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- 2026-05-08 19:19:37
- Policy
- Lipiodol's suspension of price cuts has been extended
- by Kim, Jung-Ju Jul 27, 2020 09:41am
- The court decided to extend the suspension of drug price cuts against Guerbet Korea's Lipiodol Ultra Liquid (Iodized oil, 12.8g/10mL). The court set the suspension period to 30 days from the date of the sentence of judgment in preparation for prolonged litigation. Seoul Administrative Court decided to suspend execution of a decision related to Lipiodol in the 'Pharmaceutical reimbursed list and the upper limit table (Notice No. 2020-124)' promoted by the MOHW in June. Earlier, the MOHW planned to lower the drug price on the 1st of this month at the same time as Fattiodol (generic for Lipiodol) by Dongkook was listed. According to the government’s drug price formula, the MOHW lowers the upper limit of the product with the same route, ingredient, and formulation as the first listed product. If the government cuts the drug price as planned, Lipiodol 12.8g/10mL will drop 30% from ₩19,000 to ₩133,000. It will be regulated once again from ₩13,000 to ₩101,745. However, the court will make a final decision as the company raises issues with the government's decision. According to the suspension, the previous drug price of ₩190,000 will be temporarily held until the 30th day from the date of judgment. The final date has not been set.
- Policy
- Janssen launches clinical trial of Lazertinib-Amivantamab
- by Lee, Tak-Sun Jul 27, 2020 06:27am
- Janssen is conducting a clinical trial of Lazertinib for non-small cell lung cancer treatment with Amivantamab (JNJ-61186372). In 2018, Yuhan had transferred its technology of Lazertinib, a third-generation EGFR targeted anticancer drug to Janssen, to a total of ₩1.4 trillion. The MFDS approved IND for clinical trial for Phase Ib of Lazertinib-Amivantamab submitted by Janssen Korea on the 24th. Yuhan is currently leading the clinical trial of Lazertinib in Korea. Yuhan is conducting a phase III clinical trial of primary treatment for patients with locally advanced or metastatic non-small cell lung cancer with positive epithelial growth factor receptor-activating mutations. This clinical trial conducted by Janssen Korea is to evaluate the safety and pharmacokinetics of combination therapy with JNJ-73841937 (Lasertinib), the 3rd generation EGFR-TKI monotherapy or human bispecific EGFR and cMet antibody JNJ-61186372 (Amivantamab). As a multinational clinical trial, 8 of the 120 subjects were domestic. Clinical trials will be conducted at Bundang Seoul National University Hospital, Samsung Medical Center, Seoul National University Hospital, and Yonsei Severance Hospital. Janssen launched a large-scale global clinical trial in September last year to evaluate the combination of Amivantamab and Lasertinib. In particular, Johnson & Johnson (J&J) group has high expectations to point out the combination therapy as a promising pipeline. Janssen's goal is to complete the application for approval to the Food and Drug Administration (FDA) by 2023. In this combined clinical trial, Yuhan announced in April that it would receive a technical fee of $35 million from Janssen. It is noteworthy whether Janssen will succeed in debuting a new drug for non-small cell lung cancer developed by Korean pharmaceutical company.
- Policy
- No serious adverse effects for Duvie have been reported
- by Lee, Tak-Sun Jul 24, 2020 01:22pm
- After 6 years of post-marketing investigation of Duvie (Lobeglitazone sulfate), a new diabetes drug developed by Chong Kun Dang, serious adverse effects that cannot rule out a causal relationship with the drug has not been reported. The results of this PMS are positive because Thiazolidinediones (TZD) drugs had issue of side effects. The MFDS announced that it has prepared a proposal to change the permits according to the results of the recent re-examination of Lobeglitazone sulfate formulation, and will accept comments by August 4. Products including Lobeglitazone sulfate have a total of 5 items including Duvie 0.5mg by Chong Kun Dang in July 2013, and Duvimet XR (Lobeglitazone sulfate-Metformin HCl). Duvie was subject to reexamination (PMS) until July 3 of last year. The post-market investigation for Duvie was conducted on 3,056 people in Korea for 6 years. As a result, the incidence of adverse effects was reported as 7.10% (217/3,056 people, 341 cases) regardless of the causal relation. 1.11% (34/3,056 people, 37 cases) showed serious adverse effects that were not related to causality. It is GI related adverse effect (less than 0.1%) such as IBS. However, no serious adverse drug reactions were reported. 25 unexpected cases (20/3056 people, 0.65%) that cannot be excluded from causality were reported, and facial edema was sometimes found. TZD-based drugs can cause or worsen CHF in some patients and should be administered with the care by physician. The MFDS reflected this in the product package insert. As a result of the post-marketing investigation by Duvie, edema was found in 14 of 107 patients (13.08%) with congestive heart failure in NYHA class I or II who received this drug for more than 52 weeks. In addition, hospitalization and exacerbation due to CHF were reported to be 0.93% (1/107), respectively. Duvie received attention because it was a TZD-based drug, such as Avandia (Rosiglitazone), which was withdrawn from the side effects of cardiovascular disease at the time of approval. However, since TZD-based drugs such as Actos (Pioglitazone,Takeda) resolve issue of side effects through clinical research, they have recently recorded high sales in the diabetes treatment market. Dubie recorded ₩19.2 billion in outpatient prescriptions based on UBIST last year, and has established a reputation as a successful new drug developed in the market.
