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- 2026-04-16 14:43:38
- 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."
- Opinion
- [Reporter’s view] The reality of dispensing separation
- by Jung, Heung-Jun Jul 21, 2020 06:10am
- COVID-19 caused a lot of concerns in the first half of this year in outpatient pharmacies and it was also a time for indirect evaluation, revealing the negative aspect of dispensing separation. Most pharmacies are complaining of deterioration in management due to COVID-19 , and the damage to pharmacies which receive many prescriptions is even worse. In particular, the pharmacies located in front of hospitals and the pharmacies on the same floor of clinics have economic damage and the business recovery is also unclear. Although its location was competitive, it suffered significant losses in COVID-19 crisis. Even during the period of supplying public masks, the sales volume of masks in pharmacies on the same floor as clinics was generally low, and as the prescription was reduced, it was not condition to focus on OTC sales. The situation is similar for pharmacies in front of the hospital. As a result, the high dependence on location and prescription became a negative factor. The hospital is forced to wait for normal operation as soon as possible, so the pharmacists are more frustrated. Sales of some pharmacies increased due to masks, disaster relief funds, and increased visits and OTC sales. It is not that pharmacies centered on OTC are better than prescriptions. If there is a crisis in the operation of a pharmacy optimized for division of labor, it is necessary to think about new ways of operating the pharmacy. It also means that it may be necessary to re-evaluate separation of prescribing and dispensing pharmaceuticals in its 20th year and present structural improvements. Someone may come up with a consultation-type pharmacy or drugstore. Others may be talking about the initiatives of health functional foods or quarantine products. Considering that COVID-19 aftermath is prolonged and that there is no guarantee that a second COVID-19 will not occur, it is not something unreal If the pharmacy's settlement in the first half started with COVID-19 and ended with public masks, In the second half of the rest, we should take time to find answers to the questions COVID-19 asked.
- Company
- Complaint on how NHIS unveiled pricing negotiation guideline
- by Eo, Yun-Ho Jul 20, 2020 06:19am
- The pharmaceutical industry in Korea is complaining on how National Health Insurance Service (NHIS) announced the drug pricing negotiation guideline. According to the industry sources, Korean Research-based Pharmaceutical Industry Association (KRPIA) has recently submitted a statement to NHIS regarding the public opinion collection procedure. At the second biannual meeting convened between NHIS and pharmaceutical industry organization on July 8, the government body has presented the detailed guideline on risk sharing agreement (RSA)-covered drug pricing negotiation, general drug pricing guideline and detailed operation guideline on price-volume agreement (PVA) negotiation. However, NHIS officials retrieved the disclosed guideline information, regardless of the organizations’ prior demand, immediately after presenting them. The participants of the meeting had to suggest limited opinions without the time to thoroughly review the guideline. And as NHIS stated the guideline would not be disclosed properly in the future, the industry organization criticized the government body for the lack of proper communication. Accordingly, KRPIA urged the government to disclose the revision for all industry entities to thoroughly review the material and to collect their opinions for further improvement in the system. In fact, the Health Insurance Review and Assessment Service (HIRA) has previously accepted the public opinion on the guideline and detailed evaluation criteria on negotiating drug for 80 days, as much as Ministry of Health and Welfare (MOHW) does for the administrative notice period. The industry source said, “The government demanding for suggestion when creating a situation without letting the industry fully understand the details is completely unfair. A guideline is practically a regulation that realizes criteria and statutes, therefore, disclosing the details to collect the public opinion is essential.” Meanwhile, the revision NHIS has unveiled included adding drug requiring negotiation or pricing calculation, fine-tuning regulations and expanding subject for RSA among drugs approved with Phase III clinical evidence development, and revising the detailed guideline on the PVA negotiation.
- 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.
