- LOGIN
- MemberShip
- 2026-04-16 16:22:27
- Opinion
- [Reporter’sView] A good administrative move by government
- by Eo, Yun-Ho Jul 06, 2020 10:44am
- Korea’s Ministry of Health and Welfare (MOHW) withdrew the plan to apply the stepped drug pricing reduction on drugs transferred by business restructuring in just four months to reflect the pharmaceutical industry’s opinion. It was first announced in February, and the revision was updated in June. The industry has been in a chaos for a while as the government mentioned of a possibility of applying stepped pricing on the transferred drugs. Initially, the stepped drug pricing, in effective from August, sets the upper limit pricing a drug, regardless of qualifying two criteria for top-level pricing, at 85 percent of either the lowest pricing or 38.69 percent of the first-in-class drug, if the number of listed same-substance drugs exceeds 20. However, the Pharmaceutical Decision and Adjustment Criteria amended in last February opened room for the stepped pricing to be used on a product that succeeds business status due to corporate restructuring—for example in case of M&A, corporate split or license sell-off. Accordingly, companies like Pfizer Pharmaceutical Korea (Upjohn) and MSD Korea (Organon) preparing for multiple transfer of original products to the respective split off companies, feared of the possible pricing reduction. Takeda Pharmaceuticals Korea that recently sold off an antidiabetic treatment pipeline to Celltrion could not be completely free from the same fear. Relevant industry organizations like Korean Research-based Pharmaceutical Industry Association (KRPIA) and Korea Pharmaceutical and Bio-pharma Manufacturers Association (KPBMA) submitted statements to urge MOHW to exempt transferred products from stepped pricing reduction, and requested for flexible interpretation of the regulation. Surprisingly, MOHW’s action was even more straightforward. The Pharmaceutical Decision and Adjustment Criteria were revisited again and announced the newest amendment last month. Fortunately, it subsided the industry’ complain fast. In this day and age of high-cost drugs, the Korean government puts forth ‘trade-off’ as the key regulatory approach to lessen the expenditure on off-patent drug for compensation on new drug coverage. As for the government, the initial plan was a great chance. Besides generics, lowering the pricing of the transferred original would put generics pricing higher than the original, and most likely the same substance drug pricing would fall, automatically. But the government accepted the industry’s logic behind its argument. A good communication can also lead to another opportunity. Hopefully, the government could result in good trade-off while listing new drugs or expanding coverage in the future.
- Policy
- Samsung Bioepis' Adalloce prefilled pen was approved
- by Lee, Tak-Sun Jul 06, 2020 06:15am
- Samsung BioepisSamsung Bioepis’ pen type product of Humira (Adalimumab) biosimilar named Adalloce has additionally approved in Korea It is evaluated as a product with improved convenience of administration than Adalloce PFS that was approved in September 2017. The MFDS approved Samsung Bioepis' Adalloce prefilled pen 40mg on the 3rd. This product is an injection type in a pen equipped with a colorless and transparent pre-filled syringe. It is a self-injectable form that can be administered by the patient himself, such as the previously approved Adalloce PFS. However, the pen formulation has the advantage of not only reducing the fear of the injection needle due to the lack of exposure to the injection needle, thereby reducing the possibility of contamination. Adaloche prefilled pen is simple to use because the injection drug is automatically injected by pressing the button on the injection site. Humira, which is the original drug of this product, has both pre-filled syringe and pre-filled pen formulations, and the preference of pen formulations is high. It has been reported that most patients with pen formulation experience pain reduction following injection. Adalimumab is mainly used in patients with rheumatoid arthritis. However, Adalloce has not yet been released in Korea. This is because Humira's fastest patent expires in June 2022. However, Samsung Bioepis succeeded in invalidating the Humira patent, which was scheduled to expire on July 18, 2023, through a trial request, and laid the foundation to release it sooner. Currently, Samsung Bioepis' Adalloce is the only product that has the same ingredient (Adalimumab) as Humira in Korea. Last year, Humira's domestic sales (based on IQVIA) amounted to ₩96.2 billion, and it is a very large-scale drug that is close to ₩100 billion. Samsung Bioepis has been selling Humira's biosimilar in Europe since October 2018 under the name Imraldi. Biogen, which sells Imraldi in the European market, said last year that its sales were $184 million, more than 10 times higher than ₩16.7 million in 2018. It is the No. 1 market share in Humira biosimilar products. It is an analysis that Imraldi is leading among the four biosimilars due to the advantages of price competitiveness and convenient pen formulation in the European market. It is highly anticipated that it will become a competitive with Humira if it is released in Korea.
