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- 2026-05-18 11:51:55
- Company
- ↑38% of drug exports in the first half
- by Kim, Jin-Gu Jul 19, 2021 05:56am
- In the first half of the year, Korea's pharmaceutical exports recorded about ￦4.5 trillion. There is a possibility that it will surpass ￦10 trillion within this year. In particular, exports of medicines to Germany have increased significantly. In the first half of this year alone, more than ￦1.5 trillion was exported to Germany. Germany's share of domestic pharmaceutical exports exceeded one-third of the total. According to the Korea Customs Service on the 15th, Korea's pharmaceutical exports in the first half of this year are estimated at $3,915.86 million. The figure rose 38% from $2843 million in the first half of last year. Due to the prolonged corona crisis, it is observed that it is consistently performing well in drug exports. Semi-annual drug exports were in the mid- to late $1 billion by the second half of 2019, but have been in the middle of more than $2 billion since the first half of last year when the corona crisis began in earnest. In the first half of the year, imports of drugs amounted to $3.989 billion. The trade balance of drugs, which deducted imports from exports, was $6.92 million. It turned from a deficit of $847.22 million in the first half of last year to a surplus. This is the second consecutive surplus since second half of last year. Attention is focusing on whether it will change its record-high export performance recorded last year. Semi-annual drug exports since 2017 (Unit: $billion, Korea Customs Service) Total exports of drugs last year amounted to $6.89355 billion, the highest ever. In particular, more than $4 billion was concentrated in the second half of the year. Assuming that it will produce export performance similar to last year in second half of this year, it is predicted that it will be able to surpass ￦10 trillion by end of this year. Top 10 countries in drug exports in the first half of 2020 and the first half of 2021 (Unit: $billion, Korea Customs Service) By country, exports of medicines to Germany were high. In the first half of the year, $1.352.63 billion of medicines were exported to Germany. It accounted for more than one-third (34%) of domestic pharmaceutical exports. Last year, exports to Germany accounted for 22%. Exports of drugs to the United States, the largest exporter of drugs, have declined significantly. It was $46.72 million in the first half of last year, but fell 32% to $274.83 million in the first half of this year. Exports to Japan rose 30% ($168.23 million → $219.38 million dollars), the Netherlands 345% ($45.1 million → $288 million), and China 14% ($119.27 million → $136.47 million). Exports to Turkey fell 54% ( $327.31 million → $149.83 million), while Brazil also fell 9% ( $96.37 million → $87.32 million).
- Policy
- Aduhel has been applied for permission in Korea
- by Lee, Tak-Sun Jul 19, 2021 05:56am
- Recently, Aduhel (Aducanumab), a new drug for Alzheimer's disease approved by the U.S. Food and Drug Administration (FDA), has applied for permission in Korea. Aduhel is a new drug for Alzheimer's disease approved by the U.S. FDA in 18 years, the first drug to target the amino acid peptide β-amyloid known to be involved in the disease. The FDA approved after much meandering last month, but controversy still persists. According to industry sources on the 15th, Biogen Korea recently applied for Aduhel's approval from the MFDS. Aduhel was approved by the U.S. Food and Drug Administration on the 7th (local time) on condition that a post-marketing investigation would prove its effectiveness. The FDA determined that Aduhel's therapeutic benefits over risk for Alzheimer's patients. Aduhel did not meet the primary evaluation variables in EMERGE and ENGAGE clinical trial studies. Accordingly, in November last year, the FDA advisory committee decided that there was insufficient evidence to prove its effectiveness. However, Biogen further analyzed the clinical data and applied for approval from the FDA based on validation in the high dose group. Aduhel was approved, but the controversy continues. Three FDA advisors who opposed Aduhel's approval resigned, raising controversy over the appropriateness of the permit. The FDA recently asked the Office of Independent Inspectors (OIG) to investigate Aduhel's approval. Some say that indications may have been reduced as the FDA suggested prescription guidelines and added that patients with mild cognitive impairment or early Alzheimer's should start using Aduhel. The MFDS has been reviewing new drugs approved by the U.S. FDA and European EMA by applying advantage. Therefore, most of them were granted without difficulty. It is expected that Aduhel will not be able to gather consensus during the screening process as controversy continues even after approval. However, it is believed that the demand for new drugs for Alzheimer's disease will be actively reflected in the licensing review. In June last year, Aduhel was approved for clinical 3b in Korea and tested its efficacy on 41 patients.
