases that are regularly problematic. From this year, the Ministry of Health and Welfare & the Ministry of Science and ICT will jointly support the cause of dementia, develop the pathogenesis, predict and diagnose early diagnosis, prevent and treat the development of treatment technology, and will also invest in the development and diagnosis of key brain diseases such as brain development disorders, emotional disorders such as depression, and damage to the nervous system. In order to strengthen its ability to respond to infectious diseases, it will invest ₩24.4 billion in developing technologies for preventing and treating infectious diseases, including developing new and emerging virus response technologies. Seo-gon Ko, a director of basic source research policy, said “Biofield is a technology-based industry, and securing core technology leads to the preoccupation of the market, there are also characteristics that new market is developed based on convergence technology, and the government will actively support the development of future medical technologies by combining R&D , artificial intelligence, and big data with bio to preoccupy the global core market”.
- Policy
- ATP-based reduction on immunosuppressant Certican
- by Kim, Jung-Ju Jan 09, 2020 06:24am
- Price of Novartis’ immunosuppressant Certican (everolimus), still in prolonged pricing reduction cancellation litigation with the government, would be reduced based on actual transaction price (ATP) survey result. The pricing reduction on Certican would be enforced after the ongoing litigation reaches its final decision as it still has administrative suspension order in effect. According to pharmaceutical industry sources on Jan. 6, Korea's Ministry of Health and Welfare (MOHW) is planning to announce amended Pharmaceutical Reimbursement Listing and Maximum Reimbursed Price on Jan. 9. The ATP-based pricing reduction refers to the government lowering price of drugs by a rate within ten percent of weighted average value calculated according to the recently surveyed ATP. Previously, the government has decided to alter Certican's pricing as Chong Geun Dang Pharmaceutical exclusively launched a generic, Certirobel, with Preferential Sales Approval. Accordingly, MOHW authorized pricing reduction of Certican in four different doses, based on the principle automatically lowering price of the original when a first generic is listed. Opposing on the government's decision, Novartis filed an administrative litigation and requested suspension of pricing reduction enforcement, which the court accepted and sustained the original pricing. The suspension request has been accepted on Mar. 15, May 31 and June 28 last year for three times, and currently the court's decision to suspend the pricing reduction until 30 days after the final decision on the appeal has been maintained. Certican's pricing has been kept unchanged with the repeated suspension order, but the government has to adjust the original maximum reimbursed price before with the ATP survey result. However, if the pricing reduction is enforced as planned, before the court’s order of suspension, the ATP-based pricing reduction would not be necessary as the first reduction rate is steeper than the ATP-based reduction rate. The government was first planning to lower the drug pricing down to 1,592 won for 0.25 mg, 2,546 won for 0.5 mg, 3,180 won for 0.75 mg and 3,714 won for 1.0 mg.
