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- 2026-05-09 17:28:01
- Policy
- Unfair profit of orphan drugs will be readjusted
- by Lee, Jeong-Hwan Jan 23, 2020 06:15am
- The KOEDC (Korea Orphan & Essential Drug Center) took the first step toward improving the 'profit for difference' of urgently imported drugs, which had been disputed for over 20 years. The KOEDC will soon discuss the detailed procedures for drug price adjustments with the Ministry of Health and Welfare & the HIRA, for the purpose of permanently eliminating the profits from urgently imported drugs. In particular, The KOEDC are considering not only one-time drug price adjustment, but also regularizing the re-adjustment system every six months or one year. An official of the KOEDC said on the 20th, “We are currently selecting drugs that need to adjust the price due to the large difference in profits, and apply for collective price adjustment by next month after meeting with the Ministry of Welfare and the HIRA”. The problem of unfair profit of orphan drugs is regarded as chronic disease. If the KOEDC unveils the policy of price restructuring, the illegal disputed earnings will soon disappear. In last year's National Assembly audit, many members of the parliament have pointed out that the KOEDC spent about ₩6.5 billion on unfair profits for the past five years and spent it on institutional expenses. In response, Young-mi Yoon, the president of the KOEDC, embarked on a discussion on rebalancing of drug costs with the HIRA to fundamentally solve the problem of drug price gaps and delivered a plan to eliminate the proceeds. Proceeds will be generated when the center purchases insurance contracts of emergency drugs from abroad and imports them into Korea. For example, the profit generated when the center buy ₩10,000 abroad for a orphan drug with a domestic insurance price of ₩20,000 is ₩10,000. Indeed, the difference between the import price of a drug and the high insurance price is the profit, but there is a problem that the national budget and national tax, the cost of health and pharmaceutical drugs, are unnecessarily wasted. There are a total of 17 insurance-listed items in Korea. The KOEDC will select the item with the largest drug price difference, apply for the drug price adjustment to the Ministry of Health and Welfare and is to eliminate controversial proceeds. In detail, the center plans to complete the request for price re-adjustment next month after a selection of drug price-adjusted items reflecting the changes in the total price of drugs and the VAT for each item through the meeting with the HIRA related officials. Drug rebalancing is the process by which the KOEDC re-adjust urgent import drug prices that is out of the range. In addition, the center also planned to regularize the drug price adjustment system. It is a policy to enforce the price adjustment repeatedly for all of the urgent imported drugs handled every six months or one year. The center official said, "We will re-adjust drug prices sequentially from items with large difference in profits as discussed with the Ministry of Health and Welfare, and currently reorganizing the entire 17 listed urgent imported drugs, as well as planning regular realignment procedures for 6 months or 1 year".
- Policy
- SK Chemicals’ hemophilia drug Afstyla wins MFDS approval
- by Lee, Tak-Sun Jan 23, 2020 06:15am
- Hemophilia treatment Afstyla, developed by SK Chemicals, has won an approval for sales in Korea. The drug has licensed out its technology to Australia-based CSL in 2009. Ministry of Food and Drug Safety (MFDS) has authorized commercialization of Afstyla (lonoctocog Alfa (recombinant Factor VIII)) on Jan. 20. The licenser is Zanovex Korea, a subsidiary of global pharmaceutical distributor Zuellig Pharma. SK Chemicals’ blood product-manufacturing subsidiary, SK Plasma would be in charge of the sales in Korea. The U.S. Food and Drug Administration (FDA) granted approval on Afstyla in May 2015, and European Medicines Agency (EMA) also approved the treatment in January 2017. In Australia, where CSL is based, the treatment received the approval in April 2017. The Korean-developed treatment was approved first in overseas and entering the Korean market later. The drug is a recombinant factor VIII single-chain therapy for hemophilia A, developed by SK Chemicals. After the preclinical phase, the technology was licensed to Australia’s biotechnology firm CSL for all clinical trials. Existing hemophilia A treatments had two separate proteins combined, but Afstyla forms one whole structure with two proteins that improves stability of the treatment significantly and provides an option of twice-weekly dose. Compared to existing treatment options, the treatment apparently has enhanced productivity by ten-fold and doubled the stability. Specifically, Afstyla has doubled the duration of action of alternative options, and shows effect with only administration of twice or three times a week. Most of other hemophilia treatments are administered three to four times a week. However, some say Afstyla’s launch in Korea is late in the game as a once-weekly subcutaneously injected hemophilia treatment was approved in Korea last year and other Korean pharmaceutical companies like GC Pharma are developing investigational drugs. The hemophilia A treatment market in Korea is estimated to be around 150 billion won. While CSL is in charge of Afstyla’s global sales, SK Chemicals receives royalty on global sales and payment for agreed sales milestones. The Korean company is estimated to have earned approximately 6.5 billion won from Afstyla royalty last year.
