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- 2026-05-06 09:54:44
- Policy
- Referencing lowest A8 price will result in a supply crisis
- by Nho, Byung Chul Jan 29, 2024 06:05am
- Health authorities and the pharma-bio industry are at an impasse over the implementation of 'A8 external reference pricing reassessments.’ Engaged in a tug-of-war, the two parties have difficulty finding common grounds. The Ministry of Health and Welfare, the Health Insurance Review and Assessment Service, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, and the Korea Research-based Pharmaceutical Industry Association, have been meeting since the end of 2022 and have completed the 5th round of negotiations as of this month, but they have been unable to reach a consensus, with each being busy making mutual claims. The ‘reassessment for the A8 external reference pricing system’ was proposed to add Canada to the existing list of A7 countries (U.S., U.K., Germany, Switzerland, Italy, France, and Japan) as a detailed reference point for drug price reevaluations. During initial discussions, there was talk of expanding the number of countries to A9, to include Australia and Canada, but Australia was removed due to strong public opinion that the 2 countries with the lowest drug prices were selected to cut prices. The issue that remains in the restructured external reference pricing system is that health authorities are sticking to using the lowest listed prices among A8 countries, while the industry believes using the average of the highest listed price is best. The average and median values, excluding the upper and lower extremes and U.S. drug price, are also considered options but are not on the table. Following a comprehensive discussion process scheduled for the end of next month, health authorities are now looking to implement the program as soon as 2025 after an appeal process in the middle of this year. Initially, the A8 external reference pricing system was planned to be applied only to diabetes, hypertension, and hyperlipidemia drugs, but there always remains a possibility that it could be extended to virtually all drugs, including anticancer drugs. If the health authorities adhere to their original proposal, the ramifications of its megatonne drug price cut are self-evident. Moreover, it is likely to add fuel to the fire of essential drug supply disruptions that arose due to the unstable price of drug substances due to the aftermath of the COVID-19 pandemic and the Ukraine-Russia war. In addition, the A8 drug price reference countries do not have a large number of data submission drugs or salt-modified drugs compared to Korea, therefore major price cuts for these drugs are also expected. An industry insider said, "Following the bulk drug price reduction in 2012 and the linkage of drug prices upon fulfillment of the ‘self-bioequivalence tests-DMF registration' requirement in 2019, there is a lack of objective basis for conducting drug price cuts using reference countries overseas that is currently being planned by the health authorities. Imposing such a policy is nothing short of an invasive act against domestic medicines and could lead to a serious industry contraction." As it is common for drug prices to be determined by taking into account all the specificities of the country's economy, society, and culture, therefore, it is not common sense to use the low drug prices set in one or two countries as a reference or standard. In addition, according to some research service data, Korea's generic price is 53.55% of the original price, ranking fourth among OECD countries, so it is difficult to say that Korea has a high drug price structure. The drug price reevaluation using the A8 external reference pricing system had been sparked by a booklet that had been published by Canada’s Patented Medicine Price Review Board, which was released at the 2022 National Assembly Audit, but the booklet seems to be an intuitive interpretation that is far from a precise report, as it lacks the correction values of domestic new drug and generic drug prices at that time and now. In other words, concluding that domestic generic drug prices are higher than those of external reference countries is highly likely to cause distortions in the drug pricing system, as it does not consider how the generic drug prices were set to the high insurance drug prices the multinational pharmaceutical companies received at the time of initial listing. Another industry insider said, "There is a strong sentiment that we should expand the drug price referencing to Canada and use it as a reference point for reevaluation. If the application of the system is expanded to include new drugs introduced from abroad and homegrown new drugs, this may not only discourage R&D efforts but also deprive patients of the right to treatment."