- Company
- Onivyde is expected to be eligible for insurance coverage
- by Eo, Yun-Ho Jul 16, 2021 05:54am
- The new pancreatic cancer drug Onivyde is expected to be listed on the insurance benefit. According to the industry, Servier recently concluded a negotiation with the NHIS for the listing of Onivyde(Irinotecan HCl). As a result, it is expected that new insurance benefits will be available in pancreatic cancer treatment. Onivyde is eligible for the benefit if it passes the final procedure, the Health Insurance Policy Committee. It is the first achievement in about four years since domestic approval was made in August 2017. The drug has passed the DC of major medical institutions, including Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, Asan Medical Center, and Sinchon Severance Hospital. Combination of Onivyde and 5-FU/LV are available for patients who fail primary treatment based on Gemcitabine. Through a global NAPOLI-1 study, Onivyde significantly improved treatment performance by combining with the existing secondary treatment option 5-FU/LV in patients who failed Gemcitabine based primary treatment. It has become a reminder of the importance of sequential treatment strategies in treating metastatic pancreatic cancer. If Gemcitabine-based chemotherapy is used as a secondary chemotherapy for metastatic pancreatic cancer, it is the only treatment recommended by NCCN to be Category 1. Onivyde was approved by the Food and Drug Administration (FDA) in October 2015. Since then, Baxalta has acquired permission in Europe in October last year, and Shire has taken over development and sales rights in the global market except for the United States and Taiwan. Servier took over Shire's anti-cancer drug division and was granted permission from 2019.
- Policy
- Once 'out of stock' Bayer Aspirin 100mg to be discontinued
- by Lee, Tak-Sun Jul 16, 2021 05:54am
- Bayer decided to discontinue domestic supply of its antipyretic analgesic, ‘Bayer Aspirin 100mg.’ Despite the company’s explanation that the decision was made due to poor sales, the pharmacys’ eyes are not so kind on the company's decision as they have suffered shortages of stock issues regarding the product. According to the Ministry of Food and Drug Safety on the 15th, Bayer has decided to discontinue the supply of its Bayer Aspirin 100mg tablet on the 31st of this month. Bayer Korea explained, “We made the difficult decision to discontinue import of the product due to a decline in sales. We will discontinue supply with the last import of the product on December 29th last year." However, the company will continue to import and sell the Bayer Aspirin 500mg tablet. The company plans to inform wholesalers and HCPs with an official notice at the time of discontinuation. As the indication, effect, dosage, and regimen of the 100mg and 500mg doses are identical, it seems unlikely that the market withdrawal of the 100mg dose will cause a supply shortage. Bayer Asprin tablets are used to reduce and relieve mild to moderate pain from the common cold and other conditions such as headaches, toothaches, sore throats, menstrual pain, muscle and joint pain, backache, and minor arthritis pain. Patients aged 15 and over may take 500mg~1000mg orally once every 4 hours. As the starting dose is 500mg, it is true that the 100mg tablets are sold less. However, as the dose is increased or reduced according to the patient's age, condition, and symptoms, and a lower dose is required for pediatric patients without an indication, the 100mg tablet does have its use. The Aspirin Protect tab. is also a 100mg product but it has a totally different indication as it is used for the prevention of cardiovascular diseases. Pharmacies have been less trusting of Bayer Aspirin products due to their frequent out-of-stock issues. In particular, in 2017, the company's relocation of its manufacturing plant from Germany from Indonesia had halted sales of the drug for over a year. The company resumed sales in November 2018, but the instability in supply and demand continued with the 100mg product later becoming temporarily out-of-stock. A pharmaceutical industry official said, “The Bayer Aspirin 100mg tablet was out of stock in June, but I didn’t expect the company to stop importing the drug completely. Due to the long-term out-of-stock issue of the 500mg product, I have lingering distrust in the company’s ability to provide a stable supply.” Bayer Aspirin was made by chemist Felix Hoffman in 1897 using acetylsalicylic acid based on a willow bark extract. The product, which has been sold for over 120 years, was released in Korea in 1980. According to IQVIA, the Bayer Aspirin tablet sold around 1.7 billion won in sales in Korea last year.
