- LOGIN
- MemberShip
- 2026-05-18 18:57:16
- Policy
- Bayer applies for approval of ‘Finerenone’ in Korea
- by Lee, Tak-Sun Jul 09, 2021 05:57am
- A groundbreaking new drug developed by Bayer is undergoing review for approval in Korea. The drug is known to inhibit disease progression in chronic kidney disease (CKD) patients with diabetes. According to industry sources on the 8th, Bayer applied for the approval of its ‘finerenone (Kerendia tab)’ to the Ministry of Food and Drug Safety in Korea. Finerenone, which was developed by Bayer, is considered to be a potential global blockbuster by the company. Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist (MRA) that selectively acts on mineralocorticoid receptors to block harmful effects on the kidneys and the heart. It is reported to be particularly useful for patients with chronic kidney disease and diabetes. In a Phase III trial (FIDELIO-DKD) presented at the Annual Meeting held by the American Society of Nephrology in October last year, patients who took finerenone had an 18% lower risk of developing a composite of kidney failure, a sustained reduction of at least 40% in estimated glomerular filtration rate (eGFR) from baseline, or death from renal causes than those who took the placebo. The study enrolled approximately 5,700 patients with CKD and Type 2 Diabetes. Diabetic CKD patients have a risk for kidney damage and eventually kidney failure, despite currently available treatments. Bayer believes finerenone will be effective in delaying disease progression in this patient population. The drug has received a Priority Review designation by the U.S. FDA in January. With the designation, in the U.S., finerenone is expected to be approved within the second half of this year at the earliest. The drug is also under review by the EMA. Soon to face patent expiry for some of its products including Xarelto and Eylea, Bayer has expectations high for its new drugs, including finerenone.
- Company
- Researchers find COVID-19 Txs more effective than remdesivir
- by Kim, Jin-Gu Jul 09, 2021 05:56am
- A Korean research team of the Korea Advanced Institute of Science and Technology (KAIST) discovered new drug candidates for the treatment of COVID-19. Some of the candidates are expected to have a better effect than the currently approved remdesivir (product name: Veklury). On the 8th, the joint research team of Sang-yup Lee, Distinguished Professor of Chemical & Biomolecular Engineering at KAIST, and Dr. Seung-taek Kim, researcher of Institut Pasteur Korea (IPK)’s Zoonotic Virus Laboratory announced that they have discovered potential candidates for treating COVID-19 using their virtual screening technology. The team opted for a drug repurposing strategy using virtual screening. In other words, the team sought to find substances that may help treat COVID-19 among drugs with verified efficacy and safety. The researchers first built a virtual library on 6,218 drugs that are FDA-approved or in clinical trials, and then applied their newly developed virtual screening technology. The accuracy of the system was improved by adding structural similarity and interaction similarity analysis modules to the existing docking simulation-based virtual screening technology. Summary of the COVID-19 treatment development process using virtual drug screening technology (source: KAIST) Using the platform, the team selected 38 candidate compounds that inhibit the protease and RNA-dependent RNA polymerase needed for the replication and proliferation of the COVID-19 virus. Then, the efficacy of the candidates was verified by the Institut Pasteur Korea. Testing was conducted using a monkey’s kidney cells infected with COVID-19. Of the 38 candidates, 7 compounds showed antiviral activity. The 7 compounds that showed promise were further verified on human lung cells to be narrowed down to three: omipalisib, and tipifarnib, and emodin. Among these, omipalisib was found to have an antiviral activity that is over 200 times higher than that of remdesivir. Antiviral activity of tipifarnib was found to be similar to remdesivir. Omipalisib is currently being studied in a clinical trial as a treatment for cancer and pulmonary fibrosis. Tipifarnib is being studied in a clinical as a treatment for and progeria, and emodin, which is derived from plants, is being studied in a clinical trial as an anticancer drug. The research team is planning a preclinical trial on these 3 candidate substances. In the preclinical trial, the team aims to minimize toxicity and reach the effective concentration for treating COVID-19. Regarding the findings, Professor Sang-yup Lee said, ”With the research, we were able to prepare a base technology to promptly respond to new emerging viruses. We will continue our research to develop technologies applicable to new infectious viruses as well as variants of the coronavirus.”
