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- 2026-05-19 16:08:59
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- Epidiolex can be prescribed at general hospitals in Korea
- by Eo, Yun-Ho Apr 28, 2021 06:05am
- Epidiolex can be prescribed at general hospitals in Korea According to related industries, Epidiolex (Cannabidiol, CBD Oil), a hemp-based drug for the treatment of patients with rare and intractable diseases among children with epilepsy, has passed the drug commitee (DC) of Seoul National University Hospital. Epidiolex has been reimbursed this month. Since this drug was recognized as an urgently introduced drug by the MFDS in March 2019, it has been struggling to register benefits. With the application of this benefit, the drug cost to be taken by patients has been significantly reduced from about ₩6.7 million per three months to ₩440,000. However, for patients with epilepsy covered by insurance, it is expected that there will be discussions for improvement in the future, used to treat seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome, or tuberous sclerosis complex (TSC) in patients 2 years of age and older. The KOEDC played a big role in applying Epidiolex's benefit. The center lowered its domestic supply price to ₩1.1 million through drug price negotiations with the original developer GW Pharmaceuticals, and the registration process was undertaken based on this price, and it was finally listed on April 1. However, even after registration, there are issues to resolve such as supply and demand problems, indications and expansion of benefit standards according to the increased demand. The key is whether Epidiolex can be used stably in the domestic medical field. The third completed phase 3 trial was a comparison of 20 mg/kg per day with placebo in patients with Lennox–Gastaut syndrome. The primary efficacy outcome of median reduction in drop seizures was significantly in favor of Epidiolex with 43.9% versus 21.8% for placebo (P = 0.0135). In patients with Dravet syndrome, a significant decrease in the median convulsive seizure (tonic, clonic, tonic-clonic, or atonic) frequency was seen in patients treated with Epidiolex when compared with placebo within the first month of the maintenance period (P = 0.002 ). The primary outcome endpoint was significant and showed a median reduction of 38.9% for CBD versus 13.3% for placebo (P = 0.01) .Also, side effects such as sleepiness, dizziness, and headache may occur when taking Epidiolex, but it is non-hedonic with no known abuse potential.
- Company
- Viatris Korea-Jeil Pharm to co-promote Lipitor Plus from May
- by Eo, Yun-Ho Apr 28, 2021 06:05am
- Lipitor Plus (ezetimibe/atorvastatin calcium trihydrate) On the 27th, Viatris Korea and Jeil Pharmaceutical announced that they will launch and co-promote the dyslipidemia treatment ‘Lipitor Plus (atorvastatin and ezetimibe)' from May 1st. Jeil Pharmaceutical had received approval for Lipitor Plus from the Ministry of Food and Safety on February 18th, in 3 dosages - 10/10mg, 10/20mg, 10/40mg – for the treatment of primary hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH). Lipitor Plus uses atorvastatin, the same active pharmaceutical ingredient (API) used in ‘Lipitor (atorvastatin).’ Jeil Pharmaceutical will manufacture the drug using the original API provided by Viatris Korea. By adding Lipitor Plus to the company’s portfolio in addition to the existing Lipitor, which verified its LDL-C lowering effect and safety profile in large-scale global and domestic clinical trials, the companies expect to be able to provide more personalized treatment options for patients with dyslipidemia in Korea. Viatris Korea and Jeil Pharmaceutical will jointly carry out domestic sales and marketing promotions for Lipitor Plus. Building on the solid partnership established between the two companies through the joint promotion agreement on Lipitor for the treatment of dyslipidemia, the companies plan to inform the clinical field of the clinical value and latest findings of Lipitor Plus. “Based on the partnership between the two companies, we will continue to listen closely to the needs of our patients and HCPs in the changing environment to provide better accessibility,” said He young Lee, Country Manager of Viatris Korea. Viatris Korea is the Korean subsidiary of the Viatris Group that was launched in November 2020 through a merger between Global Pfizer’s business division Upjohn and the global healthcare company Mylan. The company changed its name to Viatris Korea in February.
