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- 2025-12-23 20:02:58
- Policy
- One-time ￦2 billion therapy Zolgensma to be soon approved
- by Lee, Tak-Sun May 27, 2021 05:56am
- Zolgensma (onasemnogene abeparvovec-xioi), a new gene therapy drug that attracted attention due to its high price of nearly 2 billion won per single shot, is soon to be approved in Korea. As a spinal muscular atrophy gene therapy, Zolgensma is also called a ‘one-shot treatment’ as only a single dose is required during a patient’s lifetime. As the drug is about to be approved, whether the drug will be allowed reimbursement is expected to be the key issue. On the 26th, industry sources said that the Ministry of Food and Drug Safety (MFDS) completed the safety and efficacy review for Zolgensma. The results are expected to be announced soon. Zolgensma was designated as an orphan drug in December 2018 but was not formally approved in Korea. The drug has gained much attention as a treatment for SMA that needs to be administered only once. SMA is caused by a defect or mutation in the SMN1 gene that leads to a deficiency of motor neuron protein. Without proper treatment, patients with SMA would need to depend on assistive devices and even result in death. When administered, For Zolgensma, an SMN1 gene is inserted inside a virus vector, which is then injected into the patient's body to induce the production of SMN1 protein. Various SMA treatments such as Spinraza (nusinersen, Biogen) and Evrysdi (risdiplam, Roche) have been recently released in Korea; however, the demand for the one-shot Zolgensma stays strong. The issue at hand is its price. The price of a single shot of Zolgensma is 2.5 billion won in the U.S. and 1.89 billion won in Japan. Experts say that the reimbursement standards in Korea are not sufficient to evaluate ultra high-priced drugs and that a new evaluation model needs to be designed for such drugs. In a forum held on the 13th, Professor Hye-Young Kang of the Department of Pharmacy at Yonsei University said, “The optimal plan for each country should be prepared in consideration of each country’s history, culture, and economy.” She continued, “Adopting a reimbursement model from other countries may be dangerous as we cannot fully implement or understand the details or backgrounds of the models used in other countries.” On this, Yoon-Seok Yang, head of the Division of Pharmaceutical Benefits at MOHW said, “We can apply the current risk-sharing agreement scheme to evaluate the reimbursement of Zolgensma.” Explaining that the drug may be evaluated under current reimbursement standards, he added that “However, the payment structure needs to be deeply considered.” Meanwhile, Novartis’s ‘Kymriah,’ another ‘one-shot treatment’ indicated for the treatment of acute lymphoblastic leukemia (ALL), was approved in March and is in the process of being evaluated for reimbursement.
- Policy
- Combination vaccine Priorix-tetra by GSK has been revoked
- by Lee, Tak-Sun May 27, 2021 05:55am
- The final license will be revoked because GSK's licensed combination vaccine "Priorix-tetra" did not submit the review data in November 2013. The vaccine is the first MMRV vaccine in Korea to have chickenpox prevention added to existing measles, rubella, and infectious mastitis. However it seems that GSK has not been able to actively respond to the cancellation as demand in Korea has decreased. The MFDS ordered GSK's Priorix-tetra to be revoked on the 17th. It will take place as of June 1st. This product is a live virus vaccine mixed with measles, mumps, rubella and chickenpox, and was approved by the MFDS in November 2013. In particular, it was comfortable because the existing MMR vaccine combined with chickenpox prevention requires a second injection. However, there was not much demand for MMRV vaccines because the NIP separately designated MMR vaccines and chickenpox vaccines. Furthermore, GSK's MMR vaccine Priorix is included in the NIP. Priorix has been co-sold by SK Bioscience since this year. It seems that the company did not actively respond even if the MFDS requested unfulfilled reexamination data. This is because it believes that it will be difficult to increase demand in the future. Eventually, the vaccine disappeared from the domestic market after seven years of approval.
