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- 2026-04-10 18:48:20
- Opinion
- [Reporter's view] Implications of Lucentis biosimilar
- by Lee, Tak-Sun Feb 27, 2023 05:57am
- The domestic prescription drug market is not a market where prices can operate with competitiveness. This is because paying patients do not have the option to choose a product, and doctors who have the option do not have a margin on sales of insurance drugs, so there is little incentive to prescribe low-priced products. Because of this, even generics that sell products with the same ingredients want a higher insurance limit. However, in the product market where treatment costs are high and the number of products is small, price competition sometimes takes place. A good example is Lucentis biosimilar, a treatment for macular degeneration. Only two companies, Chong Kun Dang and Samsung Bioepis, entered the market for Lucentis biosimilars in January. Both companies put pressure on the original Lucentis by setting an upper limit that was less than the calculated amount. Chong Kun Dang's generic price is 300,000 won per bottle, which is only 36.6% of the original price limit of 820,636 won. Samsung Bioepis Amelivu was listed at 463,773 won, 56% of the original 828,166 won. In the case of biosimilars, you can receive an upper limit of 80% of the original amount, but the two companies were listed at a lower price than this in consideration of price competitiveness. Samsung Bioepis Amelivu will lower the price again in March. It will be reduced by about 24.5% from the existing 463,773 won to 350,000 won. Some analyze that they were conscious of the lowest price Chong Kun Dang products. Such voluntary cut competition is very welcome from the perspective of health insurance authorities. This is because companies can see the effect of reducing insurance financial expenditures as a result of voluntary cuts. Drugs that are cheaper than the calculated amount play a role in reducing finances, but there is no great benefit either. Products with scheduled sales prices that are lower than the calculated amount may also be subject to a drug price reduction by applying PVA. If the upper limit is not lowered during the PVA monitoring period, it will be subject to the same follow-up management as other products. There are also few government incentives to enhance the market competitiveness of low-cost drugs. Although there is a policy that provides incentives to pharmacists if they substitute cheaper drugs among the same-component drugs, it is not easy for pharmacists who do not have the right to choose prescription drugs. It is difficult for patients as well as medical staff to compete for low-cost drugs in a situation where the reliability of originals is much higher than that of latecomers such as generics or biosimilars. Therefore, low-price competition is entirely the responsibility of pharmaceutical companies. Doctors who have the right to choose products should be persuaded of the justification for choosing low-cost drugs. We hope that the low-price strategy of the two pharmaceutical companies will lead to success in the Lucentis biosimilar market. It is hoped that price cuts will be activated through the appearance of low-cost drugs that are rare and competitive in the domestic market, and that this will serve as an opportunity to increase the reliability of generics. The government should also promote the positive function of generics to the market by implementing more aggressive incentive policies for pharmaceutical companies that sell low-cost drugs.
- Company
- Will Luxturna will be deliberated by DREC for reimb?