- Policy
- Reevaluation to first review underperforming drug
- by Kim, Jung-Ju Jan 08, 2020 06:19am
- The government reaffirmed the listed drug reevaluation subject would prioritize drugs with clinical efficacy underperforming than initially expected. Gradually conducted on all subjected drugs, actions following up the reevaluation, such as pricing reduction or reimbursed indication revocation or reduction on drug not reaching expected efficacy agreed on during listed pricing negotiation, would be decided after the result is out. On Jan. 7, Korea’s Ministry of Health and Welfare (MOHW) announced listed drug reevaluation principles, as a part of the National Health Insurance (NHI) Comprehensive Plan, and briefed current status of severe disease treatment-centered insurance coverage enhancement. First, the ministry plans to differentiate reevaluation type and conduct in phases to accommodate diverse properties of various drugs. The drug properties would mean new drug or drug with underperforming efficacy listed for NHI reimbursement through selective reimbursement, high-cost and severe disease treatment, conditional approval or pharmacoeconomic evaluation (PE) exemption tracks. MOHW explained, “The reevaluation would first review drugs not demonstrating expected level of clinical efficacy, while detailed evaluation procedure, criteria and schedule would be open as much as possible to keep them transparent.” And noting on the public’s concern about the objective of the reevaluation, the ministry official stressed “Follow-up actions like resetting reimbursement criteria and pricing, maintaining reimbursement and others would be decided depending on the evaluation outcome. So it does not mean definite revocation of reimbursement.” The official elaborated that each item has a number of indications and actual effectiveness in the field, patient demand and necessity could be different and affect the decision accordingly. The official also added the NHI coverage has been expanded since the announcement of NHI Coverage Enhancement Policy, centering anticancer and rare disease treatment. Total 421 items, including anticancer and rare disease treatments, were listed within a year from the government’s announcement in July 2018 to July last year. For an instance, Biogen’s spinal muscular atrophy (SMA) treatment Spinraza was originally priced at 92.35 million won per vial (5 ml), but the patient copayment went down significantly as it was listed for reimbursement in April last year. According to the government, the treatment is an expensive drug costing a patient approximately 300 million won to 600 million won annually. But NHI reimbursement was granted and copayment ceiling system was applied, which dropped patient copayment to around 5.8 million won a year. The government also cleared reimbursement for Sanofi-Aventis’ novel treatment for severe atopic dermatitis, ‘Dupixent Prefilled Syringe 300 mg’, and brought down copayment to around 5.8 million won like Spinraza. The patient copayment was decreased steeply as it was a first drug to sign newly expanded risk sharing agreement and was applied with copayment ceiling system. When it was still non-reimbursed, a patient had to pay 26 million won annually per patient. MOHW explained, “The NHI coverage would expand but selectively based on feasibility of NHI reimbursement depending on the improvement in clinical efficacy, reimbursement criteria and basic principle of moderate pricing evaluation. Focusing on severe disease treatments with high social demand, the government would continue to expand insurance coverage.”
- Company
- Near miss, tension in the Middle East
- by Kim, Jin-Gu Jan 08, 2020 06:18am
- Amid rising military tensions between the United States and Iran, there is also concern about bad influence on trade between Korea and Iran. In the case of drugs, exports have already been blocked since last year. There is also concern that the resumption of exports will be postponed indefinitely. According to the Korea Customs Service's import and export statistics on the 7th, pharmaceutical products exported from Korea to Iran for the past five years (January 2015-November 2019) totaled $90 million. The annual average is $18 million. Earnings are $20,000 over five years, virtually zero. Compared to Korea's total exports of pharmaceuticals ($ 36.24 million, provisional in 2019), the proportion is small at 0.5%. Imports and Exports of Pharmaceuticals to Iran by Year, Data: Korea Customs Service Exports to Iran steadily increased to $ 13.78 million in 2015, $ 17.9 million in 2016, $ 22.89 million in 2017, and $ 24.5 million in 2018, but dropped sharply to $ 10.95 million last year. Considering that last year's statistics are up to November, a significant decrease is observed. The sharp drop in exports last year was due to US sanctions against Iran. The United States has sanctioned trade with Iran since 2010. However, medicines were classified as 'humanitarian trade items' and recognized as an exception. In 2018, pharmaceutical exports were at an all-time high as sanctions eased. But in last May, the United States raised sanctions. At the same time, it refused to recognize even humanitarian trade items. In fact, the export of medicines to Iran has been blocked. Last October, the International Court of Justice decided that "sanctions could not be imposed on humanitarian trade," but the US still does not follow. Korea is in the same situation. In this situation, the military tension between the United States and Iran is at its peak, and the resumption of humanitarian trade is indefinitely postponed. If the situation prolongs, the pharmaceutical industry will inevitably lose ₩21 billion annually. .A pharmaceutical industry official said, “In recent years, more and more pharmaceutical companies have entered or are advancing into the Middle East .However, the situation has raised concerns not only in Iran but also in the Middle East”.