- Policy
- 55,000 doses of Mordena vaccines will be released in a week
- by Kim, Jung-Ju May 26, 2021 06:05am
- Moderna's 55,000 mRNA-like COVID-19 vaccines will arrive in Korea next Monday, or the 31st. The COVID-19 vaccine, developed by foreign pharmaceutical companies in Korea, is the third since AstraZeneca and Pfizer, and has been rapidly introduced since the signing of an MOU between health authorities and companies. The MOHW announced on the 24th that 55,000 Moderna vaccines will arrive at domestic airports around next Monday. Afterwards, Moderna's products will be approved by the licensing authorities and will be officially used. While President Moon Jae-in 's visit to the united states, the South Korean Ministry of Trade, Industry and Energy and the MOHW signed an MOU with Moderna to cooperate in discussing investment and production in Korea. The main contents include ▲ Moderna's efforts to invest in mRNA vaccine production facilities in Korea and recruit Korean workers, and ▲the Korean government's cooperation to support Modena's investment activities in Korea. Moderna signed a contract with Samsung Biologics for consignment production of vaccines and plans to produce hundreds of millions of doses of vaccine and supply it to the world starting from the third quarter. It is expected that it will have a positive impact on domestic supply and demand.
- Policy
- Moderna COVID-19 vaccine is finally licensed
- by Lee, Tak-Sun May 25, 2021 06:03am
- Moderna COVID-19 Vaccine has obtained a final item license in Korea. The MFDS announced on the 21st that GC Pharma has decided to permit imported items on the condition that it submits a final report on clinical trials for Moderna COVID-19 Vaccine, which it applied for permission for imported items on April 12. Moderna COVID-19 Vaccine is an mRNA vaccine developed by Moderna in the United States that injects the COVID-19 antigen gene in the form of mRNA to synthesize antigen proteins in the body and neutralizes and removes viruses when COVID-19 invades the body. The vaccine prevents COVID-19 at 18 years of age or older, after thawing, Moderna COVID-19 Vaccine 0.5 mL is additionally inoculated four weeks after each inoculation, and the storage conditions are 7 months at freezing (25 to 15℃) and 1 month at refrigeration (2 to 8℃). It can also be stored at room temperature (8-25°C) for 12 hours before opening It is the fourth licensed COVID-19 vaccine in the country. It is the second licensed mRNA vaccine in Korea, receiving CMA or Emergency Use Authorization from 39 countries including Europe (EMA) and the United States and the World Health Organization (WHO). A total of three clinical trials conducted in the U.S. (Phase 1, Phase 2a, Phase 3) were submitted for the MFDS' clinical trial, and safety and effectiveness were evaluated in phase 3 clinical trials conducted in the U.S. At the "Final Inspection Committee" meeting held at 10 a.m. on the same day, the members reviewed the MFDS' review results and the two previous consultations, and decided to grant the item on condition of submitting the final clinical trial report. The final inspection committee decided to reflect the caution that although the safety of the vaccine is generally good, the number of predicted cases of inoculation tends to increase after the second dose, such as more pain, fatigue and chills. The overall safety measures are appropriate, and the "risk management plan" decided to continue to monitor the safety of the nervous system, such as peripheral neuropathy and dehydration diseases, and to continuously collect and evaluate abnormal cases arising from clinical trials and use after permission. The MFDS explained that it also approved additional imported items produced in Italy on the same day, with the same vaccine as COVID-19 Vacine AstraZeneca, which was licensed for domestic manufacturing on February 10. "We quickly launched a licensing review process for Moderna vaccine applied by GC Pharma, and we did our best to thoroughly verify its effectiveness and safety," said Kim Kang-lip, head of the MFDS." "It has closely verified its effectiveness, safety and quality in accordance with internationally harmonized licensing standards and systems with developed pharmaceutical countries such as the U.S. and Europe to help people receive safe vaccines," he said.
