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- 2026-05-02 01:27:50
- Policy
- Sanofi signs PVA negotiations for hemophilia drug 'Alprolix'
- by Lee, Tak-Sun Dec 19, 2024 05:52am
- Product photo of Alprolix The ceiling price for Sanofi's 'Alprolix,' a new treatment for hemophilia B, is expected to decrease through price-volume agreement (PVA) negotiations. This drug was approved in May 2017, and reimbursement listed in June of the following year. According to industry sources on December 18, the National Health Insurance Service (NHIS) and Sanofi-Aventis Korea agreed on Alprolix's PVA negotiations (TYPE-NA). Alprolix has been considered for the PVA negotiation for the first time after it was reimbursement listed in June 2018. The TYPE-NA negotiation is conducted when the ceiling price is adjusted by the TYPE-GA price or when the bill amount of the same product has increased by more than 60% or 10% from the previous year's bill, and the increase is more than KRW 5 billion. The current negotiation was possible because Alprolix's ceiling price had not been adjusted due to TYPE-GA negotiation, and it met the criteria for TYPE-NA negotiation four years after the first listing. This biological drug received approval in May 2017 as a daily preventive therapy to suppress and prevent bleeding, manage pre- and post-operative care, and reduce the frequency of bleeding in hemophilia B. The pharmaceutical company accepted price 100% below the weighted average price of substitute medicines and was exempted from undergoing the drug negotiation process. It only negotiated for the expected claim amount and successfully listed for reimbursement in June 2018. The ceiling price is KRW 1,181. Meanwhile, the Swedish biotechnology group Sobi owns Alprolix's global sales rights. Sobi partners with Sanofi to sell Alprolix. Sobi established a joint venture with Handok in South Korea in April, named 'Sobi-Handok.'
- Policy
- Hyperphosphatemia treatments undergo generation change
- by Lee, Tak-Sun Dec 19, 2024 05:52am
- Drugs that improve hyperphosphatemia in patients with chronic kidney disease are undergoing a generation change in the domestic market. Following the launch of the new drug Nephoxil Cap (ferric citrate, Kyowa Kirin Korea) last year, generic drugs containing sevelamer have continued to grow, and news of the withdrawal of existing drugs is also arising. According to industry sources on the 18th, Fosrenol Tab (lanthanum carbonate), which was supplied by JW Pharmaceuticals in Korea, will be discontinued. Fosrenol has been imported and sold by JW Pharmaceuticals from Takeda. With the termination of the supply contract, its supply to the domestic market is expected to be gradually discontinued by February next year. Fosrenol is a non-calcium phosphate binding agent that was approved in Korea in January 2006. It formed a three-way tie with Renvela (Sanofi) and Invela (SK Chemical) as a treatment for hyperphosphatemia in 2022. However, Fosrenol’s competitiveness weakened as generic drugs containing sevelamer carbonate, such as Renvela and Invela, were released to the market in July 2022, and the new drug Nephoxil Cap was launched last year. Last year, sales of Renvela, Invela, and Fosrenol all declined. Renvela’s sales fell to KRW 9.2 billion in 2023, down 4% from the previous year, and Invela’s sales fell to KRW 7.4, down 15%. Fosrenol's sales were flat at KRW 4.1 billion ($4.1 billion), the same as the previous year. The emergence of sevelamer generics and new drugs are disrupting the existing market structure. Nephoxil, which was launched last year, is a drug for hyperphosphatemia in chronic kidney disease patients undergoing hemodialysis and is particularly praised for lowering the risk of side effects such as hypercalcemia and vascular calcification of calcium-based binders with iron-based binders. In particular, Kyowa Kirin Korea, which supplies the drug, not only succeeded in getting the drug on the reimbursement list within a year by accepting the weighted average price of KRW 377, which is 90% of the weighted average price of alternative drugs, showing competitivity in drug price. Not only new drugs but also the highest-selling sevelamer drug has seen its number of tablets increase to 9 due to the emergence of generics. This situation explains why Fosrenol, which showed stagnant sales, eventually withdrew from the domestic market. On the 5th, 3 Fosrenol products also withdrew their domestic marketing authorizations. “The market for hyperphosphatemia treatments has recently seen intensified competition as non-calcium-based drugs with fewer side effects have gained prominence due to expanded reimbursement,” said a pharmaceutical industry insider. ”In addition, the introduction of new drugs has weakened the competitiveness of existing products.”