- Company
- Jeil's anti-cancer drug business is doing well
- by Nho, Byung Chul Jul 08, 2021 05:59am
- It is noteworthy that Jeil is investing in expanding the lineup of anticancer drugs and research and development in related fields. Jeil, who entered his 33rd year of anti-cancer drug business, has a strategic relationship with Kyowa Kirin and Taiho in Japan and is making efforts to distribute original anti-cancer drugs. When the new anti-cancer drugs were introduced in the late 1980s, Jeil established a separate anti-cancer sales and marketing team to strengthen its professional capabilities and make communication between doctors and salespeople a top priority. The most likely anti-cancer drugs are Grasin300 PFS (Kyowa Kirin), Neulasta PFS(Kyowa Kirin), UFT(Taiho), Ts-1(Taiho), and Lonsurf (Taiho). The first anti-cancer drug introduced by Jeil was UFT(Tegafur·Uracil), which was first released in Korea in 1989. It is effective in relieving symptoms such as head and neck cancer, stomach cancer, rectal cancer, liver cancer, lung cancer, prostate cancer, uterine cervical cancer, and breast cancer, etc. UFT has capsule formulations and granules, which are usually administered three to six capsules a day, and the granules are taken in two to three doses of 300 to 600 mg. In 1993, Grasin300 PFS (Filgrastim) was released. The drug, which is a granulocyte colony-stimulating factor (GCSF) preparation, has indications of neutrophilosis, bone marrow dysplasia, regenerative anemia, congenital and idiopathic neutrophilia (HIV) infections. In 2004, the company launched a treatment called Ts-1(Gimeracil, Oteracil Potassium,Tegafur) for stomach, head and neck cancer, pancreatic cancer, and non-small cell lung cancer, providing a variety of treatment options for domestic patients. In 2014, it released Neulasta (Pegfilgrastim), the second generation G-CSF and co-sold it in Korea with Kyowa Kirin. Last year, Lonsurf (Tipiracil+Trifluridine) was introduced to provide new options for colon cancer treatment, and has continued its long sales experience in the domestic anticancer drug market. Lonsurf passed DC of 50 hospitals nationwide, including Seoul National University Hospital, Samsung Medical Center, Asan Medical Center, and Severance Hospital in the first year of its launch. Based on UBIST, it ranks first in sales in the field of oral anticancer drugs newly approved in 2020, and is recognized for its efficacy. Lonsurf is expanding its share of the colon cancer market using a specialised sales network. Attention is also focusing on Onconic therapeutics, which was established last year to improve its position in the anti-cancer drug R&D field. Bio company Onconic therapeutics is a subsidiary 100% invested by Jeil and is expected to grow as an organization focused on the development of immune and targeted anti-cancer drugs. A year after its establishment, the company announced the results of Phase 1 for PARP (Poly ADP-ribose Polymerase) and JPI-547 at ASCO, drawing attention from Big Pharma. Phase I of the clinical trial evaluated the medicinal efficacy, safety of JPI-547 in patients with terminal solid cancer, according to Lim Seok-ah, a professor of hemato-oncology at Seoul National University Hospital, announced at the poster session. It is encouraging to identify the potential as a new treatment for ovarian cancer that does not respond to existing PARP treatments. Based on the results of this Effects are expected in HRD and PARP inhibitor resistant patients, including BRCA. "Based on the 30-year history of introducing anti-cancer drugs, we are continuously expanding our specialized sales network in related fields." said a representative of Jeil. "We will strengthen the pipeline of new items and improve our long-term research and development capabilities in the anticancer drugs market through open collaboration with Onconic Therapheutics."