- Policy
- Remote GMP inspections not recognized from April
- by Lee, Hye-Kyung Jan 29, 2024 06:05am
- The GMP inspections, which were temporarily allowed non-face-to-face due to the difficulty of on-site evaluations during the COVID-19 outbreak, are gradually returning to ordinary procedures. After switching the pre-approval GMP item inspections back to full on-site inspections in December last year, the Ministry of Food and Drug Safety (MFDS) now decided to recognize only on-site reports rather than the written reports, which had been recognized for a limited time due to difficulties in conducting on-site inspections. From April 25, the only written reports the MFDS will accept are vendor audit results from on-site inspections. In order to import active pharmaceutical ingredients (API), the company must submit a GMP certificate of API issued by the government or public institution of the country of manufacture. However, when the company seeks to receive a supply of the APIs for the manufacture of finished pharmaceutical products, vendor audit results based on an on-site inspection of the finished pharmaceutical product manufacturer are also recognized as a GMP certificate. Due to the COVID-19 pandemic, It had been difficult to conduct on-site inspections, which was why the MFDS had recognized written inspection result reports. The MFDS stated, "During the COVID-19 pandemic, it was difficult to conduct on-site inspections, which was why we temporarily recognized written inspection reports. However, with the end of the COVID-19 pandemic, we will give a 3-month grace period and then recognize only on-site GMP inspection reports from April." Previously, the MFDS had replaced GMP on-site inspections with remote inspections such as by reviewing PIC/S report data during the COVID-19 outbreak, but since September last year, it has been phasing out the flexibilities that were put in place and started on-site inspections for some items, new drugs, or aseptic preparations, conducting a phased transition back to on-site inspections. As regulatory agencies such as the U.S. and PIC/S have announced that non-face-to-face inspections cannot replace on-site inspections, the MFDS is also converting some parts of the non-face-to-face inspections back to on-site inspections.
- Company
- Will Polivy secure reimbursement approval this year?
- by Eo, Yun-Ho Jan 29, 2024 06:04am
- Roche Korea’s Polivy (polatuzumab vedotin) The question of whether ‘Polivy,’ a B-cell lymphoma treatment, will be listed for insurance reimbursements this year is garnering significant attention. According to industry sources, Roche Korea’s Polivy (polatuzumab vedotin), a treatment for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), is expected to be presented to the Health Insurance Review and Assessment Service (HIRA)’s Cancer Disease Review Committee on the 31st. Previously, in 2021, Polivy made an initial attempt to obtain reimbursement listing for its third-line treatment as a combination therapy with BR therapy (bendamustine/rituximab). However, Polivy did not receive approval from the Cancer Disease Review Committee. In the first half of last year, Roche applied for reimbursement as a first-line treatment, in combination with other pharmaceuticals, including rituximab plus cyclophosphamide, doxorubicin, and prednisone. As the first CD79b-directed antibody-drug conjugate (ADC), Polivy received approval for its indication as a first-line treatment in Korea in November 2022. This approval was granted approval based on the demonstrated efficacy in Phase 3 POLARIX clinical trial results. The POLARIX trial conducted follow-up of all patients for more than 24 months. During the 28.2-month follow-up period, patients with DLBCL treated with first-line Polivy and R-CHP combination therapy showed a 27% reduction in the risk of disease progression or death compared to those treated with R-CHOP. Among the most commonly reported adverse reactions of Polivy combination therapy, with a frequency of more than 30%, are peripheral neuropathy (52.9%), nausea (41.6%), neutropenia (38.4%), and diarrhea (30.8%). DLBCL, which is an aggressive form of blood cancer, is the most common type of non-Hodgkin lymphoma. In Korea, approximately 5000 patients are newly diagnosed with DLBCL every year. DLBCL falls into the category of aggressive lymphoma, which requires immediate treatment due to the fast progression of the disease. About half of the patients reach remission following treatment due to their positive responsiveness to the therapy. However, approximately 30-40% of the patients are still non-responsive to the standard therapy, R-CHOP, or experience remission after receiving first-line treatments. Most patients with relapsed or refractory DLBCL experience recurrence within two years, and the duration of survival after recurrence is estimated to be only six months. Despite these critical conditions, not many effective treatment options are available for patients with relapsed or refractory DLBCL.