- Policy
- Integrating PMS with RMP to protect new drug information
- by Lee, Tak-Sun Jul 20, 2020 06:19am
- The post-marketing surveillance (PMS) system that monitors new drug’s adverse reaction experienced by patients to maintain the drug safety would be integrated with the risk management plan (RMP) review system. The number of investigated subjects would be reasonably adjusted and the data protection system for the authorized new drug would be created separately. On July 16, Korea’s Ministry of Food and Drug Safety (MFDS, Minister Lee Eui-kyung) announced a plan to revise the post-marketing drug safety management system that mainly focuses on integrating the current PMS with RMP, which aims to manage a drug safety in all lifecycle. Implemented from 1995, Korea’s PMS reevaluates safety and efficacy of new drug or some prescription drug by investigating adverse reaction reported from uncertain number of samples. The PMS system not only monitors adverse reaction reports after the product release, but it also protects product information and restricts follow-on drug’s marketing approval. The RMP, in effective from 2015, basically enforces new drugs and rare disease drugs to draw up and comply with comprehensive safety management plan including pharmacovigilance plan and routine risk minimization activities. But apparently, the public has been raising their voices demanding for a systematic improvement, as 77.5 percent of the RMP subjects were selected again as subject for PMS. To prevent redundancy and harmonize with international standard, MFDS intends to gradually implement the changes. For the first phase to be implemented by the end of the year, the redundancy in RMP and PMS would be removed. And by the end of 2021, the second phase would enhance the efficiency in RMP and by the end of 2022, the integrated RMP would cover the entire post-marketing safety management system. The three key amendments of the plan are harmonizing with the international post-marketing drug safety management system, streamlining pharmacovigilance system by reinforcing collected safety information, and establishing data protection system. The first phase would be on reasonably adjusting information submission criteria to remove redundant data submission by conducting RMP and PMS review simultaneously. The overlapping materials for regular report would prioritize RMP review, and the ‘post-marketing investigation’ section would be replaced by PMS. And for the post-marketing investigation fitting to each quality of drugs, the government plans to revisit the calculation of the number of subject based on prevalence rate and indications. Currently, the sample subject number is limited to 600 to 3,000, but the bracket would be better calculated according to the qualities of each product. The phase 2 of the policy revision would establish a legal basis and raise the administrative predictability by clarifying the compliance criteria. The key amendments are on integrating PMS and RMP subjects, improvising RMP submission period and procedure, reinforcing submission of periodic safety update reports, and strengthening adverse reaction analysis by priority review types. The third phase intends to unify the entire post-marketing safety management as a RMP review. The government aims to harmonize with the international standard of post-marketing drug safety management system by integrating PMS with RMP, and opening a data protection system. Minister Lee Eui-kyung said, “The importance of post-marketing drug safety management has been highlighted by monitoring the adverse reactions of drugs unpredictable at the time of approval and using the safe drugs,” and “the ministry would continue to strengthen the post-marketing safety management by gradually improving the system efficiency between the government and the industry.”
- Company
- Prescription performance has been recovering since June
- by Chon, Seung-Hyun Jul 20, 2020 06:19am
- The overall outpatient prescription growth in the first half of this year has slowed. It remained at the same level as last year in the aftermath of COVID-19. However, prescription performance has been recovering since June, unlike April and May. As the fear of COVID-19 spread in the first quarter, patients received prescriptions all at once and total prescription volume decreased in April and May, but it is analyzed that the prescription market has also been revitalized after the return to normal social activities. According to UBIST on the 15th, the total outpatient prescription amount in the first half of last year was ₩7.35 trillion, a 0.02% decrease from the previous year. Although the prescription performance has been growing every year, it has been slowing down this year. Rx amount & increase/decrease rate in the first half of each year (Unit: ₩100 million, %, Source: UBIST)The prescription amount in the first half of last year rose 6.9% from the previous year. In the first half of 2017 and the first half of 2018, the prescription amount increased by 5.6% and 8.1%, respectively. The prescription amount in the first quarter was ₩3,703 billion, an increase of 2.7% from the previous year. However, the prescription amount in the second quarter decreased by 2.7% to ₩3,647.4 billion. In the first and second quarters of 2019, the outpatient prescription prices rose 5.5% and 8.3%, respectively, compared to the previous year, but the prescription market was sluggish in the second quarter of this year. It is analyzed that the prescription market in 2Q was slow in the aftermath of COVID-19. It is analyzed that a large number of prescription gaps occurred in the second quarter as patients who were reluctant to visit medical