- InterView
- Takeda, “Alunbrig improved both OS and QoL”
- by Jul 08, 2021 05:58am
- Medical Science Liaisons (MSLs) in Medical Affairs of pharmaceutical companies act as a ‘bridge’ between healthcare professionals and companies. They gather the unmet needs of HCPs and establish strategies for new drugs to address such needs. MSLs also deliver academic data and expertise based on clinical grounds in compliance with local regulations to HCPs, patients, and internal employees. Competition has been fierce in the non-small cell lung cancer treatment market, particularly the ALK targeted therapy market, with the introduction of various new drugs. The market is moving on from the one-and-only 1st generation treatment, Pfizer’s ‘Xalkori,’ to 2nd generation products. By order of entry, three 2nd gen products - Novartis’s ‘Zykadia (ceritinib),’ Roche’s ‘Alecensa (alectinib),’ and Takeda Pharmaceutical’s ‘Alunbrig (brigatinib)’ – have entered the market. Among these, Roche and Takeda’s products are in the fiercest competition. The role and responsibility of MSLs in charge of these products have also increased. Dailypharm met with Bokyung Kim, MSL at Takeda Pharmaceuticals Korea’s to hear about the ALK-positive NSCLC treatment market, its unmet needs, and the role and strategy of Alunbrig in this market. Bokyung Kim, MSL at Takeda Pharmaceuticals Korea -Could you give us a brief introduction about yourself and your role in Medical Affairs of Takeda Pharmaceuticals Korea? = SInce entering Takeda Pharmaceuticals Korea as an MSL in October last year, I have been in charge of Alunbrig for 9 months. I meet with healthcare professionals to identify the unmet needs in the field to establish strategies based on the demand. In the company, I discuss with various business divisions to set the direction for Alunbrig and prepare the necessary medical grounds so that our drug can contribute to resolving the unmet needs in the field. In the past, the Medical Affairs division mainly performed tasks to support other business divisions in the company, however, perception of the role of our department has started to change around 10 years ago. Medical Affairs now develops core strategies for new drugs, serving as a bridge between various business units as well as research and development. Also, the unit provides academic data and expertise to internal and external stakeholders in an objective and fair manner in compliance with the local code of medical ethics and regulations and provides academic advice. -At the time Alunbrig was introduced to Korea, other ALK-targeted therapies were already in the domestic market. Were there any difficulties due to this late entry? =Other treatments that were released before Alunbrig have brought treatment benefits to patients, however, unmet needs still existed in various areas, ranging from treatment effect, adverse events, quality of life, to convenience in administration. I believed that the introduction of Alunbrig could bring new treatment benefits that existing treatments were unable to provide. -What unmet need still remains due to characteristics of ALK-positive NSCLC in Korea? =ALK mutation occurs in around 4-5% of all NSCLC patients and occurs more commonly in women and Asian patients. Also, it is found more frequently in non-smokers compared to other NSCLCs and affects a relatively younger population in their 50s to 60s. Therefore, in addition to data on survival such as progression-free survival (PFS), other factors such as tolerance, medication adherence, and quality of life should also need to be considered collectively. The biggest unmet need in the treatment of ALK-positive NSCLC lies in brain metastasis and tolerance. This patient population has a higher risk of brain metastasis than other lung cancer patients. How long a drug can delay brain metastasis, and how effective the drug is in patients with brain metastasis must be considered. Also, people may have developed tolerance to TKI targeted drugs, therefore, how effective the drug is in such a population is also an important consideration. -With Alunbrig approved for insurance benefit in April as a 1st-line therapy, all ALK-targeted drugs introduced to Korea are now available with reimbursement from 1st line. What strengths does Alunbrig have over other ALK-targeted therapies with regards to its mechanism of action? How effective was the drug in patients with brain metastasis in clinical trials? =Unlike other existing treatments, Alunbrig was developed into a unique U-shaped platform. This structural design allows the drug to bind more strongly to the ATP attachment site that is used as an energy source when activating the ALK gene. In a preclinical trial, the drug selectively bound to ALK mutant variants to act stably in the body. Furthermore, Alunbrig demonstrated superior progression-free survival (PFS) and improved health-related quality of life (QoL) versus Xalkori, the existing first-line treatment option, in the Phase III ALTA-1L trial. In particular, in the second interim analysis, Alunbrig demonstrated superior clinical efficacy over Xalkori in the first-line setting regardless of brain metastasis in all ALK-positive NSCLC patients. Also, Alunbrig demonstrated a differentiated PFS improvement compared to Xalkori from early on in patients with brain metastasis that are difficult to treat. In addition, Alunbrig significantly reduced HR compared to Xalkori, to 0.25. So far, the data presented from the ALTA-1L trial only covers up to a two-year follow-up study by June 28th of 2019. We expect to see longer survival data when the final results are released soon. -Compared to other drugs that conducted investigator-assessed trials, the ALTA-1L trial was designed closer to the real world with BIRC-assessed endpoints. Why did the study choose to use BRIC-assessed results, which would have brought out more conservative results? =According to FDA guidelines, review from an independent evaluation committee can minimize bias. This is not essential in randomized, blinded