- Policy
- Lilly’s UC drug Omvoh is soon to be approved in KOR
- by Lee, Hye-Kyung Jan 26, 2024 05:51am
- Lilly's ulcerative colitis treatment Omvoh (mirikizumab-mrkz) is nearing approval in Korea. Omvoh received U.S. FDA approval in October last year and settled as the first and only interleukin-23p19 (IL-23p19) antagonist for the treatment of moderately to severely active ulcerative colitis (UC) in adults. According to industry sources, the Ministry of Food and Drug Safety recently completed a safety and efficacy review for Omvoh’s marketing authorization in Korea. MFDS’ completion of the safety and efficacy review means that marketing authorization for the drug is imminent. Omvoh is the only ulcerative colitis treatment that selectively binds to the p19 subunit of IL-we and inhibits interaction with the receptor. Ulcerative colitis is a chronic inflammatory disease of unknown cause characterized by inflammation localized in the mucosal or submucosal layers of the large intestine, and the p19 subunit plays an important role in the development of inflammation associated with ulcerative colitis. The FDA’s approval was based on results from the LUCENT program, which included two randomized, double-blind, placebo-controlled Phase 3 clinical trials consisting of LUCENT-1 - a 12-week induction study (UC-1) - and LUCENT-2 - a 40-week maintenance study (UC-2) for 52 weeks of continuous treatment. All patients in the LUCENT program had past treatments, including biological treatments, that did not work, stopped working, or that they could not tolerate. After 12 weeks of treatment with Omvoh, 65% of patients achieved clinical response and 24% achieved clinical remission compared to placebo (43% and 15%, for clinical response and clinical remission, respectively). Among those who achieved clinical response at 12 weeks, one-half (50%) achieved steroid-free clinical remission at one year, compared to placebo (27%). Per a post-hoc analysis, 99% of patients who achieved clinical remission at 1 year were steroid-free. Patients in steroid-free clinical remission were steroid-free for at least 3 months prior to the end of the 52-week assessment. In 2018, a Phase III trial for Omvoh was approved by the Ministry of Food and Drug Safety under the same details as the LUCENT program, and completed in Korea. Omvoh was approved in Japan in March and in Europe in June last year.
- Policy
- P2T for LG Chem’s obesity drug LB54640 approved in Korea
- by Lee, Hye-Kyung Jan 26, 2024 05:51am
- LG Chem’s generic obesity treatment, 'LB54640,' has been approved for a Phase II clinical trial in Korea. On the 24th, the Ministry of Food and Drug Safety approved LG Chem’s application to initiate a randomized, placebo-controlled, double-blind Phase II study with an open extension period to evaluate the efficacy and safety of LB54640 in patients with acquired hypothalamic obesity. Hypothalamic obesity is a type of syndromic obesity that results from abnormalities in endocrine, hypothalamic, genetic, frontal, and metabolic systems. It is classified as a rare form of obesity that occurs in approximately 1% of pediatric obesity patients. The Phase II study will be conducted at Seoul National University Hospital until March 1, 2025. Global clinical trials for LB54640 had previously been approved in the U.S. and Europe. LB54640 is a once-daily (oral) treatment for obesity that targets the action pathway of the MC4R (melanocortin-4-receptor) protein, which is known to deliver satiety signals. According to LG Chem, results of the Phase I study showed LB54640’s potential with up to 3% reduction in body weight in the highest-dose group over 28 days of treatment. The drug received orphan drug designation from the U.S. Food and Drug Administration (FDA) as a treatment for LEPR deficiency in September 2020 and for POMC deficiency in June 2022. Meanwhile, LG Chem signed an agreement with Rhythm Pharmaceutical to transfer the global development and marketing rights for its orphan drug LB54640 on the 5th. The agreement, which amounts to USD 350 million (KRW 400 billion), includes an upfront payment of USD 100 million (KRW 130 billion). Upon successful commercialization, the company will receive separate sales royalties based on annual sales.
