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- 2026-04-08 16:59:22
- In-Hwa Choi will become KRPIA's new Policy Director
- by Eo, Yun-Ho Jan 16, 2024 06:08am
- KRPIA's head of policy position, which had remained vacant for about a year, is soon set to be filled. According to industry sources, the Korean Research-based Pharmaceutical Industry Association (KRPIA) recently named In-Hwa Choi (60), current Access and Policy Head at Roche, to oversee the association's policy business. Choi will succeeding the former Director Min-Young Kim (53, current Director of Market Access at Gilead Sciences Korea) who resigned in February last year. The new Director Choi will retire from her role as Access & Policy Cluster Lead at Roche this month (January). KRPIA has been operating without a policy lead for about a year after its former Director Min-Young Kim left to work as the Head of Market Access (MA) at Gilead Sciences Korea. Therefore, Choi's appointment is expected to strengthen the association's capability to engage in policy-related external activities. Director Choi graduated from Ewha Womans University College of Pharmacy and started her career as a public pharmacist for the Central Pharmaceutical Affairs Council. After working at Boryuong Pharmaceutical and Taejoon Pharmaceutical, she joined Roche in 2001, where she has been in charge of policy-related businesses such as market access (MA) and regulatory affairs (RA) for over 2 decades.
- Company
- Reimbursed drugs hit four-year low amid regulatory changes
- by Chon, Seung-Hyun Jan 16, 2024 06:08am
- The number of drugs on the health insurance reimbursement list has reached its lowest point in four and a half years. Due to pricing revisions for generic drugs and regulations related to joint development, the introduction of new drugs is significantly reduced. The number of approvals has decreased by more than 70% compared to the figures from four years ago. According to the Health Insurance Review and Assessment Service (HIRA) report on the 16th, the total number of drugs listed on the reimbursement listing as of January 1st was 22,889. This represents a decrease of 754 drugs compared to 23,643 drugs listed in January of the previous year. Furthermore, the number of reimbursed drugs has reached its smallest in four years and four months, compared to 22,912 drugs reimbursed in September 2019. The number of drugs listed for reimbursement peaked at 26,527 in October 2020 and has been steadily decreasing. Over the course of three years and three months, there has been a decrease of 3,638 drugs. In other words, 3,638 more drugs have been either withdrawn from or forced to exit the market compared to new drug entries into health insurance reimbursements in the past three years. The number of listed drugs for reimbursement was 20,689 in November 2018, and it increased to 26,527 in October 2020, increasing by 5838 in just a year and eleven months. Over this period, the volume of listed drugs for reimbursement expanded by 28.2%, demonstrating that new drug entries exceeded market exits. Out of the 22 months from November 2018 to October 2020, December 2019 witnessed a decrease in the number of listed drugs compared to the previous year. In other words, for the remaining 21 months, the scale of listed drugs was larger compared to previous months. In contrast, the number of listed drugs for reimbursement has consistently declined. While there was an increase of 497 more drugs listed over the two months from October to November 2023, this increase is a temporary phenomenon attributable to the opening of the generics market for diabetes drugs. During this period, as the patent for the diabetes treatment ‘sitagliptin’ expired, a significant number of generic products entered the reimbursement listing. Sitagliptin is an active ingredient in the DPP-4 inhibitor-class diabetes treatment ‘Januvia.’ The number of currently listed drugs reached its lowest point in 33 months, following a total of 25,694 in February 2020. The number of listed drugs for reimbursement has significantly decreased as a result of the revision to the drug pricing system. The decrease in the number of reimbursed drugs since 2020 was primarily initiated by the revised drug pricing system. The revised drug pricing system, implemented in July 2020, requires generic products to meet both bioequivalence testing and the use of registered raw materials to maintain a maximum reimbursement price of 53.55% compared to the current patent-expired original drugs. The revised drug pricing system includes a stepped pricing system, which involves a lower maximum reimbursement price for drugs that are newly listed for reimbursement. If there are twenty or more generic versions available for a specific active ingredient in the market, the maximum reimbursement price for newly listed items can be set at up to 85% of the previous lowest price. Because the drug pricing significantly decreases when a pharmaceutical company does not develop the drug itself or undergo bioequivalence testing, generics