- Company
- 'Vyloy' to expand treatment options for gastric cancer
- by Whang, byung-woo Dec 19, 2024 05:52am
- Vyloy (active ingredient: zolbetuximab), a Claudin-18.2-targeting gastric cancer therapy, is rising as the new treatment option for stage 4 gastric cancer despite an issue related to companion diagnostics. As the number of newly diagnosed patients with Claudin-18.2 increases in clinical practices, the drug will be more widely used from the early next year when it launches as non-reimbursed. Vyloy logoVyloy is the first and only Claudin-18.2-targeted treatment. A monoclonal antibody that is designed to work by binding to It binds to Claudin-18.2, a protein expressed in the stomach. In South Korea, Vyloy was approved by the Ministry of Food and Drug Safety (MFDS) as a 'First-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy for patients with CLDN18.2-positive, HER2-negative unresectable, locally advanced, or metastatic gastric adenocarcinoma or esophageal cancer.' It is gathering attention from experts since a new targeted treatment option for stage 4 gastric cancer has emerged decades after the introduction of 'trastuzumab'-based therapy for HER2-positive patients. At the Korean Society of Medical Oncology-American Association for Cancer (AACR) joint symposium held last month, two accounts of Phase 3 clinical trials were presented. The SPOTLIGHT and GLOW studies, which conducted sub-group analysis of Korean patients, show that the drug has reduced the risk of death by half in patients with locally advanced and metastatic gastric cancer. The Vyloy group had a median progression-free survival (PFS) of 12.8 months compared to 8.1 months of the placebo group, which shows that both groups had longer PFS than all patient groups. 12‧24 months PFS for the Vyloy group were 53% and 30%, and those for the placebo group were 32% and 23%. Additionally, the Vyloy group had a median overall survival of 30.0 months, twice longer than the 15.8 months of the placebo group. 12‧24 months overall survival for the Vyloy group was 78% and 54%, whereas those for the placebo group were 65% and 34%, demonstrating that the Vyloy group's death risk was lower by 50%. "The introduction of Vyloy, targeting the new biomarker for gastric cancer Claudin-18.2, will bring paradigm shift of the treatment outcome of locally advanced or metastatic gastric cancer with limited treatment options until now in South Korea," Dr. Keun-Wook Lee, Professor in the Department of Oncology at Seoul National University Bundang Hospital. The drug's clinical application in South Korea was likely to be delayed as a companion diagnostic (CDx) used to diagnose Claudin-18.2 has been considered for assessment as a new health technology. However, the drug is categorized as having 'companion diagnostic pricing (Level 1).' "The pathology department states that Level2 companion diagnostic pricing is needed for the drug that requires companion diagnostic. However, now, patients can be readily treated with the drug as Level1," Professor A from a tertiary general hospital, who requested to remain anonymous, said. In other words, If Vyloy's companion diagnostics had been assessed as a new health technology, the drug's entry into the domestic market would have been delayed by over one year. However, such concerns have now been resolved. Clinical anticipates Vyloy's prescription to be made in early 2025 when Vyloy launches in South Korea. "Diagnosis reveals that Claudin-18.2 is more frequent than expected with 3-4 individuals out of 10 new patients," Professor A said. "We expect the drug to be in stock by the end of January or February. Its use in patient treatment is expected to be higher."