- Company
- New CKD drug Kerendia lands in general hospitals in KOR
- by Eo, Yun-Ho Jan 26, 2024 05:51am
- The landing procedure for the new chronic kidney disease drug 'Kerendia' is in full swing in general hospitals in Korea ahead of its reimbursement listing. According to industry sources, Bayer Korea's Kerendia (finerenone) recently passed the drug committee (DC) review at Sinchon Severance Hospital. It is also undergoing a landing process at major hospitals nationwide. Kerendia, a treatment for chronic kidney disease associated with type 2 diabetes, will be listed for reimbursement next month (February). With Chong Kun Dang joining as a domestic sales partner, full-scale promotional activities are expected to unfold along with the rapid landing process. Kerendia was approved in Korea last year as a treatment for adult patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) to reduce the risk of end-stage kidney disease (ESKD) and a sustained decrease in estimated glomerular filtration rate (eGFR), and cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure. CKD is one of the most common complications of type 2 diabetes and an independent risk factor for cardiovascular disease. Although it is a progressive disease, it is difficult to detect because there are no specific symptoms until just before end-stage renal failure. In addition, when end-stage renal failure occurs, dialysis or kidney transplantation is required to maintain life, which not only imposes a significant social and economic burden but also significantly affects the patient's quality of life. Therefore, patients with type 2 diabetes need to be monitored regularly for kidney damage with kidney function tests, it is important to slow the progression of kidney disease and lower the risk of cardiovascular disease through early diagnosis and appropriate treatment. Three main factors are known contributors to kidney disease in type 2 diabetes: hemodynamic changes, metabolic abnormalities, and inflammation and fibrosis. However, current treatments primarily target hemodynamic and metabolic factors, raising the need for new therapies that target the inflammation and fibrosis factor. Kerendia is a first-in-class, selective, non-steroidal mineralocorticoid receptor antagonist(MRA) that has a novel mechanism of action that targets inflammation and fibrosis in adult chronic kidney disease with type 2 diabetes. Overactivation of the mineralocorticoid receptors can cause inflammation and fibrosis, which can lead to permanent kidney damage. By inhibiting the overactivation of the mineralocorticoid receptor, Kerendia reduces inflammation and fibrosis and inhibits kidney damage. Bayer demonstrated Kerendia’s efficacy through the Phase III trial (FIDELIO-DKD). In the study, which enrolled approximately 5,700 patients in 48 countries worldwide, Kerendia was found to reduce chronic kidney disease progression and reduce cardiovascular disease risk in adult patients with chronic kidney disease and type 2 diabetes. Patients in the study received 10 mg or 20 mg of Kerendia or placebo in addition to standard therapy. Results showed Kerendia significantly reduced the incidence of a sustained decline in eGFR of ≥ 40%, kidney failure (defined as chronic dialysis, kidney transplantation, or a sustained decrease in eGFR to < 15 mL/min/1.73 m2 ), or renal death by 18% compared with placebo. In addition, Kerendia reduced the major secondary outcome – a composite of time to first 9 occurrences of CV death, non-fatal MI, non-fatal stroke, or hospitalization for heart failure – by 14%. The overall rate of serious adverse events or acute kidney injury-related adverse events was comparable between the two groups. Meanwhile, the European Society of Cardiology (ESC) published a major revision of its 2021 guidelines for the diagnosis and treatment of acute or chronic heart failure (HF), which included Kerendia as a Class 1A recommendation in preventing hospitalization for heart failure in patients with chronic kidney disease with type 2 diabetes. In addition, the ESC recommended that patients measure their glomerular filtration rate and urinary albumin levels once a year to screen for the development of chronic kidney disease in patients with diabetes.
- Opinion
- [Reporter’s View] Conglomerates expanding into the pharma
- by Kim, Jin-Gu Jan 26, 2024 05:51am
- M&A activities have made headlines in the pharmaceutical and biotechnology (pharma and biotech) industries in early 2024. Hanmi Pharmaceutical, a leader in the Korean pharmaceutical industry, has officially confirmed its merger with OCI group, a chemical company. Additionally, Orion has acquired LegoChem Biosciences, a globally recognized bioventure company. Major conglomerate companies are expanding their scopes into the pharma and biotech industries. In the previous year, Hanwha Group entered the biotechnology materials, components, and equipment sector, while in 2022, Lotte Group launched Lotte Biologics. CJ CheilJedang also made a comeback to the industry by acquiring the microbiome company Cheonlab, three years after selling HK Inno.N. The pharma and biotech companies such as Samsung, SK, and LG have announced their plan for increased investments. This trend reflects the pharma and biotech industries as a favored choice for business expansion among many conglomerate companies. It is