- Company
- Celltrion acquires Nesina and Actos from Takeda
- by Kim, Jin-Gu Apr 28, 2021 06:05am
- (Clockwise from top left) Actos, Nesina, Edarbi, Whituben & Madipine According to the pharmaceutical industry on the 26th, some of the 18 items that Celltrion acquired from Takeda last year are still being sold under the name of Takeda. This is because the license right in Korea has not yet been completely transferred to Celltrion. Celltrion acquired the rights of 18 items for chronic disease treatment and OTC drugs from Takeda in December of last year in the Asia-Pacific region for $278.3 million (approximately ₩307.4 billion). Celltrion Pharmaceuticals in Korea and Celltrion Healthcare in the rest of the world exercise their rights. The main products are Nesina, a diabetes treatment drug based on DPP-4 inhibitor ,Actos, a diabetes treatment product based on TZD, Edarbi, a treatment drug for hypertension based on ARB, Whituben, and Albothyl, a treatment for stomatitis. Whituben and Albothyl are OTC drugs. About half of them are confirmed to have completed the transfer and transfer of domestic permits. Depending on the item and doses, the progress of the transfer and transfer operation differs. Actos and ActosRyl have been transferred to Celltrion. Actos met is still licensed by Takeda. The license for Nesina Met is still held by Takeda. Celltrion and Takeda are licensed according to the dosage of Nesina and Nesina Act. Nesina 6.25mg is licensed by Celltrion, and Nesina 12.5mg and 25mg are licensed by Takeda. Edarbi, Edarbyclor, and Whituben have licenses from Celltrion, while Albothyl still has licenses from Takeda. Celltrion maintains the domestic joint sales contract as it was before. Nesina is sold by Jeil and Edarbi is sold by Dong-A ST. Ildong is selling only ActosRyl among the Actos series. Whituben and Albothyl are sold and distributed in Korea by GC Pharma. Celltrion plans to complete the transfer of licenses within this year. An official of Celltrion said, "Because the licenses are different for each product, they are being transferred sequentially. We expect all product licenses to be transferred from Takeda to Celltrion within this year." Celltrion's total sales of 18 items acquired from Takeda are estimated at ₩80 billion per year. As soon as the domestic license transfer is completed, the sales of the item will be reflected in Celltrion 's performance. At the end of this year, sales of ₩80 billion will be fully reflected in Celltrion's sales performance.
- Company
- Generics for Eliquis have Rx amount of ₩12.7 billion
- by Kim, Jin-Gu Apr 28, 2021 06:05am
- It was found that Eliquis (Apixaban)'s cumulative prescription amount for generics, which faced a crisis of compensation for damages due to the Supreme Court decision made earlier this month, reached ₩12.7 billion. With the sale of generics stopped at once after the Supreme Court ruling, generic companies have to pay a significant portion of ₩12.7 billion. Eliquis' Rx performance is expected to rebound from next month. However, the NOAC (new oral anticoagulant) market is stagnating, and it is unclear how long it will recover. ◆Eliquis' generics withdrew from the market after recording ₩12.7 billion Eliquis' generics withdrew from the market after recording ₩12.7 billion. According to UBIST, a drug market research institute on the 26th, the cumulative prescription amount of Eliquis generics until the first quarter of this year is ₩12.7 billion. By item, Chong Kun Dang’s Liquisia, ₩4.1 billion, Samjin's Elxaban ₩2.4 billion, Yuhan's Yuhan Apixaban, ₩1.7 billion, Hanmi’s Apixban, ₩1.1 billion, and Yooyoung's Yupix ,₩900 million. Generics for Eliquis have rapidly increased their Rx performance since they were released through patent overcoming in the third quarter of 2019. It surged to ₩400 million in the third quarter of 2019, ₩800 million in the fourth quarter, ₩1.4 billion in the first quarter of 2020, ₩1.8 billion in the second quarter, ₩2.4 billion in the third quarter, ₩2.7 billion in the fourth quarter, and ₩3.2 billionin the first quarter of this year. However, the Supreme Court decision made earlier this month put the brakes on. On the 9th, the Supreme Court overturned the first and second trial rulings in the dispute between BMS and generic companies over Eliquis' product patent on the 9th and sided with BMS. BMS officially announced a claim for damages right after the ruling. Generic companies stopped selling them. It may be a turnaround in the revocation and reconciliation trial. Quarterly Rx performance of Eliquis & Generics (unit: ₩100 million, data:UBIST) The actual compensation amount is expected to be less than the cumulative prescription amount of each company. This is because the amount of compensation for patent infringement is usually determined at the operating profit level, not sales. Eliquis' generics, which were withdrawn from the market by a Supreme Court ruling, can reenter the market after September 2024, when their product patents expire. Generic companies have finally overcome the formulation patent (2031) excluding the product patent in 2019. ◆Eliquis