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- 2026-05-09 12:32:46
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- The pharmaceutical union of 2,500 people has been launched
- by Jul 11, 2022 06:03am
- The first chairman is Ahn Deok-hwan, head of the Korea Novartis union. Fifteen multinational companies and one domestic company participated in the NPU launch ceremony after three years of discussion "Working conditions are deteriorating despite increased sales in the pharmaceutical industry. Active response to common issues" The nation's largest pharmaceutical labor union has been newly created. The new labor union, which consists of a total of 2,500 pharmaceutical workers, expressed its willingness to jointly respond to the pharmaceutical company's restructuring moves. The NPU held a launching ceremony at the FKTU on the morning of the 5th. Kim Dong-myung, chairman of the FKTU, Hwang In-seok, chairman of the FKTU, Kim Ki-chul, chairman of FKTU's Seoul regional headquarters, Nam Sung-hee, chairman of FKCU's pharmaceutical cosmetics division, and Yoo Byung-jae, CEO of Novartis Korea, attended the meeting. A total of 16 domestic and foreign pharmaceutical labor unions, including ▲Novonodisc Pharmaceutical, ▲Bayer Korea, ▲Amgen Korea, ▲Ipsen Korea, ▲Novatis Korea, ▲Viatris Korea, ▲ Janssen Korea, ▲ Pfizer Pharmaceutical, ▲ Sanofi Aventis Korea, ▲Alvogen Korea, ▲Opella Healthcare Korea, ▲Merck, ▲Beringer Ingelheim, ▲AstraZeneca, ▲GSK, and ▲Hyundai Pharmaceutical. Eight unions, including Novonodisc Pharmaceutical and Pfizer Pharmaceutical Korea, have already decided to switch to industrial unions. Eight unions, including the AstraZeneca Korea Union, are preparing to switch industries. The total number of union members was about 2,500. Those who have been preparing for a new union of pharmaceutical unions for about two years since 2019 formed an integrated promotion committee for some unions and non-affiliated unions that left the KDPU, and officially established the NPU last year. In a declaration of launch, Ahn Deok-hwan, the first chairman of Novartis Korea, said, "The Korean pharmaceutical industry is suffering from job insecurity and a real decrease in wage income through the fourth revolution and COVID-19." "I felt the need for solidarity as I recognized these problems as the same problems that appeared in the pharmaceutical industry as a whole, not in a specific company," he said. He then stressed, "The NPU will firmly maintain employment stability, raise wages and welfare, and respond intensively to common problems arising from low growth and non-face-to-face operations in the name of voluntary retirement." Yoo Byung-jae, CEO of pharmaceutical industry, said in a congratulatory speech, "Congratulations on the launch of NPU. The pharmaceutical bio industry is facing a reorganization of its organizational structure to improve innovation and productivity, he said. "I think trust between employees and companies is more important than anything else for companies to grow continuously and stably." There may be conflicts of interest between each subject, but we hope to establish a constructive relationship with the NPU," he said. The NPU is closely watching the reduction of personnel due to the recent reorganization at the global level. For example, Pfizer, which is in the process of reorganizing its sales department, is likely to implement additional Voluntary Early Retirement Programs. In addition, Novartis recently announced plans to reduce the number of people worldwide by integrating the organization at a global level. In addition to the overlapping number of people due to department integration, additional personnel reduction can be made in Korea. Chairman Ahn said, "The Voluntary Early Retirement Programs have been doing ERP due to a lack of trust that the union can protect itself, even though the subject has to be a worker. The NPU will try to gain confidence in its members that it can protect them."
