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- 2025-12-24 10:01:32
- 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.
- 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.”
- 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."
- Policy
- Generic pricing negotiation from Sept to protect patients
- by Lee, Hye-Kyung Jul 17, 2020 05:55am
- Korea’s National Health Insurance Service (NHIS) plans to negotiate pricing on generics from September. On July 15, NHIS submitted briefing material for the National Assembly provisional session that elaborated the outcomes of the healthcare coverage enhancement (Moon Jae-in Care) and the government’s prospective plan to lower medical expense and reinforce safety net system. According to NHIS, its plan is to sign a National Health Insurance (NHI) reimbursement contract with generic drugs listed without pricing negotiation to enforce quality management compliance for the protection of the patient safety. And with constant rise in treatment material expenditure, the government body would analyze expenditure increase by listing types, and manage the use volume based on reasonable pricing and adjustment. To lessen the medical expense burden of the people with the Moon Care, the government is also gradually expanding the coverage on eye, chest and breast ultrasound scan in the latter half of the year as the initially non-reimbursed female reproductive system ultrasound scan was covered from last February. Following are other plans NHIS has for the coverage enhancement initiative; publishing production cost manual to standardize production cost calculation and improving credibility by adding more panel institutes like a national university hospital to provide production cost information; inducing improvement in medical service use behavior by providing counseling and medical service use history of multiple healthcare institute users and general hospital users for mild condition; promoting adequate use of drugs in chronic disease patients taking multiple medications via counseling visitation. NHIS’ big data analysis center operating with 192 seats and 525 accounts at ten sites nationwide would be expanded to provide high-quality NHI big data for research purpose. Moreover, the government would provide support on developing customized health service model and healthcare policy. NHIS stated the non-contact operation format would get more prevalent within the agency amid the post-coronavirus, and infectious disease monitoring and notification system and infection control at long-term nursing hospitals would be established.
- Policy
- Domestic vaccine development for COVID-19 aims at 2021
- by Lee, Jeong-Hwan Jul 17, 2020 05:55am
- It is expected that the government will start a clinical trial of COVID-19 blood plasma therapy in early September and will be able to secure treatments throughout the year. Antibody therapies, except for blood plasma therapies, are scheduled to go through clinical trials, and the government expects that antibody therapies will be secured in Korea in the first half of next year. Although the government aims to complete vaccine development within 2021, it is difficult to determine the timing of development because of the many variables and the additional factors required for actual administration. Kwon Jun-wook, Deputy Director of the Central Disease Control Headquarters, said in a Q-and A session after a briefing on the current situation of COVID-19 in Korea. The Central Disease Control Headquarters explained that Forty-two serious ill patients are taking Remdesivir, an Ebola treatment, using a re-creation (repositioning) method related to COVID-19 treatment. In addition, he said that Plasma therapy is the first to be promoted as a therapeutic agent. He said that vaccine development is the key to COVID-19's response. The Central Disease Control Headquarters aims to mass-produce vaccines that have achieved safety and effectiveness within 2021. However, he said that the development of vaccines has many variables, so it is impossible to guarantee the final development time. In particular, it is explained that there are many additional tasks required for development of vaccines such as delivery strategies, supply and demand, transportation systems, inoculation personnel, inoculation priority, safety monitoring, and development formulation. "The development of plasma therapy is being promoted. Lilly, a large-scale multinational company, is currently conducting phase III clinical trials quickly," said he. Korea is expected to make a blood plasma therapy for clinical trials this week with the participation of COVID-19 confirmed patients. He said, "However, it takes a month for the blood plasma to be formulated. The manufacturing and processing process itself is complicated, and pooling, testing, and toxicity tests are also required." and he added, "In Korea, the clinical trial for blood plasma drugs begins in early September, and the goal is to secure blood plasma drugs within the year." "The development of antibody treatment systems other than blood plasma treatments are under development as planned. Antibody therapy drugs are clinically targeted to be secured in Korea in the first half of next year," said Vice President Kwon. “Vaccines have various platforms, different expert evaluations, and there are DNA vaccines or mRNA, etc.” He said that a lot of efforts are being made to develop vaccines around the world and Mainly, three domestic companies are trying to develop vaccines. "Our goal is to mass-produce vaccines that have demonstrated safety and effectiveness in Korea within 2021," he added.