- Policy
- 2nd AZ·Pfizer·Moderna shot prevents variants by 80%
- by Lee, Hye-Kyung Jul 16, 2021 05:54am
- Study results on the preventive effect of the AstraZeneca, Pfizer, and Moderna vaccine against variants showed that the vaccines had a preventive effect of over 80% after completing the two-dose regimen. The prevention effect was greater against the Alpha variant than the Delta. In preventing symptomatic infections, the vaccines had a similar prevention effect against variants and the original virus. Mixed vaccination using the AstraZeneca and Pfizer vaccine showed a neutralizing antibody response that was similar or higher than that of those using two shots of the same vaccine and the systemic reaction was at an acceptable level. The National Evidence-based Healthcare Collaborating Agency (NECA, President: Kwang-hyub Han) and the Korean Academy of Medical Sciences (KAMS, President:Ji-Tae Choung) jointly presented the results of the "Rapid review on issues regarding COVID-19 vaccines" study on the 15th. On the preventive effect of the current COVID-19 vaccines against variant strains such as the Alpha, Beta, Gamma, and Delta strains, the vaccines demonstrated a clinically significant effect (prevention of symptomatic infections, hospitalizations, and death). Regarding the preventive effect of the vaccines against variants, the vaccines were slightly less effective against the variants compared to the original virus, but still, the vaccine had a preventive effect of over 80% when subjects completed the two-dose regimen. The vaccines had a stronger preventive effect against the Alpha variant than the Delta. In preventing symptomatic infections, the preventive effect was of the vaccines was at a similar level for variants and the original virus. When completing a single shot of vaccination, the risk of hospitalization and deaths from variant infection was reduced by 78-96%, and after the second shot, by 86-96%. Also, the vaccines' effect on reducing hospitalization and deaths was not largely different against different types of variants, however, the data available as of now were insufficient to discern the severity of the events. Mixed vaccination using the AstraZeneca and Pfizer vaccine showed a neutralizing antibody response that was similar or higher than that of those using two shots of the same vaccine. Systemic reactions increased after the use of mixed vaccines, but at an acceptable level. On the immunogenicity after receiving mixed vaccinations, the study showed that receiving mixed vaccinations also elicited a neutralizing antibody response against the COVID-19 virus. In general, immune response increased after mixed vaccinations compared to two doses of the AstraZeneca vaccine, and was similar or higher than that measured after two doses of an mRNA vaccine (Pfizer, Moderna). The mixed vaccination had increased systemic response compared to two doses of the same vaccine, but was tolerable and at an acceptable level. However, as only short-term safety studies existed on mixed vaccination, it was difficult to evaluate the adverse events that have a low incidence using studies based on the current scale. The mixed vaccination regimen had increased immune response against the variants compared to two shots of the AstraZeneca vaccine and had an increased or reduced effect compared to two shots of the Pfizer vaccine, depending on the type of variant. But the limitation was that only small-scale studies with limited results existed for review. No direct studies on preventing infections were available and only studies with immunogenicity results existed for review. Mi-young Choi, head of Clinical Evidence Research Team at NECA said, “This study was the first systemic literature review conducted on the use of mixed dose vaccinations and activities against the variant strains. As most of the reviewed literature were studies in progress or unpublished, quantitative and qualitative limitations do exist in our study.” KAMS Policy Director Ho-kee Yum (Chair of the Expert Committee for COVID-19 Response, Korean Medical Association) said, "We can predict and respond to new infectious diseases to a certain extent by studying existing clinical data. I believe the release of reliable study results from a medical society and the government like this will contribute greatly to reducing the public anxiety that has been rising recently and in overcoming the pandemic.”