- Policy
- Pfizer, challenges Velcade’s generic market
- by Lee, Tak-Sun Jan 22, 2020 10:47pm
- Pfizer will show anticancer generics (Pfizer Bortezomib, generic for Velcade) used in multiple myeloma. It is expected to compete with the original drug by Janssen and six domestic generics. The MFDS approved the Pfizer Bortezomib 3.5 mg of Pfizer Korea on the 21st. It is the same ingredient of Janssen Korea’s Velcade (Bortezomib). The difference is that the velcade is attached to the trimer, while the Pfizer’s Bortezomib has monohydrate attached to the main component. In conclusion, the same effectiveness is shown for multiple myeloma and mantle cell lymphoma. The original 'Velcade' is a blockbuster drug that generates about ₩10 billion in sales in Korea. In December 2015, the generic market was opened due to patent expiration, but it has maintained its market share due to the characteristics of the cancer drug market that prefers the original. Moreover, it is licensed as a first-line treatment for patients with multiple myeloma. About 8000 patients with multiple myeloma are known in Korea. Multiple myeloma is a type of blood cancer that occurs in plasma cells, the final stage of maturation of B lymphocytes, a type of white blood cell. Symptoms such as bone pain, and symptoms caused by bone marrow dysfunction. Janssen's Darzalex and Celgene’s Revlimid are available. As Velcade's patent expired in December 2015, generics for Belcade by Chong Kun Dang and Samyang Biofarm launched at a low price. Since then, generics for Boryung, ACE Pharma, Korea United Pharm, and Alvogen Korea have been approved. Seven companies are competing, including the original Janssen. Although there are few competitors, generic sales are still small enough to compete the original. An official of the related company said, "Even if there are few competitors because of the original loyalty in the anticancer drug market, there is no room for generics to enter the market." In this situation, Pfizer has challenged the generic market with imported products. Pfizer is showing a variety of anticancer drugs such as Sutene, Xalkori and Ibrance, and is expected to show its competitiveness as a generic because of the high reliability of domestic medical institutions. It is noteworthy that Pfizer will use the success story as generics in the anticancer market.
- Policy
- The leukemia drug 'Venclexta', formulary approved
- by Lee, Hye-Kyung Jan 22, 2020 06:27am
- Venclexta (Venetoclax), a drug used to treat chronic lymphocytic leukemia (CLL) that by Abbvie Korea, got formulary approval. The HIRA announced in December last year that Venclexta 10 mg, 50 mg and 100 mg were adequate for their benefits. Abbvie received Venclexta’s permission from the Ministry of Food and Drug Safety on May 29, and filed a formulary request with the HIRA. Venclexta has been approved as a monotherapy for the treatment of patients with chronic lymphocytic leukemia who are relapsed or refractory to chemoimmunotherapy and B cell receptor pathway inhibitors. CLL is a blood cancer caused by abnormally increased lymphocytes in the blood. In the West, CLL is the most prevalent leukemia, but in Korea, it is a rare disease that accounts for only 0.4-0.5% of all leukemias. On the other hand, the HIRA evaluates the reimbursement adequacy of drugs after deliberation by the drug reimbursement and evaluation committee in accordance with Article 11-2 of the regulation for criteria for providing reimbursed services in the NHI. The final evaluation result may be changed in the event of changes in the specific reimbursement range and standard items of the drug, changes in the permission of the item requested for decision, and withdrawal (cancellation).