- Company
- Byung-Jae Yoo to head integrated Novartis Korea
- by Eo, Yun-Ho Jul 08, 2022 06:25am
- General Manager Byung-Jae Yoo Byung-Jae Yoo (49) was appointed the head of the integrated Novartis Korea. Suhee Shin, General Manager of the Oncology Business Unit at Novartis submitted her resignation. According to industry sources, Novartis Korea has been integrating its Pharmaceuticals and Oncology Business Unit with the goal of completing the integration within the year. The company had been operating 2 business units independently under one name, but the two units have operated separate support departments, including marketing·sales as well as drug pricing·government relations·approval departments. In the integration process, the business units will be competing for the head position of each department. As Yoo was nominated as the head of the integrated business unit, how the structure of Novartis Korea would change remains to be seen. Novartis’s Asia-Pacific Region also appointed the former head of its Pharmaceutical Business Unit as Head of the integrated Novartis Asia-Pacific. Meanwhile, Yoo joined J&J in 2006 after completing his MBA at Harvard Business School through the company’s International Recruitment & Development Program. Since then, Yoo had held various roles in the company, including at North America’s Endovascular team, DePuy UK, and DePuy Australia. In Korea, he served at North Asia’s Cardiovascular Care Business Unit and was appointed the Managing Director of Johnson & Johnson North Asia to oversee Korea, Taiwan, and Hong Kong in 2017. In October last year, Yoo was appointed General Manager of Novartis Korea.
- Company
- Dong-A ST prepares to make another leap with Actonel
- by Eo, Yun-Ho Jul 07, 2022 05:55am
- Dong-A ST is attempting to make another leap with ‘Actonel,’ a bisphosphonate drug that is now sold exclusively by the company. According to industry sources, Dong-A ST has been working to land Sanofi’s bisphosphonate osteoporosis treatment Actonel (risedronate) at major medical institutions in Korea after it started to exclusively supply the drug in October last year. As of now, the drug has passed the drug committees (DCs) of 64 medical institutions including the ‘Big 5 tertiary hospitals’ of Korea - the Seoul National University Hospital, Seoul Asan Medical Center, Sinchon Severance Hospital, etc. Actonel, which is one of the representative bisphosphonate bone resorption inhibitors, has ruled the ranks in the Korean osteoporosis treatment market after its release in 2003, but then lost its share to new drugs such as Amgen’s ‘Prolia (denosumab).’ Therefore, what performance Dong-A ST will make with Actonel remains to be seen. With additional landings made, Actonel’s various strengths such as the 150mg formulation have been newly or additionally listed at hospitals. Sanofi discontinued the supply of its 5mg and 35mg strengths last year, and Dong-A ST plans to attract prescriptions while stabilizing the supply. Actonel has demonstrated its efficacy by reducing the relative risk reduction (RRR) of osteoporotic fractures and the risk of vertebral, hip, and nonvertebral fractures over its competitors from six months after intake. Meanwhile, Actonel EC 35mg is an enteric-coated tablet that can be taken once a week regardless of meal intake to treat osteoporosis in postmenopausal women. Actonel 150mg is taken 30 minutes before or 2 hours after meals monthly to treat osteoporosis in postmenopausal women.
- Company
- Two pharmaceutical unions unite with each other
- by Jul 07, 2022 05:54am
- NPU Launching CeremonyWith the birth of the nation's largest pharmaceutical industry union, the number of unions affiliated with the Federation of Korean Trade Unions in the pharmaceutical industry has increased to two. This includes corporate unions that have withdrawn from the existing industrial unions, drawing keen attention to the background. The NPU was launched on the 5th as an industrial union under the Federation of Korean Chemical Worker's Union (KCTU). The NPU has ▲ Novonodisc, ▲Bayer Korea, ▲Amgen Korea, ▲Ipsen Korea, ▲Novartis, ▲Viatris Korea, ▲Janssen, ▲Pfizer Pharmaceutical, ▲Sanofi Aventis Korea, ▲Alvogen Korea, ▲Opella Healthcare Korea, ▲Beringer Ingelheim, and ▲Hyundai. It is the largest union group in the pharmaceutical industry with a total number of 2,500 members. Among them, some corporate unions, including Novartis Korea, Merck Korea, AstraZeneca Korea, and Pfizer Korea, have belonged to the KDPU in the past. It is the first union in the pharmaceutical industry established in 2012 and is also affiliated with the Federation of Korean Chemical Workers' Union. With the introduction of new NPUs into existing KDPUs, two types have existed in the pharmaceutical industry. Some corporate unions that have been active in the KDPU left the union between 2019 and 2020, and formed an integrated promotion committee to devise a new coalition. On top of that, the current NPU started with the participation of unaffiliated unions. In the current KDPU, where some corporate unions have escaped, branches such as Allergan, Mundipharma, Zuellig Pharma Korea, and BMS Korea remain. NPU's first chairman, Ahn Deok-hwan, explained that the reason why he moved from the KDPU is "a difference in philosophy aimed at." It is interpreted that there was a difference of opinion with the existing executive in the process of preparing countermeasures for one agenda. It is understood that opinions will also be mixed in detailed operation plans. The new coalition considered a coalition that recognizes independence as each corporate union in the initial phase of the initiative. However, as the discussion materialized, it was judged that industrial unions were appropriate to increase bargaining power and legal recognition. Kang Seung-wook, secretary-general of the NPU, said, "As the discussion progressed, I chose the current industrial union because I thought acting as a coalition and acting as a industrial union were different." "As a pharmaceutical industry union, I am determined to do it properly," he explained. He also expressed his willingness to join forces with the KDPU. Chairman Ahn said, "Just as unions do not have to be one, I think various types of unions can compete or complement each other and produce better results." "We will be solidarity with the KDPU and help each other with what we need and have a complementary relationship," he said.