- Policy
- National Assembly is paying attention to news of AZ-Pfizer's
- by Lee, Jeong-Hwan May 24, 2021 05:50am
- Overseas studies have shown that the second shot of the Pfizer-Biontech vaccine after the first shot of the COVID-19 vaccine developed by AstraZeneca (AZ) and Oxford University is effective and safe. The National Assembly also seems to be interested in responding to domestic quarantine authorities regarding cross-vaccination. Based on overseas research results, The KCDA has decided to carry out research on cross-vaccination of COVID-19. According to the multiple members of the National Assembly's Health and Welfare Committee on the 20th, quarantine authorities such as the KCDA will be asked about the possibility of cross-vaccination and future plans for the COVID-19 vaccine. This is because overseas studies have shown that the immune effectiveness of AstraZeneca vaccine and Pfizer vaccine has been raised during the first and second cross-injections, respectively. The Carlos III Health Institute said Monday that it had tested 670 people aged 18 to 59 who had been vaccinated against AstraZeneca and concluded that they were "very safe." In the group that was inoculated with Pfizer, the immune response increased 120 times a week later, and the same level of immunity was maintained in the group that was only the first inoculation with AstraZeneca vaccine. Neutralizing antibodies that neutralize the COVID-19 increased seven times after the Pfizer vaccine. The effectiveness is more than twice as high as that of the first and second vaccinations with AstraZeneca alone. Only 1.7% reported side effects when cross-vaccinated with AstraZeneca and Pfizer vaccines. Symptoms were mainly limited to headaches, muscle aches and fatigue, which were not serious, the researchers said. If the cross-vaccination effect between the virus vector vaccine and the mRNA vaccine is proven, it will directly affect the plan and status of vaccination for COVID-19 in Korea. This is why quarantine authorities, as well as the ruling and opposition parties of the National Assembly, are forced to react sensitively. As overseas research results come out, domestic quarantine authorities are also stepping up efforts to check the efficacy and safety of cross-vaccines. The KCDA said it was conducting a cross-vaccination study at the Korea National Institute of Health. The main goal of the study was to establish additional vaccination plans for AstraZeneca inoculators. The National Assembly is also expressing high interest in overseas research results and domestic research plans. The domestic supply and demand rate of COVID-19 vaccine and inoculation rate have been the main issue between the ruling and opposition parties. If effectiveness and safety are confirmed in cross-vaccination studies by quarantine authorities, the National Assembly will also be able to change or improve its national vaccination plan, which will change the focus of pending questions. An official of the National Assembly's welfare committee said, "The government has already secured the amount of vaccines that all citizens will receive and has also set up a supply and demand plan." However, the U.S. and others are reviewing various opinions every day on the need for booster shots or the amount of youth inoculation. "The effect of cross vaccination is a variable that can greatly improve not only the global inoculation plan but also domestic supply and demand." Another member of the National Assembly said, "If cross-vaccination between virus vector Astra vaccine and mRNA vaccine does not have a big problem with efficacy and safety, and increases the effect, it will be good news now that "There is still a lack of evidence on cross-vaccination and quarantine authorities will check the status and direction."
- Policy
- 438,000 doses of Pfizer Vaccines are received on the 19th
- by Lee, Jeong-Hwan May 24, 2021 05:50am
- On the 19th, an additional 438,000 doses of COVID-19 vaccine, which South Korea directly contracted with Pfizer, will arrive in South Korea. It is part of the 7 million units that are scheduled to be supplied in the first half of the year, which are received in small quantities every week. Lee Sang-won, head of the Central Disease Control Headquarters epidemiological investigation and analysis team, said in a regular COVID-19 briefing on the 18th, "438,000 doses of contracted Pfizer vaccines will arrive at Incheon Airport tomorrow as scheduled. The rest will be supplied every week without a hitch." This supply is for the third week of May. It is expected to arrive at Incheon International Airport in the early morning of the 18th at 438,000 doses, the same as last week. Earlier, the government decided to receive 7 million doses of COVID-19 vaccine during the first half of the year. The total amount of Pfizer vaccine contracted by the government is 66 million doses (for 33 million people), including additional contracts of 40 million doses (for 20 million people). If supply is completed by this week, 3.312 million Pfizer vaccines will be received in Korea. By the end of June, there will be 3.688 million doses left. Currently, 1.75 million doses are scheduled for May and 3.25 million doses for June.