- Policy
- Pariet holder was changed from Janssen to Kolmar in 20 years
- by Lee, Tak-Sun Jul 06, 2020 06:15am
- The domestic license holder for 'Pariet', a PPI used for GERD, has been changed in 20 years. As Janssen Korea operates the Hyangnam factory until next year, the manufacturer has finally changed. Eisai Korea is in charge of sales. According to related industries on the 3rd, the permit holders of Pariet licensed in 2000 were changed from Janssen Korea to Kolmar Korea, and an insurance code was newly established reflecting this from July. Accordingly, items whose license holder is Janssen Korea can only be claimed by this December. Since last year, Janssen Korea has been in the process of transferring manufacturing. This is because the operation of the Hyangnam Plant until next year will no longer produce Pariet, which was commissioned and manufactured in Korea. It is developed by Eisai, and Eisai Korea is in charge of sales. Janssen Korea has established a relationship since Pariet launched in Korea in 2000. In addition to permitting, manufacturing and production, the company also conducted joint sales with Eisai Korea. It closed sales in 2015, and was transferred to Kolmar Korea at this time. Pariet has recently released a low dose product, and is strengthening its marketing by conducting joint sales with Yuhan Corporation. Pariet is also receiving reflex benefits according to anti-ulcer drug Ranitidine has been banned due to the detection of NDMA, a carcinogen, It is noteworthy whether Pariet, whose license has changed from Janssen Korea to Kolmar Korea in 20 years, will making its way up once again in Korea with a new partnership.
- Company
- GC Pharma has signed a contract to supply Pfizer's Rapamune
- by Jul 06, 2020 06:15am
- GC Pharma is launching a sale of Rapamune (Sirolimus), an immunosuppressive agent of Pfizer Korea. PfizerAccording to the distribution industry on the 3rd, GC Pharma signed a supply contract with Pfizer Korea for supply of Rapamune 0.5·1·2mg on the 19th of last month and began selling on the 1st of this month. Rapamune is an immunosuppressive drug released by Pfizer Korea with a domestic license in March 2006. It is used to prevent long-term rejection of patients with kidney disease and to treat patients with lymphangioleiomyomatosis (LAM). Rapamune's annual prescription amount is low at ₩2 billion. According to IQVIA, the annual sales from 2015 to 2019 were ₩2.4 billion. In the case of Rapamune 1 & 2mg, the drug price is expected to drop slightly from this year, and sales are expected to fall further. As a result, Rapamune has not released generics for 5 years after the patent expires in 2013. Only in August 2018, Chong Kun Dang was the first Korean pharmaceutical company to receive a generic named Raparobell. The generic got listed this year. With the drug price cut and generics, the impact of GC Pharma's sales of Rapamune is expected to be minimal. Nevertheless, the reason for choosing Rapamune is considered to reflect the company's willingness to empower the rare disease field. GC Pharma has a rare disease team and provides treatment for many rare diseases such as Hunter syndrome, hemophilia, and Fabry disease. An official in the pharmaceutical industry said, "As GC Pharma is focusing on the rare disease field, it seems to be a choice to increase the market influence by expanding the related pharmaceutical items rather than sales."
- Company
- Hanmi appealed patent lawsuit of Galvus
- by Kim, Jin-Gu Jul 06, 2020 06:14am
- GalvusAs soon as the Patent Judge sidede with the original company in the patent dispute of Galvus (Vildagliptin), a DPP-4 inhibitor-based diabetes treatment agent, Hanmi immediately announced its appeal. An official from Hanmi said in a call with Dailypharm on the 2nd, "We will appeal immediately and receive a trial for the scope of the patent once again." Earlier, on the 1st, the Intellectual Property Trial And Appeal Board made a decision to raise the hand of the original company in the patent dispute surrounding Galvus. The patent dispute was triggered when Hanmi and Korea United Pharm filed a claim against Novartis to confirm the passive scope of rights. About this trial, Hanmi evaluated that it was a meaningful patent challenge to overcome the high patent barrier of multinational pharmaceutical companies. Hanmi Pharm attempted a new patent evasion strategy to develop Galvus’ generic. Based on four indications (1, 2, 4, and 5 indications) except for one of the five indications applied to Galvus, the marketing authorisation of the MFDS was recently obtained. Galvus 5 indications of Galvus. Hanmi has obtained the marketing authorisation from the MFDS based on the four indications except for the third indication. However, the Intellectual Property Trial And Appeal Board ruled that four indications in addition to one indication excluded by Hanmi have an extended patent. It was the intention that the five indications correspond to a treatment regimen belonging to the same disease group (type II DM). Accordingly, Hanmi decided to appeal immediately and decide the patent court. Separately, Hanmi won the trial of invalidation of the extension of the duration of the patent for a substance at the existing patent tribunal. It was decided that the extended patent period of 187 days was invalid. Novartis appealed to the patent court. The second trial is scheduled for August 13th. An official from Hanmi said, “We expect that Hanmi's action will stimulate the drastic patent challenge of domestic pharmaceutical companies against multinational pharmaceutical companies. we will go to the strong pharmaceutical country based on our own innovation strategy.”