- by Eo, Yun-Ho Feb 27, 2023 05:56am
- Industry attention is focused on whether progress will be made in discussions for the reimbursement of the one-shot retinal dystrophy treatment Luxturna. It was found that it is highly likely that Novartis Korea’s Inherited Retinal Dystrophy (IRD) treatment Luxturna (voretigene neparvovec) will be presented as an agenda for deliberation by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee next month (March). Although the company applied for reimbursement of the drug in September 2021, no progress had been made on its listing since then. Being a high-priced one-shot treatment for a non-life-threatening condition, these factors have acted as a barrier to the reimbursement listing until now. By replacing the defective or defective RPE65 gene - one of the causes of IRD - with a normal gene, Luxturna restores the visual function of an IRD patient with a single administration. In other words, the drug provides a fundamental cure for IRD. Therefore, the passage depends on how well the company conveys the value of Luxturna in preventing blindness to the authorities. In the U.S., the drug was granted a Breakthrough Therapy Designation by the FDA in 2014, the drug was approved as an orphan drug in 2016, then granted priority review and a fast-track designation in 2017. IRD is a rare intractable disease in which vision loss occurs due to mutations in genes responsible for the structure and function of retinal photoreceptors. In addition to over 20 ophthalmologic diseases, there are currently over 300 genes that have been identified as being associated with IRD. IRD, which is caused by the mutation in the RPE65 gene, causes abnormalities in the visual cycle of the retina that converts visual information into a neural signal and delivers it to the brain. The mutation in the RPE65 gene reduces the RPE65 protein essential to the visual cycle and destroys the retinal cell, gradually narrowing the field of vision to eventually result in blindness. Meanwhile, the efficacy of Luxturna was demonstrated through a Phase III trial that was conducted on IRD patients with confirmed biallelic RPE65 mutations. Study results showed that the group of patients that received Luxturna demonstrated statistically significant improvements in their functional vision compared to the control group at one year of treatment. Using the mean score of the multi-luminance mobility test (MLMT), which evaluates the ability to complete the obstacle course at low light levels by recreating the daily walking environment, as the primary endpoint at one year of treatment, the MLMT score change in the Luxturna treatment group was 1.8 points, which was 1.6 points higher than the 0.2 points in the control group.
- Policy
- The value of pharmaceutical bio innovation is reflected
- by Lee, Jeong-Hwan Feb 24, 2023 05:53am
- Second Vice Minister Park Min-sooSecond Vice Minister of Health and Welfare Park Min-soo promised to support the biopharmaceutical sector by implementing drug pricing policies that reflect innovative values and improving the certification system for innovative pharmaceutical companies. Vice Minister Park also asked biopharmaceutical companies to make efforts to create blockbuster new drugs and jobs through bold technology development investment and open innovation. Vice Minister Park made this announcement at the '78th KPBMA regular general meeting' held at the KPBMA on the 21st. Vice Minister Park said, “The biopharmaceutical industry is at a very important juncture in leaping into the global market by having the capacity to develop innovative new drugs and to produce and export high-quality, large-scale medicines.” “We will support our biopharmaceutical industry to grow to the level of sixth in the global market through the establishment of mid- to long-term strategies such as a roadmap for regulatory innovation in the health sector and manpower training plans,” he said. Vice Minister Park said, "We will strive to improve related systems such as drug prices and innovative pharmaceutical company certification systems to appropriately compensate for the value of corporate innovation and ensure a stable supply of essential medicines." Please create blockbuster-level new drugs and create more jobs." Afterward, Vice Minister Park presented the Minister of Health and Welfare Commendation to five people of merit and expressed gratitude for their hard work in the pharmaceutical bio industry.
- Opinion
- [Reporter’s View] Decide whether to offer free HCV testing
- by Jung, Sae-Im Feb 24, 2023 05:53am