- Company
- First KRAS lung cancer drug Lumakras released next month
- by Jul 07, 2022 05:54am
- Non-small cell lung cancer patients with KRAS mutations are expected to be able to receive treatment with the targeted anticancer therapy ‘Lumakras (sotorasib)’ starting this August. Amgen announced it will actively increase diagnostic tests and pursue reimbursement listing for the drug to increase accessibility to the only KRAS-targeted therapy in Korea. On the 6th, Amgen Korea held a press conference to celebrate the launch of Lumakras in Korea at the Plaza Hotel in Jung-gu, Seoul. Myung-Ju Ahn, Professor of Hematology-Oncology at Samsung Medical Center Lumakras was approved as the first targeted anticancer therapy to target the KRAS mutation, in February this year by the Ministry of Food and Drug Safety. Lumakras is indicated for use as second-line or subsequent treatment for patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer. Amgen succeeded in receiving FDA approval and commercializing Lumakras in only 3 and a half years after discovering the candidate substance in November 2017. Lumakras binds with the P2 pocket near the KRAS G12C switch II to lock the mutated protein in an inactive state. By selectively inhibiting the signaling oncogenic activity, Lumakras can prevent tumor cell growth without affecting the wild-type KRAS, Myung-Ju Ahn, Professor of Hemato-Oncology at Samsung Medical Center who attended the press conference, said, “KRAS mutations rarely occur concurrently with other common mutations in EGFR, ALK, ROS1, etc. It is deeply associated with cigarette smoking, and STK-11 mutations were concurrently expressed in 1/4 of the cases. Also, patients with KRAS mutations have a poorer prognosis than those without.” According to the 2-year long-term data that was presented recently, Lumakras achieved an objective response rate (ORR) of 40.7% in 174 pre-treated patients with KRAS G12C-mutated NSCLC. Also, Lumakras demonstrated a median duration of response (DOR) of 12.3 months and a disease control rate (DCR) of 83.7%. Results also showed a median progression-free survival (PFS) of 6.3 months and overall survival (OS) of 12.5 months with 32.5% of patients still alive at two years. Lumakras is characterized by its high safety. The drug specifically binds to KRAS G12C. Major adverse responses found in patients in the clinical trial were mostly mild and predictable Grade 1 and 2 adverse events. No new safety signals for LUMAKRAS were identified in the 2-year long-term follow-up as well. On this, Professor Ahn said, “Lumakras has good tolerability as it specifically responds to G12C before differentiation without affecting wild-type KRAS. 81% of the patients that participated in the trial had cancers that progressed despite intensive treatment with immunotherapy or chemotherapy, and Lumakras showed an excellent therapeutic effect in these patients.” Professor Ahn also expressed high expectations on the expandability of Lumakras, which is currently used for second-line or higher treatment, as various trials on its combined use with other immunotherapy drugs are underway. Ahn said, “Cancer immunotherapy drugs are currently applied reimbursement for first-line treatment of advanced NSCLC in patients with a PD-L1 expression rate of 50% or higher, but a trial on Lumakras is being conducted on its use in combination with a cancer immunotherapy drug in patients that who show poor response to immunotherapy and have negative PD-L1 expression. I believe the drug will eventually become a first-line treatment in KRAS-mutated NSCLC.” In particular, 20% of patients with KRAS-mutated NSCLC concurrently express STK11 mutations, in which immunotherapy drugs show poorer effect. Therefore, there are also expectations that a Lumakras+immunotherapy combo may show an effect in PD-L1 negative patients that have STK11 mutations. At the conference, Amgen expressed its determination to make various efforts to increase access to Lumakras, which will be officially released at first-line hospitals in August this year. The company will make efforts to list Lumakras for reimbursement and activate diagnostic tests to identify patients with KRAS mutations. Miseung Kim, Senior Manager at Amgen Korea said, “We will actively engage in discussions with HCPs and health authorities in Korea to increase patient access to Lumakras by increasing diagnostic testing for KRAS mutations and receiving reimbursement, etc.”
