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- 2026-05-08 18:53:09
- Policy
- Tamsulosin-mirabegron drug opens competition in Korea
- by Lee, Tak-Sun Apr 01, 2021 06:05am
- KyungDong Pharmaceutical is to start a Phase III trial on a combination drug consisting of a prostatomegaly treating agent tamsulosin and an overactive bladder treating agent mirabegron. The drug is expected to begin a commercialization race against Dongkoo Bio & Pharma that already received approval on Phase III trial. Without any preceding combination drug with the two agents in the market, the patients would get to appreciate more convenient regimen if the drugs are successfully launched. On Mar. 25, South Korea’s Ministry of Food and Drug Safety (MFDS) granted an approval on KyungDong Pharmaceutical’s 'KDF1905’ Phase III clinical trial protocol. The trial would use tamsulosin and mirabegron as test subject. Tamsulosin is a well-known prostatomegaly treatment, and mirabegron is an overactive bladder treatment. Astellas have developed and been supplying the brands of Harnal-D (tamsulosin hydrochloride) and Betmiga (mirabegron). Particularly, the two drugs have been popular among the South Korean urologic treatment market. UBIST reported Harnal-D has generated 72.6 billion won and Betmiga 65 billion won last year for outpatient prescription. A study result on confirming the improvement in lower urinary tract symptoms expressed in patients with prostatomegaly has been already published. In 2018, a team of researchers led by Professor Hidehiro at Asahikawa Medical University, Japan, observed the voiding symptom in 656 patients using both mirabegron and tamsulosin, and found the patient who used the drugs showed statistically significant improvement compared against the placebo group. Also the combination showed outstanding improvement in treating overactive bladder symptoms compared against the placebo. As the prostatomegaly and overactive bladder treatments are frequently prescribed in combination, the South Korean pharmaceutical companies have been focused on developing a combination drug. But none of them have been commercialized, yet. Besides KyungDong Pharmaceutical, Dongkoo Bio & Pharma has also initiated the Phase III clinical trial from last January on the tamsulosin-mirabegron combination drug. The South Korean company has a strong portfolio with drugs used for dermatologic and urologic treatment. As two companies started the Phase III trials on the same-agent drug, the pharmaceutical industry is closely following the companies to see who nabs the market authorization first. And because the two single-agent drug markets are big, other pharmaceutical companies may change their competition strategy depending on the combination drug’s success in the market.
- Policy
- Generic for Arcoxia were first approved
- by Lee, Tak-Sun Apr 01, 2021 06:05am
- Generic for Arcoxia (Etoricoxib, MSD Korea), an anti-inflammatory analgesic drug, was first approved on the 25th. The first licensed companies also succeeded in avoiding patents and obtained generic exclusivity. The MFDS approved four generic of Etoricoxib on the 25th. Boryung Etoricoxib 30mg, Arlico's Alicoxib 30mg, Reyon's Ecoxia, and Daewoo's Elicoxibe 30mg were licensed. They are produced by consignment by Arlico. These companies also succeeded in patent challenge by avoiding Arcoxia's crystalline patent. Accordingly, it has also obtained generic exclusivity granted to companies that have applied for the first license and succeeded in patent challenge. According to generic exclusivity, the sale of the same drug is prohibited from March 26 to December 25. Four items acquired the Generic Market Exclusivity for 9 months. The Generic Market Exclusivity was acquired, but the sales of the original Arcoxia were also not high. In the nonsteroidal anti-inflammatory analgesic market, Celebrex (Celecoxib, Pfizer) recorded an outpatient prescription of ₩40.6 billion last year. MSD conducted a clinical trial of Arcoxia in Korea. As it was a successor to Vioxx, which was expelled from the market due to cardiovascular risk, it was necessary to dispel the safety controversy. However, it was not easy to settle in the market because Celebrex's sales performance is good and there are more than 100 Celebrex generics out there. Moreover, unlike Celebrex, which has multiple indications, Arcoxia was only recognized for osteoarthritis. PMS on December 22 last year was terminated, and domestic generic companies immediately accepted the application for permission. Since only crystalline patents remained in the patents, generic companies succeeded in avoiding patents early. Generic companies are expected to enter the market immediately after registration. Competition is difficult because there are many items of the same family in the market. However, it is expected to take advantage of the effect of a new product as a first generic and cause a sensation in the osteoarthritis market.