clinical trials, however, as chemotherapy is often the standard treatment in cancer treatment, comparing this with oral anticancer drugs in a blinded trial is realistically not possible. This is why the trials are designed as open-label trials, in which case, BIRC assessment is required. We used BIRC-assessed primary endpoints according to the guideline recommended by the FDA to increase the objectivity and fairness of our trial. -How does Alunbrig affect patients with regards to their quality of life? = ALK-positive NSCLC occurs commonly in the socially active 50s. Therefore, studies on Alunbrig assessed the improvement in quality of life in addition to the drug’s efficacy. Assessed with the representative tool used for quality of life in cancer patients, EORTC QLQ-C30, the Alunbrig arm maintained the quality of life without worsening for 26.7 months vs. Xalkori. Also, convenience in administration is also an important factor to consider in long-term treatment. Many studies on long-term treatment experience from chronic diseases among others have shown that convenience in administration is very important for the quality of life and prognosis of patients. Alunbrig’s 1 tablet once daily administration is expected to contribute to the improvement of quality of life in these patients. *Dose and schedule of first-generation Xalkori is 1 tablet taken twice daily. Zykadia is taken in 3 capsules once daily, and Alecensa is taken in 4 capsules twice daily. -How was Alunbrig received in the field after being approved for reimbursement as first-line? Some have said that Alunbrig and Alecensa have similar efficacy in patients with brain metastasis. What is your view on this? =Alunbrig was positively reviewed by HCPs since being reimbursed as second-line treatment due to its good treatment effect in patients. With its reimbursement expanded in April, doctors have highly rated the drug as a new treatment opportunity for patients with an unmet need and for those who saw unsatisfactory effects from existing first-line therapies. Expectations were high as Alunbrig had shown high clinical effects in patients, but they were also highly satisfied in terms of convenience in administration. Also, the company’s efforts to promptly approve and reimburse Alunbrig in Korea as soon as it was approved as a first-line in the U.S. were positively received. Alunbrig and Alecensa have both shown better effects than Xalkori in clinical trials on patients with brain metastasis. We cannot directly compare the two drugs due to a lack of head-to-head study, however, patients should consider various aspects in addition to treatment effect, such as tolerance and convenience in administration when selecting their treatment. -Some patients hesitate using Alunbrig due to its pneumonia adverse reaction. =In the field, clinical practitioners have deemed that the symptoms after administering Alunbrig were similar to pneumonia, but is an EOPE (Early-Onset Pulmonary Events) that occurs temporarily. In some patients, symptoms similar to pneumonia may appear temporarily, but when the symptom is resolved early on, the symptom has the characteristic of not occurring again during the period of administration. Also, clinical experts in Korea have also said that EOPE symptoms are reversible adverse reactions that are fully manageable and can be quickly recovered.
- Company
- Chong Kun Dang loses 1st substance patient suit on ‘Xarelto
- by Kim, Jin-Gu Jul 08, 2021 05:58am
- Pic. of Xarelto Chong Kun Dang has lost its first trial targeting the substance patent of Bayer’s new oral anticoagulant (NOAC) ‘Xarelto(rivaroxaban).’ Whether Chong Kun Dang will modify its strategy to preoccupy the market through a release of its generic before substance patent expiry due to this ruling is gaining attention. On the 6th, the Intellectual Property Trial and Appeal Board (IPTAB) has ruled in favor of the original manufacturer Bayer, in a trial to confirm the passive scope of rights for Xarelto’s substance patent that was filed by Chong Kun Dang. Chong Kun Dang had solely challenged Xarelto’s substance patent in December last year. This was interpreted as a strategy made to overtake SK Chemicals and Hanmi Pharmaceutical that is currently leading the Xarelto generic market. SK Chemicals and Hanmi Pharmaceutical were the first to succeed in avoiding Xarelto’s formulation patent. The two companies finally won in December last year after the case went up to the Supreme Court, and secured exclusive marketing approval for Xarelto's 2.5mg formulation. However, both companies were unable to overcome the substance patent, and are unable to release the generic version until Xarelto’s substance patent expires in October this year. Chong Kun Dang made the bid for victory by challenging Xarelto’s substance patent. Then, in May, the company released its Xarelto generic 'Riroxia Tab.' 15mg and 20mg' in the market, before Xarelto’s substance patent expires. This was an attempt to preoccupy the market alone by avoiding the substance patent. Chong Kun Dang’s bold attempt was considered a risky game - if the company wins the case, the early release of its generic will not have constituted a patent infringement, but if it oses, it could bring serious repercussions from patent infringement. However, Chong Kun Dang lost the first trial. Based on the current situation, it has been analyzed that Chong Kun Dang's risky attempt is highly likely to fail and that Chong Kun Dang will have to bear the burden of patent infringement. For now, Chong Kun Dang is highly likely to appeal the case, as the higher courts may decide otherwise. Some industry officials also believe that even if Chong Kun Dang loses in the end, the end results will not be bad in terms of profit or loss. An official explained, “From Chong Kun Dang’s view, the profit gained by preoccupying the market while the patent suit is reviewed by higher courts may be greater than the compensation for damages that the company will owe to Bayer from the patent infringement."