- Company
- SMA tx Evrysdi has been applied for insurance benefits
- by Jul 16, 2021 05:54am
- Roche's Evrysdi, the second treatment for spinal muscular atrophy (SMA) in Korea, began the process of registering insurance benefits eight months after approval. According to the pharmaceutical industry on the 15th, Roche Korea applied to the HIRA earlier this month for the registration of the oral SMA treatment Evrysdi(Risdiplam). Evrysdi is the second domestically licensed treatment for spinal muscular dystrophy after Biogen's Spinraza. Although it was approved in November of last year, it has not been officially released in markets yet. A third treatment for spinal muscular dystrophy, Novartis' Zolgensma, has been approved. Novartis completed the application last month using the evaluation linkage system. Evrysdi was approved first, but Zolgensma's reimbursement was faster. Evrysdi is expected to be easy to register because it is cheaper than the previously listed Spinraza. Zolgensma are most expensive, so there are many concerns about which pay model to apply. Spinraza was also not easy to register at a high cost of nearly ₩100 million per vial at the time of the process. It took months before it was presented to the Pharmaceutical Benefits Advisory Committee. The final price of Spinraza is ₩9,2359,131. It costs ₩554.15 million per person in the first year, and ₩277.07 million from the following year. Patient's copayment is 10% of the total cost. Since Spinraza, which is already more expensive, has been reimbursed, it is not difficult to register if Evrysdi's drug price negotiation goes well. Evrysdi is also likely to follow the Expenditure Cap (RSA) applied to Spinraza. Zolgensma is a "one-shot treatment" that is only taken once in a lifetime, but the price is about ₩2.5 billion (based on the U.S.), the most expensive drug in Korea. The government and the company are considering ways to reduce the financial burden of health insurance. The company proposed a value-based RSA. The government are reviewing the Amortized Payment model. However, the only drug listed as Value-based RSA is "Evoltra," an acute lymphocytic leukemia treatment, and the Amortized Payment model is a new model that is attempted for the first time. It is expected to take some time to set detailed items such as standards and evaluation methods. Meanwhile, Evrysdi met the criteria for 'sitting without help' in BSID-III 12 months after treatment in the FIREFISH clinical trial of 41 infants from 2.2 to 6.9 months of age. 88% of patients on Evrysdi over two years survived without respirators for two years. In addition, the SUNFISH study of 180 patients aged 2-25 demonstrated improvement in motor function evaluation scale MFM-32 of Evrysdi in the 12th month of treatment.
- Policy
- Patients with SCLS shouldn't get Janssen vaccine
- by Lee, Tak-Sun Jul 16, 2021 05:54am
- The MFDS said Janssen COVID-19 vaccine should not be vaccinated for people with a history of Systemic Capillary Leak Syndrome (SCLS). This is in accordance with the European EMA recommendation and is similar to the action that was taken on the AstraZeneca vaccine on the 14th of last month. The MFDS released the Dear Healthcare Professional Letter on the 12th. EMA's PRAC announced that Systemic Capillary Leak Syndrome should be added as a new side effect of the Janssen vaccine. It reviewed three cases of Systemic Capillary Leak Syndrome in Janssen COVID-19 vaccine recipients, one with a history of Systemic Capillary Leak Syndrome and two with fatalities. Systemic Capillary Leak Syndrome is a rare and serious condition that causes fluid leakage in small blood vessels (moscevascular), mainly resulting in edema in arms and legs, hypoglycemia, blood concentration, and hypoglycemia (critical blood protein). The MFDS said it will add related precautions to the manual by compiling the current status and safety information at home and abroad, stressing that people with a history of Systemic Capillary Leak Syndrome should not be vaccinated against Janssen vaccine.
- Policy
- Generic for Galvusmet was first approved
- by Lee, Tak-Sun Jul 16, 2021 05:54am
- The timing of the sale varies depending on the results of the Supreme Court's lawsuit against the validity of the patent. Hanmi has been approved for the first time in Korea as a generic for Galvusmet, a diabetes complex affiliated with Novartis' DPP-4 inhibitor. Hanmi developed Vildagliptin HCl and licensed both single and multi-drugs including Vilagliptin. Attention is focusing on whether it will preoccupy markets as it has made efforts to commercialize them early. The MFDS approved Hanmi's Metformin HCl-Vildagliptin HCl. Vildaglmet is the first generic for Galvusmet to be licensed in March 2008. It contains the same Vildagliptin HCl as the single Vildagle approved by Hanmi in February this year. The original Galvusmet is a salt-free Vildagliptin. Vildaglmet is the first licensed Galvusmet in Korea, so it is likely to be released first in the market. Material patent of Vildagle can be released earlier than other companies. The material patent expires on 4 March 2022. An-Gook and Hanmi have reduced the term of 187 days on the Intel Property Trial and Appeal Board and 55 days on the Patent Court through a lawsuit against the extension of the patent. It was shortened in the second trial. If the Patent Court cites the Intellectual Property Trial and Appeal Board's verdict, both companies' products can be released within the year and can be released next year according to the Patent Court. However, the Supreme Court may not recognize the claim for invalidation of the extension. If Supreme Court accepts the an extension of patent term, Ahn-Gook and Hanmi, which filed a patent suit, can be the first to put the product on the market before other companies. Hanmi can release both products at the same time because both single and comination drugs are licensed. This is because all patents related to compound drugs have been avoided. Hanmi has experience in co-selling Galvus with Novartis from 2014 to 2016. After the expiration of the copromotion, Hanmi worked on generic development and set up a strategy to preoccupy the market. It sought early release only with permission for efficacy and effects that did not violate patents, but lost a patent lawsuit. Since then, the product has been withdrawn. Outpatient prescription for Galvus and Galvusmet amounts to ₩8.1 billion and ₩36.4 billion, respectively. Hanmi does not have DPP-4 inhibitors. Therefore, early release of Vildagle and Vildaglmet is expected to expand in the diabetes market.