- Policy
- The NIID-Moderna discusses the cooperation plan for R&D
- by Kim, Jung-Ju Mar 31, 2021 06:06am
- The quarantine authorities are holding a video conference with Moderna, a COVID-19 vaccine company, to discuss cooperation measures such as R&D. It plans to continue development cooperation not only with related companies but also with US research institutes. KWON Jun-wook, Vice Head of Central Disease Control Headquarters explained this at a regular briefing on the 'COVID-19 Outbreak in Korea' held today (26th). Previously, the NIID held a short video conference with the president of Moderna at 10 pm on the 25th. They exchanged and discussed each other's proposals on cooperation, research and development, and production of vaccines. He said, "We plan to proceed with more detailed cooperation plans, such as signing an MOU with Moderna, centering on the NIID through working-level discussions in the future. We will conduct video conferences with the NIAID and develop cooperation with other vaccine manufacturers." The quarantine authorities will then distribute and disclose public briefings or materials as soon as results or results are released after working-level consultations.
- Policy
- Is Forxiga generic same as solvate-modified drug?
- by Lee, Tak-Sun Mar 30, 2021 06:06am
- A product image of Forxiga Pharmaceutical companies developing generics of an antidiabetic Forxiga are concerned that the products would get struck by receive sales ban due to preferential sales rights. The related criteria are not clarified enough for companies to predict the result. According to the pharmaceutical industry sources on Mar. 29, the companies are hectic developing generic drugs sharing the same active pharmaceutical ingredient (API) with AstraZeneca’s antidiabetic treatment, sodium-glucose co-transporter-2 (SGLT2) inhibitor Forxiga (dapagliflozin propanediol hydrate). So far none of the companies have requested for approval review, but seven bioequivalence tests were approved to this date. There are already 50 Forxiga follow-on drugs consisting of the API, dapagliflozin. But these drugs do not share the same solvate as Forxiga’s (propanediol hydrate). And 23 out of the follow-on drugs have received the preferential sales right. Solvate is a compound of higher order created between solvent molecule and ion. Generally, when a solvate consists of water molecule, it is then called hydrates. They won the preferential sales rights as their request to nullify Forxiga’s second patent (to expired on Jan. 8, 2024) was accepted. The preferential sales rights were validated as the companies won against the AstraZeneca’s appeal to overturn the decision. The case is currently pending at the Supreme Court as the multinational pharmaceutical company requested for further consideration. However, some generic companies are also participating in this case. Generic companies plan to release their products immediately after the first substance patent (to be expired on Apr. 7, 2023), if the patent nullification decision is sustained. But the issue is in the preferential sales rights won by the solvate-modified products. When the preferential sales rights come effective, same products cannot be sold. The preferential sales rights are effective from Apr. 8, 2023 through Jan. 7, 2024. The generic makers are now conflicted if the generics are considered as identical to the solvate-modified product. Typically, salt-modified drugs are not categorized as same as an original or generic drugs. However, it is unclear whether the solvate or hydrate-modifying drug is the same drug. If the generic drug is not the same drug, the patent-evading generic can be sold from Apr. 8, 2023, regardless of the preferential sales right. Otherwise, the generics would be unable to enter the market until Jan. 7, 2024, and the release date would be pushed by nine months. Even the industry is disputing over whether the solvate-modified drugs and generic drugs should be considered the same. An industry associate explained, "If the Ministry of Food and Drug Safety (MFDS) has reviewed the solvate-modified drug based on the submitted evidence like a salt-modified drug in the first place, then it should be considered different like a salt-modified drug." On the other hand, some argue that in the U.S., a solvate-modified drug falls under the same category as a generic, therefore, it should be considered the same. MFDS has yet to publish a clear guideline on the issue. The ministry is to start the discussion, when the generics request for the approval. With the ambiguous standard, generic makers are thinking of delaying the market release by nine months. A pharmaceutical industry patent expert commented, “The conflict is deepening as the number of drugs with solvate like Forxiga is extremely limited and there has not been a case where a solvate-modified drug receiving the preferential sales rights. MFDS should clarify the guideline before the generics applies for the market approval the set the order right”