- Policy
- Generic pricing should be at original’s 40%-45%
- by Lee, Hye-Kyung Jan 08, 2020 06:17am
- The national insurer’s research result claims the volume of generic would increase up to 73 percent to 82 percent if the use of generic is promoted, if the present lump-sum generic pricing reduction is brought down to 40 percent or 45 percent of the original price before patent expiration. Currently, the lump-sum pricing reduction drops generic pricing to 53.55 percent of the initial pricing of the original. To improve pharmaceutical supply structure, the research report recommended three-step enforcement of distribution and new drug-related strategic policies, including; generic pricing reduction policy, generic use promotional policy and pharmaceutical distribution system improving policy. Korea’s National Health Insurance Service (NHIS) recently published a final report of a year-long cosigned study of improving drug supply and purchase program on All Public Information In-One (ALIO) conducted with Sungkyunkwan University’s academic-industry cooperation research team (Principal researcher: Professor Lee Sang-Won of Pharmaceutical Technology & Business Management Department at School of Pharmacy). Also known as ‘Pharmaceutical Product Life-cycle Research Report,’ the study was directly ordered by President Kim Yong-ik of NHIS, who spent 250 million won on the massive research project. According to the report on Jan. 6, the research team has laid down regulatory policy recommendations in categories of pharmaceutical supply structure, generic supply structure, pharmaceutical distribution structure, and Korean-made new drug supply structure. ◆ Pharmaceutical supply structure: The university research team suggested reforming pharmaceutical supply structure to secure financial health of National Health Insurance (NHI), to supply good quality drugs and to expand Korean generic items’ market share. To achieve the goal, the report recommended seven objectives in three categories; improving generic supply structure (generic quality standard strengthening policy, off-patent drug pricing reduction policy, generic use promoting incentive policy); distribution structure (distribution company competitiveness enhancing policy, fair trade order reinforcing policy); and new drug supply structure (corporate R&D investment expanding policy, technology commercialization supporting policies). The team predicted the seven objectives could be implemented in three steps. Starting from generic quality standard enhancing policy, Step 2 off-patent drug pricing reduction policy and generic use incentive policy and Step 3 distribution structure and new drug supply structure shifting policies should follow, the researchers claimed. The Step 1 objective, generic quality standard enhancing policy, was prioritized as it affects the three policy goals overall, which are ‘NHI financial health,’ ‘outstanding drug supply’ and ‘self-sustained medical technology.’ Policies targeting distribution and new drug supply have been assigned under Step 3 objective, because their importance level was apparently lower than that of generic policies. The researchers commented, “The importance of generic quality standard enhancing policy and generic drug pricing reduction policy are very high and they require intricate plan of action. Also they need to consider each interest group’s stance.” ◆ Generic supply structure: The research team stated the present volume of generic use in Korea (61.8 percent as of 2017) should meet the average level of OECD member countries (over 70 percent) to leverage generic supply structure and industry. To realize the goal, bringing down the generic pricing is essential. The report calculated the ratio of generic use in overall drug volume could be raised up to 73 percent to 82 percent, assuming generic use would soar when the price is dropped to 40 percent to 45 percent of the original’s initial price. Previously, the researchers mentioned of three policies—generic quality standard enhancing policy, off-patent drug pricing reduction policy and generic use incentive policy—to achieve the aim to reform pharmaceutical supply structure. The policy objectives of reforming generic supply structure is to lower pricing to the level of competitive market and increasing volume on par with advanced countries, while enhancing the quality of generic items. More detailed objectives of enhancing generic quality includes tightening management standard change after approving and conducting stringent Good Manufacturing Practice (GMP) due diligence. As