Rx cost reduced by 13%, Will earnings recover from the second quarter? Following the Supreme Court ruling and the subsequent suspension of generic sales, Eliquis is expected to be rebounded in prescriptions from next quarter. Eliquis' Rx amount for the first quarter was ₩10.7 billion. Compared to the same period last year (₩12.3 billion), it decreased by 13%. Eliquis' Rx amount increased to ₩12.5 billion in the second quarter of 2019 just before the generic launch, but has declined since. In the NOAC market, Daiichi Sankyo's Eliquis, Bayer's Xarelto and Boehringer Ingelheim's Pradaxa are competing. It is the key to whether the existing prescription performance of generics will be entirely occupied by Eliquis or will be distributed to other items. Another variable related to the recovery of Eliquis Rx results is the stagnation of the NOAC market. The total NOAC market size increased to ₩46.9 billion until the third quarter of last year, but since then it has decreased for the second consecutive quarter. The market size in the first quarter of this year was ₩44.8 billion. Prescriptions for all three original items decreased excluding Lixiana. Bayer's Xarelto decreased 3% from ₩12.3 billion in the first quarter of last year to ₩11.9 billion in the first quarter of this year. Boehringer Ingelheim's Pradaxa decreased 16% from ₩3.8 billion to ₩3.2 billion. Lixiana, which is the number one in the market, posted sales of ₩15.8 billion in the first quarter, the same as in the first quarter of last year.
- Policy
- The government signed an additional 40 million doses
- by Kim, Jung-Ju Apr 28, 2021 06:05am
- The government has signed an additional 40 million doses of Pfizer's COVID-19 vaccine product. As a result, Korea has secured twice the amount of vaccine vaccination in the country, enabling it to achieve the goal of forming collective immunity in November. Pan-government vaccine introduction TF (Team Leader Kwon Deok-cheol, Minister of Health and Welfare) announced that an additional purchase contract for 40 million Pfizer COVID-19 vaccines (for 20 million people) was signed by holding an emergency briefing during the day on the 24th. The government explained that after forming a pan-government vaccine introduction TF to stably supply COVID-19 vaccine on the 1st, it has mobilized all of its government-wide capabilities, including diplomatic efforts, by consistently meeting with each vaccine pharmaceutical company. This contract is the result of ongoing negotiations by discussing the supply of vaccines through video conferences with Pfizer with Kwon Deok-cheol, head of the Pan-Government Vaccine Introduction Task Force on the 9th and 23rd of this month. ◆Signed an additional purchase contract for Pfizer vaccine= This year, a total of 66 million doses of Pfizer vaccine, which was originally 26 million doses and 40 million doses contracted, were supplied, resulting in a total of 33 million Pfizer vaccines. Pfizer's vaccine has been supplied in 1.75 million doses so far, including 7 million doses by the end of June, and plans to supply 59 million doses sequentially from the third quarter. Pfizer vaccines have been supplied regularly every week since the start of supply on March 24th. With the signing of an additional purchase contract this time, the foundation for a more stable supply of COVID-19 vaccine has been laid. ◆COVID-19 Vaccine Supply Status and Plan The total number of COVID-19 vaccines secured by Korea this year amounted to 192 million doses, a total of 99 million. This is the amount that can be vaccinated for about 1.9 times of the total population in Korea and 2.75 times for the 36 million vaccination targets for the formation of collective immunity. The vaccine contracted for this year was for 79 million people, enough to secure collective immunity, but additional purchases laid the foundation to accelerate the time to achieve collective immunity. It is possible to prepare for additional demands that may arise in the future, such as the 3rd vaccination (called booster shot) to cope with the mutant virus and the expansion of the target age for vaccinations under the age of 18 to prepare for the uncertainty in the international vaccine supply and demand. First of all, the government plans to do its best to achieve the target inoculation for 12 million people with the 18.09 million doses confirmed by the end of June. AstraZeneca and Pfizer vaccines, which are currently being vaccinated, have already supplied 3.87 million doses of vaccine, and a total of 18.09 million doses will be supplied by the second quarter. The government plans to closely monitor the vaccine supply situation on a full-cycle basis to ensure that 18.09 million doses will be supplied without disruption, while additionally introducing some of the Novavax, Moderna and Janssen vaccines within the first half of the year, so that up to 20.8 million doses can be supplied. The government said, "By the end of June, 12 million people are vaccinated to prevent infection in high-risk groups such as nursing hospitals, facility admissions, and residents, thereby preventing severe and