- Company
- GC Pharma, the most likely company to produce Covivak
- by Nho, Byung Chul Jul 08, 2021 05:58am
- Chumakov Institute recently visited Andong Animal Cell Verification Support Center. Russia's Covivak is likely to be produced in domestic CMOs. According to industries, MPC, which is a South Korean corporation to introduce Covivak, recently signed a contract with Pharm Bio-tech, a Russian company that has rights to produce and publish in Russia, to acquire shares (37.5%). Among the domestic companies that invested in securing the stake, Wellbiotec, HumanN, and Nexton Bio became Pharm Bio-tech shareholders. MPC is also expected to establish a joint venture for Pharm Bio-tech and Covivak production, sales, and distribution in Korea to run vaccine businesses for ASEAN countries. The fact that it has become the second largest shareholder of Pharm Bio-tech, which has Covivak production and copyright, is interpreted as including technology transfer conditions, not just CMO production. It can also secure dividends based on sales performance of vaccine exports. This is in contrast to Samsung Biologics' production of Moderna COVID-19 vaccine CMO, which has yet to be confirmed whether or not the technology will be transferred. GC Pharma and Andong Animal Cell Demonstration Support Center are among the CMO and CDMO pharmaceutical bio companies that will produce Covivak. According to industry estimates, it takes about two months for the technology transfer of the Chumakov Institute researchers at the Russian Federal Academy of Sciences, and is likely to be completed by September at the latest. It is expected that production of Covivak will be possible around October. MPC, which is in charge of South Korea's Covivak business, said, "It is difficult to answer questions related to consignment production, consignment development and production." "However, all companies that are interacting agree that South Korea should become a global outpost for producing COVID-19 vaccines, and we will be able to produce positive results."
- Company
- Y-Biologics has transferred anti-cancer drug technology
- by An, Kyung-Jin Jul 08, 2021 05:58am
- Y-Biologics announced on the 6th that it has signed a license agreement with French pharmaceutical group Pierre Fabre for antibody candidates. The deal is worth up to 116.4 billion won, including upfront fee and Milestone. Under the deal, Y-Biologics grants Pierre Fabre the right to exclusively develop and commercialize YBL-003, which has been developed for solid cancer treatment purposes worldwide. YBL-003 is a type of Checkpoint inhibitor that controls macrophage function and T-cell activity to reactivate the immune system of the tumor microenvironment and kill cancer cells. It is an early-stage leading material, and milestones can occur whenever the development of YBL-003, such as preclinical and clinical, proceeds and reaches commercialization goals. Technical fees for sales are guaranteed separately. However, detailed contract terms such as initial down payment were not disclosed. Industry sources say that the license contract for YBL-003, which is an early stage of development, could be concluded because the two companies maintained a close cooperative relationship while conducting joint research since last year. They have agreed to study three targets every year and jointly study and transfer up to 15 targets during the contract period. The joint research contract between the two companies is three years, and the contract can be extended for the next two years. YBL-003 is considered highly likely to be used as an immune anticancer drug for solid cancer targets as it can expand its adaptations to stomach, lung and breast cancer. Pierre Fabre plans to develop a new design drug optimized for tumor treatment through preclinical and clinical development after the introduction of YBL-003. This contract is the first of 15 targets, and there is a possibility that additional contracts will be made in the future. Pierre Fabre is the second largest pharmaceutical group in France. Last year's sales amounted to 2.3 billion euros. Recently, while adjusting R&D priorities, it has focused on apothecary fields such as targeted treatment and immuno-tumorology. In addition to colon cancer, breast cancer, lung cancer, and melanoma, it is known that there is a high interest in pre-cancer diseases such as photokeratosis. Y-Biologics is a bio-venture that specializes in developing antibody new drugs based on its own platform. It was founded in 2007 by Dr. Park Young-woo, who has been working on antibody new drugs for 20 years in LG Life Sciences. It is discovering and developing various pipelines based on original technologies such as more than 100 billion kinds of human antibody library "Ymax-ABL" and dual antibody platform "ALiCE". It is currently in the process of listing on KOSDAQ through technical specials within this year. Earlier this year, it passed the screening, receiving A ratings from two professional evaluation agencies designated by the Korea Exchange, and filed a preliminary review of KOSDAQ listing in May. Park Young-woo, CEO of Y-Biologics, said, "I am very happy to sign the first license agreement with Pierre Fabre. As joint research is underway on another innovative target, we expect cooperation between the two companies to further develop innovative immune tumor treatments targeting the tumor microenvironment."