- Policy
- Doctor's note not needed for requesting vaccination leave
- by Kim, Jung-Ju Mar 30, 2021 06:06am
- From now on, ‘vaccination leave’ on request would be able for those receiving vaccination against COVID-19, even without a doctor’s not. COVID-19 Central Disaster and Safety Countermeasures Headquarters (CDSCH) discussed promoting the COVID-19 vaccination leave for adverse reaction as reported by the Ministry of Health and Welfare (MOHW) Central Disaster Management Headquarters (led by Minister Kwon Deok-Cheol) and Ministry of Employment and Labor (MOEL, Minister Kim Woo Ho). The need of giving vaccination leave has been raised since there have been cases of workers interfered by post-vaccination fever and body ache. According to the vaccination adverse reaction monitoring results, 32.8 percent of the vaccine receivers responded that they felt discomfort, while 2.7 percent of them visited healthcare institutions. 1.4 percent out of the total vaccine receivers reported to healthcare institutes through the adverse reaction monitoring system according to the Infectious Disease Control and Prevention Act. Surveying about 5,400 vaccine receivers from 20 randomly selected nursing hospitals, about 75 people (1.4 percent) requested to take a day off from the work. Adverse reactions were usually expressed within 10 to 12 hours after vaccination and recovered within 48 hours. Major adverse reactions were pain at the vaccinated spot (28.3 percent), muscle ache (25.4 percent), fatigue (23.8 percent), headache (21.3 percent). and fever (18.1 percent). Also, the younger the receiver was the higher the rate of discomfort complains was reported. Based on the discussion with related government body and the survey result, the Central Disaster Management Headquarters prepared a plan to promote the use of vaccination leave, so the people would feel safe to get inoculated. The vaccination leave is to be issued for the vaccine receivers, who requested for the leave due to an adverse reaction. The leave request can be processed only with the receiver’s request and without a doctor’s note. And regarding the day of inoculation and required time, the government recommended using an official vacation or paid vacation days. Considering that the adverse reaction begins within 10 to 12 hours after vaccination, one day of vacation is given the day after the vaccination, and if there is an actual symptom of adverse reaction, an additional one day can be used. On the day of vaccination, it is recommended and instructed to give leave for the time required for vaccination. This is taking into account that general adverse reactions improve within two days, and one should visit a healthcare institute if the adverse reaction continues for 48 hours or more. Vaccination leave would come in effect from coming Apr. 1, according to the previously established vaccination plan and schedule. Inoculation of social welfare facility workers will begin from the first week of April, and social welfare facilities will take measures to utilize sick leave, paid leave, and work exclusions, depending on the conditions of each business and facility. If the facility manager deems that it is necessary to exclude work, the business should grant a paid leave. Moreover, the relevant industry organizations would assertively negotiate with healthcare institutes, such as nursing hospitals, where the vaccination is ongoing, to use the vaccination leave. While the vaccinations for school nurses and essential social force like police, firefighters and military are scheduled from the first week of April and June, respectively, the vaccination leave would be applied based on the interpretation of the regulation by the Ministry of Personnel Management and the Ministry of the Interior and Safety. The flight attendants, scheduled to receive vaccination in May, would also receive vaccination leave through the government’s negotiation with the airlines. The government also plans to recommend and guide private enterprises to grant paid leave or utilize sick leave, if available, for the vaccination leave without losing the pay. MOEL plans to disseminate guidelines for workplaces and actively guide them through Regional Employment and Labor Office. And the Ministry of Trade, Industry and Energy (MOTIE) is planning to call for request cooperation by various relevant organization and association like Korea Chamber of Commerce and Industry and Korea Employers Federation. The Ministry of SMEs and Startups plans to actively guide and induce participation by related associations and organizations through regional offices and affiliated agencies. In addition, the government plans to revise the Infectious Disease Control and Prevention Act to establish a legal basis stipulating the post-vaccination leave.