death, and through vaccinations for COVID-19 treatment, response personnel, and health care workers. We expected to be able to contribute to the maintenance of the quarantine system." From July, AstraZeneca and Pfizer, as well as Novavax, Moderna, and Janssen vaccines are expected to be supplied in earnest. Accordingly, a total of 100 million vaccines are planned to be supplied by the end of September. The total amount negotiated by the end of September is about 80 million doses of AZ, Pfizer, Novavax, Moderna, and Janssen, and when added to the supply in the first half, about 100 million doses of vaccine will be supplied by the end of September. This is an amount that can be vaccinated to more than 50 million people, and if the supply is smooth, it will be possible to inoculate all 44 million people over the age of 18 with only the amount until the end of September. In order to form collective immunity, vaccination of about 36 million people, or 70% of 52 million people, is necessary. The government said, "Through this additional purchase contract, it is possible to secure a sufficient amount of vaccine and achieve early achievement even after meeting the goal of forming population immunity in November." This is the result of specifying the supply schedule of vaccines, which were scheduled to be supplied in the second half of the year, by pursuing additional contracts through the pan-government vaccine introduction TF and expanding the volume of existing contracted vaccines in the third quarter. Although the supply and demand of vaccines worldwide is uncertain, the government said that through additional purchase contracts and quarterly consultations on supply, the government laid the foundation for more stable and rapid vaccination. About 90 million doses to be supplied in the fourth quarter will be used to respond to a variety of situations in a relaxed manner, and to actively utilize additional vaccinations if necessary. The government said, "In the future, we plan to actively cope with various situations that may arise during the vaccine supply and demand process through comprehensive support such as approval of COVID-19 vaccine, release of national lots, and supply of raw and subsidiary materials. By the end of June, 12 million people will be vaccinated and all government-wide capabilities will be mobilized to achieve collective immunity in November." Minister Kwon Deok-cheol said, "The government will do its best to prevent quarantine, introduce vaccines, and vaccinations so that the people's precious daily lives can be restored. I sincerely ask the people to believe in and actively cooperate with the government's plans and guidance for securing vaccines and vaccinations." The government plans to continue meticulous efforts on vaccine safety. The KCDA Commissioner Jeong Eun-kyeong said, "The vaccines contracted by our government are products that have been approved for safety, and the benefits of vaccination outweigh the risks. I hope you will actively participate in the order of vaccination."
- Company
- Roche Korea’s new NMOSD treatment Enspryng is approved
- by Eo, Yun-Ho Apr 27, 2021 06:05am
- Roche’s neuromyelitis optica spectrum disorder (NMOSD) treatment ‘Enspryng’ was approved in Korea. On the 25th, Roche Korea announced that the Ministry of Food and Drug Safety (MFDS) approved Enspryng (satralizumab) for the treatment of adults with aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD), NMOSD is a rare autoimmune disorder of the central nervous system that primarily damages the optic nerve and spinal cord, causing loss of vision and neurological damage. Although its clinical characteristics are similar to multiple sclerosis, over half of the patients with NMOSD experience severe loss of vision and gait disturbance to the extent that the patient becomes wheelchair-bound within 5 to 10 years. In particular, 80-90% of the patients experience frequent relapses. As even a single relapse could cause permanent disability, preventing relapses through maintenance therapy is a key goal in the treatment of NMOSD. Enspryng has an innovative mechanism of action that selectively inhibits interleukin-6 (IL-6) receptor activity, which plays a key role in the inflammation associated with NMOSD. The novel recycling antibody technology applied to Enspryng allows for a longer duration of antibody circulation and a longer IL-6 inhibition effect. Also, the new drug has improved dosing convenience allowing the patient or his/her caregiver to inject Enspryng subcutaneously every four weeks at home as maintenance therapy. The MFDS approval is based on the results of the two Phase III clinical studies ▲ SAkuraSky and ▲SAkuraStar. In the studies, Enspryng demonstrated its clinical efficacy in preventing and reducing the risk of relapse in patients with all states of AQP4-IgG seropositive NMOSD. Among AQP4-IgG seropositive patients, over 9 out of 10 patients who were treated with Enspryng and immunosuppressant combination therapy, and over 7 out of 10 patients treated with monotherapy remained relapse-free for approximately 2 years (96 weeks). SAkuraSky, the