- Company
- Novartis most challenged for its patents, followed by Pfizer
- by Kim, Jin-Gu Jul 16, 2021 05:54am
- Among pharmaceutical companies, Novartis was found to have received the most amount of patent challenges since 2016. Over the past five and a half years, 33 generic companies had filed a total of 121 patent suits against Novartis' 15 patents on 8 products. In addition to Novartis, generic companies also targeted Pfizer, Boehringer Ingeheim, Astellas, and AstraZeneca. The same went for domestic companies. United Pharma, Alvogen Korea, Boryung Pharmaceutical, and Chong Kun Dang were also challenged on their patents by generic companies. ◆Generic companies challenge patents of 8 Novartis products On the 13th, Dailypharm’s tally of patent challenges in the biopharmaceutical sector since 2016 showed that Novartis has received the most challenges from generic companies. Generic companies had challenged 15 patents of 8 drugs owned by Novartis. A total of 121 requests for appeal and trial were filed by the companies against Novartis. In the same period, the total number of appeals and trials claimed (scope of right + invalidation suits) amounted to 1,042. In other words, 1.2 cases in every 10 patent suits filed had targeted Novartis. The 8 products that received patent challenges were;▲heart failure treatment ‘Entresto’; ▲DPP-4 inhibitor antidiabetic ‘Galvus’; ▲Breast cancer treatment ’Afinitor’; ▲ glaucoma treatment ‘Simbrinza eye drops’; ▲ conjunctivitis treatment ‘Pazeo eye drops’; ▲ COPD treatment ‘Xoterna’; ▲ chronic iron overload treatment ‘Exjade FCT’; and ▲ immunosuppressant ‘Certican’ The interesting point is that only 2 of the drugs among those in legal dispute are blockbuster drugs that bring over ₩10 billion in annual sales. According to the pharmaceutical market research institution IQVIA, only Entresto (₩21.7 billion) and Afinitor (₩14.9 billion) recorded over ₩10 billion in sales among the 8 Novartis products. The other products, Exjade (₩8.5 billion), Galvus (₩7.3 billion), Certican (₩6.9 billion), Xoterna (₩6.2 billion), Pazeo (₩4.1 billion), and Simbrinza (₩2 billion) all recorded less than ₩10 billion in annual sales. The analysis is that generic companies are now actively seeking patents not only for the well-sold large items but also for small and medium-sized sales items. Five or fewer generic companies have requested a judgment for each of the products that sold less than ₩10 billion. Also, Novartis targeted the most is because the company has that many patents. As of the 12th, Novartis has 151 patents (on 69 drugs) listed on Korea’s patent list. This is the most amount of patents registered among domestic and multinational pharmaceutical companies combined. In other words, despite the aggressive patent challenges filed by generic companies over the past 5 and a half years, Novartis has kept over 80% of its patents safe and sound. ◆Followed by Pfizer with 106 patent cases > Boehringer Ingelheim with 95 cases > Astellas with 89 cases The runner-up was Pfizer. Pfizer received the second-most amount of patent challenges after Novartis since 2016. A total of 106 patent trials were filed on 8 patents of 6 drugs. Pfizer's sedative ‘Precedex,’ the pneumococcal vaccine ‘Prevenar 13,’ smoking-cessation treatment ‘Champix,’ antidepressant ‘Prestiq,’ JAK inhibitor immunology drug ‘Xeljanz,’ and neuropathic pain treatment ‘Lyrica’ were the targets. The 4 products other than Precedex and Pristiq were blockbusters that raised over ₩20 billion in sales last year. Also, Boehringer Ingelheim (95 cases), Astellas (89 cases), and AstraZeneca (80 cases) received patent challenges from generic companies. Boehringer Ingelheim received patent challenge for its SGLT-2 inhibitor diabetes treatment ‘Jardiance,’ NOAC ‘Pradaxa,’ and Parkinson’s disease treatment ‘Mirapex.’ Astellas was challenged for its patents on its OAB treatment ‘Betmiga' and immunosuppressant ‘Advagraf.’ AstraZenca’s SGLT-2 inhibitor ‘Forxiga’ also was a target of focus for patent challenges. Among domestic companies, United Pharma, Alvogen Korea, Boryung Pharmaceuticals, Dong-A ST, and Chong Kun Dang were also actively targeted for their patents. In the case of United Pharma, 4 patents on its gastrointestinal symptom treatment ‘Gastiin CR,’ antiplatelet drug ‘Cilostan CR,’ and expectorant ‘Levotics CR,’ were targeted by generic companies. A total of 28 pharmaceutical companies had filed 80 patent trials. Alvogen Korea was challenged by 50 pharmaceutical companies for one single drug - its antithrombotic drug ‘Sarpodipil SR.’ Also, 44 generic companies challenged Boryung Pharmaceuticals 'patent on its antihypertensive combination drug ‘Dukarb.’ Dong-A ST also was challenged by 31 generic companies on its gastritis drug ‘Stillen 2X.’ Chong Kun Dang was challenged for the patent of two of its drugs – its GERD treatment ‘Eso Duo’ and its antihypertensive combination ‘Telminuvo.’ The patents held by domestic companies that the by generic companies targeted are all Incrementally Modified Drugs (IMDs). In other words, the drugs do not separately hold a substance patent and are therefore relatively easy to target. The analysis is that the patent challenges focused on IMDs as most were well-sold products that brought over ₩10 billion a year.
- Policy
- Kymriah's benefit is urgently needed
- by Lee, Jeong-Hwan Jul 15, 2021 07:07pm
- Leukemia patients have urged rapid health insurance registration of the first end-stage leukemia-Lymphoma CAR-T treatment, Kymriah. Korea Leukmia patients organization asked the government to register Kymriah's benefit and pharmaceutical companies to come up with reasonable financial burdens to strengthen access to medicines for leukemia patients. In a statement, the Korea Leukemia patients organization repeatedly called on the government to push for rapid health insurance benefits, including the introduction of Kymriah, at the fifth Cancer Drugs Benefit Appraisal Committee to be held on the 14th. The organization called for a rapid health insurance registration system for new drugs directly linked to life, such as Kymriah. It also added that Novartis Korea should come up with reasonable financial sharing measures to prevent the recurrence of some immuno-cancer drugs, which have delayed health insurance benefits due to controversy over high-dose financial sharing. "Even if Kymriah is passed at the Cancer Drugs Benefit Appraisal Committee on the 14th, the health insurance benefit will not be completed until November this year at the earliest because the NHIS' negotiations and health insurance policy committee procedures are required," said the Korea Leukemia patients organization. It said, "Most patients with recurrent or end-stage acute lymphocytic leukemia or lymphoma die within three to six months. If Kymriah is covered by health insurance in November, many of the 200 patients expected to be treated annually." It said, "It is a pity that patients who cannot afford to pay about 460 million won (non-reimbursed medical expenses disclosed on Samsung Medical Center's website) have to die while waiting for health insurance to be applied." "The government should complete health care benefits within six to seven months, just like Leclaza, the late-stage lung cancer treatment," the organization said. The organization said, "In the case of Kymriah, the scope of 'new drugs directly related to life' should be determined through social discussions, and health insurance should be applied first by the HIRA." The organization also said that "the HIRA's Cancer Drugs Benefit Advisory Committee, the NHIS' Pharmacological Benefit Advice Committee, and the Health Insurance Policy Committee will take the lead." "Glibec, the world's first targeted treatment for chronic myeloid leukemia, was approved by the MFDS on June 20, 40 days after the FDA approved it in May 2001. "In November, five months after the approval, the MOHW announced health insurance benefits. Twenty years later, the Kymriah process should not be delayed than Glivec. "Since August 30, 2017, when Kymria was approved by the U.S. FDA, the issue of high-priced drug prices has been raised."