- Policy
- Lot release for Pfizer's COVID-19 vaccine was completed
- by Lee, Tak-Sun Mar 30, 2021 06:05am
- The MFDS announced that it has released a national lot of 250,000 people (500,000 batches) of Comirnaty that Pfizer Korea has applied for on the 28th (Sun). The national lot release is a system that the state confirms once more the quality of the vaccine is assessed comprehensively by evaluating the results of the 'validation test' for each vaccine manufacturing unit (lot) and the 'data review' that produced and submitted the test results as permitted by the manufacturer to determine the quality of the vaccine before distribution to the market. The MFDS established the test method through verification of the manufacturer's test method data from November last year for the rapid release of the national lot of Comirnaty, and thorough introduction of equipment necessary for the test such as ultra-high performance liquid chromatography, etc. It explained that it has been preparing a national lot release. In addition, it added that the MFDS has newly established an RNA analysis room and secured an additional cryogenic freezer to store samples for national lot release to ensure that the test can proceed smoothly. The MFDS confirmed the effectiveness, safety, and quality through a verification test of about 500,000 batches of Comirnaty and a review of data on manufacturing and testing. The MFDS verified the effectiveness by conducting potency tests, confirmation tests, and content tests to measure the amount of the genetic material showing the effect and the amount of lipid nanoparticles surrounding the genetic material. It also revealed that the product was not contaminated by conducting a purity test and an endotoxin test. In addition, quality consistency was confirmed by reviewing the quality test data issued by the manufacturer's quality assurance manager. Comirnaty is an RNA vaccine. It is a vaccine made by wrapping genetic material (mRNA) containing COVID-19 antigen protein information with Lipid Nano Particles (LNP). It has a mechanism to induce an immune response. An official from the MFDS said, "We will do our best to ensure that the Korean people can receive the vaccine with confidence by thoroughly verifying COVID-19 vaccine introduced in Korea by maximizing the relevant infrastructure such as experts and equipment necessary for the release of the national lot." This lot released Pfizer COVID-19 vaccine is planned to be inoculated to elderly people aged 75 or older starting April 1.
- Policy
- From drug approval to follow-up management
- by Lee, Hye-Kyung Mar 29, 2021 04:20pm
- The NHIS established drug price management from January 1 of this year, and began step-by-step management for stable supply of drugs and drug cost management. Along with the establishment of the Drug Price Management Office, the TF of the Drug Management Department was established, and an improvement plan to apply various research services conducted so far to the field is prepared. The full-cycle management plan for released by the NHIS is divided into steps such as item permission, reimbursement registration, distribution and supply, and follow-up management. First of all, the drug product approval stage is under the responsibility of the MFDS, but the NHIS began negotiations on previously listed drugs in connection with the clinical re-evaluation of the MFDS from last December. According to the order of the MOHW, it is underway for 230 items of 130 drugs subject to clinical reevaluation, except for Choline alfoscerate 122 items extended until April 12, Ateroid by Alvogen Korea, Mesocan 50mg by Chodang, and Aju Vesseldue-F Soft Cap decided to withdraw the item during the negotiation process. As a result of negotiating payback in conjunction with clinical reevaluation for the first time, 47% of clinical reevaluation items are withdrawn or negotiated, and the remaining 53% are negotiating. The NHIS said, "The MFDS will proceed with a contract to recover drug costs for drugs that are not effective through monitoring the results of the review of drug safety and effectiveness." In the reimbursement registration stage, the drug price negotiation rules were revised after the Lipiodol status in 2019, which contained the obligation to supply drugs, and from October last year, a negotiation procedure was introduced for all drugs, and contracts for mandatory provisions such as supply and quality management were signed. The drug price negotiation management system was reorganized to reinforce management such as negotiations following the introduction of the comprehensive evaluation system and to negotiate registered drugs in connection with the reevaluation