pivotal Phase III study that evaluated the efficacy and safety of Enspryng in combination with immunosuppressive therapy enrolled 83 patients with NMOSD aged 12 to 74. Results showed that 89% and 78% of patients on Enspryng combination therapy were relapse-free at weeks 48 and 96, achieving a 62% reduction in the risk of relapse compared to patients on placebo (placebo-immunosuppressant therapy combination). In particular, the study showed that 92% of the AQP4-IgG seropositive patients, the patient group approved for the use of Enspryng, remained relapse-free at weeks 48 and 96, and Enspryng reduced the risk of recurrence by 79% compared to placebo. SAkuraStar, the pivotal Phase III study evaluating the efficacy and safety of Enspryng monotherapy, enrolled 95 patients with NMOSD aged 18 to 74. Results showed that 76% and 72% of patients treated with Enspryng remained relapse-free at weeks 48 and 96, and reduced the risk of relapse by 55% compared to the placebo group. 83% of the patients with AQP4-IgG seropositive NMOSD who were treated with Enspryng remained relapse-free at week 48, and 77% at week 96, reducing the risk of relapse by 74% compared to the placebo group. Enspryng was approved by Health Canada (HC) and Japan’s Ministry of Health, Labour and Welfare (MHLW) in June last year. The drug also received approval from the US Food and Drug Administration in August of the same year.
- Policy
- Results of HIRA’s preemptive response to COVID-19
- by Lee, Hye-Kyung Apr 27, 2021 06:05am
- In the ‘2020 sustainable management report’ published by the Health Insurance Review and Assessment Service (HIRA), the institution cited its preemptive COVID-19 response as one of its achievements last year. HIRA, which had organized a COVID-19 Countermeasure Promotion Committee in response to the COVID-19 pandemic, evaluated its performance to conclude that it had monitored 68,652 cases of international arrivals, sold 2.5 trillion won's worth of K-diagnostic agents as exports to 170 countries and supported 939.9 billion won in compensation to hospitals and small businesses impacted with COVID-19. In particular, the 'identification system for repeated mask purchases’ played a key role in resolving the ‘mask shortage crisis’ that arose in the early COVID-19 period. According to HIRA, the five-part mask supply system was implemented within 5 days of the mask shortage crisis. During the early stages of its implementation, pharmacies and post offices were designated sellers of the public face masks. HIRA ran an emergency response team 24/7, and disclosed inventory information regarding the public masks every five minutes. HIRA then implemented the identification system for repeated mask purchases. The authorities ordered pharmacies and mask sellers to log the mask sale information of each individual on the portal service for medical institutions, then compared and inspected the sales and cumulative purchasing information to prevent repeated purchases. HIRA’s report states that the identification system for repeated mask purchases helped resolve the public's inconvenience of having to wait in line at pharmacies and other stores to purchase the masks. In February of this year, upon request by the Korea Disease Control and Prevention Agency (KDCA), HIRA had completed the development of a treatment (remdesivir, legdanbimab) management system. In addition, HIRA had dispatched 216 epidemiological investigators to institutions and medical sites including the Central Disaster and Safety Countermeasures Headquarters, Central Disease Control Headquarters, screening clinics, and quarantine centers. This year, HIRA plans to work with KDCA and continue to align its infectious disease response support system by automating the provision of epidemiological data. To accommodate the government's request for the development of patient-specific treatment status and statistical information system for each COVID-19 confirmed case in each city and province, HIRA organized a temporary organization and started to provide the requested service to KDCA, cities and provinces, and quarantine institutions (health centers, medical institutions, etc.) from March last year. Meanwhile, HIRA has provided 3.94 million cases of infectious disease information to medical institutions by advancing the Drug Utilization Review (DUR) service and International Traveler Information System (ITS). Also, HIRA monitored the appearance of symptoms through a phone survey on all incoming international travelers (Korean and foreigners, 68,652 cases) to detect the inflow of COVID-19 cases in advance. Also, HIRA self-acclaimed its achievements, stating that its efforts in allowing rapid entry of COVID-19 diagnostic tests into Korea's health insurance system and establishing a follow-up management system had contributed to the establishment of the world-class K-disease control and prevention system. HIRA said, “We have conducted 203 times more tests than the number of patient occurrences, and 17 diagnostic reagent products from 15 Korean companies were listed, achieving 2.5. trillion dollars in overseas exports."