- Policy
- Drug purchase per Korean is OECD average 1.3 times higher
- by Kim, Jung-Ju Jul 24, 2020 06:24am
- It was found that the sales of medicines per capita in Korea amounted to USD 643 US PPP. This is 1.3 times more than the OECD 49 PPP average among OECD member countries. Antidepressants are about one-third of the average in member countries, but antibiotics are still high, with 1.6 times more. The MOHW (Minister Park Neung-Hoo) analyzed the level and status of Korea and each country by major indicators of OECD Health Statistics 2020 published by the OECD. As a result of analyzing the behavior of health care use, the number of outpatient visits per capita in 2018 was 16.9 per year, the highest among OECD countries. This is 2.5 times higher than the average of 6.8 times in member countries. Looking at representative countries, Japan visited 12.6 times and was the second most frequent after Korea. On the other hand, some countries were less than three times. It was counted as 1.9 times in Colombia, 2.7 times in Sweden, and 2.8 times in Mexico. Looking at the amount of pharmaceutical sales and consumption in 2018, the amount of pharmaceutical sales per capita in Korea was 642.6 US dollars PPP, which was higher than the OECD average of 499.6 US dollars PPP. By country, countries such as Belgium (759.6), Czech Republic (740.0), and Germany (697.5) had more drug sales per capita than Korea. Looking at the consumption of major drugs, antidepressants were 21.0DDD/thousand/day (hereinafter referred to as DID), about 1/3 of the OECD average (64.3DID), while antibiotics were 29.8DID, about 1.6 of the OECD average (18.1DID). The life expectancy of Koreans is 82.7 years, which is higher than that of OECD countries (80.7 years), and the mortality rate of major diseases is generally lower than the OECD average. On the other hand, the percentage of people over the age of 15 who think they are healthy (32.0%) was the lowest among OECD countries. As a result of analyzing the health risk factors, the proportion of overweight and obesity (34.3%) among the population over 15 years old, which is a major cause of chronic diseases, was the second lowest among OECD countries. However, the daily smoking rate (17.5%) and the annual alcohol consumption per capita (8.5ℓ) of the population aged 15 years or older in Korea were OECD average. The average OECD smoking rate was 17% and alcohol consumption was 8.8l. Among medical resources, the level of physical resources such as magnetic resonance imaging (MRI) and computed tomography (CT) is higher than the OECD average, and Hospital beds are 12.4 per 1,000 population, about 2.8 times the OECD average (4.5).. On the other hand, the MOHW explained that the number of physicians (including doctor of oriental medicine) is 2.4 per 1,000 population and the nursing workforce is 7.2 per 1,000 population, which means that human resources are small among OECD countries. In fact, the average number of physicians per 1,000 population of OECD is 3.5 and nursing staff is 8.9.