- Company
- Novonodisk labor union announces union struggle on 7th
- by Eo, Yun-Ho Jul 07, 2022 05:54am
- Novonodisk Pharmaceutical's labor union under the NPU will hold regular general meetings and fight for all members. Novonodisk labor union is currently fighting against ▲ wage negotiations broke down in 2021, ▲petition of the Ministry of Labor regarding wage arrears due to the change in the disadvantage of the sales department incentive system, and ▲ the Ministry of Labor's petition for unpaid wages due to the failure to provide gas costs for managers. According to the NPU, the Novonodisk union wanted to negotiate with the management to solve the problem, but there has been no progress in discussions yet. The union said it began a picket fight on the 14th of last month and is preparing for a group rally at 2 p.m. on the 7th. Heo Nam-jin, chairman of the Novonodisc union, said, "The union wants a company that is democratic, fair and respectful of each other, and all members feel that they are receiving fair wages, including job security." The NPU plans to actively support the Novonodisc labor union, pointing out the situation in which the union rather asks the company to abide by the actual laws of Korea. The NPU is scheduled to launch a joint struggle between the Sanofi-Aventis Korea labor union on the 5th and the Novonodisk labor union in its second action. The NPU was launched on the 5th and is an industrial labor union with a total of 16 pharmaceutical bio unions, and is chaired by Ahn Deok-hwan, chairman of the Novartis Pharmaceutical Union.
- Company
- Next-gen breast cancer drug, pneumococcal vaccine to come
- by Jul 06, 2022 05:47am
- New big drugs, including a pneumococcal vaccine, a macular degeneration treatment, and a breast cancer treatment, are expected to receive approval from the Ministry of Food and Drug Safety in the second half of this year. According to industry sources on the 6th, new drugs such as ▲Vaxneuvance (MSD) ▲Enhertu (Daiichi Sankyo) ▲Vabysmo (Roche) ▲Nexviazyme (Sanofi) ▲Exkivity (Takeda Pharmaceutical) may be approved within the year. 18 drugs from 14 companies have been approved as new drugs in the first half of this year. ◆’Enhertu’ acclaimed at ASCO, makes the first step in HER2 positive breast cancer Pic of EnhertuAstraZeneca and Daiichi Sankyo’s breast cancer treatment Enhertu (trastuzumab deruxtecan) has recently received attention with its groundbreaking data. The drug first received approval for the treatment of HER2-positive breast cancer in the US in December 2019 as a next-generation antibody-drug conjugate (ADC). Enhertu received acclamation at the ASCO 2022 meeting that was held in June this year after presenting data that the drug had improved progression-free survival, reduced disease progression and risk of death even in HER2-low expression breast cancer regardless of hormone receptor (HR) status. The field of HER2-low expression breast cancer has had a high unmet need as it was unsuited for treatment with HER2-targeted therapies. In Korea, Enhertu is expected to be first approved as a third-line treatment for HER2-positive metastatic breast cancer. Daiichi Sankyo Korea owns the license for Enhertu in Korea. Roche’s ADC ‘Kadcyla’ also has the same mechanism of action and is indicated for the treatment of HER2-positive breast cancer. Enherto aims to surpass Kadcyla in the market with head-to-head trial results. According to results from the DESTINY-Breast03 that compared Enhertu and Kadcyla as second-line treatment for HER2-positive metastatic breast cancer, Enhertu reduced the risk of disease progression and death by 72% compared to Kadcyla. Also, the objective response rate (ORR) was significantly higher, 80% in the Enhertu group as compared to 34% in the Kadcyla