expected that these conglomerate companies will play a central role in shaping the future of the Korean pharma and biotech industries. Currently, there are varying opinions on the industry outlook. However, a prevailing positive analysis is emerging concerning the increased investment in the Korean pharma and biotech industries. Until now, one of the significant differences between the Korean pharma and biotech industries and global big pharma has been investment size. Korean companies’ business model of licensing out potential candidate products to global big pharma is prevalent because Korean companies often struggle to manage the substantial costs associated with completing the clinical process. The entry of conglomerate companies with substantial available funds into the pharma and biotech industries has the potential to bolster R&D capacity. At the same time, concerns are emerging regarding the current trend, given the distinctive nature of the pharma and biotech industries. In the industry, drug development entails costs and time. Enormous investments and enduring patience until the final product is achieved are prerequisites. Typically, it takes around 10 years to identify a candidate product and bring it to market following clinical trials. Even if efforts to expedite development through open innovations, a waiting period of at least 4-5 years may be necessary. According to the report from the Biotechnology Innovation Organization (BIO), the average success rate of new drug development projects to obtain FDA approval for marketing between 2011 to 2020 stands at 7.9%. Even if a company secure FDA approval, it does not guarantee a business success. Successful commercialization and achieving business success in the global market are distinct processes. Korean industry giants have frequently achieved success through a method referred to as, ‘compressed growth’ in their respective fields. The question now arises whether the pharma and biotech industries will experience a similar period of compressed growth. These industry giants must endure extended periods of efforts until they reach success, while recognizing the possibility of commercialization failure. "Some employees from other subsidiaries seem to view the pharma and biotech industries as resembling a 'money pit,’ characterizing it as a sector that demands substantial financial resources but lags in delivering outcomes,” staff member from the pharma and biotech industries said. "From their perspective, our sector appears to require substantial investments, yet immediate returns are not apparent. However, this viewpoint may not be entirely fair." Conglomerate corporations entering the pharma and biotech industries with substantial investments is a positive development. However, more than financial investment is needed. Equally crucial, alongside these significant investments, is patience. It remains to be seen whether these large corporations can withstand a long and challenging journey through clinical trials, coupled with the weight of potential setbacks and failures.
- Policy
- MOHW “Drug pricing for listed drugs is set to be reduced"
- by Lee, Jeong-Hwan Jan 26, 2024 05:50am
- The Ministry of Health and Welfare (MOHW) In February, the government will post the outcomes of notifications of the second-round review & assessment, analyzing the upper limit of standards and requirements associated with the drug pricing reduction of currently listed generics. The adjusted prices will take effect on March 1st. The drug pricing reduction related to market-based actual transactions will be determined in the next round of implementation due to an incomplete review of national essential drugs and drugs in short supply. On the 24th, the Ministry of Health and Welfare (MOHW) representative explained the notifications mentioned earlier during a meeting with KSPANEWS. The MOHW initially planned to implement the drug pricing reduction in January, following re-assessment of reimbursement listed drugs and a survey of prices in actual transactions. However, this implementation was postponed. The MOHW has decided to implement the drug pricing reduction, reflecting the outcomes of the second-round reassessment of listed drugs, beginning on March 1st, following the notification process in February. Yet, the reduction related to the actual transaction will be postponed until further notification. There are approximately 1,000 items related to drug pricing reductions for listed drugs. However, the MOHW has clarified that considering the significant changes in drug pricing for a substantial number of drugs, they have included a preparatory period to minimize misunderstandings between pharmacies, marketing companies, and pharmaceutical companies. The MOHW has sought the opinions of companies to prevent the recurrence of the confusion that occurred during the first-round reevaluation of drug pricing reduction for listed drugs. In the initial round, the simultaneous processing of drug pricing reduction related to the volume-price linkage negotiations led to confusion among pharmacies and pharmaceutical companies. "We have not yet finalized the implementation date of price reduction associated with actual transactions due to ongoing reviews related to essential drugs and concerns surrounding the drugs in short supply," a representative of MOHW explained.