- Policy
- Antibiotics & Viagra were detected in the Han River
- by Lee, Jeong-Hwan May 21, 2021 05:27am
- As Viagra (Sildenafil) was detected in the Han River, the drinking water source, for the first time following the residual antibiotics in the soil and rivers, related government ministries are criticized for not only identifying the situation but also preparing measures to prevent recurrence. It was focused on identifying whether waste medicines were the cause and preparing measures to prevent soil and water pollution through policy improvements, and consultations between ministries such as the MFDS and the Ministry of Environment seem urgent. On the 17th, the National Assembly asked the government to solve the problem of "the detection of Viagra in Han River" centered on the Health and Welfare Committee. Recently, Kim Hyunook's research team at University of Seoul released a paper that erectile dysfunction drugs Viagra (Sildenafil), Cialis (Tadalafil) and Levitra(Vardenafil) were detected in the Han River, a drinking water source. The title is "Contribution of Sewage to Occurrence of Phosphodiesterase-5 inhibitors in Natural Water," which confirmed the components of erectile dysfunction drugs in both Jungnangcheon and Gangnam Tancheon in Gangbuk, Seoul. The detection of antibiotics in the soil and rivers has already been confirmed, but this is the first time that erectile dysfunction drugs have been found. The National Assembly also takes this issue seriously. This is because soil, water pollution and ecosystem destruction issues caused by waste medicine are reported every year. Currently, the National Assembly's Health and Welfare Committee is pending a bill called "mandatory drug guidance for pharmacists" proposed by Choi Yeon-sook. a member of the People Power Party. The bill allowed pharmacists to impose a fine of up to 1 million won in case of violation and mandatory guidance of the disposal drug treatment law during medication guidance. The head of the Ministry of Food and Drug Safety also designated waste medicine collection day every year to promote the treatment method, and included a clause that obligates waste drug containers and packaging. In April, the Health and Welfare Committee decided to continue reviewing the bill. It is unclear whether the bill will be reexamined due to the Viagra detection issue of Han River water. Apart from the bill, the National Assembly is asking the MFDS and the Ministry of Environment to take measures to properly identify the cause of the problem and come up with measures to prevent a recurrence. They want to closely analyze why erectile dysfunction drugs were detected in the Han River, whether they are related to the incident, and consider measures to prevent recurrence based on analysis of the cause. The MFDS and the Ministry of Environment are expected to investigate the case. "The fact that erectile dysfunction drugs were detected in the Han River, a drinking water source, is a big problem," a National Assembly official said. "The MFDS and the Ministry of Environment should not delay responsibility." The official said, "If waste drugs are the cause of the Han River water crisis, we should improve policies and legislate to solve the problem." "We can't ignore the problem of detecting the active ingredients of medicine in the soil and river every year," he said. "It is time for clear cause analysis and countermeasures through cooperation between ministries."
- Policy
- Samsung & Pfizer compete in Avastin biosimilar market
- by Lee, Tak-Sun May 21, 2021 05:26am
- Samsung Bioepis and Pfizer will compete in the domestic market for anti-cancer drug Avastin (Bevacizumab, Roche Korea). There will be a rare competition between domestic companies and global companies over generics. The MFDS approved Jairabeve of Pfizer Korea on the 18th. Jairabeve (Bevacizumab) is biosimilar for Avastin in Roche, Korea. Equivalence between Jairabeve and Avastin has been demonstrated. Clinical trials were conducted to assess the equivalence of drug in a total of 388 patients with progressive or metastatic non-small cell lung cancer with healthy adult male volunteers, demonstrating statistical equivalence. Avastin recorded sales of ₩118 billion in South Korea last year. It is ranked third in sales. It is used for metastatic direct connective bowel cancer, metastatic breast cancer, non-small cell lung cancer, progressive or metastatic kidney cell cancer, glioblastoma, epithelial ovarian cancer, ovarian or primary peritoneal cancer, and cervical cancer. Earlier in March, Samsung Bioepis was first licensed for biosimilar for Onbevey in Korea. Onbevey is not yet on the list. Industries predict that the two drugs will compete in the second half of this year. As Samsung Bioepis has been targeting the domestic market in partnership with large domestic pharmaceutical companies such as Yuhan and Daewoong , chances are high that it will form partnerships with domestic pharmaceutical companies again this time. Pfizer has a well-established distribution network for large hospitals in Korea, so the release of biosimilar will also affect Roche's Avastin, the original drug. In the biosimilar market, not only Samsung Bioepis and Celltrion but also global pharmaceutical companies are releasing products one after another, which is expected to compete with domestic pharmaceutical companies.