group. This is why expectations for Enhertu are high in Korea. In June, a public petition was filed for the approval and reimbursement of Enhertu and received consent from 14,000 citizens. ◆ MSD makes reattempt at pneumococcal vaccine with Vaxneuvance Pic of Vaxneuvance Vaxneuvance is a next-generation pneumococcal vaccine developed by MSD that has first been commercialized in the US in July last year. The vaccine had received approval for the indication to prevent invasive pneumococcal disease caused by 15 Streptococcus pneumoniae serotypes in adults 18 years of age or older, and then extended its indication to all ages 6 weeks and older. MSD is attempting to reclaim its reputation in the field of pneumococcal vaccines with Vaxneuvance. Pfizer Korea’s 13-valent pneumococcal vaccine Prevenar 13 accounts for the largest share of Korea’s pneumococcal vaccine market. Prevenar 13 had sold 38.1 billion won in sales last year according to IQVIA. ‘Prevenar 13’ is a PCV13 that prevents infection from 13sttreptococcus pneumoniae serotypes (3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F). It may be administered to all those aged 6 weeks or older. Vaxneuvance, prevents infection from 15 streptococcus pneumoniae serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F). ◆ Exkivity to enter as the second EGFR Exon20 insertion mutations targeted therapy Pic of Exkivity Takeda Pharmaceuticals Korea’s ‘Exkivity (mobocertinib)’ that targets EGFR Exon20 insertion mutations is also expected to be approved within the year. Exkivity was approved in the US in September last year as a treatment for metastatic non-small cell lung cancer (NSCLC) with EGFR Exon20 insertion mutations. Exkivity is considered a competitor to Janssen’s ‘Ryvrevant (amivantamab)’ that was approved in February this year, as both drugs target EGFR Exon20 insertion mutations. Exon20 insertion mutations are found in approximately 10% of patients with EGFR mutations and are known to not see an adequate effect from existing EGFR-targeted anticancer therapies due to its various subtypes. The two drugs are taking different paths with their similar but different characteristics. Clinical trials are underway for Ryvrevant as a dual inhibitor that targets Exon 20 and MET mutations, as a monotherapy in MET Exon 14 skipping mutations, and as a combination therapy with Leclaza in common EGFR mutations. On the other hand, Exkivity is seeking to expand its indication to HER2 mutations in lung cancer. Unlike the injection-type Ryvrevant, Exkivity comes in an oral formulation. ◆’Vabysmo,’ first dual inhibitor for macular degeneration to enter Korea Pic of VavysmoRoche is expected to release its new macular degeneration treatment ‘Vabysmo (faricimab)’ in Korea within this year. Vabysmo is the first bispecific antibody that targets both the VEGF which is commonly targeted by existing ocular disease treatments as well as Ang-2 which is considered to be the cause of retinal disease to block both pathways. The drug was approved in January this year as a treatment for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME). Vabysmo has demonstrated non-inferiority over Eylea in improving vision outcomes in 4 Phase III studies on nAMD and DME when administered at intervals of up to 4 months. This market is currently led by Bayer’s ‘Eylea’ and Novartis’ ‘Lucentis,’ which had raised 70.5 billion and 35.1 billion respectively in sales last year. Novartis’s Lucentis follow-up ‘Beovu’ has also recently joined the competition. Vabysmo is expected to differentiate itself from its competitor with its dual inhibition of action. However, Vabysmo would need to overcome the barrier of being a new drug in a field where HCPs prefer drugs with high safety due to long-term administration.