produced by Contract Manufacturing Organizations (CMOs) have seen a more substantial decline in approval. Recently, the number of approvals for prescription drugs has significantly declined. Last year, the number of approvals for prescription drugs was 1,046, showing a decrease of 6.4% compared to the previous year. Compared to 2021, which had 1,600 approvals, there was a 34.6% decrease in approvals over two years. Since 2019, when there were 4,195 approvals, the scale of approvals for prescription drugs has shrunk by 75.1% over four years. Compared to four years ago, the number of approvals for prescription drugs decreased by 3,149. The number of approvals for prescription drugs was 1,562 in 2018, averaging 130 approvals per month. In 2019, this figure increased to 4,195, more than doubling to an average of 350 approvals per month. By May 2019, the monthly approvals reached 584. However, starting in 2020, it gradually declined and returned to the previous year’s level. From October 2018 to July 2020, over 100 prescription drugs were approved each month. However, in August 2020, after 23 months, the number of approvals for prescription drugs dropped to less than 100 per month. Last year, there were only two months with over 100 approvals for prescription drugs. The regulatory barriers for approvals have also been raised. Starting in July 2021, with the implementation of the revised Pharmaceutical Affairs Act, the number of incrementally modified drugs (IMD) and generics that can be approved through a single clinical trial has been limited. This new regulation, known as the '1+3' rule, restricts the number of IMD and generics approved through a single clinical trial. When a pharmaceutical company conducts bioequivalence tests directly and manufactures the drug in the same facility using the same prescription and manufacturing method for all production processes, the utilization of bioequivalence data is restricted to three times. In other words, only four generics can be approved based on one set of bioequivalence tests. Clinical trial data is also limited to products from the pharmaceutical company that conducted the tests directly, in addition to three other products for which a clinical trial data agreement is possible. In the past, when a particular pharmaceutical company obtained approval for generics through bioequivalence testing, other pharmaceutical companies frequently used the same documentation for obtaining approvals for CMO generics. However, due to the regulation of joint development, the "unlimited copying phenomenon of generics" has become practically impossible. There are criticisms suggesting that the government may have played a role in the increase in generic drug approvals in 2019 and 2020. The government's measures at strengthening regulating generics may have resulted in this surge in generic approvals. In 2018, there was a ban on the sale of 175 pharmaceutical products containing the active ingredient valsartan, used to treat high blood pressure, due to excessive impurities. In response, the Ministry of Health and Welfare (MOHW) and the Ministry of Food and Drug Safety (MFDS) established the "Committee for Improving Generic Drugs Policies" to formulate measures to control the excessive production of generics. However, as pharmaceutical companies attempted to secure generic products in advance, there was a temporary surge in generic approvals. Following the government’s regulatory revision, the number of generic approvals returned to previous levels.
- Company
- 'Discussing Rinvoq based on Korean RWD'
- by Eo, Yun-Ho Jan 15, 2024 05:47am
- Professor Ahn Ji Young, affiliated with the Department of Dermatology at the National Medical Center The value of Real World Data (RWD) increases in areas where the development of new treatment options has been slow, primarily due to insufficient medical field experience and limited information beyond randomized controlled trials (RCT). Atopic dermatitis is one of the fields that has seen a shortage of new drugs in the past. However, in recent years, there have been notable shifts in prescription patterns, with the inclusion of JAK inhibitors and interleukin inhibitors. Amidst ongoing developments, Korean researchers have unveiled RWD research findings related to the JAK inhibitor 'Rinvoq (upadacitinib)' in Korean patients. The study, led by Professor Ahn Ji Young from the Department of Dermatology at the National Medical Center, involved a retrospective analysis of the medical records of 85 atopic dermatitis patients who were treated with Rinvoq for a minimum of 16 weeks between Oct. 2021 and Dec. 2022 at the National Medical Center. As as result, Rinvoq demonstrated clinically significant improvements in patients with moderate to severe symptoms, as indicated by evaluation parameters including the Eczema Area and Severity Index (EASI), Pruritus numerical rating scale (pNRS), Life Quality Index (LQI), Patient-Oriented Eczema Measure (POEM). DailyPharm sat with Professor Ahn for an interview. -What was the background for