- Eight years have passed since discussions began on adding hepatitis C (HCV) screening as a free item in Korea’s national health examination program. Despite various supporting evidence that was produced during the period, including the feasibility study that started in 2016, and an analysis that showed that it was cost-effective to include HCV as a national health examination item, as well as the results of the pilot project, the government's intentions are still unclear. Recently, more feasibility analyses and follow-up management measures have also been released on the matter. One of the major reasons why the government was reluctant to introduce HCV screening to the national health examination was its prevalence rate. The first principle among the five conditions that must be satisfied for items to be added to the system is for the disease to be a ‘serious health condition,’ which is evaluated by whether the prevalence rate is 5% or higher. However, the prevalence rate of HCV is around 1%, therefore being unable to satisfy the condition. Its highest prevalence rate is in the 1.7% range for those aged in their 70s. Although the global prevalence rate of HCV remains below 1%, the World Health Organization has a different view on the gravity of the situation. The WHO had set the goal of eradicating HCV by 2030 and urged governments to actively implement policies on their part to achieve this goal. This goal was set as HCV can be easily cured with early diagnosis with the development of treatments, but also carries an increased risk of developing severe diseases such as liver cirrhosis or liver cancer when left untreated. The direct-acting antiviral (DAA) medications that were introduced to the field led to the era of curing HCV. Also, a retreatment option exists for the 1% of patients who fail treatment. This is why the WHO defined HCV as the next disease that can be eradicated after the smallpox virus. Even so, Korea is still stuck on the prevalence rate. An official from the Ministry of Health and Welfare who had attended the ‘32nd Conference of the Asian Pacific Association for the Study of Liver 2023 (APASL 2023),’ mentioned the prevalence rate of HCV in Korea, saying “Korea has a national health examination system in place for all citizens. Therefore, adding HCV screening as an item to the system can have a serious impact, and items should be careful and conservatively added in strict compliance with the set principles.” The remark seems to have been made to imply the authorities' stance on whether HCV screening, which has a low prevalence rate, should be included in the health examination system that is for the entire Korean population. If the prevalence rate was going to be a barrier in the first place, the government wasted more than KRW 1.3 billion in research funds on a concluded issue. No matter how cost-effective the introduction of hepatitis C screening is, all discussions become meaningless if the government raises prevalence as an absolute requirement. But diseases with a prevalence rate of less than 5% are already included for screening in the national health examination system. Therefore, the prevalence rate cannot be an absolute criterion for introducing items in the national health examination system. The government will soon be reviewing the research results that were newly presented this year. If it mentions the prevalence rate again this time, it would be safe to interpret their stance as saying, “Actually, the prevalence is just an excuse and the government has no intention of investing money in HCV." After 8 years of false hope, now is the time to draw a conclusion already.
- Company
- US approval of Celltrion Yuflyma was delayed
- by Feb 24, 2023 05:53am
- Celltrion has confirmed that the U.S. Food and Drug Administration (FDA) will complete the Yuflyma final approval review by May of this year. Celltrion announced on the 23rd that it had confirmed that the final approval review of Yuflyma would be completed by May of this year while continuing discussions with the FDA. Earlier, the U.S. approval process for Yuflyma was somewhat delayed as foreign finished drug manufacturers in charge of finished product production received criticism from the FDA. Celltrion emphasized that the delay in FDA approval of Yuflyma was due to the situation of overseas finished manufacturing plants that had nothing to do with Celltrion's own technology. Overseas finished drug manufacturing plants received an appropriate grade by resolving the issues pointed out after FDA inspections. The conformity level is a level given when a manufacturer voluntarily requests corrective action when unreasonable matters are found but the violation is not serious. Celltrion Group will be able to sell Uplyma in the US from July 1 after reaching a patent agreement with a company that owns Yuflyma's original drug. Apart from FDA approval, we are working on a pre-work to introduce the product to the US market in time for the launch. Celltrion Healthcare acquired Celltrion USA in August last year for direct sales in the United States, securing a license and distribution network for pharmaceuticals in the United States. It has completed securing local experts to lead the US business by recruiting Thomas Nusbickel, who has extensive experience in biosimilar commercialization at global pharmaceutical companies, as CCO of the US corporation.