- Policy
- Naglazyme RSA ends, 20.6% price cut from March
- by Kim, Jung-Ju Jan 22, 2020 06:27am
- Insurance prices have fallen by more than 20% since March, when Naglazyme (Galsulfaze) by Samoh Pharmaceutical has concluded a risk-sharing contract (RSA) agreement. According to pharmaceutical companies' strategies, such as price competition, there are a total of eight products that will be lowered on their own benefits next month. According to the industry on the 19th, the Ministry of Health and Welfare is pursuing ‘the revision of drug reimbursement list and the upper price limits’. The criteria for application are as follows, but the timing of application differs depending on the product. ◆Naglazyme’s RSA terminated= Samoh’s Naglazyme with the end of the RSA, is applied as regular reimbursement. The drug was not easily covered because it was expensive until now. In the past, the government increased the accessibility by registering the drug in insurance as a refund pharmacy negotiation pilot project, and introduced the RSA in Korea, and maintained the drug access on the RSA track in March 2016 after the end of the project. The RSA contract lasted for four years, and in preparation for the termination of the drug contract, the NHIS negotiated a drug price on a general track with the company. Negotiations were priced at ₩1,492,815 per 5mg/ml, 20.6% lower than RSA price. The new drug price starts in March shortly after the RSA contract expires. ◆Lowered the upper limit due to the price-volume agreement negotiation conclusion= This time, there are a total of 1 drug for which the price is lowered after negotiating with the NHIS. The government is conducting post management of drug prices through Price-Volume agreement linkage, which lowers drug prices by re-negotiating drugs with higher anticipated dosages and claims compared to those listed on drug insurance. Samoh's Vimizim is a new drug that is listed as a drug price negotiation, and the same product group charges are more than 30% higher than the expected billing amount. Price-Volume agreement system(Type Ka) has been applied. Here, the same product group means a drug having the same company name, route of administration, ingredient, and dosage form. The closing price of the negotiations was ₩995,661, 2.3% lower than the previous price. New drug price will be effective from June 1. ◆Voluntary upper limit adjustment (voluntary lowering)= A total of eight items will be lowered as the pharmaceutical company voluntarily decides to lower its insurance price. The government calculates and re-adjusts a manufacturer, a consigned manufacturer, or an importer to apply for a price cut at a price lower than the listed maximum drug price. In general, it is a measure of cuts in line with its policies following market competition. Looking at the items, Chong Kun Dang's Esoduo 40/800mg drops by 14.7% from ₩1,078 to ₩920, and Huon's Cinacal from ₩2,267 to ₩2,020 by 10.9%, respectively. Celltrion’s Truxima dropped 6.1% from ₩871,323 to ₩817,823, and Jinyang Pharmaceutical's Jinicough drops 2.9% from ₩102 to ₩99. New drug pricing will begin next month. ◆Preservation of production cost of shortage prevention drugs= A total of two drugs are designated as shortage prevention drugs or the price has been preserved. The government designates drugs that are necessary for patient care or are not profitable and that manufacturers, consigned manufacturers, or importers avoid production or import, drugs that require the preservation of production and import costs as a shortage prevention drug and preserves production costs. Myung In Pharm’s Vivaquin is the drug that raised the upper limit due to the conservation of production cost, It is up 21.2% from ₩255 to ₩309. In addition, Shin Poong’s Malafree was designated as a cost-preserving drug. The drug price is ₩309 per tablet. New drug prices will be applied from next month.