conducting the RWD research in Korea? RCTs were available, but there could be disparities between RCT data and data collected from patients in real-world clinical settings. Furthermore, overseas data frequently originate from research that primarily involves Caucasian populations. While the drug dosage may be the same, variations can arise in the medical environment and conditions between Asian or Korean patients and those in other countries. There are also situations that cannot be satisfied solely through overseas clinical studies. Considering these factors, the objective was to acquire data customized for Korean patients. With this data, it will be possible to share information with medical professionals in Korea, potentially leading to more effective patient treatments in the future. -What was the research design? This research was not originally planned as part of the study but was conducted retrospectively after the data had already been collected. Once a substantial volume of patient data had been gathered, we analyzed the data from these patients, covering periods from the start of treatment up to 2, 4, and 16 weeks, in order to monitor changes in the patients' conditions. In addition, we assessed various parameters including pNRS, DLQI, POEM, ADCT, and others. Furthermore, we examined the types of side effects experienced by patients during treatment and identified which drugs had proven effective for those who showed improvement. We evaluated various conditions to determine which aspects indicated a positive response in patients. The research findings showed that Rinvoq demonstrated a rapid onset of action during the early stages of treatment, particularly in patients with elevated eosinophil counts. This research has allowed us to identify points that could be beneficial for patients. -Can eosinophil count possibily be a biomarker? Yes. Patients with high eosinophil counts may experience positive effects from Rinvoq treatment, and we concluded that this outcome can be explained through a specific mechanism. -What were the conditions of patients? Based on the data from patients with atopic dermatitis lasting for 16 weeks or more between 2021 and 2022 at the National Medical Center, it was found that there was a slightly higher proportion of males among these patients. Typically, these patients had developed atopic dermatitis during childhood. Approximately 19% of patients developed the condition after reaching adulthood. Many patients often mention that they developed atopic dermatitis after reaching adulthood. However, upon further inquiry, it is common to find that these patients actually experienced atopic dermatitis during childhood, but it improved during that time and then worsened again after they became adults. -Any other prominent results, in addition to eosinophil counts? Based on the research results, we examined which parts of the body showed the most improvement. In terms of the body, there was overall improvement. There were concerns about the effect of interleukin inhibitors like "Dupixent (dupilumab)" on the condition of the head and neck, but Rinvoq showed improvement across various body parts. In terms of symptoms, lichenification and excoriation were more common in the acute phase, especially lichenification tended to become hardened in the chronic phase. These symptoms improved rapidly, and patients expressed high satisfaction with these improvements. -Can it be seen as the characteristics of JAK inhibitor? Rather than categorizing it as a JAK inhibitor, it is seen more as a distinctive feature of Rinvoq. Among Korean and Asian atopic dermatitis patients, lichenification is often observed, so the improvement of lichenification is a highly significant aspect. Although not yet conclusive, with more data in the future, it may be possible to say that this drug is particularly effective for Asians. However, the issue is that there was a significant occurrence of acne. While it typically appears in clinical trials at around 10%, in this research, it was observed in nearly 40% of cases. Additionally, It was observed that the incidence of acne decreased with an increase in age. -What are the benefits of Rinvoq found from the research? The key benefits include rapid onset of action and its effectiveness in improving itching. In real-world clinical practice, Rinvoq is the preferred treatment option when patients suffer from itching, -Are all JAK inhibitor and interleukin products covered by insurance? Are there any frustrations regarding the current reimbursement criteria? One of my frustrations would be the switching. Doctors affiliated with the Korean Atopic Dermatitis Association might agree to this. It's indeed a challenging situation when a patient is unable to switch to another medication, even when the initially prescribed drug proves to be ineffective. Since accurate biomarkers are not available, medical professionals often face difficulty in determining the most suitable medication for a patient right from the start. Therefore, switching should be reimbursed.