- Policy
- SK Bioscience participates in supply of COVID-19 vaccine
- by Kim, Jung-Ju Jul 24, 2020 06:23am
- A domestic pharmaceutical bio company has been recognized for its production technology and has joined the world development leader multinational companies and the global production supply chain of COVID-19 vaccine. The government is trying to supply domestically some of the vaccines produced in Korea. The MOHW (Minister Park Neunghoo), today (21st) at 4 pm at the SK Bioscience Research Institute (Seongnam Pangyo), with AstraZeneca (CEO Pascal Soriot) and SK Biosciences (CEO Ahn Jae-yong), The AstraZeneca-Jenner Institute (University of Oxford) has signed a Letter of Intent (LOI) for a global supply of vaccine candidates under development and cooperation in securing domestic supplies. According to the World Health Organization (WHO), the vaccine being developed by the AstraZeneca-Zener Institute is currently attracting attention from around the world as one of the most likely vaccines to enter Phase III of COVID-19 vaccine candidates. The vaccine has been in Phase III clinical trials in the UK, Brazil and South Africa since June. AstraZeneca and SK Biosciences have been participating in discussions as partners for global manufacturing and production. And the government explained that the result was achieved by signing LOI ( a Letter Of Intent) today. The signing ceremony for this LOI was attended by Minister Park Neunghoo, British Ambassador to the Republic of Korea Simon Smith, CEO Sang-Pyo Kim of AstraZeneca Korea, The vice president of SK Discovery Chey Chang-won , and SK Bioscience chief Ahn Jae-yong, It was conducted by the participation of AstraZeneca Global Chief Executive Officer (CEO) Pascal Soriot participated in the video conference. LOI included ▲ fast and stable production and export cooperation for the fair global supply of vaccines ▲ strengthened production capacity to respond to increasing demand ▲ domestic supply efforts, and three-way cooperation. The government explained that this is the first time that a domestic company has joined the global supply chain of excellent vaccines, which is gaining global attention, for the first time. The MOHW will continue to discuss that some of the vaccines produced by SK Biosciences will be supplied to Korea. It is expected to be a representative example of cooperation between the government and companies in the global epidemic of infectious diseases, in that it will secure a stable supply and demand system for successful vaccine development. The government will continue to pursue two-track strategy centered on the 'COVID-19 Treatment and Vaccine Development Support Committee,' which will continue to be shared by related ministries, and will continue to provide support for domestic companies' own vaccine development, as well as the rapid acquisition of overseas vaccines that are rapidly developing. At the signing ceremony, Minister Park said, "We are proud that Korean technology can contribute to the production of vaccines that are supplied to the world, and it is also a great achievement to establish a preemptive domestic supply and demand system," He also added, "The Korean government will also actively participate in the international community's solidarity efforts to ensure equitable distribution and accessibility since the development of the vaccine."
- Policy
- Quadrivalent flu vaccines by GC and SK Bio get lot release
- by Lee, Tak-Sun Jul 23, 2020 06:11am
- Korea’s top influenza vaccine manufacturers GC Pharma and SK Bioscience have passed the government’s lot release side-by-side for their quadrivalent vaccines. Korea’s Ministry of Food and Drug Safety (MFDS) explained the approval was about a couple of weeks earlier than previous years, as the seasonal influenza could spread with COVID-19 at the same time. As of July 22, MFDS announced the approval of three lots of GC Fluquadrivalant pre-filled syringe injection by GC Pharma (Q60220002, Q60220003 and Q60220004) and three lots of SKY Cellflu Quadrivalent prefilled syringe by SK Bioscience (Q022002, Q022003 and Q022004). The six lots all together can immunize total 875,000 recipients. MFDS elaborated the ministry cut over ten days from the usual lot release period (35 days) for the vaccines to be flawlessly distributed and used in the healthcare system, while COVID-19 shows similar symptoms as a seasonal flu. The first lot release was green lit in early August last year. Director Jung Ji-won of Vaccine Testing Division at National Institute of Food and Drug Safety Evaluation (NIFDS) stated, “While the healthcare system has to focus on COVID-19, unnecessary confusion could be caused by influenza demonstrating similar symptoms and spreading along with COVID-19,” so the ministry “accelerated the lot release for the influenza vaccines.” Accordingly, the influenza immunization season can start earlier depending on the decisions by general healthcare institutes. But the National Immunization Program (NIP) would still be provided from September like previous years. Sources report all influenza vaccines to be distributed in the domestic market would be quadrivalent vaccines as the NIP newly added quadrivalent vaccine this year. A quadrivalent vaccine is used to prevent all four influenza viruses the World Health Organization (WHO) designates every year. Although the vaccines manufactured by GC Pharma and SK Bioscience are quadrivalent vaccines, GC Pharma uses egg-derived vaccine and SK Bioscience uses cell-cultured vaccine. MFDS projected influenza vaccine lot for approximately 27 million recipients would be released this year, and noted a special lot release team for influenza vaccine was formed as of July 21 to process double the supply of the demand before the immunization season.