- Policy
- The MFDS will enact a law covering special cases
- by Lee, Tak-Sun Jul 16, 2020 05:54am
- The MFDS decided to promote the establishment of a law covering special cases to support the approval of vaccines and treatments for new infectious diseases such as COVID-19. It also plans to establish the Central IRB to expedite clinical trials. The MFDS made the announcement through the 'Major Business Reports' submitted to the National Assembly on the 15th. The MFDS plans to focus on establishing an institutional foundation to support COVID-19 treatment and vaccine products. First, it plans to promote a law covering special cases of the development and provision of public health crisis response products for rapid screening and approval of infectious diseases and vaccines, and support for development. In addition, the establishment of the Central IRB for rapid and integrated deliberation of multi-center clinical trials is being promoted through amendments to the Pharmaceutical Affairs law. In this regard, Seon-woo Kang , a member of Democratic Party of Korea had proposed a partial amendment to the Pharmaceutical Affairs law. The Central IRB provides patient support, including consultation on the operation of the clinical trial committee for each institution and compensation for damages. The MFDS has been operating a high-speed program since April, and has been promptly reviewing COVID-19 treatment and vaccines. It provides research support for candidate substances, TF team, and overseas development status and review information. As of June 30, 41 products received support such as consultation. In addition, it is making efforts to rationalize the clinical trial review procedure for COVID-19 therapeutics and vaccines, and to expand the institutions conducting clinical trials. In the past, the subject listened to the face-to-face description and signed a handwritten signature in order to consent to the clinical trial, but in the clinical trial of the COVID-19 treatment, the subject listened to non face-to-face explanation and improved the consent to be recorded or photo files. The MFDS said, "We will stop the spread of COVID-19 and seek a quick solution to COVID-19 through the development of therapeutics and vaccines."
- Policy
- Use patent of Xarelto 2.5mg listed late
- by Lee, Tak-Sun Jul 15, 2020 07:54am
- Xarelto 2.5mgAlthough Hanmi and SK Chemicals acquired market monopoly rights as a follow-up drug to the anticoagulant drug (NOAC), Xarelto 2.5mg (Rivaroxaban), it may not exercise its right. This is because the use patent for Xarelto 2.5mg has been listed in the MFDS after the acquisition of the rights of both companies. According to the MFDS, Hanmi and SK Chemicals obtained generic exclusivity right on July 5, 2016, with Riroxiban 2.5mg and Rivaroxaban 2.5mg, respectively. The generic exclusivity period is from October 4, 2021 to July 3, 2022, when the material patent ends. Both companies succeeded in evading the patent for Xarelto 2.5mg, and were granted the right to generic exclusivity through the first application for permission. At the time, only the composition patent and the material patent were registered in the MFDS. Accordingly, the two companies that avoided the composition patent exercised the right to generic exclusivity after the termination of the material patent. However, in September of last year, Bayer Korea registered a use patent of Xarelto 2.5mg. The application patent expires on June 7, 2022. There is only a way to invalidate the patent in order for Hanmi and SK Chemical to release the patent normally during the copyright period, avoiding patent infringement. It should be launched from June 8, 2022, when the patent ends. The fact that the right to terminate the copyright was July 3, 2022. This use patent contains the contents of the use as a drug for the prevention or treatment of thromboembolic disorders. Xarelto 2.5mg has recently changed its efficacy and effectiveness. At the time of the first item approval ▲Reduced risk of stroke and systemic embolism in patients with non-valve atrial fibrillation ▲Treatment of cardiac venous thrombosis and pulmonary embolism ▲Reduced risk of recurrence of cardiac venous thrombosis and pulmonary embolism ▲co-administered with acetylsalicylic acid (ASA) alone or with ASA plus Clopidogrel or Ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers. Recently, Xarelto, ▲ co-administered with acetylsalicylic acid (ASA) alone or with ASA plus Clopidogrel or Ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers, ▲co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events.·Changed to effect. Hanmi and SK Chemicals' generic exclusivity items were replaced with the same indications. All of the altered indications are known to be related to the use patent. Recently, Xarelto 2.5mg has been shown to reduce the risk of death from stroke, myocardial infarction and cardiovascular disease in adult patients with coronary artery disease or symptomatic peripheral arterial disease when used in combination with ASA. Based on this, a recent overseas conference recommends a combination therapy of Xarelto 2.5mg-ASA for high-risk chronic coronary syndrome patients. It is expected to boost the market preemption effect if the generic exclusivity is released earlier than the competitor based on the monopoly. It is noteworthy how Hanmi and SK Chemicals will respond to lately registered patents.