- InterView
- ‘2nd line opt for CMV is limited…should improve access'
- by Son, Hyung-Min Jan 15, 2024 05:36am
- Sung Shin, Professor of Kidney and Pancreas Transplantation at Asan Medical Center (Director of General Affairs, the Korean Society for Transplantation) An expert had suggested that we improve access to a new cytomegalovirus (CMV) treatment drug that has shown effect in patients with resistance as CMV has a major impact on transplanted organs. Sung Shin, Professor of Kidney and Pancreas Transplantation at Asan Medical Center (Director of General Affairs, the Korean Society for Transplantation) expressed so at a meeting with Dailypharm, explaining how Livtencity, which has been shown to be effective in second-line treatment, could be beneficial amid the rising number of CMV patients developing resistance to existing first-line therapies. CMV is a member of the herpesvirus family that causes infectious diseases. The risk of CMV infection is particularly high after organ transplantation when the patient’s immunity is lowered. CMV is a common complication in kidney transplant patients, to the extent that around half of the patients report infections. If not treated in time, it can lead to a variety of complications, including pneumonia and lung inflammation, but treatment options are limited for patients who develop resistance to first-line therapy, raising the need for new second-line options. Takeda's CMV therapy, Livtencity (maribavir), has demonstrated efficacy in patients who are resistant or intolerant to existing first-line therapies. In clinical trials, Livtencity demonstrated more than double the CMV viremia clearance rate compared to existing treatment options and had lower toxicity. Professor Shin welcomed the introduction of a new class of antivirals for resistant and treatment-refractory CMV and emphasized the need for its reimbursement to increase patient access to Livtencity CMV, predominantly affects organ transplant patients, and can potentially be fatal Delayed treatment of CMV can lead to the infection of various organs. Especially in the early stages of transplantation, when immunity is low, it can lead to severe pneumonia, enteritis, sepsis, and even death. CMV infection is known to be especially prevalent in kidney transplant patients. More than 2,000 patients receive kidneys in Korea every year. According to reports, more than 50% of them are infected with CMV, and more than 10% of the infected patients show infected symptoms. As much as it is difficult to receive a kidney transplant, it is also important to manage various viruses after the transplant. Professor Shin said, “CMV infection is associated with earlier loss of function in the transplanted kidneys compared to uninfected patients. Also, CMV infection is associated with a significantly higher risk of fatal pneumonia and death from severe infections.” As such, early administration of effective antiviral therapy is important for organ transplant patients susceptible to infections. However, with a reported 60% resistance rate to existing first-line antivirals such as ganciclovir and valganciclovir, only a limited range of second-line CMV treatment options exist due to toxicity issues. MSD's Prevymis (letermovir) has emerged as a prophylactic therapy for CMV infection, but can only be used up to 100 days after organ transplantation. Professor Shin explained, "The goal of CMV treatment is the achievement of complete negative viral load. We consider the treatment a failure if the virus increases after 2 weeks of treatment or does not decrease sufficiently. This could be due to the virus itself being genetically resistant to antivirals or the patient's poor medication adherence to antivirals.” "After developing a resistance, patients may use the same drug again or consider using second-line options such as foscarnet or cidofovir. However, there are limitations to the use of these agents because of their severe nephrotoxicity, which can be fatal in kidney transplant patients." Livtencity enters the scene...showing promise in patients with resistant CMV Livtencity is the drug that can address these concerns. It works by inhibiting a kinase called UL97 that allows the virus to multiply inside the cellular host. The drug’s efficacy and safety compared to existing treatment were confirmed through the Phase III SOLSTICE study. Study results showed that Livtencity demonstrated a CMV viremia clearance rate of 55.7%, more than double the 23.9% achieved with valganciclovir/ganciclovir, foscarnet, or cidofovir arms that used the drugs alone or in combinations. Also, Livtencity is associated with fewer side effects compared to existing therapies. Patients taking immunosuppressants after transplant often have poor kidney function, and Livtencity reduced their dosing burden with its low toxicity. In terms of safety, Livtencity was associated with a 1.7% incidence of neutropenia. This was 15 times lower than the 25.0% in the ganciclovir/valganiclovir arm. "The negative conversion rate was better in the Livtencity arm, and the Livtencity arm also showed a significantly higher negative conversion rate at 16 weeks of follow-up. It also showed a lower rate of adverse events such as neutropenia and nephrotoxicity, with very few discontinuations due to adverse events being reported. Livtencity’s developer Takeda’s reimbursement application for its drug had passed the Drug Reimbursement Review Committee in December last year and the company has been negotiating drug prices with the National Health Insurance Service since this month. Professor Shin stressed that insurance reimbursement is necessary for Livtencity’s broader use to benefit more patients. Professor Shin emphasized, "CMV is a virus that has a significant adverse effect on the survival rate of all transplant recipients, even among the opportunistic infections that can occur with solid organ transplant and hematopoietic stem cell transplants. Delaying its treatment increases the risk of rejection, therefore, early and effective treatment is very important." He added, "In this regard, we should welcome the introduction of a new class of antivirals for resistant and treatment-refractory CMV, as it is a blessing for transplant patients in practice. Insurance coverage for the drug is all that more important as it relieves the Livtencity’s burden of cost for healthcare providers and patients in Korea."