- Company
- Shingrix may be prescribed in 93 general hospitals in Korea
- by Eo, Yun-Ho Feb 24, 2023 05:52am
- The shingles vaccine ‘Shingrix’ has quickly landed in medical institutions in Korea after starting vaccinations. According to industry sources, GSK Korea’s recombinant vaccine Shingrix passed review by drug committees of 93 medical institutions in Korea, including tertiary hospitals - Samsung Medical Center, Seoul National University Hospital, Asan Medical Center - as well as general hospitals - Kangbuk Samsung Medical Center, Kyung Hee University Medical Center, Korea University Hospital (Buro, Anam, Ansan), Soonchunhyang University Hospital Seoul, Ajou University Hospital, and Hanyang University Hospital. Considering how vaccination had started in December in earnest, the vaccine has settled quickly in the market. Shingrix is the first shingles vaccine approved in Korea that combined a non-live antigen with GSK's vaccine adjuvant. It offers protection from shingles in adults over 50 who are at increased risk of shingles from age-related decline in immunity. In two Phase III clinical trials (ZOE-50, ZOE-70) that were conducted on 15,411 adults aged over 50 years of age, Shingrix showed a 97.2% efficacy compared to the non-vaccinated group and over 90% efficacy in those aged 70 years and above. The rate of serious adverse events was similar in the Shingrix arm and the placebo arm. The interim analysis of the ZOSTER-049 (ZOE-LTFU) extension study that was conducted to follow up ZOE-50 and ZOE-70 showed that Shingrix’s shingles prevention effect continued for at least 10 years after vaccination. Also, Shingrix’s safety profile was confirmed through 5 clinical trials that were conducted on immunocompromised patients aged 18 years and older. Based on such evidence, patients who received autologous hematopoietic stem cell transplantation or have solid cancer, blood cancer, or received solid organ transplants that have an increased risk of shingles are also eligible to receive vaccination with Shingrix. Kyung Young Yoon, Professor of Infectious Disease at Korea University Anam Hospital, said, “Complications from shingles greatly reduce patients' quality of life. Therefore, it is important to prevent this in advance. As the first and only non-live recombinant vaccine approved in Korea that demonstrated a prevention effect and safety profile through global clinical trials, I believe Shingrix will open a new paradigm in shingles prevention in Korea.” Meanwhile, GC Biopharma and Kwangdong Pharmaceutical signed a co-promotion and distribution agreement with GSK for Shingrix in Korea and are carrying out promotional activities for the vaccine.
- Policy
- Expansion of insurance coverage for diabetes drugs
- by Lee, Tak-Sun Feb 24, 2023 05:52am
- SGLT-2 inhibitory antidiabetic drugs (from left: Forxiga, Jardiance, Xigduo XR, Jardiance Duo)While the combination benefit between SGLT-2 diabetes treatment and other treatments is expected to be applied from April, the two-drug regimen between SGLT2 and DPP4, which was omitted from the current discussion, is also expected to be reviewed. It is expected that if the SGLT2+DDP4 complex is applied for reimbursement, it will naturally be sorted out through discussion. According to the industry on the 23rd, some SGLT2+DPP4 combinations have applied for reimbursement to the HIRA. It is known that AstraZeneca's 'Qtern', Boehringer Ingelheim's Esglito, and LG Chem's SGLT-2 inhibitory antidiabetic drugs (from left: Forxiga, Jardiance, Xigduo XR, Jardiance Duo) applied for benefits. MSD's Steglujan is also expected to apply for benefits sooner or later. These items are being promoted to be registered as a benefit in time for April when the benefit is expanded. This is because they are products developed by the original developer of original ingredients, so they can be registered as products regardless of patents. However, 82 products of Dapagliflozin + Sitagliptin approved by domestic pharmaceutical companies are scheduled to be registered after September 1, when the substance patent for Sitagliptin (Januvia) expires. While pharmaceutical companies with combination drugs welcome the news of an increase in reimbursement, attention is focused on whether reimbursement for two-drug combination therapy is also applied. The concomitant benefit drugs currently being discussed for benefit expansion are triple therapy such as metformin + SGLT-2 + DPP-4, metformin + SGLT-2 + TZD, and some SGLT-2 items + sulfonylurea or insulin combination therapy. This is because the 2+DPP-4 two-drug regimen is missing. If the benefit expansion plan is applied as planned, the two-drug combination of SGLT2 + DPP4 should be used as a three-drug regimen with Metformin. As SGLT2 or DPP4 drugs are currently used alone, the pharmaceutical industry insists that these two-drug therapies should also be covered. The HIRA believes that if the SGLT2+DPP4 complex is applied, it is highly likely that the second drug will also be reviewed. An official from The HIRA said, “If a two-drug combination drug is applied for, we will not organize traffic regarding whether or not the second drug will be covered.” There is," he explained. If the review of whether or not to pay for the second system is prolonged, it cannot be ruled out that the third system will be started first, and whether or not the second system will be covered will be discussed later. Judging from the discussion so far, the three-drug combination of metformin + SGLT2 + DPP4 is advantageous in terms of ease of administration, but there are currently no domestically approved drugs.