- Policy
- Prior notification of drug permit changes extended to 2025
- by Lee, Hye-Kyung Dec 19, 2024 05:52am
- The operation of the pilot program, 'Advance Notification System for Drug Change Permit', which allows drug manufacturers and importers to apply for change permits on their preferred date, will be extended. According to industry sources on the 18th, the Ministry of Food and Drug Safety (MFDS) will extend the pilot project until December 31 next year to collect sufficient data to evaluate the system and in consideration of industry demand. The Advance Notification System for Drug Change Permit is a system in which the MFDS and drug manufacturer/importer discuss the date of a drug’s permit change in advance, taking into account the manufacturing and import schedule of the company before processing the change, and then approving the change according to the applicant's desired date. The system had been operated only for new drugs, orphan drugs, and advanced biopharmaceuticals until now. Still, as of May 30, the system had been expanded to include drugs subject to production, import, and supply interruption reports. In the case of drugs subject to production, import, and supply interruption reports, their inclusion in the system may be subject to change according to the list announced by the Health Insurance Review and Assessment Service in late December. Drug manufacturers and importers must obtain a change permit from the head of the MFDS when changes are made to authorized drugs, and then manufacture and import products reflecting the changes. Previously, when the MFDS’s approval process for a drug permit change application was completed, its approval was processed without any notification, making it difficult for companies to predict the date of approval. To address this, the MFDS has established an advance notification system for drug permit changes and plans to institutionalize it through evaluation after completion of the pilot program. The system allows a company that applies for a change permit and enter a notice of the desired change period into the NEdrug system after the MFDS completes review. The change date must be set after the statutory deadline, and extensions can be requested within the statutory period of the civil complaint. Adjustment of the date of change approval through the advance notification system is only applicable to cases where it is necessary to process (extend) the period later than the original processing period due to the manufacturing and import schedule of the drug in question in order not to affect the existing approval process.
- Company
- Kuhnil signs licensing agreement with Mochida
- by Whang, byung-woo Dec 18, 2024 05:55am
- Kuhnil Pharm announced on the 16th that it has signed a sales partnership agreement for Epadel, an original version of the highly purified eicosapentaenoic acid (EPA) ethyl ester formulation, with Mochida Pharmaceutical in Japan. Founded in 1913, Mochida Pharmaceuticals is a leading Japanese innovative pharmaceutical company that has played a leading role in the development of high-purity omega-3 fatty acid products. Epadel (generic name: icosapent) is a highly purified EPA ethyl ester formulation developed by Mochida as the world's first medical drug. The drug is indicated for hyperlipidemia and ulcer, pain, and chilliness associated with arteriosclerosis obliterans in Japan. Through this agreement, Kuhnil Pharm will own exclusive development and marketing rights to Epadel in Korea. Epadel has demonstrated an effect in preventing cardiovascular disease through Japan’s EPA Lipid Intervention Study (JELIS Study). Currently, Epadel’s active pharmaceutical ingredient is supplied by Nissui Corporation, which has advanced EPA purification technology and the capacity for mass production. Han-Kuk Lee, CEO of Kuhnil Pharm said, “The agreement allows us to add a new formulation to our existing portfolio, which includes Omacor and Rosumega, which have been leading the market for hyperlipidemia treatment, and further strengthen our leadership in the Korean hyperlipidemia market. Epadel will be a great treatment option for hyperlipidemia patients in Korea.
- Opinion
- [Reporter’s View] ERP hits industry again
- by Eo, Yun-Ho Dec 18, 2024 05:55am
- Another round of layoffs at multinational pharmaceutical companies are underway with the nearing end of the year. Starting in the second half of the year, 5 companies have already launched early retirement programs (ERPs). The reasons are varied. Whether it's their cash cow crisis, divestitures, or mergers and acquisitions, multinational pharmaceutical companies are taking a hard look at their situation and making layoffs where they deem necessary. This has become a common occurrence in the pharmaceutical industry. In fact, multinational pharmaceutical companies have made mergers and acquisitions (M&A) this year in a variety of rare disease areas, including autoimmune diseases, radiopharmaceuticals, cell therapies, and Alzheimer's disease treatments. They have focused on acquiring rare disease pipelines through small deals under $5 billion. Most of the spin-offs and divestitures of multinational pharmaceutical companies are driven by their “separation of innovation and legacy.” While the companies have undergone activities under the major premise of “choice and focus,” the spin-offs and divestitures have also brought a negative side effect - layoffs. Especially when it comes to layoffs as a result of divestitures, it's not your typical ERP. It's called voluntary retirement, but it's much less “resource-oriented." That's why the news of such an ERP process often leads to labor-management conflicts. The good news is that ERPs in multinational companies offer significant compensation. Especially ERPs that were initiated by spinoffs or selloffs often offer industry-leading compensation packages. For those who have been thinking about changing jobs, ERP can be a good thing. But not everyone wishes to change jobs. For some people, a company is more than just a place to make a living, it's a source of value and pride. When layoffs are unavoidable, companies should focus on maximizing compensation and succession. The coercion behind the word “voluntary” is something that needs to be addressed, and the size of the layoffs should not be vague. There are no good layoffs. Even if some people are happy, they are few and far between. Some people will feel a sense of loss and disconnection just knowing that they've been labeled as redundancies. As the company the employees relied on and were proud of, as an independent pharmaceutical company and not just a Korean subsidiary of a multinational pharmaceutical company, the companies should take the initiative to convince the headquarters if there is room for improvement and take an interest in the future of their employees.