- Company
- Tarlatamab designated as an orphan drug for SCLC
- by Eo, Yun-Ho Jan 15, 2024 05:36am
- Amgen’s drug candidate ‘Tarlatamab,’ intended for treating small cell lung cancer (SCLC), has received orphan drug designation in Korea. The Ministry of Food and Drug Safety (MFDS) announced this decision through its first orphan drug designation posting of the New Year. The approved indication is for treating adult patients with progressive SCLC whose cancer had progressed after previous second-line treatments. The research team led by Professor Ahn Myung Ju, from the Division of Hematology-oncology in the Department of Medicine at Samsung Medical Center, has confirmed Tarlatamab as a potential treatment for second-line treatment in SCLC. Their research article was published in the New England Journal of Medicine (NEJM). The research team demonstrated the treatment potential of bispecific T-cell engagers like Tarlatamab. Tarlatamab is a novel bispecific T-cell engager drug that recognizes antigens present on both cancer cells and immune cells. Even when cancer cells manage to evade immune cells, Tarlatamab can engage immune T-cells, directing them to closely target cancer cells and initiate an attack. Professor Ahn’s research team conducted this research with the goal of identifying a novel therapeutic strategy that could maximize the effects of Tarlatamab while ensuring the safety of patients. They conducted a study enrolling 220 patients who had not responded to the first-line treatment for SCLC, from 56 institutions across 17 countries and randomly assigned to clinical groups for evaluation. According to the U.S. Food and Drug Administration (FDA), the research team administered two different doses of Tarlatamab, 10mg and 100mg, to patients and assessed various prognosis such as treatment reactions and drug-related side effects. As a result, the optimal dosage for the drug was determined to be 10mg of Tarlatamab administered every 2 weeks, which led to clinical improvements in prognosis and a reduction in side effects. According to the research group, patients who received 10 mg showed an objective response rate of 40%, which was higher than the 32% response rate observed in those who received a 100 mg dose. The median progression-free survival in the 10-mg group was 4.9 months, higher than the 3.9 months in the 100-mg group. The overall survival, measured at nine months following the treatments, was 68% for the 10-mg group and 66% for the 100-mg group. The 10-mg dose demonstrated a higher treatment effect with fewer side effects. Since Tarlatamab is a T-cell activating therapy, the most common side effect is ‘cytokine release syndrome.’ In the 10-mg group, 51% of the patients experienced cytokine release syndrome, whereas, in the 100-mg group, 61% did. “SCLC, classified into limited and extended stages, is characterized by its rapid progression without clear incremental stages. For most patients, metastasis to other lungs or organs presents treatment challenges. Currently, treatment options remain limited. Consequently, I hope that ongoing research will contribute to alleviating the suffering of patients,” Professor Ahn said.