- Policy
- Daewoong also enter the Vemlidy late-stage drug market
- by Lee, Tak-Sun Feb 23, 2023 05:46am
- Gilead’s hepatitis B treatment Daewoong Pharmaceutical and Chong Kun Dang will also enter the late-stage drug market for Vemlidy, a chronic hepatitis B treatment previously occupied by Dong-A ST. Daewoong and Chong Kun Dang's products received a month's delay in obtaining approvals, and their benefits were also applied a month later. According to the industry on the 20th, from March 1, Daewoong Pharmaceutical's Vemlidy and Chong Kun Dang's Tenofobell-A will be covered. The two products are salt-modifying drugs of Gilead Sciences' 'Vemlidy'. Daewoong Vemlidy has Tenofovir Alafenamide HemiFumarate as the main ingredient, and Chong Kun Dang Tenofobell-A has Tenofovir Alafenamide Succinate as the main ingredient. These products succeed in the patent challenge through salt change, obtain generics for exclusivity, and are released before generics when the patent has not expired. The drug price calculation standard for salt-changing drugs is 90% of the original. Daewoong Vemliver costs 2828 won, which is 80% of the original Vemlidy (3,535 won). Chong Kun Dang Tenofobell-A costs 2,439 won, which is 69% of the original price. This amount is cheaper than Donga ST Vemlia's 2,474 won, which was previously applied for benefits. Each generic has a different drug pricing strategy, and it is noteworthy how it will affect market sales. Meanwhile, Jeil Pharm's 'Tecavir-D', which was licensed in the same month as Daewoong's and Chong Kun Dang's, is not on the March reimbursement list. Vemlidy is an upgraded version of Gilead's existing hepatitis B treatment 'Viread'. The patent is scheduled to expire on August 15, 2032, and a generic drug with the same ingredient will have to wait another nine years. Last year, Vemlidy's outpatient prescriptions (based on UBIST) were 47.1 billion won, up 18% YoY.
- Policy
- 9 bepotastine besilate antihistamines listed for reimb
- by Lee, Tak-Sun Feb 23, 2023 05:46am
- Leading bepotastine besilate product Sustained-release antihistamine drugs that contain bepotastine besilate will be listed for reimbursement for the first time in Korea. The original bepotastine besilate product developed by Mitsubishi Tanabe Pharma Corporation is Tarion. Tarion was sold by Dong-A ST in 2004 in Korea, and the company withdrew from the Korean market in December 2017 after the drug’s patent expired. Therefore, only its generics that contain the same ingredients and salt-modified products are currently being sold in the Korean market. According to industry sources on the 21st, 9 sustained-release antihistamine products will be listed for reimbursement at a ceiling price of KRW 326 from March 1st. Companies that own related products are the CMO Dongkoo Bio&Pharma, and Mother’s Pharmaceutical, Eden Pharma, Yungjin Pharm, Kukje Pharma, Shin Poong Pharm, Hutecs Korea Pharmaceutical, Myungmoon Pharm, and Union Korea Pharm. This is the first time a sustained-release product that contains bepotastine besilate was listed, and currently ninety-two 10mg bepotastine besilate is taken twice a day, and one once-daily 5mg product is available in the market. Currently, the ceiling price for all the 10mg products is KRW 148 per tablet. By daily dose, the 10mg short-acting drugs cost KRW 296, which is cheaper than the sustained-release drugs, which cost KRW 326. In addition to bepotastine besilate, bepotastine salicylate products that contain a different salt is also available. Also, there are sustained-release products available for bepotastine salicylate. 