- Company
- Celltrion launches subsidiary 'BioSolutions' for CDMO
- by Cha Jihyun Dec 18, 2024 05:55am
- Seo Jung-jin, chairman of Celltrion Group (source: virtual press conference photos).Celltrion group launches Celltrion BioSolutions, a company specializing in drug contract development and manufacturing organization (CDMO). The company aims to build a manufacturing plant and research center next year and generate sales from 2028. According to the Financial Supervisory Service on December 17, Celltrion acquired 2 million shares of Celltrion BioSolutions for KRW 10 billion. After the acquisition of shares, Celltrion will secure 100% of the shares of Celltrion BioSolutions. "We have decided to commence the CDMO business in September, considering increased demands for biological drugs globally and consistent requests for CDMO services from Korea and foreign markets," Celltrion said. "We have quickly established a corporate body and initiated establishing infrastructure, such as a manufacturing facility, and running the business." The new corporate body plans to provide services for drug development spanning all stages, including new drug candidate identification, cell culture, manufacturing development, clinical trial planning, regulatory document preparation, and commercial production. Lee Hyuk-jae, senior vice president of Celltrion, has been appointed the CEO of Celltrion BioSolutions. Lee has experience in product approval, clinical trials, and production. Based on Celltrion's experience running a contract manufacturing organization (CMO) service, Celltrion BioSolutions aims to challenge the competition. Previously, Celltrion had a history of running a CMO service in 2002. However, as the company reestablished its core value of the company as a biosimilar developer in the late 2000s, the company discontinued the CMO service. "We plan to secure production by reducing the cost of expansion based on Celltrion's experience running a drug CMO service for global pharmaceutical companies spanning all phases of the pharmaceutical business, such as various business project records, proprietary production, and approvals, and also by securing price-cost competitiveness through high production·efficiency," Celltrion said. The company is reviewing site candidates for the new corporation's production facilities. Celltrion plans to design production facilities in South Korea with a maximum capacity of 200,000 liters, beginning construction on the first plant with a 100,000-liter capacity next year. The company will continuously assess the optimal location to ensure sustainable production and supply while expanding production capacity. The investment in the new company will be funded through internal capital and external funding. Initially, Celltrion plans to allocate up to KRW 1.5 trillion of its capital to establish facilities and launch contract development (CDO) services. Following this, the company plans to secure an additional KRW 1.5 trillion in external funding to expand specialized overseas research centers and to develop next-generation modality production facilities. The company plans to place multiple large·small-scale bioreactor placements to enable mass production in the new facility. Celltrion also plans to establish production facilities for next-generation modalities, including antibody-drug conjugates (ADC), multi-antibody therapies, cell and gene therapies, and peptide-based new drugs. To expand into new modality areas, strengthen production capabilities, and enhance technological competitiveness, the company will establish specialized research centers domestically and internationally, including in the United States, Europe, and India. The company aims to offer an integrated CDMO solution through the convergence of technologies. The company expects commercial production to begin in 2028, which is expected to generate significant revenue. "Based on our know-how accumulated over 20 years, Celltrion has commenced a CDMO company that could provide customized service spanning all phases of drug development for clients," Celltrion said. "Celltrion BioSolutions will strive to provide truly end-to-end service based on cost-price competitiveness and customer-oriented policy."