- Policy
- HIRA says antibiotic prescription in flu down by 0.12%
- by Lee, Hye-Kyung Jul 22, 2020 06:16am
- [A look into Drug Reimbursement Evaluation Report 2019] Last year’s antibiotic prescription rate on acute upper respiratory tract infection fell by 0.21 percent from the previous year and was recorded at 38.30 percent. The number of drug item per prescription also climbed down by 0.05 item from 3.72 items in 2018 to 3.67 items in 2019. Korea’s Health Insurance Review and Assessment Service (HIRA) has recently published a statistic report on drug reimbursement evaluation in 2019 addressing some key trends found. The reimbursement evaluation was based on 12-month outpatient prescription records from January to December 2019 billed by tertiary hospital, general hospital, hospital, nursing institute, clinic, dental hospital and clinic, public health center, public health center regional offices and healthcare centers. The total 813,680,000 bills with total pharmaceutical expense of 14.97 trillion won were evaluated. ◆Prescription rate in antibiotics and injection: Compared to the previous year at 38.42 percent, last year’s antibiotics prescription rate in acute upper respiratory tract infection was at 38.30 percent with a 0.12-percent-point dip. The rates of 48.36 percent, 37.69 percent, 32.05 percent and 10.58 percent were recorded from hospital, clinic, general hospital and tertiary hospital. The prescription rate in third-generation cephalosporins or later antibiotics for acute upper respiratory tract infection was at 8.80 percent last year, with an increase of 1.14 percent point from the year before. But the prescription rate in quinolone antibiotics was same was the previous year. Meanwhile, macrolide antibiotics prescription rate was 15.03 percent in last year with 0.65 percent point increase from the year before. The antibiotics prescription rate in respiratory system disease (J00-J47) reached 48.76 percent last year and was increased by 0.35 percent point from the year before. The rates were recorded at 49.94 percent, 49.49 percent, 35.20 percent and 18.12 percent in hospital, clinic, general hospital and tertiary hospital, respectively. Last year’s antibiotics prescription rate in acute lower respiratory tract infections at 59.05 percent grew by 0.47 percent point from the year before. The rate was increased from all healthcare institutes and the biggest growth from 46.66 percent to 47.21 percent was in tertiary general hospitals. The antibiotics prescription rate in other respiratory system disease last year was average 47.25 percent based on 49.27 percent, 47.13 percent, 31.47 percent and 18.12 percent in clinic, hospital, general hospital and tertiary hospital, respectively. The respective antibiotic prescription rates in acute otitis media and unspecified otitis media in pediatric patients were at 81.52 percent and 83.98 percent last year. Within tertiary hospitals, the prescription rates in respiratory system disease was highest in acute lower respiratory tract infection (J20-J22) at 37.31 percent, followed by acute upper respiratory tract infection (J00-J06) at 32.49 percent, other upper respiratory tract diseases (J30-J39) at 19.32 percent, chronic lower respiratory tract infection (J40-J47) at 6.98 percent and influenza and pneumonia (J09-J18) at 3.91 percent. Acute lower respiratory tract infection was billed the most from hospitals and clinic, acute upper respiratory tract infection and chronic lower respiratory tract infection were billed the most in general hospital and tertiary hospital, respectively. In order of acute otitis media (52.24 percent), unspecified otitis media (43.41 percent) and chronic otitis media (4.35 percent) were prevalent in otitis media in pediatric patients. Hospitals and clinics billed the most for the disease, and tertiary hospital and general hospital billed the most on unspecified otitis media. Injection prescription rate in last year was marked at 15.13 percent, dropping by 1.22 percent point from the year before. The prescription rate was also recorded at 17.06 percent, 14.77 percent, 7.38 percent, and 1.81 percent in clinic, hospital, general hospital and tertiary hospitas, respectively. ◆Number of drug item per prescription: The number of drug item per prescription was tallied at 3.76 items, 