- Policy
- Nabota, Phase III clinical trial will be conducted
- by Lee, Tak-Sun Jan 21, 2020 06:25am
- Daewoong's botulinum toxin preparation 'Nabota' is speeding up the indication of treatment as well as improving the wrinkles of the glans. Nabota, which has four indications, is in the final phase of clinical trials to prove the effectiveness of improving the square jaw. The Ministry of Food and Drug Safety approved the Phase III clinical trial plan to demonstrate the efficacy of improving Nabota's bilateral hypertrophy (square jaw). The clinical trial will be conducted at Chung-Ang University Hospital, which has undergone Phase II. When Nabota acquires the indication, there will have five effectiveness. Currently, Nabota is can be used to treat ▲a temporary improvement in moderate to severe severe glabellar wrinkles associated with corrugator muscle and/or proerus muscle activity in adults aged 20 to 65 years, ▲treatment of upper limb muscle stiffness associated with stroke in adults 18 years and older, ▲temporary improvement of moderate to severe external angular wrinkles (eye wrinkles) associated with orbicularis oculi activity in adults 18 years and over 65 years ▲ treatment of benign essential eyelid spasms in adults 18 years and older. Of these, eyelid spasm indications were obtained last June, the most recent. For 230 adults, Nabota demonstrated non-inferiority by comparison with Botox. After 4 weeks of administration, 96.15% of the Nabota group and 96.12% of the Botox group showed improvement of eyelid spasms. Daewoong expects that botulinum toxin has great potential not only in the beauty market but also in the therapeutic market, and thus, the acquisition of indications will increase competitiveness on the global stage. For reference, Botox (Allergan), which Nabota used as a reference, has eight indications. It has been recognized for its effects in various areas including strabismus and eyelid spasms, spinal malformations, treatment of cirrhosis, primary hyperatrophic hypertension, muscle stiffness, temporal improvement of worry lines, headache relief in migraines, and bladder dysfunction. Meditoxin of Medytox, which is fighting a legal battle on Daewoong about technology infringement, has five indications. Meditoxin targets domestic and international markets with the effects of benign essential eyelid spasms, treatment of acute malformations, temporal improvement of glacial wrinkles, local muscle stiffness associated with stroke, and temporary improvement of eye wrinkles. Botulinum preparations are expanding into treatment areas as well as basic wrinkle improvement. Daedal Research, a global market analyst firm, predicts that the global botulinum toxin market will reach $5.9 billion (about ₩7 trillion) in 2021, and the therapeutic market will account for about $3.2 billion (about ₩3.8 trillion). In Korea, more than 90% is used for cosmetic purposes, but in the US and overseas markets, it is known that botulinum toxin is used more for therapeutic purposes. Nabota is also investigating its potential as a treatment for male hair loss, triangular hypertrophy and tearing symptoms. Nabota was introduced to the US market last year through Evolus. Evolus reported that the first year of performance in the overseas market has raised about ₩40 billion.
- Policy
- Mothers joins competition to develop Orlistat tablets
- by Lee, Tak-Sun Jan 21, 2020 06:24am
- Original Product, XenicalOrlistat, generic for Xenical, a fat absorption inhibitor used in the treatment of obesity, is being actively developed to change the product from capsules to tablets. CMG & Motherspharm are accelerating product commercialization. The Ministry of Food and Drug Safety approved the Phase III trial plan of ZEROfat tablets on Motherspharm. ZEROfat tablets were developed after the development of fat absorption inhibitors, Orlistat. Motherspharm has ZEROfat capsules with the same ingredients. Currently all 24 Orlistat formulations approved in Korea are capsules. The reason Motherspharm develops a formulation change is that tablets are more convenient to store and higher medication compliance than capsules. Capsules contain gelatin, which can cause digestive problems, making patients less compliant with the medication. In addition, tablets are known to be resistant to higher temperatures and humidity than capsules, and have the advantage of being easy to store and carry. Tablets can also be divided. Orlistat is widely prescribed in the domestic obesity drug market, so if tablets with increased medication compliance are expected, the demand will be high. The domestic Orlistat market is estimated to be about ₩25 billion. Orlistat, unlike other psychotropic obesity drugs that stimulate the central nervous system and suppress appetite, inhibits the function of lipolytic enzyme lipase to reduce the body's absorption of fat. CMG Pharm is also developing Orlistat tablets. In last September, the company received a phase III trial plan for CMG Orlistat tablets 120mg and is working on commercializing products. Both CMG and Mothers are likely to have success in commercialization as they have entered phase III clinical trials with formulation changes. Of the two companies, it is noted who will receive the product license first.