- Company
- Hanmi loses first trial in patent dispute over Galvus
- by Kim, Jin-Gu Jul 06, 2020 06:14am
- GalvusNovartis won the patent dispute between Hanmi and Novartis over the DPP-4 inhibitor-based diabetes treatment agent Galvus (Vildagliptin). The Intellectual Property Trial And Appeal Board made a decision to dismiss the passive right scope verification trial requested by Hanmi on the 1st. Hanmi has filed a total of eight trials for Galvus patent, but the Board has dismissed it. On the same day, Korea United Pharm also lost. It is expected that the trial will have a significant impact on Novartis' application to the Seoul Central District Court for a prohibition of sales disposition, a lawsuit for patent infringement claim, and a lawsuit to cancel an item license. ◆Hanmi's new strategy, Patent challenge by dividing indications In July 2018, Hanmi filed a judgment against Novartis to confirm the passive scope of rights for Galvus and Galvusmet's material patents. In the following year, Hanmi applied for permission of Vildagle, salt-changing generic for Galvus. Hanmi applied for a product license except one of the five indications of the original drug, Galvus. It was Hanmi's new patent avoidance strategy. Hanmi unveiled the logic that Novartis' patent is limited to only 3 out of 1-5 indications applied to Galvus. The indication is said that it is used dual oral therapy in combination with Metformin, Sulfonylurea, thiazolidinedione in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy. Galvus In other words, Hanmi asserted that since the validity of Galvus’ patent right only affects the indication #3 and not the rest of indication #1, #2, #4, and #5, Vildagle also does not infringe patent of Galvus. Novartis refuted this. In fact, the claims of Hanmi made an unreasonable demand because indications were included in the same scope (type II DMtreatment). The MFDS approved the application for Hanmi in January this year. In April, insurance benefits were decided. However, Hanmi has not yet released the product. As the Intellectual Property Trial And Appeal Board decided to take Novartis side on the 1st, the challenge of Hanmi has been put on hold. Vildagle's release schedule has been postponed indefinitely. ◆Dutasteride was applied, but why is it not Vildagliptin This patent dispute is of great interest in the industry. It is because expectations are raising whether the challenge of Hanmi will be a new path to generic's patent evasion strategy. It is said that Hanmi got a hint from patent dispute of Dutasteride in 2015. Patent dispute of Dutasteride was similar to Galvus, but proceeded with another issue. At that time, Generic company claimed that the patent for the substance was extended because original company's Dutasteride (Brand name: Avodart) was limited to the permission for prostate hyperplasia. In other words, it was argued that the patent right has no effect in the case of 'hair loss', another indication of Dutasteride. Based on these claims, the MFDS approved it because Generic company applied only one indication for hair loss. The generic company won the patent dispute. The Intellectual Property Trial And Appeal Board judged that the effective right of Dutasteride patent was limited to prostate hyperplasia and did not affect hair loss. Generic succeeded in launching a hair loss indication and before the patent expired. ◆Pharmaceutical industry expects new patent avoidance strategy The Judge's decision has not been released. However, in the industry, it is persuasive to argue that the case of Dutasteride and Galvus is different. In the case of the Dutasteride dispute, the indications of prostatic hyperplasia and hair loss are markedly different, whereas the Galvus dispute is virtually the same indication and cannot be regarded as the same case. Generic companies was expecting the result. A domestic patent official said, "It is true that we thought about whether to challenge patent evasion in the same way as Hanmi, but the possibility of success did not seem so high, so we were waiting for the result of this dispute." He added that there is no plan to file a referee with this strategy, the Intellectual Property Trial And Appeal Board did not accept the claim that it should judge the identity of medical use based on the individual indication. Another official in the pharmaceutical industry said, "If Hanmi leads the case with an appeal, it is unlikely that the trial will be overturned." The trial is expected to have a significant impact on other lawsuits between Novartis and Hanmi. Three related lawsuits are in progress. Novartis has filed a lawsuit against the Seoul Central District Court for infringement and prohibition of sale and filed a lawsuit against the Seoul Administrative Court to cancel the item permission, which is the main lawsuit of the provisional injunction. Three cases are currently pending. If the court accepts the provisional disposition, it is expected that Vildagle will not be available for the time being.