- Company
- MFDS in a month-long silence regarding Champix issue
- by Jul 07, 2021 05:54am
- Confusion in the field continues as the impurity issue of the smoking cessation treatment ‘Champix(varenicline)’ remains unresolved. Contrary to the U.S. and Canada, where the authorities preemptively provided guidelines to patients and HCPs while notifying them of the product recall and the possibility of impurities, the Korean health authorities have kept their silence for over a month. The Ministry of Food and Drug Safety had ordered Champix manufacturer Pfizer and other domestic manufacturers to investigate the impurities earlier last month. However, this fact was not publicly announced by the authorities and was disclosed through Dailypharm’s report on the 14th of last month. Pfizer had first stopped the supply of Champix, however, confusion remains in the field. The official notice that Pfizer had sent to distributors on the 11th last month did not indicate any possibility of impurities. In the notice, Pfizer wrote, “The product is out of stock due to supply shortage. We are experiencing a shortage due to disruptions in global distribution. We expect to resume supply from mid-July (subject to change).” An official from the distributing industry said, “We became aware of the impurity issue through the news article. We are still unsure whether to sell or keep the current inventory, and whether resupply will be possible from mid-July. We asked Pfizer directly but didn’t get a clear answer.” On this, an official from Pfizer said, “(The reason for not specifying the possibility of impurities) We were focusing on notifying the distributors of the shortage in supply.” The official continued, “We are doing our best to address the situation, from inspecting for impurities to preparing follow-up measures.” However, a month has passed since the issue arose, and still no guideline has been issued for the prescription and intake of Champix to inform patients and HCPs. This is in stark contrast to how the U.S. and Canada provided guidelines while announcing the recall due to concerns over impurities. On the 8th and 30th of last month, Canadian health authorities had advised HCPs to “Not dispense the 5 lots of Champix that were affected due to the potential safety risk posed by long-term exposure to this impurity, and consider using available alternative products on the market,” while announcing the recall of Champix due to safety concerns. On the 2nd of this month, the U.S. FDA has also alerted people of the” voluntary recall of nine lots of Champix.” The FDA advised “healthcare professionals to consider other available treatment options for the patient’s medical condition,” and that “patients should continue taking their current medicine until their doctor or pharmacist gives you a replacement or a different treatment option.” In addition, the FDA recommended Pfizer revise its recall to the consumer level so that medical institutions and patients may request a refund for the Champix currently in the market.” However, Korea’s MFDS has not announced any official position on this matter. This lead to patients newly being prescribed the drug even after the issue rose to the surface. “I only became aware of the impurity concern in an article after being prescribed the drug. I am taking medications for hyperlipidemia, so I specifically asked my doctor about precautions when taking the drug, and the doctor assured me there was no issue. I believe the doctor wasn’t aware of this impurity issue either. With no guidelines set on this matter, I am not sure whether I should start taking the Champix I was prescribed or not,” said one patient. It is yet unclear at which stage the 'N-nitroso-varenicline' impurity detected in Champix occurred, and what the standards are. Also, whether the problem is limited to some lots (manufacturing unit), or is an issue for the formulation itself that contains varenicline is uncertain.