- Opinion
- [Reporter’s View] HIRA's role in managing high-priced drugs
- by Kim, Jin-Gu Jan 15, 2024 05:36am
- In 2012, Soliris, a treatment for paroxysmal nocturnal hemoglobinuria (PNH), was listed for reimbursement in Korea. The drug, which cost more than KRW 5 million per vial and up to KRW 500 million for a year's supply, sparked controversy over "ultra-high-priced drugs” at the time. Since then, drugs more expensive than Soliris were introduced and reimbursed one after another. Novartis' Kymriah and Zolgensma were two representative examples. Zolgensma is listed at KRW 1.982 billion per kit, and Kymriah at KRW 360 million per treatment. Although the number of doses required per drug varies, as of the end of last year, a total of 26 drugs cost more per unit than Soliris. Among them, Biogen's ‘Spinraza,’ Novartis' ‘Lutathera,’ AstraZeneca's ‘Ultomiris,’ BMS' ‘Yervoy,’ Anterogen’s 'Cupistem,’ JW Pharmaceutical's ‘Hemlibra,’ Pfizer's ‘Besponsa,’ Anterogen’s ‘Remodulin,’ and Sanofi-Aventis' ‘Lemtrada’ cost more than KRW 10 million per unit. Truly, the era of ultra-high-priced drugs has arrived. Moreover, drugs that far exceed the price of Zolgensma are awaiting entry in Korea. Lyfgenia, a treatment for sickle cell anemia that was approved by the U.S. Food and Drug Administration (FDA) in December last year, has a price tag of USD 3.1 million (KRW 4.1 billion). ‘Casgevy’ and ‘Exa-cel,’ which were approved around the same time, cost $USD 2.2 million (around KRW 2.9 billion) each. And many other drugs that cost more than USD 1 million are yet to be introduced to Korea. The hemophilia B treatment ‘Hemgenix’ costs USD 3.5 million, the cerebral adrenoleukodystropha treatment ‘Skysona’ costs USD 3 million, the beta-thalassemia treatment ‘Zynteglo’ costs USD 2.8 million, the leptin deficiency treatment ‘Myalept’ costs USD 1.26 million, and Hutchinson-Gilford progeria syndrome treatment Zokinvy costs USD 1.07 million. Most of these are 'one-shot drugs' that treat diseases caused by genetic abnormalities. Given the development speed and recent advances in gene editing technology, industry experts say it is only a matter of time before more expensive drugs appear. The annual cost of KRW 500 million, which was astronomical at the time of Soliris’s introduction, now falls in the ‘modest’ range among ultra-high-priced drugs. The government is also expressing significant concerns over the issue. Earlier this year, the Health Insurance Review and Assessment Service set up a ‘Pharmaceutical Performance Evaluation Department’ dedicated to the post-listing management of high-priced drugs. It took over the duties of the New Drug Performance Management Division, which was established as a temporary organization under the Office of Benefits Management in September 2022. For now, the office is in charge of evaluating the performance of high-priced drugs such as Kymriah and Zolgensma but will expand its responsibilities to include post-listing management of drugs that are exempt from submitting pharmacoeconomic evaluation data. This seems to be a timely move in the era of ultra-high-priced drugs. It's time to prepare for the next step. Given that drugs even more expensive than Zolgensma are expected to be introduced into Korea in the future, one single department, however, dedicated, may not be enough to take on the responsibility of managing all of the listed high-priced drugs. The changes to come call for a more fundamental reorganization of the system. The number of drugs listed through tracks that do not require pharmacoeconomic evaluation, which is the basis of Korea’s health insurance reimbursement system, is increasing every year. However, due to limited health insurance finances, it is impossible to blindly allow the listing of all ultra-high-priced drugs. We need to prepare for the entry of another wave of ultra-high-priced drugs, including the establishment of a separate fund, which is just beginning to be discussed. Korea eagerly awaits the establishment of a new system that can receive public consensus.