for the mechanism of drug pricing reduction, the report recommended reforming actual transaction price (ATP)-based drug pricing reduction and lowering drug price on the level of competitive market. For the ATP-based pricing reduction, the study argued the existing system of calculating reduction rate by each item should be changed to calculate by same class medicine. The report elaborated the change would reduce not only a specific item’s pricing, but affect all items in a same class, which would enable supply of low-priced drugs. Then sales of a company with capacity to supply mass amount of low-priced products would surge and eventually push up the efficiency of NHI expenditure management, the researchers added. Moreover, the report said the equal drug pricing system should be abolished and should rather differentiate pricings of generic and original, bringing down the generic pricing from the current level of 53.55 percent of the original pricing to 40 percent to 45 percent level. Basically, the generic pricing would not reach the level of off-patent original pricing. The report added another recommendation to constantly monitor pricing of off-patent drug market and regulate pricing reduction on generic listed for a long time or with pricing unchanged despite multiple listed generics. After enhancing generic’s quality and lowering pricing, incentive policy is recommended to promote further active use of generic. Increasing demand for low-priced drug in the market would ultimately expand volume of generic use and promote price competition. To increase the demand for low-priced drug, the report proposed the following; providing incentive for using more generic to doctor and pharmacist; reforming payment system to adopt capitation; prescription budget cap; or diagnosis related group payment; and lowering patient copayment or providing incentive point. On the other hand, the report also proposed increasing generic use by the purchasing power of the insurer, NHIS. Apparently, the insurer could select and announce a generic item capable of supplying low-priced product among multiple generic items in equivalent class, or set and mandate alternative prescription goal for pharmacist on preferred generic item. ◆ Pharmaceutical distribution structure: The researchers claimed the currently convoluted distribution models should be better sorted out. Depending on a distributor’s business management and scale, the type of distributors should be divided into ‘Total Distributor (owning a nationwide sale network and dealing logistics and commercial distributor),’ and ‘General Distributor (commercial sales),’ and ‘Contract Sales Organization (CSO).’ And the researchers argued idealistic image of Korean drug distributor should be set forth by establishing distributor evaluation index and designating an Innovative Distribution Company based on ‘Special Act on Fostering and Support Pharmaceutical Industry,’ 한국의약품유통협회 회원사 527개 대상 의약품 유통 현황 및 선진화 방안을 위한 설문조사 For the changes to be made, approval management and post-management should be reinforced through distributor license renewal and capital reappraisal, all the while government due diligence and statute reform should follow to prevent expedient direct wholesale, such as abusing authoritative position of healthcare institute. Besides, the report presented tasks to reform structure, regulation and environment of the pharmaceutical supply by adopting ‘Pharmaceutical Purchasing Card’ to set straight wholesale profit margin inflated with unreasonable distribution cost; forming ‘Supply Chain Council’ with pharmaceutical company and distributor’s representative to talk about minimum profit margin; enhancing logistics and minimizing return through improved minimum packaging unit and labeling; and requiring aggregation; fostering distribution and marketing specialists to advance distribution industry. ◆ Korean-made new drug supply structure: The research team stated the supply structure of new drug developed in Korea should be strengthened in both quality and quantity by inducing innovativeness of new drug, and by setting a reasonable supply volume goal based on global level productivity of new drug. Average 19 new drugs are launched annually these days, but only 1.9 items or ten percent of them are made in Korea. To expand supply of Korean-made new drug and improve its innovativeness, the researchers proposed reinforcing Innovative Pharmaceutical Company support system, changing new drug R&D policy, supporting open innovation and fostering development and commercialization capability.