- Company
- [Reporter's view] Korean patients to name specific drugs
- by Eo, Yun-Ho Jul 07, 2021 05:54am
- A growing number of patients are looking for specific "Rx drugs." Patients who wanted certain OTC by visiting pharmacies are now finding a doctor and wanting certain Rx drugs. It is said that the demand for prescription, which was made in the past in the line of original and generics, is even spreading to the area of anticancer drugs. Times have changed. Patients or their families are now searching for new drugs or the clinical trial database (clinicaltrial.gov). When domestic licensed drugs are not covered by insurance benefits, complaints are poured out to the HIRA, the MOHW. Cheongwadae's petition is no exception. A professor at a university hospital said, "Patients already know the concept of reimbursement and non-reimbursement, and they demand a combination of prescriptions for the drugs. Of course, I try to reflect the patient's expression as much as possible, but sometimes I'm embarrassed by ridiculous demands." For example, diabetes patients who were taking Sulfonylurea are asking for DPP-4 inhibitors or hypertension patients who were taking ARB single drugs are actually asking for prescription of ARB+CCB complex drugs. But the right to prescribe Rx is a doctor's own right. The public has delegated them to doctors with expertise for their health. Even if the public's level of knowledge is high and there is distrust in the current medical society, the prescription of Rx drugs should be prioritized by professionals' medical judgment.
- Policy
- Generic prices are 41-54% more expensive than foreign ones
- by Lee, Hye-Kyung Jul 07, 2021 05:53am
- The level of generic prices in Korea is 41 to 54% higher than that of foreign generics. This leads to an interpretation that if domestic generics are replaced with foreign medicines, 41-54% of costs will be reduced if only tariffs and transportation costs are compared. The findings were recently published by The Korean Association of Health Economics and Policy in its "The Cross-National drug price computing on the methods" (Korea University's College of Pharmacy, Bae Eun-mi, Choi Sang-eun, Kang Daewon, and Kyungsun Shin). To investigate generic drug price levels in Korea, we conducted a cross-national drug price comparison. Also, it was investigated whether the price level could differ when the price comparison method was changed. Bilateral comparisons with 15 countries were conducted for the top 23 molecules based on health insurance claims data. As a result, the price level of generic drugs in Korea was slightly different depending on the method, but it was overall higher than that of comparison countries. The weighted average price of generics was similar to that of the brand, and none of the launch date, the market share, and the number of competing items appear to affect the drug price level. This study has demonstrated the sensitivity of cross-national drug price comparisons to the methods used, including comparison countries, weights, and price type. A total of 23 ingredients are included in this analysis, and the 2016 claims for these drugs are about ₩2 trillion. It accounted for 18.4% of all claimed medicines at ₩800 billion. According to the analysis, the price level of generics in 15 countries could be seen as 61% to 78% of Korea on average (simple average comparison basis), and the average of Group A, which has a higher economic level than Korea, was 77% to 88% of Korea's drug price level. When usage weights are applied, the level of drug prices in foreign countries is lower, indicating 41%-54% of the level of drug prices in Korea. In terms of the level of drug prices by country, Switzerland and Japan were the only countries that could be said to have higher generic prices than Korea. Some countries, such as the United Kingdom and Germany, had higher generic prices than Korea, but it was not known at what level the actual price (the country's weighted average price) was formed between the highest and lowest prices. The price level of brand drugs was formed slightly higher than the generic weighted average in Korea, and the weighted average of generic drugs in Korea was located at the top of the overall generic price range. Korea's upper limit price included wholesale distribution margins and VAT without a separate retail margin, and the average of 15 countries was similar to that of Korea (94-114%) compared to that of other countries. The drug price level by ingredient was overwhelming for systemic antibiotics, digestive systems, and metabolic medicines compared to brand drugs, but the price was similar to brand drugs. When listed in order of the amount of claims, the Korean generic price was higher than the foreign generic price in the ingredients with high claims. The earlier the initial notice date, the higher the proportion of generic drugs used, but the lower the price compared to brand and foreign generic prices. Although the generic share of ingredients with a large number of items was high, the price level was not lower than that of foreign countries, apart from the presence of competition. "Considering that most countries (excluding the UK) in the analysis use a reference pricing system and that there will be price competition between generics, it can be assumed that there will be more use of low-cost generics," the research team said.