- Company
- Numerous K-Bio drugs secure FDA ODD
- by Son, Hyung Min Dec 18, 2024 05:55am
- Korean pharmaceutical and biotech companies seek to enter the market for rare diseases through the orphan drug designation. Th rare disease field has a small pool of patients, but companies can obtain an exclusive status by acquiring innovative new drugs when they succeed and create high-added value. New drug candidates from various companies, including Hanmi Pharm, GC Biopharma, GI Innovation, and Rznomics, successfully obtained the U.S. Food and Drug Administration (FDA)'s Orphan Drug Designation (ODD). According to industry sources on December 16, twenty-one new drug candidates under development by Korean pharmaceutical and biotech companies received ODD from the FDA. ODD provides companies developing treatments for patients with rare and intractable diseases, which have a disease prevalence of under 100,000 population, benefits such as expedited review, tax reductions, and exclusive status for new drugs. Pharmaceutical companies, Boryung·GC Biopharma, have secured FDA's ODD in the first half of the year In the first half of this year, new drug candidates by Boryung, Rznomics, NeoImmuneTech, SPARK Biopharma, SN BioScience, Oscotec, Ingenium Therapeutics, Dr. Noah Biotech, Hanmi Pharm, GC Biopharma, and GI Innovation have successfully obtained ODD. First half-year 2024 report: new drug candidates by Boryung, Rznomics, NeoImmuneTech, SPARK Biopharma, SN BioScience, Oscotec, Ingenium Therapeutics, Dr. Noah Biotech, Hanmi Pharm, GC Biopharma, and GI Innovation have successfully obtained ODD. Boryung's BR-101801, a novel drug candidate to treat blood cancer, was the first to receive FDA ODD this year. Boryung is investigating BR-101801's potential in various blood cancers, including peripheral T-cell lymphoma and mycosis fungoides. In January, it received the approval for the treatment of angioimmunoblastic T-cell lymphoma. BR101801 is the first-in-class drug candidate to inhibit phosphoinositide 3-kinase (PI3K)γ/ δ and DNA-dependent protein kinase (DNA-PK). It can effectively induce cell death through triple target inhibition and suppress a cancer protein c-Myc. NeoImmuneTech's NT-I7 received an ODD in the treatment of pancreatic cancer. NT-I7 is a novel drug candidate that targets interleukin (IL)-7, which regulates T-cell development and function. It has been investigated for various indications. Besides the current ODD for pancreatic cancer, NT-I7 received ODDs in the treatment of CD4 lymphocytopenia (2019), multifocal leukoencephalopathy (2020), and glioblastoma (2023). A Fabry disease treatment, LA-GLA, developed jointly by Hanmi Pharm and GC Biopharma, successfully received an ODD in the United States. LA-GLA is formulated for once-per-month subcutaneous administration. Fabry disease is a type of lysosomal storage disorder (LSD) resulting from a genetic deficiency in a particular enzyme, leading to metabolic alterations. In June, GI Innovation's GI-102, a candidate immunotherapy for cancer, received FDA ODD. The company is developing GI-102, which acts on CD80 and interleukin (IL)-2. IL-2 is involved in immune cell proliferation and activation, and CD80 blocks CTLA-4, a receptor preventing immune cells from attacking cancer cells. In the second half of this year, 11 new drug candidates received FDA's ODD In the second half of this year, eleven new drug candidates from Korean pharmaceutical and biotech companies received ODD in the United States. Second half-year 2024 report: new drug candidates by K-Bio companies, including Zymedi, Connext, iLeadBMS, HysensBio, and Rezolute, successfully received the FDA Zymedi successfully received the FDA's ODD for its antibody-drug ZMA001 in July. ZMA001 targets intractable disease, pulmonary hypertension. Pulmonary hypertension is a disease characterized by narrowing of the blood vessels in the lungs, leading to increased pulmonary blood pressure and ultimately causing heart failure. In South Korea, approximately half of the patients with pulmonary hypertension die within five years of diagnosis. While treatments such as phosphodiesterase type 5 (PDE5) inhibitors and calcium channel blockers (CCBs) have been used, they only provide symptom management. More new drugs are needed. ZMA001, a human monoclonal antibody, prevents inflammatory macrophages from infiltrating the lungs, fundamentally inhibiting pulmonary hypertension symptoms from the initial stage. In preclinical animal model studies, ZMA001 demonstrated superior efficacy to existing drugs. In August, Connext's acute graft-versus-host disease (GVHD) treatment, 'CNT101,' was added to the FDA's ODD list. CNT101 is a recombinant protein that targets the TLR5 receptor expressed on epithelial and immune cells and is being developed as a treatment for acute radiation syndrome caused by radiation exposure. Connext explains that CNT101 minimizes gastrointestinal tissue damage resulting from radiation toxicity during hematopoietic stem cell transplantation, thereby preventing the onset of GVHD. In October, a