institutions, especially those with chronic diseases, were prescribed large quantities of medicines at a time. It has been reported that the number of patients receiving prescriptions for 3 to 6 months in advance increased significantly when the number of COVID-19 confirmed patients increased. In addition, it is estimated that the number of visits to hospitals may have decreased as the frequency of disease occurrence among infants and children has decreased due to factors such as postponement of school, social distance, and strengthening of personal prevention of epidemics. Quarterly Rx amount trend (Unit: ₩100 million, Source: UBIST) The size of the prescription market in January was ₩1.25 trillion, a 4.4% decrease from the same period last year. However, the prescription amount in February increased by 13.0% to ₩1.21 trillion. As New Year holidays were pulled to January earlier than the previous year, the increase/decrease rate of the prescription amount in January and February was analyzed to vary. In March, the total prescription amount increased to ₩1.23 trillion, up 1.4% from the previous year, and the prescription market in the first quarter remained stable despite the spread of COVID-19. In the second quarter, the outpatient prescription amount in April was ₩1.19 trillion, a 8.7% decrease from the same period last year. In April 2018 and April 2019, the prescription amount increased 8.3% and 13.1%, respectively, compared to the same period last year, but this year it has declined. In May, the total outpatient prescription amount was ₩1.16 trillion, a decrease of 9.4% from the previous year. It fell 1.8% from April, the lowest this year. Monthly outpatient Rx amount trend (Unit: ₩100 million, Source: UBIST) It is interesting to note that the prescription market has recovered rapidly since June. The prescription scale last month was ₩1.26 trillion, 11.7% higher than last June. Prescriptions in June 2018 and 2019 rose 5.0% and 3.0%, respectively, from the previous year. It was significantly higher than the previous year despite COVID-19 outbreak. the prescription drug market in April and May was temporarily sluggish due to the fear of COVID-19 in the first quarter, and it seems to have regained growth from June. In particular, when the number of COVID-19 confirmed patients surged mainly in Daegu & Gyeongbuk, the sales activities of pharmaceutical companies also contracted significantly. Since the first COVID-19 confirmed patient in Korea on January 20, pharmaceutical companies have refrained from visiting salesmen to medical institutions. Since the middle of February, the number of COVID-19 patients has increased rapidly, and most of the pharmaceutical companies' salespeople have entered telecommuting. A significant number of patients received long-term prescriptions at one time and it is analyzed that they caused a prescription gap in April and May. The prescription drug market seems to have recovered since the spread of COVID-19 patients began to stabilize in April and social distance campaign had shifted to distancing in daily life. The size of prescription amount in the market is also estimated to have stabilized since June. In the industry, it is continually increasing due to the increase of the elderly and chronic patients. It is said that the entire industry will not contract due to short-term issues such as infectious diseases. According to the analysis, unlike the tourism and cultural industries, it is difficult to lead to a sudden recession because the pharmaceutical industry is affected by patient demand rather than the external environment.
- Policy
- Minister Park is trying to preliminarily secure Remdesivir
- by Lee, Jeong-Hwan Jul 20, 2020 06:19am
- Minister Park Neung-Hoo, from the MOHW said he is trying to maximize the estimated number of seriously ill patients in Korea to preliminarily secure the Remdesivir, known as a cure for COVID-19. One of the criteria for the distribution of Remdesivir around the world is the number of seriously ill patients, so it aims to do its best to ensure that it meets domestic demands as much as possible. On the 15th, at the general meeting of the Welfare Committee of the National Assembly, Minister Park responded to the question of Kang Ki-yun, a member of United Future Party. Kang Ki-yun pointed out that if Remdesivir is effective in COVID-19 treatment, securing a lot in a short period of time is part of preemptive prevention. He pointed out that it was not enough that the KCDC had requested only 5,360 special import from Gilead, a developer of Remdesivir. "People are anxious about COVID-19," said he. "If there is no currently available remedy other than Remdesivir, it is necessary to secure them in reserve quickly and accelerate the development of COVID-19 treatments to relieve public anxiety." Minister Park responded that Remdesivir was proven to be effective, but it is not a totally curable drug, and is committed to negotiating preliminary security with the largest estimate of seriously ill patients in Korea. Minister Park said, “Remdesivir reduces the length of hospital stay by 31% in clinical trials. It is not a completely curable drug, and Seoul National University Hospital is participating in clinical trials and the results are coming out.” He added, “One of the criteria for distributing Remdesivir to countries around the world is how many patients are seriously ill and we are negotiating excessively with the expected number of patients." Minister Park said, "The government and Korean pharmaceuticals are working day and night to develop COVID-19 domestic treatments. I expect that there will be a domestic treatment available by the end of the year."