- Company
- Tension on impurity diabetic drugs is for a month
- by Chon, Seung-Hyun Jan 08, 2020 06:17am
- The whole view of the MFDS It's been a month since concerns of impurity Metformin were triggered overseas, but there are still no clear conclusions. Expectations are raised in the pharmaceutical industry that there is no recovery country other than Singapore and that it can only be a surprise. However, there is still a lot of tension that if there is a recovery from the excess of impurities from overseas, there will be an instant spark in Korea. According to the industry on the 5th, no further follow-up measures have been taken at home and abroad for a month after some Metformin recovery measures have been taken in Singapore. Molecular structure of MetforminOn December 4, last year, the Singapore Health Sciences (HSA) surveyed 46 Metformin products sold locally and recovered three products. This is because NDMA above the daily allowance was detected. Shortly after Singapore's recovery, Metformin impurities were investigated in the US and Europe. The US Food and Drug Administration (FDA) has begun investigating the detection of NDMA in Metformin products in the United States. The European Medicines Agency (EMA) has also ordered companies to investigate Metformin's NDMA detection. Japan's Ministry of Health, Labor and Welfare also instructed manufacturers and distributors of Metformin-containing preparations to conduct risk analysis on NDMA incorporation of ingredients and drug products and report the results. A month has passed since then, but no conclusions have been made regarding the recovery of Metformin in countries other than Singapore. No follow-up has been made in Korea yet. This is not the same as the case of Valsartan and Ranitidine. The biggest difference is that both Valsartan and Ranitidine have been preempted in Europe and the United States. Valsartan immediately suspended the sale of products using the drug substance when recovery news came from Europe. Ranitidine began collecting inspections in the country after cases of discontinuation in the United States, and secondly suspended all products after announcing "no problem." In Korea, the MFDS has already submitted the usage data of Metformin preparations from pharmaceutical companies. Last month, the MFDS instructed pharmaceutical companies to submit the production history of the drug containing 'Methformin HCl' and the system for investigation of the active drug substance by the 17th. Pharmaceutical companies submitted the total number of drugs containing Metformin-containing products, items and number of production records, and items and number without production record to the MFDS. The Metformin lineage survey at the MFDS is a preliminary motion in preparation for the detection of impurities. If a problem occurs in a particular drug substance or drug product, the intention is to follow up quickly and accurately based on the results of the systematic investigation submitted by the pharmaceutical company. In the pharmaceutical industry, anxiety continues: "Is there a problem with the drug substance used in products recovered from Singapore?" The MFDS formalized its stance on the 16th to conduct an investigation into Metformin impurities. It is known to look into the NDMA detection potential in the Metformin’s chemical structure and manufacturing environment. The industry points out that there is no standardized Metformin NDMA test, which limits the self-inspection. As soon as possible this week, the MFDS will draw up a test method for detecting N-nitrosodimethylamine (NDMA) in Metformin and present it to pharmaceutical companies. Initially, the plan was planned to be completed by the end of last year, but the schedule was delayed. Given the NDMA test method of Metformin preparation, it is expected to be actively checked in Korea. The pharmaceutical industry is expecting a final conclusion on whether or not to detect NDMA after the preparation of the test method. The possibility of preferentially conducting a collection inspection on the drug substance used in products recovered in Singapore is raised. Metformin's drug product recovered from Singapore has never been imported into Korea. In Singapore, however, it was determined that the recovery of the test results for the drug product, not the drug substance. If Metformin preparations are collected in the US or Europe, the same raw materials or finished drugs can be promptly inspected in Korea. In reality, it is impossible to conduct a full survey on Metformin preparations in Korea. Metformin is the most widely prescribed diabetic drug used as a primary treatment for glycemic control in patients with type II diabetes. There are 642 Metformin-containing products in Korea. Virtually all pharmaceutical companies have Metformin. Metformin is overwhelmingly larger than Valsartan and Ranitidine. According to UBIST data of drug research institutes, the outpatient prescription market of Metformin-containing drugs in 2018 was estimated at ₩420 billion. Ranitidine, which had been suspended from selling all its products, formed a prescription scale of about ₩200 billion, which is more than double the market. The unit price of Metformin is less than ₩100. In terms of usage, it is overwhelmingly higher than Ranitidine. Pharmaceutical companies are already paying attention to domestic and international measures. In the face of massive losses in Valsartan and Ranitidine, there is a strong concern that Metformin can cause irreversible loss if fire breaks out. Some pharmaceuticals are struggling to minimize the damage, saying “NDMA has not been detected by our own tests,” even though the FDA's test method was not proposed. An official of the pharmaceutical company said, “There are no test methods yet, and there are not enough organizations to check, so we did not proceed with NDMA inspection of metformin, and plan to check quickly after the preparation of test method”.