Target Protein Degrader (TPD) molecular glue from iLeadBMS, Ildong Pharmaceutical's subsidiary specializing in new drug development, was designated as the FDA's ODD. iLeadBMS is developing a molecular glue that targets cyclin-dependent kinase 12 (CDK12), a protein that controls the expression of cancer-related genes. A complex formation between CDK12 and Cyclin-K is known to influence the growth and metastasis of cancer cells in refractory cancer. Earlier this year, iLeadBMS presented preclinical results at the ESMO Targeted Anticancer Therapies Congress 2024 (ESMO TAT 2024), demonstrating that its molecular glue effectively inhibits CDK12 activity and induces degradation of Cyclin-K, thereby suppressing the growth of HER2-negative gastric cancer cells. This success led to the designation of the drug as an orphan drug for gastric cancer. In December, HysensBio's treatment for amelogenesis imperfecta received ODD in the United States. Amelogenesis imperfecta is a rare genetic disorder that impairs the formation of enamel on teeth. The disease causes symptoms such as tooth sensitivity, erosion, and fractures, and currently, no effective treatment options are available. Rezolute, Handok’s US subsidiary, received the FDA ODD for its 'RZ358,' a treatment for tumor-mediated hyperinsulinism. VasThera's pulmonary arterial hypertension therapy 'VTB-10' also received the FDA's ODD this month.
- Policy
- Generic drugs without originals released in KOR
- by Lee, Tak-Sun Dec 18, 2024 05:54am
- Takeda Generic versions of drugs whose original versions are unavailable in Korea are expected to be released one after another. This is becoming a Korean phenomenon, where original drugs withdraw from the domestic market due to low drug prices and generics fill the void. According to industry sources, the National Health Insurance Service has begun negotiations for the reimbursement of a generic version of Otezla (Apremilast). Otezla is Amgen's treatment for psoriatic arthritis and psoriasis, which was approved in November 2017 but withdrawn from the market in June 2022. The drug had difficulty being listed for reimbursement. The drug had become the top-selling oral psoriasis treatment in the global market but was not even properly showcased in the Korean market due to the reimbursement hurdle. The analysis is that the drug missed its prime reimbursement time while changing hands three times, from Celgene, BMS, to Amgen. In the meantime, competitors such as Cosentyx, Stelara, Skyrizi, and Taltz entered the reimbursement market, weakening Otezla’s competitiveness in the domestic market. In Korea’s situation, as the price of the later entrants is set lower than their competitors, the pharmaceutical company’s concerns have deepened. In addition, with the patent’s expiry date approaching and the domestic generic companies’ patent challenges against Amgen, the company announced Otezla’s withdrawal from the market. As a result, generic products without original versions are on the verge of receiving reimbursement in Korea. The drugs are: Dong-A ST’s Oteria Tab, Daewoong Pharmaceutical's Apsola Tab, Chong Kung Dang's Otebell Tab, Dongkoo Bio Pharm’s Otemila Tab, and Han Lim Pharm’s Psopre Tab. In October, the Drug Reimbursement Evaluation Committee of the Health Insurance Review and Assessment Service (HIRA) held a review on the adequacy of Otezla generics and determined that their reimbursement was adequate if their price was less than the assessed value. As a result, the pharmaceutical companies accepted a price lower than the assessed value and moved on to the negotiation stage with the NHIS. Now that they have accepted the assessed value and moved on to the negotiation stage, it is expected that the products will be launched with reimbursement in the first half of next year at the latest. Takeda’s P-CAB class gastroesophageal reflux disease drug ‘Vocinti Tab (vonoprazan fumarate)’ is also expected to be the first generic product to enter the reimbursement market without an available original drug. This is because generic development by domestic pharmaceutical companies is in full swing, and Vosinty withdrew its license on the 12th. Generic companies are aiming for an early market launch by avoiding Vosinty’s patent. The product patent for Vosinty Tab expires in December 2027, but it can be released in October next year if the patent’s extended term is invalidated through patent avoidance. Vosinty also has missed the golden time for reimbursement in Korea. It is analyzed that it lost its competitiveness as domestic pharmaceutical companies' P-CAB class products such as K-CAB and Fexuclue Tab were first released on the domestic market. An industry official said, “U generic companies have the advantage of greater flexibility in drug pricing because their drug development cost is relatively low. They can enter the domestic health insurance market with a relatively lower price than the original companies, Therefore, it will be interesting to see how generic drugs without original drugs perform in the domestic market.