- Policy
- Korean government designates remdesivir essential drug
- by Lee, Tak-Sun Jul 06, 2020 06:14am
- Product image of remdesivir (Source: BBC) The Korean government has designated specially imported COVID-19 treatment remdesivir, and clinically used COVID-19 treatment Kaletra (lopinavir/ritonavir) as National Essential Drugs. National Essential Drugs are designated to be constantly monitored for stock and supply flow, and to receive support for special importation clearance or contract manufacturing in Korea in case of shortage. After a pan-government deliberation, the Ministry of Food and Drug Safety (MFDS, Minister Lee Eui-kyung) has decided expand the list of National Essential Drug from 403 items to 441 on July 2 to better manage the supply of drugs used to respond against disaster or emergency like COVID-19. Minister of Health and Welfare and Minister of Food and Drug Safety come together to agree on the special designation of drugs necessary in the healthcare scene but cannot solely rely on the function of market to stabilize flow of supply. The pan-government meeting for the essential drugs designation consists of nine government bodies including MFDS (chair), Ministry of National Defense, Ministry of the Interior and Safety, Ministry of Health and Welfare and Office for Government Policy Coordination. The latest list newly added total 38 items, such as three COVID-19 relevant drugs (remdesivir injection, lopinavir and ritonavir solutions), 31 drugs to respond against disaster or emergency (epinephrine used for CPR), and four items recommended by related government body like Korea Centers for Disease Control and Prevention (KCDC). Now the National Essential Drug list has 441 items consisting of four COVID-19 related treatments, 46 disaster response or emergency care treatments, 31 emergency antidotes, 31 tuberculosis treatments, 99 hepatitis virus, parasite and other infectious disease treatments, 33 vaccines, and 10 basic parental nutrition solutions. The government constantly monitors supply and stock of the essential drugs, and takes prompt actions to stabilize the supply by MFDS clearing special importation or using contract manufacturing organization to domestically supply the products. MFDS official said, “More of National Essential Drugs would be designated in the future to securely grant patient access to drugs in desperate need of special management,” and “The government would always strive to supply drugs essential to the public health.”
- Company
- AML treatment Rydapt can be prescribed in general hospitals
- by Eo, Yun-Ho Jul 03, 2020 06:18am
- Novartis' new acute myelogenous leukemia drug 'Rydapt' can be prescribed in general hospitals. According to the related industry, acute myeloid leukemia (AML) treatment, Rydapt (Midostaurin) has passed the pharmaceutical committee (DC, drug commitee) of Big 5 Hospitals, such as Seoul National University Hospital and AMC. It was approved as an orphan drug in Korea last year as a FLT3 inhibitor and can be prescribed for ▲combination of high-dose Cytarabine with standard Cytarabine or Daunorubicin induction therapy for new AML patients with positive FLT3 mutation ▲Aggressive systemic mastocytosis, systemic mastocytosis with hematologic neoplasm, mast cell leukemia. FLT3 inhibitors are also well known as 'HM43239', Hanmi’s candidate. The effectiveness of Rydapt has been demonstrated through ATIFY studies. The study was the largest of all clinical trials involving 3,277 AML patients with specific gene mutations. Patients treated with Rydapt in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy experienced significant improvement in overall survival (OS) with a 22% reduction in the risk of death compared with chemotherapy plus placebo. In patients in the Rydapt arm, OS was 74.7 months vs. 25.6 months in the placebo arm. AML is the most common form of leukemia, accounting for about 65% of adult acute leukemias. The incidence increases with age. AML is primarily treated by administering 2 to 3 drugs such as Anthracycline in combination. The problem is that after the first chemotherapy, up to 50% of cases of recurrence of leukemia cells fall below 5%, even if the degree of 'complete remission' reaches 50 to 70%. Official from Society of Hematology said, “It is important to reduce the number of cancer cells in the early stages of AML. We are looking forward to the emergence of an option that can be prescribed to patients who are not able to apply induction techniques, which is an important issue.”