- Product
- Eventually, Fulcare’s YouTube Ad is deleted
- by Jung, Heung-Jun Jul 20, 2020 06:18am
- Deleted video capture When Mennarini Korea's athlete's foot drug Fulcare’s YouTube advertisement raised a problem saying that Ads excluded pharmacist skills, the pharmaceutical company deleted the video and began to rectify it. The content of the controversial advertisement is a scene where Another patient who was waiting for a patient who visited the pharmacy for athlete's foot symptom recommends Fulcare. Pharmacists protested that it was “an advertisement that ignored pharmacies and pharmacists,” and on the morning of the 15th, some local pharmacist societies called for an immediate cessation of advertising. When the controversy broke out, Menarini Korea apologized to the pharmacists for the inappropriate image, and immediately switched the controversial video to private. An official from Menarini Korea said, "The video in question was immediately removed. It will not be used in the future. This video has hurt the pharmacists who have worked hard and dedication in the front line of the public health." "We take the matter seriously and prepare a plan to prevent recurrence," he said. This is an explanation that the consultation and product recommendation were intended to be included in the video. However, it may be illegal for the pharmaceutical affairs law to be referred to as 'expert recommendation'. Also, it was intended to highlight the fact that it is OTC drug and can only be purchased at a pharmacy. Considering that it is an online video for consumers, he also conveyed the intention of making such as the point that the patient tried to express the part explaining his or her disease. The official said, "It is entirely wrong to fail to reflect carefully, and we are sincerely sorry for the confusion and inconvenience caused by this." also he added, "we will do our best to actively reflect the opinions of pharmacists in all future marketing activities and avoid recurrence." Then, the reason why this advertisement was controversial can be found by looking at the ‘Guidelines for Provision of Information on Drug Ads and Rx drugs’ by the MFDS. In the guidelines, doctors, dentists, and pharmacists are not allowed to recommend and guarantee medicines in advertisements. This is because, according to the guidelines, the characteristics of the social perception of the healthcare practitioner have a large impact on consumers perception of the medicine. In addition, it is judged that it is against the regulations for entertainer and the public to wear gowns to make them look like pharmaceutical experts. Accordingly, pharmaceutical companies produce advertisements in a manner recommended by the general public. "pharmacist should not recommend it. It can be seen as a violation for entertainer to wear a pharmacist's gown. Therefore, in the pharmaceutical industry, advertisements are presented in a way that the general public explains or recommends." he said. This Fulcare’s YouTube ad was shot especially in the pharmacy, so the pharmacists were against it. The official said, "There weren't many commercials in the background of the pharmacy. If this was done outside the pharmacy, the situation may have been different."
- Company
- Rx of NOAC is recommended in COVID-19 epidemic
- by Eo, Yun-Ho Jul 17, 2020 05:55am
- NOAC products in KoreaThe need for prescription of New Oral Anti-Coagulant (NOAC) is also emerging in COVID-19 outbreak. NOAC does not require periodic INR (International Normalized Ratio) monitoring, thus reducing visits to clinics unlike Warfarin. For this reason, NOAC is a good treatment option for patients who are unable to go to the hospital or need long-term prescription due to self-isolation. At the Anticoagulation Forum (AC Forum), which consists of antithrombotic therapists around the world, Warfarin-treated patients who can convert to NOAC are recommended to switch to NOAC to minimize the risk of COVID-19 exposure because frequent hospital visits increase the risk of exposure to COVID-19. Similarly, the National Institutes of Health (NIH) published in the '2020 COVID-19 Treatment Guidelines' included the need to consider switching from Warfarin to NOAC for isolated patients, and many societies including the Royal Pharmaceutical Society in the UK have worked together to establish guidelines for the safe switching from Warfarin to NOAC in March this year. The guidelines provide detailed information, including a patient population that can switch from Warfarin to NOAC, a safe switching process, and features and checklists for each NOAC product. .An official from the Korean Heart Rhythm Society said, “I agree with the recommendation to expand the NOAC prescription in COVID-19 situation .I think NOAC is a drug that can be prescribed by clinics ."Things are different now .I think it will not be a problem if the condition of the patient, such as renal function, is checked and prescribed according to the permission,." Meanwhile, according to the '2018 KHRS Expert Consensus Recommendation for Oral Anticoagulants Choice and Appropriate Doses: Specific Situation and High Risk Patients', 'Eliquis (Apixaban, NOAC)' is first recommended for high-risk patients with advanced age, decreased renal function, and gastrointestinal bleeding .This drug has been confirmed by ARISTOTLE, a major clinical trial, to reduce the risk of stroke and systemic embolism, and to reduce the risk of major bleeding and mortality, compared to Warfarin in patients aged 75 years and older.