- Company
- MSD virtually prohibits one-on-one product presentations
- by Apr 27, 2021 06:04am
- MSD Korea has proposed new rules for one-on-one product presentations with doctors. Product presentations that are not for business purposes are minimized, and the limit for meals is lowered from ₩100,000 per person to a maximum of ₩70,000. It is expected that the labor-management conflict will intensify as a counter-argument has been raised within the business that it is a'substantially banned rule'. On the 23rd, MSD Korea announced the reorganized guidelines for product presentations to its employees. According to this, from this coming May ▲Meetings with speakers scheduled to lecture ▲Details that require a lot of time, such as changes in new drugs, indications, and guideline changes ▲One-on-one products under the approval of NSM only when in-depth details are needed for important business purposes. The pre-lecture meeting with the speaker is when in-depth discussions about products and diseases are necessary to determine and prepare the contents of the lecture. Details that take a lot of time include new drug launches, new indications, adverse reaction issues, supply-related, insurance benefits, and important clinical data updates. An important business purpose refers to business-related discussions after product presentations and Q&A, or when additional discussions on other business-related topics such as marketing, insurance benefits, supply, etc. are necessary in relation to products or diseases.If this is not the case above, one-on-one product presentations must be approved by the business unit director (BUD). The limit on food and beverages that can be provided at product presentations has also been lowered. From ₩100,000 per person, lunch is limited to ₩40,000 and dinner is ₩70,000 (excluding VAT). The company said, "We hope that the product briefing sessions conducted one-on-one with the doctor will be conducted as a simple PRE. When a product briefing with meals is absolutely necessary, it is conducted with the approval of the executive, and the approval authority carefully reviews the reason why this activity must be conducted as a general briefing rather than a simple product briefing, and additional reasons are recognized..” Simple product presentations refer to light meals that are less than ₩10,000, such as coffee or sandwiches. There is a backlash from inside the business that it is a measure that effectively bans one-on-one product presentations. This is because the scope of the provisions allowed by the company is narrow and ambiguous. An official from the MSD Korea union said, "The speakers scheduled to lecture are only for some professors at general hospitals, and there are few new drugs available." "Because the important business purpose is ambiguous, there is a difference in the position between the field staff and the company. It is expected to be large.” He added, "In the end, the three provisions proposed by the company seem to be in most cases that are not possible in the field, so it is actually interpreted to mean that one-on-one meetings should not be held." Employees pointed out that the company is pushing for a unilateral change of regulations that does not take into account the business environment, which is a stronger measure than that of the pharmaceutical affairs law and the KRPIA. Earlier, MSD Korea said, "We regularly review whether the communication method with customers is appropriate and update internal regulations if necessary." It said that it will derive an appropriate plan by collecting opinions from employees
- Policy
- The industry is paying attention to the review of generics
- by Lee, Jeong-Hwan Apr 27, 2021 06:04am
- Following the generic joint bioequivalence test '1+3 Restriction Act', the Drugs for Data-Based Re-evaluation (IMD) clinical data '1+3 Restriction Act' will be submitted to the National Assembly's Health and Welfare committee (Legislative Subcommittee) to be held next week. The two bills initiated by Democratic Party of Korea Rep. Seo Young-suk and People Power Party Rep. Seo Jeong-sook, respectively, have strengthened their influence on the pharmaceutical industry if passed as a merger review was decided. A bill to upgrade the CMA (Conditional Marketing Authorization) system for clinical trials operated by the MFDS to the pharmaceutical affairs law has also been newly added as an agenda for review of the legislation. On the 21st, Kim Min-seok, chairman of the Welfare Committee, and the secretaries of the ruling and opposition parties discussed the agenda of the subcommittee on the bill. Earlier, after the plenary meeting on the 26th, the Welfare Committee