- Opinion
- [Reporter’sView] Finding the key in platform technology
- by An, Kyung-Jin Jul 03, 2020 06:18am
- The world is eyeing on companies developing platform technology for novel drug. In last few years, Korean bio technology companies like ABL Bio, LegoChem Biosciences and Alteogen have signed deals worth over a trillion won with global pharmaceutical companies on rights over platform technology that facilitates drug delivery. Each in last November and June this year, Alteogen signed two licensing agreements with global pharmaceutical companies on human hyaluronidase (ALT-B4) technology that enables intravenously injected biologics to also work as subcutaneous injection. The company earned 35 billion won from the two companies licensed in the platform technology. The number already exceeds the Korean company’s sales in last year totaling at 29.2 billion won. From last year and on, LegoChem Biosciences have inked three deals on antibody-drug conjugate (ADC) technology. The technology mediates efficient delivery of drug to cancer cells by improving the unstable linkers between protein and antibody. In March last year, LegoChem licensed out three ADC-applied novel anticancer therapies to Millennium Pharmaceuticals, a subsidiary of Takeda Pharmaceutical. And in April and May this year, the Korean company signed deals for the U.K.-based Iksuda Therapeutics to hold exclusive rights to use the ADC technology and ADC-based cancer therapy. A platform technology is defined as source technology to apply on development of new drugs. Such technology can enhance medication convenience or benefit by changing injection to oral administration or switching intravenous route to self-injectable subcutaneous injection. The biggest appeal of the platform technology in novel drug development is the potential of expansion. Generally, the probability of candidate medicine to receive sales approval at Phase I clinical trial stage is 10.4 percent, at Phase II is 16.2 percent and at Phase III is 50.0 percent. Even a company with multiple new drug pipelines cannot be completely free from the probability of failure. On the contrary, platform technology holds less risk in failure as it could be used on different candidate drug when it fails in other. For instance, Hanmi Pharmaceutical took a blow when Sanofi returned the rights over efpeglenatide, but if the neutropenia treatment Rolontis (eflapegrastim) gets approval from the U.S. Food and Drug Administration (FDA) within this year, the Lapscovery technology’s potential could be reevaluated. Like the licensing agreements LegoChem or Alteogen signed, an exclusive rights or a novel therapy based on the technology could be transferred. But also the licensing profit could be maximized by signing a non-exclusive deal on the technology. Good news to the Korean industry is that the world’s perception on Korean pharmaceutical and bio companies have significantly improved in last few years. The Korean industry’s successful outcomes are yet to be tangible, but there are many companies with platform technologies on par with other global companies. Hopefully, the heightened interest on the platform technology would induce investment on these promising companies.
- Policy
- 33 seriously ill patients are eligible for free Remdesivir
- by Kim, Jung-Ju Jul 03, 2020 06:18am
- Gilead Science Korea's COVID-19 treatment 'Remdesivir' was supplied to Korea on the 1st of today. A total of 33 seriously ill candidates will be eligible for the first free application. However, they request to be administered at the discretion of the attending physician, and whether or not to administer is determined according to the selection criteria. Jung Eun-Kyeong, Head of Central Disease Control Headquarters at the KCDC, today (1st) at the regular briefing, explained the number and severity of serious patients currently considered as the primary target. According to the Head Jung, there are reports that Remdesivir shortens the treatment period through several clinical trials. Statistically, it is still unclear, but the supply was decided by special import because the drug is expected to reduce the mortality rate. The government has decided on the selection criteria for the target of the treatment so that it can be administered to patients who have not passed 10 days, which can be called early onset. In addition, it was limited to patients receiving oxygen therapy which chest x-ray or CT pneumonia, oxygen saturation was 94% or less. Jung Eun-Kyeong, Head of Central Disease Control Headquarters said, "The criteria for this medication were selected in consideration of experts' advice and recommendations from the central clinical committee operated by the National Medical Center, and by the MFDS, but the request is made at the discretion of the attending physician.” She added that there are basic treatment policies in the early stages of the onset such as administering antiviral drugs to suppress the growth of viruses, and using treatments such as Dexamethasone, which has anti-inflammatory effects, depending on the progress. It will be necessary to check the dosing criteria while checking the onset period. On the other hand, as of 2:50 pm on the first day that the application for medication was started, there are no medical institutions that have requested to apply for Remdesivir.