- Company
- BL’s COVID-19 treatment expands indication to pneumonia
- by Lee, Seok-Jun Jul 06, 2022 05:47am
- BL is aiming to adopt an indication expansion strategy and develop 'BLS-H01,’ its new drug for COVID-19 treatment for which a Phase II trial is underway, as a broad-spectrum treatment for pneumonia. According to BL on the 5th, BLS-H01 is an immunoregulatory treatment that contains a gamma PGA. A clinical trial is currently underway to assess its effect in preventing and treating pneumonia caused by COVID-19. BLS-H01’s core ingredient, ‘gamma PGA,’ stimulates the expression of dendritic cells that are necessary for the activation of natural killer (NK) cells and immune T cells to promptly remove virus-infected cells in the lung. This mechanism of action can respond to all virus types including influenza and SARs as well as their variants. In a research BL conducted with the Korea Mouse Phenotyping Center (KMPC) under the Ministry of Science and ICT last year, BLS-H01 demonstrated its effect in animal models infected with the COVID-19 virus. BL is now setting out to develop BLS-H01 as a broad-spectrum pneumonia treatment in addition to its development as a COVID-19 treatment based on such research results. The company aims to develop a drug that fundamentally treats pneumonia beyond the level of symptomatic treatment that is aimed at improving symptoms in the absence of an effective treatment. An official from BL said, “BLS-H01 is expected to significantly improve the survival rate of patients dying from pneumonia. As the drug can minimize respiratory complications and sequela caused by chronic pneumonia that arise with long-term treatment, there is high potential for its commercial success with new drug development.”
- Company
- 2nd generation EGFR TKI Vizimpro can be prescribed in Big 5
- by Eo, Yun-Ho Jul 06, 2022 05:47am
- Pfizer's second-generation EGFR TKI Vizimpro has settled in the Big 5 General Hospital. According to related industries, Pfizer's EGFR TKI Vizimpro recently passed all five major medical institutions such as Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, Asan Medical Center, and Sinchon Severance Hospital. It was completed at major medical institutions nationwide, including the National Cancer Center, Seoul National University Bundang Hospital, Pusan National University Hospital, Chungbuk National University Hospital, and Chungnam National University Hospital. Vizimpro, which was listed on the insurance benefit list in December 2021, was designated as a priority review target by the US FDA in January 2018 and approved in September of the same year. Currently, it is licensed and used in the United States, the European Union, and Japan. In Korea, Vizimpro was approved as the first treatment for local progressive or metastatic EGFR mutation non-small cell lung cancer in February last year. VIZIMPRO is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung canker (NSCLC) with epidermal growth factor acceptor (EGFR) exection 19 deployment measurement 2185 or 85. Currently, EGFR TKI such as AstraZeneca's Iressa, the first-generation drug, Roche's Tarceva, AstraZeneca's Tagrisso, and Yuhan's Leclaza are prescribed in Korea. Competition to attract prescriptions for Giotrif and Vizimpro, the second-generation drugs, is expected to intensify in the future. The efficacy of Vizimpro has been demonstrated through ARCHER 1050, a phase 3 clinical trial. The study directly compared Vizimpro with Iressa, the first-generation drug, and a total of 452 non-small cell lung cancer patients were registered. Progression-Free Survival (PFS) reduced the risk ratio by 41% compared to Iressa, and the median PFS value was 14.7 months for Vizimpro, ahead of the Iressa administration group of 9.2 months. The results of the side effects of Vizimpro were poor. The common severe side effects of Grade 3 or higher were 14% acne and 8% diarrhea in the Vizimpro administration group, and 8% liver enzyme abnormalities occurred in the Iressa administration group. 60% of the Vizimpro administration group needed dose adjustment as a side effect.