- Company
- Ildong Idience presents 1st interim results for Venadaparib
- by Kim, Jin-Gu Jan 25, 2024 05:50am
- On the 22nd, Idience, the new drug development subsidiary of Ildong Pharmaceutical, announced that they have presented the research findings related to 'Venadaparib' at the 2024 ASCO Gastrointestinal Cancers Symposium held from the 18th to the 20th. Venadaparib is a novel targeted anticancer candidate product with a mechanism focused on selective inhibition of ‘Poly ADP-ribose polymerase (PARP).’ Idience is currently engaged in clinical development efforts for various cancer types, including gastric cancer, breast cancer, ovarian cancer, and cancers with resistance to PARP inhibitors. Idience participated in a poster session at the symposium where they shared interim results from the Phase 1 clinical study. This study involved a combination therapy of Venadaparib and chemotherapy irinotecan in patients with gastric cancer undergoing third- or fourth-line treatments. According to the presentation, in the evaluable patient group (11 patients) who received an appropriate dosage combination of Venadaparib and irinotecan, the objective response rate (ORR) was 36.4%, with a median progression-free survival (mPFS) of 5.6 months. In the clinical trial, it was observed that among all the patients enrolled, the ORR was significantly higher at 60% in the subset of gastric cancer patients (5 patients) with homologous recombination deficiency (HRD), a marker for cancer treatment. “Considering that Lonsurf (trifluridine/tipiracil), which is used as third-line standard treatment for metastatic gastric cancer, has shown ORR at 4% and mPFS of 2.0 months, the clinical result of Venadaparib is promising,” Idience staff stated. Additionally, “Current Venadaparib study is particularly valuable because considering that human epidermal growth factor receptor 2 (HER2) expression is a marker for classifying HER2-positive gastric cancer and HER2-negative gastric cancer, Venadaparib efficacy was evaluated in patients with HER2-positive gastric cancer or HER2-negative gastric cancer, “ Idience staff emphasized. Since the current study confirmed Venadaparib's competitiveness and novelty compared to existing treatments, the company plans to speed up its development process, aiming to receive approval for the clinical entry (Phase 2/3) next year. Furthermore, the company intends to utilize the expedited assessment and approval system to accelerate its commercialization agenda. Idience is one of the subsidiaries of Ildong Holdings, formerly Ildong Pharmaceuticals. The company owns several pipelines related to anticancer drugs. Currently, Idience operates businesses, including clinical development of new candidate drugs, which includes Venadaparib, license-out, and open innovations.
- Policy
- Chong Kun Dang cuts price of its Lucen BS by half
- by Lee, Tak-Sun Jan 25, 2024 05:50am
- Chong Kun Dang is offering a bargain price for its biosimilar. The company has decided to cut the price of its 'Lucen BS', a biosimilar of the macular degeneration treatment Lucentis (ranibizumab, Novartis), by half from next month. As a result, the price difference between it and the original product, as well as it and Samsung Bioepis’s biosimilar, has widened significantly. According to the industry on the 23rd, Chong Kun Dang will voluntarily reduce the insurance price ceiling of its biosimilar 'Lucentis' by half from next month. Accordingly, the price of Lucen BS Inj 10mg/ml and Lucen BS Prefilled Syringe will be reduced from KRW 300,000 to KRW 150,000. Lucen BS was launched in January last year and is the first biosimilar of the macular degeneration treatment Lucentis in Korea. At the time, Lucen BS and Samsung Bioepis ‘Amelivu’ were listed simultaneously. The two companies set the price of their generic drugs at a much lower price than the original, at a price lower than the calculated amount. At the time of its reimbursement listing in January, the price of Lucen BS was KRW 300,000, which was 37% of the original drug’s price at the time. The price difference between it and the original drug as well as Samsung Bioepis’s product has become even greater now that Lucen BS’s price has been cut by half. Currently, the original Lucentis costs about KRW 580,000 per vial, while the biosimilar Amelivu costs KRW 350,000 per vial. With Lucen BS’s price set at KRW 150,000, patients will be able to access the biosimilar at 25% of the original price. Lucen BS’s price difference with another biosimilar, Amelivu, is KRW 200,000, making Lucen BS even more competitive in the market. Chong Kun Dang conducted a Phase III trial for Lucen BS from September 2018 to March 2021 at 25 hospitals, including Seoul National University Hospital on a total of 312 patients with neovascular (wet) age-related macular degeneration. Analysis of the primary efficacy endpoint, which compared the best-corrected visual acuity (BCVA) in 3 months after drug administration, showed that the proportion of patients with vision loss of less than 15 letters was 97.95% (143/146 patients) in the Lucen BS arm and 98.62% (143/145 patients) in the original drug arm, meeting the range of equivalence between the two drugs.