confirmed the schedule of the 2nd Subcommittee on the 27th and the 1st Subcommittee on the 28th. In the Legislative Subcommittee, which will be held this time, a law under the jurisdiction of the MFDS, which was not reviewed in February, will be first reviewed. In particular, the pharmaceutical affairs law, which has a great influence on the pharmaceutical industry and pharmacy, was included. The most representative bill is the combined review of the bioequivalence test 1+3 regulatory bill (by Seo Young Seok), which aims to prevent the overrun of generic drugs, and the law limiting the number of joint use of IMD clinical trial data to four pharmaceutical companies (by Seo Jeong-sook). The generic joint bioequivalence test 1+3 regulatory bill was put forward in February, but it did not have an opportunity for review. IMD's 1+3 regulation bill, which was proposed afterwards, was newly added as an agenda, and the Welfare Committee decided to review the two bills together. If the bill passes the deliberation of the welfare committee, the impact on the pharmaceutical industry and pharmacies will be greatly increased. In particular, there are opinions that generic and IMD licensing regulations should be strengthened in preparation for the past as illegal cases of voluntarily manufacturing pharmaceuticals in violation of the GMP regulations of the Pharmaceutical Affairs Act are discovered one after another. The merged review of the 1+3 bills for IMD Next week, the Legislative Subcommittee confirms the evaluation. Including bills for vitalization of generic substitution and mandatory CSO expenditure reports Following the generic joint bioequivalence test '1+3 Restriction Act', the Drugs for Data-Based Re-evaluation (IMD) clinical data '1+3 Restriction Act' will be submitted to the National Assembly's health welfare committee (Legislative Subcommittee) to be held next week. In particular, the two bills initiated by Democratic Party of Korea Rep. Seo Young-suk and People Power Party Rep. Seo Jeong-suk, respectively, have strengthened their influence on the pharmaceutical industry if passed as a merger review was decided. A bill to upgrade the CMA (Conditional Marketing Authorization) system for clinical trials operated by the MFDS to the pharmaceutical affairs law has also been newly added as an agenda for review of the legislation. On the 21st, Kim Min-seok, chairman of the Welfare Committee, and the secretaries of the ruling and opposition parties discussed the agenda of the subcommittee on the bill. Earlier, after the plenary meeting on the 26th, the Welfare Committee confirmed the schedule of the 2nd Subcommittee on the 27th and the 1st Subcommittee on the 28th. In the Legislative Subcommittee, which will be held this time, a law under the jurisdiction of the MFDS, which was not reviewed in February, will be first reviewed. In particular, the pharmaceutical affairs law, which has a great influence on the pharmaceutical industry and pharmacy, was included. The most representative bill is the combined review of the bioequivalence test 1+3 regulatory bill (by Seo Young Seok), which aims to prevent the overrun of generic drugs, and the law limiting the number of joint use of IMD clinical trial data to four pharmaceutical companies (by Seo Jeong-sook). The generic joint bioequivalence test 1+3 regulatory bill was put forward in February, but it did not have an opportunity for review. IMD's 1+3 regulation bill, which was proposed afterwards, was newly added as an agenda, and the Welfare Committee decided to review the two bills together. If the bill passes the deliberation of the welfare committee, the impact on the pharmaceutical industry and pharmacies will be greatly increased. There are opinions that generic and IMD licensing regulations should be strengthened in preparation for the past as illegal cases of voluntarily manufacturing pharmaceuticals in violation of the GMP regulations of the Pharmaceutical Affairs Act are discovered one after another. Rep. Young-Seok Seo, who initiated the generic regulation bill, argued that it would be possible to prevent the recurrence of the BINEX incident by regulating the 1+3 joint bioequivalence test at the time of the BINEX incident. Rep. Seo Jeong-suk has also initiated a bill to regulate the IMD. The MFDS’ phase 3 clinical conditional expedited approval bill is also being reviewed by the Act Subcommittee. The bill was initiated by Democratic Party Rep. Nam In-soon, along with Rep. Jong-heon Paik, the Power of the People, and the merger was decided. The main goal is to upgrade the system for marketing approval for drugs for treatment of severe intractable diseases such as rare cancers