- Company
- There are many complaints about the revaluation of generics
- by Chon, Seung-Hyun Jul 06, 2022 05:46am
- Pharmaceutical companies complain of unnecessary waste of money on products being sold without problems. Pharmaceutical companies are struggling ahead of the general drug price revaluation. There are many concerns that the biological equivalent test, which was conducted with the aim of maintaining drug prices, could lead to a reduction in drug prices due to delays in submitting data due to COVID-19. The pharmaceutical industry continues to ask health authorities to extend the deadline for submitting data, but it has not yet been carried out. According to the industry on the 25th, the HIRA recently held a briefing session on the revaluation of the upper limit of registered drugs and proposed a schedule to receive revaluation data from October 1st to the end of February next year. The schedule for the generic drug price evaluation announced by the MOHW two years ago has been specified. It announced a plan to reevaluate the upper limit of drugs that maintain the previous drug price by submitting data on conducting biological equivalent test and using registered raw materials drugs by February 28, 2023. This is a follow-up measure to apply the new drug price system, which took effect in July 2020, to the registered generic. In the revised drug price system, generic products can receive an upper limit of 53.55% compared to the original before the patent expires only if they meet both the requirements for direct biological testing and the use of registered raw materials. Each time one requirement is not met, the upper limit is lowered by 15%. Once the pharmaceutical companies' submission of data is completed, they will go through procedures such as practical review and pharmaceutical companies' objections, and from July next year, generic drugs that have not submitted data will be lowered. Requirements for the use of registered raw materials can be met through the replacement of raw material drugs. Pharmaceutical companies are in a situation where they have to choose between accepting drug price cuts or maintaining drug prices through performing biological tests. Pharmaceutical companies are actively developing biological equivalent tests for licensed generics. The goal is to avoid drug price cuts through approval for change by creating generic through pharmaceutical research, conducting biological equivalent tests, and obtaining equivalent results. If the consignment manufacturing is converted to its own manufacturing and the permission is changed, it is using a strategy that meets the requirements of conducting biological equivalent test. However, COVID-19 has recently acted as a variable. Pharmaceutical companies faced difficulties in recruiting subjects as the number of COVID-19 confirmed patients exploded during the biological equivalent test. It is also said that there are frequent situations in which people registered as subjects leave due to COVID-19 confirmation. Due to the lack of subjects, it is inevitably difficult to perform a normal biological equivalent test. Looking at the drug equivalence standard, the biological equivalent test should be conducted on at least 12 people in the test group and the control group, respectively. This means that a biological equivalent test cannot be established unless a total of 24 or more subjects are registered. The test group or control group can be increased by recruiting additional subjects, in which case the biological equivalent test schedule is inevitably delayed. As the requirements for subjects are already strict, the biological equivalent test subjects recruitment difficulties are prolonged. According to the revised pharmaceutical affairs law, which passed the plenary session of the National Assembly in November 2018, only those who have not participated in clinical trials within six months before the test date should be selected as eligible. As it doubled from the previous three months to six months, the number of participants in the biological equivalent test has also decreased significantly. For this reason, pharmaceutical companies have recently asked health authorities to extend the deadline for submitting revaluation data through various channels, but no clear position has been made yet. Oh Chang-hyun, head of the insurance drug division at the MOHW, who attended the briefing session, said, "It is difficult to say for sure because the MFDS has yet to discuss the suspension of data submission." Moreover, pharmaceutical companies are in desperate need of a delay in submitting biological equivalent test data as they have endured a significant reduction in drug prices due to the abandonment of the biological equivalent test by consignment generic. Pharmaceutical companies have inevitably accepted drug price cuts if it is difficult to change the manufacturer of consignment generics by themselves, signaling huge losses. In July 2020, the MFDS officially banned the sale and recovery of non-equivalent products as a result of the biological equivalent test for maintaining drug prices. As a result of the biological equivalent test, the principle was established that measures such as recovery of non-equivalent products will be implemented based on the risk of grade 3. Other consignment products produced at the same manufacturing facility as generic, which has been judged to be unequal, are also likely to be recalled. With trust A supplying the same generics to 10 consignment companies, the logic is that if one of the products is non-equal, the other nine consignment generics may also be suspected of non-conformity. For pharmaceutical companies, they have no choice but to choose to accept the reduction of the drug because the risk they have to take when they start the biological equivalent test is high. It is not possible to try to convert into a company because there are no manufacturing facilities. Many companies cannot convert drugs that require separate factories from other drugs, such as PCNs, hormone drugs, biological drugs, Cephalosporins, and cytotoxic anticancer drugs, because not many companies have manufacturing facilities. Products that require special formulation manufacturing facilities such as soft capsules are also not easy to convert consignment generics' direct production. Pharmaceutical companies continue to complain that the license is an unnecessary waste of money to carry out the biological equivalent test of generic. This is because it is wasteful to conduct biological equivalent tests at a cost to maintain drug prices even though they are already being sold without problems after being recognized for safety and efficacy by the government.