- Product
- Shortage no more for Saxenda?...'will increase supply'
- by Kang, Hye-Kyung Jan 15, 2024 05:36am
- The supply of Saxenda, which had been showing stock shortages in pharmacies nationwide, is expected to soon increase in Korea. Novo Nordisk announced on the 10th that it has been gradually increasing the supply of Saxenda from this month. The increased supply is expected to reduce the hassle of pharmacies that have been sending patients away due to stock shortages and resolve the inconvenience of patients having to visit many pharmacies looking for any that have Saxenda in stock. In response to Dailpharm’s report on “Saxenda’s shortage prolonged…raises inconveniences,” Novo Nordisk said, "We are aware of the recent stock shortages of Saxedna at pharmacies that resulted from the increased demand for Saxenda due to due to increased interest in weight loss in the end-of-year and the beginning-of-year seasons. However, we have been continuously producing and distributing the drug to Korea. The company added that it has been gradually increasing the supply since January. Novo Nordisk said, "We are currently experiencing high global demand for all of our products, which is causing supply and capacity constraints across our product portfolio. Over the past 6 months, we have invested around KRW 11 trillion in our production facilities alone to ensure a stable supply of our products.” However, the company explained that is not easy to predict the exact timing of when the shortage will end, as it will take time for the increased supply to enter the market to ensure safety and quality. "We deeply understand the importance and need to ensure the continuity of treatment for our patients and are making the most efforts to stabilize the supply of our drugs for patients in Korea.” Meanwhile, there are still posts and inquiries being uploaded to local community cafes and beauty cafes asking for pharmacies or clinics that have Saxenda in stock. There are also posts uploaded to pharmacist communities asking about Saxenda supply plans or requesting exchanges.
- Company
- Boryung partners with Baxter for 2 anesthesia drugs in Korea
- by Kim, Jin-Gu Jan 12, 2024 07:06am
- Boryung announced on the 10th that it signed a sales agreement with Baxter Korea to sell inhalation anesthesia ‘Suprane Solution (desflurane)’ and blood substitute ‘Plasma Lyte 148 Inj’ in the domestic market. Suprane, developed by Baxter, is a premier inhalation anesthesia for inducing or maintaining anesthesia during surgery. It offers rapid and accurate control of the depth of anesthesia and has the lowest solubility among inhaled anesthetic, enabling fast and predictable patient recovery after anesthesia. Plasma Lyte 148 Inj is an original fluid solution developed by Baxter. It is a physiologically balanced blood substitute with sodium, magnesium, and potassium levels similar to human plasma. Plasma Lyte 148 Inj is used to replenish and adjust extracellular fluid in cases of decreased circulating blood volume and interstitial fluid and to adjust metabolic acidosis. Plasma Lyte 148 Inj, a fluid therapy that can improve therapeutic outcomes for critically ill patients, has demonstrated its effectiveness in decreasing the mortality rate in patients with SIRS when compared to the Normal Saline group. It has also been shown to reduce risk factors associated with post-operative complications in open surgeries. An additional advantage is that Plasma Lyte 148 Inj is calcium-free, allowing its administration before and after a blood transfusion, as well as during a transfusion. Inhalation anesthesia Suprane (left) and blood substitute Plasma Lyte 148 Inj 1000 mL(right). The recent contract will broaden Boryung’s portfolio of anesthesia-related drugs and enhance its business capabilities. Boryung has been actively involved in sales marketing efforts for its anti-vomiting drug ‘Naseron (ramosetron)’ and drug designed to reverse neuromuscular blockade, ‘Breathon (sugammadex).’ Naseron ranks the first in the market among ramosetron-based products, while Breathon is the second-leading product in the sugammadex-based market. With its anesthesia task force and academic sales marketing expertise, Boryung will concentrate its efforts on expanding the market share of these two products. "Suprane and Plasma Lyte 148 Inj are important drugs for ensuring the safety and quality management of surgical patients undergoing anesthesia," Jung Woong-je, RX Division Leader at Boryung, commented. "Based on these two products, our focus will center around strengthening our market presence within the field of anesthesiology."