of the drug price addition by the MOHW. The MOHW plans to link the drug price re-evaluation project, negotiate previously listed drugs, make rational evaluation of high-priced rare disease treatments, and prepare management plans. In order to manage the distribution and supply stages, the Research Service for Improving the Drug Supply and Purchasing System was completed in 2018-2019, and the specific implementation plan will be in charge of the full cycle TF. Follow-up management after drug registration is the last step in the full-cycle management. In particular, ultra-high-priced drugs such as Kymriah, which take more than ₩500 million for a single administration, are challenging to pay. The NHIS is contemplating a new payment plan for ultra-high-priced drugs in preparation for this. The NHIS plans to develop an efficient drug expenditure plan by developing a financial demand prediction model based on the analysis of the drug expenditure structure and analyzing the financial expenditure according to the characteristics of diseases and drugs (patent expiration, etc.). The NHIS Drug Price Management Office, Part 4, 1TF
- Policy
- 68% of the people said they plan to get vaccinated
- by Kim, Jung-Ju Mar 29, 2021 06:38am
- As vaccinations are being carried out in stages due to COVID-19 outbreak, 8 out of 10 people agree with the government to strengthen quarantine. In addition, 68% of the respondents answered that they will receive vaccinations in the future, indicating that they are aware of the importance of the vaccine. COVID-19 Central Disaster Management Headquarters and the Ministry of Culture, Sports and Tourism announced the results of COVID-19 Awareness Survey' today (24th). This survey was conducted for two days from the 17th to the 18th in order to increase the effectiveness of the quarantine policy based on public perception through public opinion surveys on quarantine policies such as social distancing. A survey was conducted on 1,000 adult men and women over the age of 18 residing nationwide on the awareness of COVID-19 and the extent to which quarantine regulations were practiced. The confidence level is 95% and the margin of error is ±3.1%. As a result of the survey, it was found that in the current situation of COVID-19, 83.1%, most of the citizens, agreed to strengthen the quarantine regulations. Regarding the perceptions related to COVID-19, 53.6% said the current situation was safe, and 45% said it was not safe. The possibility of infection of COVID-19 was perceived as low at 60.5%, but if infected, 86.6% perceived the damage as serious. 87.1~81.1% of the measures that demanded responsibility for violations of quarantine rules, such as claiming compensation for violations of the quarantine regulations, raising the fine for negligence, and excluding various support were positively confirmed. Among them, the necessity of claiming reimbursement rights was 87.1%, the necessity of raising the fine for negligence was 81.1%, and the necessity of excluding various kinds of support was 84.5%. Regarding the degree of practice of the quarantine rules, most of them responded that they are keeping the quarantine rules well, but others are less observing them than they are. In the case of banning private gatherings, 80.7% of respondents said they were doing very well, while only 18.7% said that others are doing very well. In the questionnaire on wearing a mask, 75.9% answered that they were wearing it well, but only 37.4% said that others were wearing it well. Most of the respondents, 87.3%, are under stress from COVID-19, and the main causes were 85.7% of uncertainty at the time of the end, 42.7% of social controversy, and 38.6% of the quarantine rules followed by myself. 61.1% of the opinions that individual behavior should be restricted rather than closure of multi-use facilities, 63.2% of opinions that the number of persons banned from private gatherings at different distances should be restricted. The survey was 63.2%. Regarding the current social distancing stage, 51.4% of respondents said,'I have heard and seen, but do not know well', and 52.1% of the reorganization proposals were recognized at a similar level. 73.2% of respondents agreed on the business hours restriction, 47.7% said that 22:00 was appropriate, and 25.5% said that 9pm (21:00) was appropriate. The willingness to receive vaccinations related to the COVID-19 vaccination was high, with 67.8% responding. As for the main reason for getting vaccination, 79.8% of the people cited the prevention of infection in their families. Following this, 67.2% responded in the order of social group immunity formation, and 65.3% in the order of their own infection prevention.