5 short-acting products and 6 sustained-release products are available each. The ceiling price for these drugs is also KRW 148 for the short-acting product and KRW 326 for the sustained-release products. However, bepotastine besilate products have been showing better performance. Among the major items, Dong-A ST’s Twolion sold the most, recording KRW 9.5 billion in outpatient prescriptions (UBIST), followed by the KRW 4.6 billion made by Daewon Pharmaceutical’s Bepostarbi, then KRW 3.2 billion by Dong Kook’s Bepotan. Among the three products, Twolion and Bepostarbi are bepotastine besilate products and Bepotan is a bepotastine salicylate product. Although the salt-modified sustained-release tablets did not perform so well in the market until now, as sustained-release tablets that contain the same ingredient as the original were released, attention is being paid to whether they will break the existing market structure and drive the market. Antihistamines work as antagonists to excess histamine caused by antigen-antibody reactions and is used for allergic conditions and early cold treatment. In the early days of COVID-19, the market size shrank with the decline in the number of respiratory patients, but last year, it was also used for COVID-19 patients, which led to an upward trend. However, it is difficult for individual companies to develop their products into blockbusters. Competition is fierce in the market with over 100 generics and salt-modified products, and there are several second- and third-generation antihistamines including bepotastine, therefore, it is not easy to foster one product. However, even if the drugs cannot become a blockbuster, the drugs show performance continuously, therefore, industry officials expect the sustained release products can also successfully settle in the market, with sales and marketing activities.
- Company
- Tabreca can now be prescribed at general hospitals in Korea
- by Eo, Yun-Ho Feb 23, 2023 05:46am
- The first MET-targeted anticancer drug, ‘Tabrecta’ can now be prescribed at hospitals in Korea. According to industry sources, Novartis Kore’s Tabrecta (capmatinib) passed the drug committees of the Big-5s general hospitals including Samsung Medical Center (SMC), Seoul National University Hospital (SNUH), Sinchon Severance Hospital, and medical institutions including the National Cancer Center, Pusan National University Hospital, etc. MET mutation is a rare type of cancer that is present in approximately 3-4% of patients with non-small-cell lung cancer (NSCLC). No treatment option had been available in this type until now, which is why attention has been rising for new drugs in the area. Tabrecta targets c-MET and was first approved as a treatment for MET exon 14 skipping mutation in NSCLC in the US in May 2020. However, the issue of reimbursement still remains an obstacle. The company applied for reimbursement in November 2021 after receiving marketing authorization in Korea. However, the agenda was unable to pass review in both Health Insurance Review and Assessment Service’s Cancer Disease Review Committee meetings in August and last month this year. Whether Novartis will apply for and succeed in listing the drug for reimbursement remains to be seen. The drug’s efficacy was confirmed through the GEOMETRY mono-1 trial in 97 patients with METex14. In the pivotal GEOMETRY mono-1 trial, Tabrecta demonstrated a 68% objective response rate (ORR) and 41% ORR in treatment-naïve and previously treated patients, respectively. The duration of response (DoR) was 12.6 months and 9.7 months, respectively. Meanwhile, Novartis is also actively studying the combined use of Tabrecta with other therapies. In particular, its combined use is expected to be able to address the issue of resistance that patients acquire after treatment with EGFR inhibitors. As such, combined use of Tabrecta with AstraZeneca’s 3rd generation EGFR TKI Tagrisso (osimerbinib) is also underway. More specifically, the study will evaluate the treatment effect of Tabrecta+Tagrisso in comparison to platinum-based chemotherapy in NSCLC patients with epidermal growth factor receptor (EGFR) mutation, T790M negative, MET-amplified who progressed following treatment with 1st/2nd generation EGFR tyrosine kinase inhibitors (TKIs) or Tagrisso. Professor Ji-Youn Han, Department of Hemato-oncology, National Cancer Center, said, “Patients who have MET amplification or overexpression have a very poor prognosis. In this sense, with the prompt introduction of MET inhibitors becoming ever important, the approval of Tabrecta, a treatment that demonstrated clear efficacy in MET exon 14 skipping mutation, holds great significance.”