- Policy
- Emergency use of KRW 5.13 mln Soliris covered for aHUS
- by Lee, Hye-Kyung Jul 15, 2020 06:32am
- Soliris (eculizumab) injection costing 5.13 million won per vial is to get coverage for an emergency administration. Korea’s Health Insurance Review and Assessment Service (HIRA) has recently made an additional checkbox on the preliminary approval application for Soliris. The government body issued a notice on July 10 stating an emergency administration of Soliris is newly available for patients with atypical Hemolytic Uremic Syndrome (aHUS). A patient with aHUS needing an emergency administration of Soliris can now tick off a box for ‘emergency administration’ on the preliminary approval application, as provided by the method and procedure of Soliris use (HIRA notice No. 2018-165, June 28, 2018). The existing reimbursement criteria and notice are applied the same on the emergency administration of the injection. Soliris was listed for reimbursement in 2012 for three years under the condition of differentiated pricing (refund type), and it became a subject to risk sharing agreement (RSA) since Oct. 1 2015, which a patient that paid the full expense can receive a partial refund on the drug from the pharmaceutical company. As stipulated by the National Health Insurance Act and Healthcare Reimbursement Criteria, the reimbursement on Soliris is granted to patients with paroxysmal nocturnal hemoglobinuria (PNH) and aHUS. But because a single vial costs 5.13 million (as of July 2020), the recipient has to get a preliminary reimbursement approval to cover the approximate yearly cost of 400 million won for three vials per two weeks. According to the HIRA’s notice on July 10, the preliminary review committee’s bimonthly meeting is scheduled on the last Thursday of every even-numbered month. But the chair of the committee may call for a meeting on other days, if need be. The preliminary approval application and relevant data for using Soliris should be submitted by the 10th of the month of review to be processed. The healthcare institute that received preliminary approval of Soliris is also required to submit a monitoring report every six month, in which the same criteria are applied.
- Policy
- Nine out of 27 patients in Remdesivir improved
- by Kim, Jung-Ju Jul 14, 2020 06:12am
- Of the 27 COVID-19 patients in Korea who took Remdesivir, 9 cases improved out of 27 patients with severe change. The positive effect was about 30%, which is only a numerical example and is still under professional review. Deputy General Manager Kwon Joon-Wook, the Central Disease Control Headquarters of the KCDC (Director, Eun-kyeong Jung), briefly explained the current status of domestic medications for Remdesivir at the regular briefing session during the day. Currently, the Central Disease Control Headquarters sent a request for special import to the Gilead Korea branch, which is a holding company of Remdesivir, and requested urgent import of 360 people for emergency use and 5000 people for preparation for the pandemic. According to Deputy General Manager Kwon, there are a total of 42 COVID-19 patients currently receiving Remdesivir. A total of 27 patients were able to detect the change in severity because the comparison between the administration group and the non-administration group was not yet completed. Nine out of 27 cases improved. However, he explained, "It is not yet known whether this improvement is due to Remdesivir or the patient's own symptomatic therapy or immunity." It was found that 15 cases were hard to judge the effect or the condition did not change, and three cases were worse. Regarding this, he emphasized again, "This is only a numerical situation, and it is necessary to seek professional judgment from the central clinical committee for the effectiveness of the treatment." Meanwhile, the Central Disease Control Headquarters applied for Remdesivir to 23 hospitals for 42 seriously ill patients, and has now completed supply to all 42 patients.