- Policy
- 6 new drugs newly listed or expanded coverage in 2021 so far
- by Kim, Jung-Ju Mar 29, 2021 05:58am
- According to the next month’s update for the pharmaceutical reimbursement list, total five items would be newly listed and improve patient access. And one already-listed drug gets to expand coverage. It is a result of enhancing the coverage based on social importance and patient needs. The South Korean government projected total 60,196 patients in the country would benefit from those drugs, costing them about 51.4 billion won annually. From January through April this year, total six pharmaceutical products have been newly listed or expanded coverage standard. January had none, but from February, the coverage on a Parkinson’s disease treatment Equfina Film Coated Tablet, a glaucoma treatment Eybelis Eye Drops and an ovarian treatment Zejula capsule have been improved. The coverage on Equfina Film Coated Tablet would benefit 7,000 patients a year, while costing 5.6 billion won. The coverage on Eybelis Eye Drops is estimated at 4.9 billion won annually, which would benefit 45,000 patients. The expanded coverage on Zejula Capsule would annually cost 2.5 billion won to provide treatment opportunity to 146 patients. From this month, the patient access on a multiple myeloma treatment Ninlaro Capsule improved with newly listed reimbursement. The government would spend about 9.6 billion won annually. Also, a neuroendocrine tumor treatment Lutathera Injection was newly listed in the same month, costing 8.8 billion won to benefit 6,890 patients annually. From Apr. 1, 20 billion won a year would be injected to treat 500 patients with a neovascular (wet) age-related macular degeneration (AMD) treatment Beovu Prefilled Syringe with reimbursement. The fact that each new coverage enhancement is to benefit a range of patient size from 45,000 at most to 146 patients at least proves the South Korean government’s healthcare coverage focus is now shifting from patient size and finance to value of a drug with high demand for reimbursement. It can be also interpreted as flexible policy and general social maturity to accept and provide an expanded coverage on expensive drugs used for rare disease treatment.
- Policy
- KRW 2.85 tln for KDCA COVID-19 vaccine supplementary budget
- by Kim, Jung-Ju Mar 29, 2021 05:58am
- The Korea Disease Control and Prevention Agency (KDCA) has secured an additional budget of 2.35 trillion won for procuring COVID-19 vaccines from overseas. This reflects additional 2.30 trillion won from this year. On Mar. 25, KDCA announced that this increase was reflected as the first supplementary budget in the year 2021. The total cost of vaccine purchase for 79 million people the government has contracted for is 3.81 trillion won, of which the additional cost in 2021, excluding the already secured budget, is 2.35 trillion won. Specifically, COVAX Facility (10 million), AstraZeneca (10 million), Pfizer (13 million), Janssen (6 million), Moderna (20 million) and NovaVax (20 million) are to supply the vaccines. To the date, the government has been sequentially expanding pre-purchase contracts according to the COVID-19 vaccine procurement plan, and has prepared necessary financial resources such as for upfront payments. The government has so far secured total 1.21 trillion won, including 356.2 billion won from last year’s contingency budget plan and 857.1 billion won from this year’s budget plan. Moreover, KDCA explained the additional cost of final vaccine payment was reflected on the new supplementary budget plan as the detailed calculation of the payments can be finalized after the negotiation over vaccine type, unit price and volume is concluded. KDCA elaborated the vaccines with already-signed contracts have been rolling out since February, and the agency would continue to roll out further doses of vaccines without an issue. And the new supplementary budget plan also reflects 1.10 trillion won for additional reserve for specific purpose, such as response against extended outbreak of COVID-19 and vaccine inoculation and related infrastructure cost. Due to finalized supplementary budget plan, the total expenditure in 2021 by KDCA was increased from 991.7 billion won to 3.34 trillion won.