3.72 items, 3.42 items, and 2.99 items in clinic, hospital, general hospital and tertiary hospital, respectively, with an average of 3.67 items. The average was reduced by 0.05 items from 3.72 items in the previous year. As for respiratory disease, the number of drug items was at 4.62 items, same as the previous year. By each healthcare institute, the number was tallied at 4.69 items, 4.63 items, 4.32 items, and 3.01 items in hospital, clinic, general hospital and tertiary hospital, respectively. The average number of drug items per prescription in musculoskeletal disease treatment was marked at 3.42 items and 0.09 item lower than the previous year average of 3.51 items. The number in clinics, hospitals, general hospitals and tertiary hospitals were at 3.44 items, 3.37 items, 3.35 items and 3.13 items, respectively. The ratio of six-or-more-item prescriptions reached 14.09 percent last year, lowered by 0.17 percent point from 14.26 percent in the previous year. The ratio was 15.30 percent, 14.66 percent, 13.77 percent, and 11.42 percent in hospital, clinic, general hospital and tertiary hospital, respectively. Most of the ratios in each healthcare institute were less than the year before. The pharmaceutical expense per each day of administration was 1,825 won, climbing up 23 won from the year before at 1,802 won. The pharmaceutical expense in tertiary hospital, general hospital, hospital and clinic reached 2,986 won, 2,169 won, 1,782 won and 1,435 won, respectively.
- Policy
- Chong Kun Dang generic to open Atozet generic market
- by Lee, Tak-Sun Jul 21, 2020 06:10am
- MSD Korea As Atozet’s post-marketing surveillance (PMS) expiration is approaching in next year, Chong Kun Dang is closely eyeing on the follow-on drug market. While many of Atozet (atorvastatin plus ezetimibe) generic makers are currently developing evidences like bioequivalence test to seek approval after Jan. 22 next year when the original’s PMS period ends, Chong Kun Dang has already submitted an approval application to the Korean health authority by providing data from individually conducted clinical trial. According to the pharmaceutical industry sources on July 17, Chong Kun Dang has completed clinical trial and requested Ministry of Food and Drug Safety (MFDS) in last April to approve an atorvastatin plus ezetimibe combination drug candidate ‘CKD-391’ as a dyslipidemia treatment. MSD Korea’s original Atozet shares the same combination of atorvastatin and ezetimibe. The PMS period for Atozet is to expire on next Jan. 22. And Korean pharmaceutical companies are preparing for the approval application procedure on their generics. MFDS has already approved 28 bioequivalence tests to compare the equivalence with the original Atozet. However, the generics can apply for the item approval only after the original’s PMS is concluded. Korea’s PMS system not only monitors post-marketing safety managements, but also protects the original’s detailed information. Chong Kun Dang’s CKD-391 has been in development since 2015 and it applied for approval early, as a generic with individual clinical trial data can be approved, regardless of the original’s PMS. If CKD-391 were to receive the government’s green light, the outstanding period of Atozet PMS would be invested to the generic. And depending on the date of the approval, Chong Kun Dang’s generic would likely to exclusively enter the follow-on drug market. As the other Atozet generics are expected to apply for approval from January next year, the government-approved Chong Kun Dang follow-on drug would be released to the market first and engage with prospective accounts as soon as possible. In 2016, Chong Kun Dang signed the Atozet co-marketing deal with MSD Korea. The Korean company with the well-established accounts list for the dyslipidemia treatment market would easily lead the generic market. Chong Kun Dang’s approach is similar to Hanmi Pharmaceutical’s Rosuzet taking over the rosuvastatin plus ezetimibe combination drug market. After licensing the rights over ezetimibe, Hanmi Pharmaceutical was able to release the rosuvastatin plus ezetimibe combination drug six months earlier than any other competitors in Korea. Currently, the hyperlipidemia combination drug market is topped by Hanmi Pharmaceutical’s Rosuzet and MSD Korea’s Atozet.