to the pharmaceutical affairs law from the existing notification, subject to the submission of the results of phase 3 clinical trials. It strengthens the management and operation of conditional permits, and contains provisions that clearly stipulate the subject of conditional permits, conditions for granting, and reasons for cancellation of permits. An amendment to the pharmaceutical affairs law (by Seo Yeong Suk) was also on the agenda, in which the name of generic substitution was changed to the same ingredient preparation, and the doctor who prescribed for follow-up notification at the pharmacy added and expanded it to the HIRA to activate the generic substitution. Pharmacy notified the physician who prescribed it afterwards, but the amendment to the pharmaceutical affairs law (by Seo Young Seok) was also on the agenda to activate the alternative preparation to be added or expanded to the HIRA. In addition to pharmaceutical companies that manufacture and sell drugs, bills that require physicians and pharmacists to report on expenditures for CSOs (pharmaceutical sales agencies) entrusted with sales promotion tasks (by Seo Young-seok, Jung Chun-suk, and Go Young-in) are also under review. Drug day is designated as a national anniversary (by In Jae-geun), strengthened management of raw material drug and national lot release (by Kim Sang-hee), increased the penalty for drugs for false and illegal national lot releases (by Kang Byung won, and mandatory braille markings and voice codes for medicines (by Hye-young Choi and Ye-ji Kim), punishment for illegal purchasers of Rx drug's (by Seo Jeong-suk and Lee Sang-heon), and obligatory guidance for pharmacists to take medicine for drug waste (by Yeon-sook Choi) were also proposed for this bill review agenda.
- Policy
- Generics for Pradaxa · Xarelto are scheduled to be released
- by Lee, Tak-Sun Apr 26, 2021 05:52am
- Xarelto (top) and Pradaxa (bottom) Due to the failure of the patent challenge, sales of the domestic NOAC (oral anticoagulant drug), generic for Eliquis (Apixaban) product, will be suspended for the time being. But within this year Pradaxa (Dabigatran Etexilate Mesylate) and Xarelto (Rivaroxaban), other types of NOAC generics are expected to be released, so domestic pharmaceutical companies' NOAC challenges are expected to continue. According to the industry on the 25th, product patents for Pradaxa and Xarelto are expected to expire this year. The product patent expires on July 17 for Pradaxa and October 3 for Xarelto. Pradaxa and Xarelto, along with Eliquis and Lixiana, are representative drugs of NOAC called post Warfarin. All of these are imported drugs, and domestic pharmaceutical companies are waiting for generic for exclusivity for Pradaxa and Xarelto to expire. Pradaxa recorded an outpatient prescription (UBIST) of ₩14.3 billion last year and Xarelto, ₩50 billion, establishing itself as a trend in the anticoagulant market. However, since these products have a high proportion of prescriptions in general hospitals, domestic pharmaceutical companies are expecting to expand to clinics when they release generics. As soon as the prodcut patent is terminated, generic drugs will be available to market. 21 pharmaceutical companies have already obtained product licenses for generics. 8 generics (Dabigatran Etexilate Mesylate) acquired generic for exclusivity, and the same drug will be banned from July 18 to April 17 next year. However, most of the already approved products are salt-modified products, so they are not subject to the ban on the sale of the same drug according to the generic for exclusivity. There are 160 Xarelto's generics. Since the original Xarelto is licensed in 4 doses, there are also a large number of generic items. Hanmi's Riroxban 2.5mg and SK Chemical's SK Rivaroxaban 2.5mg acquired generic for exclusivity from October 4 to July 3, next year. Xarelto 10mg, 15mg, and 20mg are not listed as generic for exclusivity, so most generics are expected to be released after the expiration of the product patent. However, in the case of Chong Kun Dang, it depends on the result of a trial to confirm the scope of rights requested to avoid a product patent. Chong Kun Dang's Riroxia15mg and 20mg will be listed next month. According to the patent results, there is a possibility that Chong Kun Dang will dominate the market. In the case of generics for Eliquis, the KIPO and the Patent Court of Korea accepted the claim of the generic company's patent invalidation, but the Supreme Court recently returned the case. Accordingly, generic companies recently stopped selling. generics for Eliquis were the first NOAC products sold by Korean pharmaceutical companies.