- Opinion
- [Reporter's view] The National Assembly must restore
- by Lee, Jeong-Hwan Dec 17, 2024 05:51am
- On December 14, the National Assembly passed an impeachment motion against President Yoon Suk Yeol, causing the government to be partially paralyzed. The Ministry of Health and Welfare, the Special Presidential Committee on Healthcare Reform, and the National Bio Committee face significant disruptions in their ongoing policy initiatives. On Monday, December 16, following the weekend and holiday period after the impeachment decision, Minister of Health and Welfare Cho Kyoo-hong convened an emergency executive meeting at 9 a.m. Vice Minister Lee Ki-il, Second Vice Minister Park Minsoo, and department heads and directors of all key offices attended the meeting. Minister Cho Kyoo-hong directed the preparation of emergency medical response plans, respiratory disease management measures, and emergency healthcare services for the upcoming Korean New Year holiday. Cho also emphasized consistently and thoroughly implementing the recently announced regional·essential healthcare reinforcement strategies. Cho has been steadfastly emphasizing the MOHW's duties under Prime Minister Han Duck-soo, who is currently serving as acting president. Cho also faces unavoidable administrative disruptions. Minister Cho is himself under investigation as a suspect by the prosecution. The Special Presidential Committee on Healthcare Reform, led by Chairman Noh Yeon-hong, is facing increasing opposition from the medical community, creating uncertainty about its continued operation. Similarly, the National Bio Committee, where President Yoon Suk Yeol serves as chairman, is at risk of having its launch derailed. President Yoon Suk Yeol's duties were immediately suspended, and the Constitutional Court of Korea's impeachment trial was underway, resulting in political turmoil. The ruling People Power Party's leader, Han Dong-hoon, resigned voluntarily. In contrast, Lee Jae-myung, leader of the opposition Democratic Party, proposed the establishment of a National Stability Council for the ruling party. However, this suggestion has yet to gain traction. The impeachment vote has initiated the countdown for the Constitutional Court of Korea's ruling, with a final decision expected within 180 days and a new president to be elected within 60 days of the verdict. As the presidential office, government ministries, affiliated organizations, and the entire political landscape face chaos, the healthcare, pharmaceutical, and biotech industries are also encountering damages. The future of healthcare reforms, particularly those aimed at strengthening regional and essential medical services, is uncertain. The momentum for expanding medical school quotas has diminished. The pharmaceutical and biotech industries closely monitor the government's chaos, especially regarding how new regulatory·support policies, such as drug approvals·pricing, in 2025 will take shape. The remaining task is for the government and political parties to collaborate in restoring stability to the healthcare·biotech renewal policies, which have been left in chaos and now show the sings of ongoing conflict. Instead of focusing on battles between the opposing parties after the impeachment, the National Assembly must quickly secure a path forward for healthcare reforms critical to the nation's future. Furthermore, the National Assembly must identify and promote policies that support the pharmaceutical and biotech industries, providing the necessary legislative and government administrative support.