- Policy
- Celltrion's CT-P59 was approved for phase I clinical trial
- by Lee, Tak-Sun Jul 21, 2020 06:10am
- Celltrion's development of COVID-19 antiviral antibody treatment has been approved for clinical trials in Korea. The MFDS announced that it has approved a phase I clinical trial on the 17th for 'CT-P59', a domestically developed COVID-19 antiviral antibody treatment. As a result, a total of 13 clinical trials (11 treatments, 2 vaccines) were conducted in Korea in relation to COVID-19. 'CT-P59', which was approved this time, is a gene-recombinant antibody treatment that is being developed as a new drug by Celltrion and will conduct Phase I clinical trials to evaluate safety, etc. will be conducted for healthy people. The MFDS reported that safety is confirmed in phase I trial and item approval is possible only when safety & effectiveness is secured through passing phase II/III. This drug has a mechanism that prevents infection by attaching an antibody therapeutic agent to the site where COVID-19 binds to human cells. On the other hand, in foreign countries, clinical trials of COVID-19 antibody therapeutics developed by company L and company R in the United States have been conducted in healthy people or patients. An official from the MFDS said, “Since there is a high public interest in the development of COVID-19 treatments and vaccines, we will continue to provide information on the current status of clinical trials of developed products.” He emphasized, "We plan to do our best to support necessary matters to ensure the rapid development of safe and effective COVID-19 treatment and vaccines and to ensure the treatment opportunities of our people."
- Policy
- Generic exclusivity is on the verge of change
- by Lee, Tak-Sun Jul 20, 2020 06:19am
- The system of generic exclusivity, which grants the monopoly of the market for 9 months to patented generic drugs, is on the verge of change. It is expected that the measures to improve the right to generic exclusivity that were promoted through the public-private council will soon reveal its outline. As the process of the meeting is delayed, it is expected to be achieved through amendments to the pharmaceutical affairs law this year. The goal is to improve generic exclusivity items. Generic exclusivity was introduced in 2015. With the signing of the Korea-US FTA, a licensed patent linkage system was introduced in 2012, and through the phased implementation process, generic exclusivity system that grants rights to the patent challenge generics was also introduced. Three conditions are required to obtain the generic exclusivity. The first is to claim the original drug patent for a judgment (void, passive confirmation of rights (avoidance) (However, companies that claim within 14 days of the first judgment are also recognized), the second is to win the patent trial (to establish a trial claim), and the third is to apply for permission as a generic for the first time. It seems difficult to obtain a right to generic exclusivity because all three conditions must be completed, but in reality it was not. A request was made to avoid deliberately asking to complete the requirements for the first trial, and when the request for trial was established, a request for permission to continue was filed the day after the end of the PMS. In particular, dozens of companies were bound to secure the right to dominate due to the trusteeship. Of course, some companies were conducting product development and patent challenges alone. However, in the case of new patents for granting re-examination, it was dominant that the simultaneous acquisition of generic exclusivity had to be generalized. Therefore, it is estimated that the plan to improve the right to generic exclusivity, which will be released soon, will contain content that makes it difficult to obtain the right. In particular, there are many opinions that the first judgment requirement should be removed from the expert group, and the government is also expected to implement it. If the initial judgment requirement is removed, the generic exclusivity is expected to return only to the first successful company for a patent challenge. As such, companies with advanced patent avoidance products are expected to benefit from generic exclusivity. However, as many generics frequently apply for approval after the termination of the new drug PMS, it is analyzed that the number of right to generic exclusivity will not be decreased significantly even if the first judgment requirement is deleted. However, even if the first trial was not filed, the view of the deletion of the first trial requirement in a positive way is that the company that succeeded in the patent challenge lately has the right to take advantage of the system, and it is possible to prevent the trial by not asking to meet the requirements. Instead, the number of copyrights is expected to decrease significantly if the exclusion for generic exclusivity of consigned items issued by the MFDS announced on the 16th. This is because, in the case of simultaneous acquisition of copyright, it is connected to one trustee and multiple trustees. However, it is also criticized that it can weaken a company's willingness to challenge patents through a consignment business. In addition, since the domestic pharmaceutical industry is linked to consignment regardless of the size of the company's sales, it is unlikely that the process will be easy as the pharmaceutical industry's opposition to 'excluding the right to consign goods' will be large. In particular, as the law needs to be revised, it is unclear whether the MFDS will be able to push forward the system, as various arguments are mixed in the process itself and parliamentary passage cannot be guaranteed. Some argue that the expansion of incentives to support the effectiveness of the right to generic for exclusivity can be achieved additionally. It means that the patent challenge generic can succeed in the market only by extending the 9-month period of the current monopoly and incentives linked to the drug price.