- Policy
- The MFDS releases Metformin’s NDMA test
- by Lee, Tak-Sun Jan 20, 2020 06:26am
- The MFDS has prepared a test method to properly detect NDMA (N-nitrosodimethylamine), which is a carcinogen, in the diabetes drug 'Metformin'. Unlike Ranitidine or Nizatidine, the test conditions are GC (Gas Chromatography) -MS/MS. This is the same test used by Singapore health authorities that detected NDMA in Metformin. The MFDS unveiled the test method, saying that it is also collecting drugs for sale on the market. The MFDS released its NDMA test method for Metformin using GC-MS / MS on its website on the 15th. As publicly available test methods are released, pharmaceutical companies can conduct their own tests with the test method. An official of the MFDS said, "We have prepared a test method in consideration of the test method and material properties conducted in Singapore". However, a pharmaceutical's own tests, subject to LC (Liquid Chromatography), before the test release, are expected to be re-validated. The MFDS official said that in this case, he will look at whether the LC condition test is appropriate, but it is necessary to retest as the official test method is GC. The MFDS added that it is also conducting inspections of commercial distribution items with the release of the test method. An official from the MFDS said, "We started the inspection of the distribution items on the market as we proceeded with the system investigation last month and prepared the test method, and specific test subjects and results will be disclosed later". The industry believes that NDMA has been collected and inspected for products made from the same raw materials as those for Singapore. It is observed that the source of raw materials and finished products were collected after the systematic investigation was confirmed. This is due to the fact that it takes a long time to conduct a full survey as there are 640 approved Metformin products in Korea. As the MFDS has started a full-scale investigation, the tension in the pharmaceutical industry is expected to increase. However, there are many cases where NDMA has not been detected in its own investigation, and there is no detection case outside of Singapore, so it is optimistic that there will be no problem in Korea.
- Policy
- MFDS updates drug supply suspension list from Q2 2019
- by Lee, Tak-Sun Jan 17, 2020 06:22am
- Handok and Korea AbbVie are respectively suspending the supply of antiulcer treatment Gabet tablet (ecabet sodium), and hepatitis C treatment Viekira (paritaprevir-ritonavir-ombitasvir) and Exviera (dasaabuvir sodium) in Korea. According to the pharmaceutical industry on Jan. 15, Ministry of Food and Drug Safety (MFDS) recently disclosed a list of suspended drug supply suspension from the second quarter in 2019. To prevent pseudo demand (panic-buy) on the drugs, MFDS withheld immediate disclosure of the news and posted the list on the ministry’s pharmaceutical information website after six months. Accordingly, the website has been updating last year second-quarter’s drug supply suspension list from December last year. The updated list informed Handok is ceasing the sales of Gabet 500 mg tablet after its April stock goes out as its annual sales volume has been too low. The company explained, the supply of the medicine would be unaffected, because another product with the same agent (Jeil Pharm’s Ecat 500 mg tablet) is still available in the market. Moreover, the supply of hepatitis C treatment Viekira and Exviera imported by Korea AbbVie has been suspended since August last year. The decision was made as the company’s Mavyret with improved efficacy and better administration method has been released in September 2018. GlaxoSmithKline Korea also stopped supplying Haemophilus influenza type B (HIB) vaccine Vaxemhib from August last year. Apparently, the company has decided to shut down the manufacturing of the vaccine in Korea inevitably, due to the vaccine department’s plan to improve business efficiency and to integrate and check up production line. The company noted that even if Vaxemhib supply is suspended, an alternative option, LG Chem’s HIB vaccine Euhib, is still accessible. Jeil Pharm’s