- Policy
- GSK’s dutasteride+tamsulosin combo finally enters Korea
- by Lee, Tak-Sun May 20, 2021 05:57am
- GSK will be introducing its fixed-dose ‘Avodart(dutasteride)’ and tamsulosin combination for the treatment of prostatic hyperplasia for the first time in Korea. The domestic approval has come 10 years after the approval by EMA and FDA. Considering that the combined prescription of the abovementioned two drugs is common in the prostatic hyperplasia treatment market, whether the introduction of this combination drug will change the market structure is the focus of interest. The Ministry of Food and Drug Safety (MFDS) granted GSK’s ‘Duodart capsule’ marketing approval on the 18th. Duodart capsule is a fixed-dose combination of dutasteride and tamsulosin used for the treatment of moderate-to-severe symptoms of Benign Prostatic Hyperplasia (BPH). The recommended dose of Duodart is one capsule taken orally approximately 30 minutes after the same meal each day. Duodart is a combination of two drugs - dutasteride, a dual 5α-reductase inhibitor (5-ARI), and tamsulosin hydrochloride, an antagonist of α1a-adrenoreceptors - with complementary mechanisms of action to improve symptoms in patients with benign prostatic hyperplasia (BPH). In a 4-year clinical trial of 4,844 men with BPH (the CombAT study), the group that was co-administered with dutasteride-tamsulosin showed superior symptom improvement over monotherapy of either drug at year 2. Based on the results, EMA had approved the drug in April 2010, and the FDA in June 2010. In other words, the Duodart cap, is being approved in Korea 10 years after being approved by leading authorities abroad. Also, the MFDS assigned a re-examination period for Duodart capsule until May 17th, 2027. During the re-examination period, generics made with the same ingredient cannot enter the market. Companies in Korea have also been working hard to develop a combination treatment for prostatic hyperplasia, but no products have been commercialized so far. Chong Kun Dang is conducting a Phase III trial on its tamsulosin+tadalafil combination, and Dongkook Pharmaceuticals’s dutasteride+tadalafil combination has also entered a Phase III trial. Also, Ildong Pharmaceutical and Jeil Pharmaceutical has completed the clinical trial for their tamsulosin+solifenacin combination. More recently, Dongkoo Bio&Pharma and KyungDong Pharm have entered a Phase III trial to develop their tamsulosin+mirabegron combination. However, perhaps due to GSK’s early success with the dutasteride and tamsulosin combination in 2010, the same combination has not been studied in Korea. Hanmi Pharmaceutical had received export approval for the same combination in 2017 but withdrew the approval in August last year. Pharmaceutical companies have been keen to develop a combination drug since a high proportion of patients use two drugs in combination for the treatment of prostatic hyperplasia. In particular, prescription of the tamsulosin and dutasteride combination is very common in the field, drawing more attention to the approval of GSK’s combination drug. The market for prostatic hyperplasia treatment is estimated to be around 400 billion won. Currently, Astellas has a strong influence over the market as it owns the original drugs such as tamsulosin, etc. Whether GSK will rise as the new dark horse with its combination drug is receiving much interest. Meanwhile, GSK’s dutasteride is also indicated for the treatment of hair loss among men in addition to symptomatic benign prostatic hyperplasia.
- Policy
- Generic for Madopar by Myungin was first licensed
- by Lee, Tak-Sun May 20, 2021 05:56am
- Madopar (Benserazide HCl/Levodopa) by Roche is the treatment for Parkinson's syndrome, and the generic was approved in Korea. Myungin, which is drawing attention in related markets for Perkin and Trilevo, is expected to expand its sales with the joining of generic for Madopar . The MFDS approved Myungdopar by Myungin on the 14th. Myungdopar is a drug used in Parkinson's syndrome that is generic for Roche's Madopar. It is the first generic to be introduced in Korea. After receiving approval for the first biological equivalence test plan in May 2019, Myungin began developing generic for Madopar . A single oral administration of Myungdopar to healthy adults was conducted to measure Levodopa in the blood of 57 people, demonstrating that the mean 90% confidence interval with Madopar was biological equivalent from log 0.8 to log 1.25. Madopar is a combination of dopamine precursors Levodopa and Benserazide. Levodopa reaches the brain region and increases dopamine levels. It is also a drug with Benserazide added to help sufficient amounts of Levodopa leap into the brain. This treats symptoms associated with Parkinson's disease dance and tonic. Madopar recorded ₩9 billion in outpatient Rx (UBIST) last year, ranking second after Lundbeck's Azilect (₩9.9 billion) among Parkinson's disease treatments. Myungin stands out in the treatment of Parkinson's disease as a generic company. Myungin has several treatments for Parkinson's disease, including Trilevo (generic for Stalevo) and Perkin (generic for Sinemet). Trilevo was ranked No. 1 in the generic market with ₩6 billion last year, while Perkin was ranked No. 3 with ₩3.6 billion. Rasalin, the No. 1 product in the market, was also released last year. Myungdopar, first generic for Madopar, is expected to serve as a new opportunity for Parkinson's disease treatment market.