- Policy
- AHA drug Obizur to soon receive reimb in Korea
- by Lee, Tak-Sun Jan 12, 2024 07:06am
- Takeda Pharmaceuticals Korea’s hemophilia drug Obizur is expected to soon be reimbursed in Korea. The company was found to have completed pricing negotiations with the National Health Insurance Service recently. The drug received conditional approval from the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee in October last year. According to industry sources on the 11th, Takeda Pharmaceuticals Korea recently completed negotiations with the NHIS on Obizur’s reimbursement and is set to be reported to the Health Insurance Policy Deliberation Committee of the Ministry of Health and Welfare soon. Obizur can be reimbursed in Korea in the month following the HIPDC report. Obizur is used to treat bleeding in adult patients with acquired hemophilia A. At the DREC meeting that was held in October, the committee determined Obizur’s reimbursement was adequate at a price below the appraised value. The importer, Pharmaceuticals Korea, is understood to have accepted this condition. The company also accepted a price less than 100% of the weighted average price of its substitute, thus omitting negotiations on its insurance ceiling price. Therefore, the company only needed to negotiate the estimated claims amount with the NHIS. If reimbursed, Obizur’s reimbursement process will be complete in one year since its marketing authorization in March last year, serving as a good example of expedited reimbursement. Unlike existing bypassing agents, Obizur replaces blood coagulation Factor VIII with AHA indications. Its unique mechanism of action allows Obizur to become the only AHA drug that can stably monitor patients’ blood factor VIII levels using standard assays, enabling individually tailored dosing. In a prospective, non-randomized, open-label Phase II/III study of 28 patients with AHA that evaluated the safety and efficacy of Obizur, all patients that were treated with Obizur had a positive response to treatment at 24 hours after initial dosing. A positive response was one where bleeding had stopped or was reduced, with clinical improvement or with factor VIII activity above a pre-specified target. Takeda Pharmaceuticals Korea said, “Obizur is a gene recombinant therapy that was produced by deleting the B-domain from a porcine factor VIII that is comparable to human Factor VIII. Therefore, the inhibitory antibodies in the human body do not readily recognize the treatment, allowing Obizur to replace the inactivated human coagulation factor VIII to help blood clotting and control bleeding.
- Company
- Generic companies partially win Trajenta patent challenges
- by Kim, Jin-Gu Jan 12, 2024 07:06am
- Generic companies have won the dispute over unregistered use patents of Trajenta (linagliptin). Although the unregistered formulation patent remains, this patent is reportedly relatively easy to avoid or invalidate. As such, the industry expects there is a higher possibility that generic versions of Trajenta will be released earlier after the drug’s substance patent expires in June. According to the pharmaceutical industry on the 11th, the Intellectual Property Trial and Appeal Board ruled that the validity of claims in the invalidation trials against the three Trajenta use patents by Genuone Science and others against Boehringer Ingelheim were established. Genuone Sciences had filed trials against Boehringer Ingelheim to invalidate 3 Trajenta’s use patents (10-1558938, 10-1655754, 10-1806786) in October 2020. Kukje Pharm, GC Biopharma, Mother’s Pharmaceutical, and Boryung had also joined in the trial with Genuone Sciences at the time. After about a year and three months, the first instance court, the Intellectual Property Trial and Appeal Board ruled in favor of the generic companies. All three patents expire in May 2027. If the patent challengers had lost in the first instance court, the release of a generic version of Trajenta would have been pushed back to after 2027. However, with the win, Trajenta generics will likely be available sooner, after the expiry of Trajenta’s substance patent in June this year. The first substance patent for Trajenta expired in August last year, and the second substance patent will expire in June this year. In July last year, Genuone Science and the other companies also succeeded in avoiding the unlisted formulation patent through a trial to confirm the passive scope of patent rights. It is estimated that 7 unlisted formulation patents and 1 unlisted use patent remain for Trajenta. However, industry insiders believe that the remaining patents are generally easy to avoid or invalidate or were registered later and do not have a significant impact on the early launch of Trajenta generics. Moreover, in the case of the 3 use patents, which are key to the launch of generic versions of Trajenta, the IPTAB clearly stated the grounds for their invalidation, such as lack of description and inventiveness, the generic company has a high chance of winning later trials even if the original company appeals. On the reason for invalidating Trajenta’s use patents, IPTAB pointed to “The experimental data related to linagliptin dosage is not disclosed in the patent specification, and linagliptin dosage or combination therapy with other diabetes drugs can be easily be invented from prior art." In other words, the trial court invalidated Trajenta’s patents on two grounds: lack of description and inventiveness. In effect, all 3 use patents directly related to Trajenta’s indication were invalidated, increasing the likelihood of early generic launch after the expiration of Trajenta's substance patent. Jong Hyuk Park, a patent attorney who participated in the patent trial, said, "This decision is significant in that it the court judge on the patentability of additional unlisted use patents that were later registered through divisional patent applications when the indications are already preannounced. Since it was determined that the patents were invalid in terms of both lack of description and inventiveness, it is unlikely that the decision will be reversed on appeal."