UFT-E 0.5 g granule supply has been cut as well since August last year due to the partner company’s decision to suspend supply in Korea. The company informed patient’s access to treatment would not be affected significantly as other capsule products with the same substance are available. Also, the company added it would hold on to its product license until the stock is completely out in the market and cancel it after confirming the stock-out. Supply of an original antibiotics, Finibax 0.25 g injection (doripenem monohydrate) marketed by Ildong Pharmaceutical, has been stopped from August last year. The importing company elaborated importing the product to Korea has been unfortunately ceased due to increasing deficit made by the high production cost. JW Pharmaceutical stopped importing enteral nutrition solution Encover from June last year as the Japanese manufacturer has stopped supplying the product. The Korean company has recently informed the product’s supply would resume from February. A pharmaceutical company is required to report MFDS of suspension of d any rug supply 60 days prior to the time. Apparently, the ministry is considering on disclosing the drug suspension information immediately to the public.
- Policy
- Chong Kun Dang's development of IMD is accelerating
- by Lee, Tak-Sun Jan 16, 2020 06:07am
- Chong Kun Dang is targeting the market for SGLT-2 inhibitors, a well-known drug for losing weight. Currently, MSD's original drug `` Steglatro '' is being jointly sold, and it is speeding up the development of other drugs such as Forxiga and Jardiance. In particular, post-development of Jardiance is avoiding the crystalline patent of the original drug alone, Chong Kun Dang is expected. The Ministry of Food and Drug Safety approved the Phase I study plan for Chong Kun Dang’s CKD-375 on the 24th of last month. This trial is a randomized, open-label, single-dose, cross-design trial to compare the pharmacokinetics and safety/tolerability of oral administration of high doses of CKD-375 and D390 in healthy adults. In a recent published study, the clinical reference is Jardiance Duo (Empagliflozin-Metformin). Accordingly, CKD-375 can be inferred as Empagliflozin, the main ingredient of Jardiance, and D390 can be inferred as Metformin. CKD-375 received approval for the Phase I clinical trial in last February. The trial at that time was also a randomized, open, single-dose, crossover study to compare pharmacokinetics and safety/tolerability with single doses of CKD-375 and D387, respectively, in healthy adult volunteers. Chong Kun Dang is accelerating a late-release drug of Jardiance because it seems to be due to the fact that PMS is scheduled to expire on August 11 this year. If applying for a permit at the end of the PMS, it will be the first applicant. Chong Kun Dang avoided the Jardiance crystalline patent (which is due to expire on December 14 2026) in last May as a domestic pharmaceutical company, so if it meets the conditions for the first applicant, it can obtain a generic exclusivity. A Generic exclusivity is expected to have a generic monopoly for nine months after March 11 2025, when Jardiance material patents expire. Chong Kun Dang is also in the process of authorizing the commercialization of CKD-387, another SGLT-2 inhibitor for Forxiga. Forxiga is reported to have already filed a permit application by many pharmaceutical companies after the PMS expired on last November 25. SGLT-2 inhibitors, which have a mechanism of selectively inhibiting SGLT-2, which is involved in glucose resorption in the renal glomerular filtration process, have a blood sugar strengthening and weight loss effect, and the size of the market is growing rapidly. On the basis of UBIST, cumulative prescription amount in the first half of 2019 exceeded ₩10 billion, which is a blockbuster, in the first half of the year, including ₩14.7 billion for Forxiga and ₩12.8 billion for Jardiance. Currently, only the original SGLT-2 products such as Forxiga, Jardiance, Suglat, Steglatro and Invokana are sold in Korea. Accordingly, domestic pharmaceutical companies are actively conducting patent challenge and product development in order to release generic drugs early.
