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- 2026-04-15 15:34:47
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- KMA recommends Tylenol for fever after AZ vaccination
- by Kang, Shin-Kook Mar 10, 2021 06:26am
- After the AstraZeneca COVID-19 vaccination, the frequency of fever or muscle pain was found to be 20-30%, and the KMA recommended taking Tylenol. The KMA (Chairman Choi Daejip) released a recommendation containing countermeasures after the COVID-19 vaccine vaccination to the public on the 6th. The KMA said, "In the case of the AstraZeneca vaccine that will be vaccinated this time, the frequency of fever (more than 38°C) or muscle pain after vaccination is known to be 20% to 30%. It's better not to take antipyretics if patient doesn't have a hard time." The KMA said, "There is a concern that taking antipyretic drugs will reduce antibody formation, and patient doesn’t have to go to treatment only with fever symptoms." It recommend Acetaminophen (Tylenol), which has little effect on antibody formation, in case of more than 38.5°C. The KMA said, "In case of fever within 24 hours of less than 38.5 °C, please take a break at home instead of visiting ER. If patient is having a lot of trouble and anxiety due to a high fever of 38.5°C or higher and muscle pain, consider outpatient treatment at a clinic during the day and an ER visit in the evening and at night. In the case of a fever of 38.5°C or more or a fever that lasts more than 24 hours, it is recommended to receive medical treatment."
- Policy
- Promote disclosure of anticancer drug Expedite Review result
- by Kim, Jung-Ju Mar 09, 2021 06:24am
- A revision of the law is being promoted to revise up the relevant laws and regulations, so-called Fast Track (Expedite Review) for drugs that treat serious diseases, such as anticancer drugs and AIDS drugs, and make the review process transparently disclosed. On the 5th, Rep. Nam In-soon of the Democratic Party of Korea, a member of the National Assembly's Health and Welfare Committee, proposed a partial amendment to the Pharmaceutical Affairs Act on the 5th. The current law stipulates that the Minister of Food and Drug Safety permits the establishment of facilities for the pharmaceutical manufacturing industry or items prescribed by the Prime Minister's Ordinance, and conditional marketing authorization for drugs such as anticancer drugs is stipulated in the subordinate statute. It is necessary to increase the transparency of the review by disclosing the results of review, such as item approval for drugs designated by the ordinance of the Prime Minister, and to improve the accessibility of consumers and companies to review information. This amendment upgrades the conditional permission for drugs such as anticancer drugs to the law, secures procedural justification for conditional marketing authorization, etc. with the opinion of the Central Pharmaceutical Affairs Review Committee, and improves the understanding of the public, while serious diseases, etc. The main goal is to establish a legal basis for the disclosure of review results, such as conditional marketing authorization for medical treatment drugs, designation of priority treatment targets for treatment drugs such as serious and infectious diseases, and item approval. In addition to Rep. Nam In-soon, Rep. Kang Deuk-gu, Kang Seon-woo, Kang Jun-hyun, Kim Min-seok, Kim Young-ho, Park Seong-jun, Park Hong-geun, Yang Jeong-suk, Jung Chun-suk, Joo Chul-hyun, Choi Jong-yoon, Heo Jong-sik, and Hong Seong-guk participated.
- Company
- First CAR-T treatment Kymriah was approved in Korea
- by Eo, Yun-Ho Mar 09, 2021 06:24am
- The first CAR-T treatment drug Kymriah was approved in Korea. The MFDS announced on the 5th that it has approved the world's first chimeric antigen receptor T cell (CAR-T) treatment Kymriah (Tisagenlecleucel), which was applied for approval by Novartis Korea, as the first advanced biopharmaceutical under the Advanced Renewable Bio Act. Chimeric antigen receptors (CARs, also known as chimeric immunoreceptors, chimeric T cell receptors or artificial T cell receptors) are receptor proteins that have been engineered to give T cells the new ability to target a specific protein. The receptors are chimeric because they combine both antigen-binding and T-cell activating functions into a single receptor. Kymriah is an anticancer drug in which genetic information is introduced into the patient's body so that specific antigens of cancer cells can be recognized on the surface of immune cells (T cells) collected from patients. This drug is an innovative immune cell anticancer drug that has clearly shown improved benefits in a single administration to patients with relapsed and refractory hematologic cancer, who have limited choice of other treatments. It was approved after being designated “Breakthrough Designation” in the United States and “PRIME” in Europe. Specific indications are relapsed and refractory ▲B-cell acute lymphocytic leukemia under 25 years old and ▲substantial giant B-cell lymphoma. The MFDS has thoroughly scientifically reviewed and evaluated the quality, safety and effectiveness, and post-marketing safety management plans of pharmaceuticals in accordance with the review criteria of the Advanced Renewable Bio Act. It explains that the Central Pharmaceutical Affairs Review Committee has consulted on the validity of the item approval and conformity to the system. Kymriah is a drug subject to long-term follow-up investigation pursuant to Article 30 of the Advanced Renewable Bio Act. Abnormal cases of Kymriah should be followed for 15 years from the date of administration, and the contents and results of the long-term follow-up survey should be reported to the MFDS every year from the date of initial sale. An official from the MFDS said, "We expect that the approval of Kymriah will provide a new treatment opportunity for patients with recurrent and refractory hematologic cancer who do not have an alternative drug or have not established standard treatment methods."
- Policy
- Soliris follow-on Ultomiris conditionally listed
- by Lee, Hye-Kyung Mar 09, 2021 06:24am
- Handok’s paroxymal nocturnal hemoglobinuria (PNH) treatment Ultomiris (ravulizumab) is getting closer to the National Health Insurance (NHI) reimbursement. On Mar. 4, the Health Insurance Review and Assessment Service (HIRA) convened a second meeting of the year for the Drug Reimbursement Evaluation Committee (DREC) and deliberated listing six items, such as Ultomiris, Sanofi-Aventis Korea’s Praluent (alirocumab) pen injection 75 mg and 100 mg, Kuhnil, Penmix, Boryung Pharmaceutical and Yungjin Pharm’s Pentosin (daptomycin) injection 350 mg and 500 mg. As a result, the reimbursement for Praluent injection was cleared, but Ultomiris and Pentosin were conditionally passed, where the companies would have to accept a pricing lower than the evaluated price. Ultomiris shares the same active ingredient with one of the most expensive new drugs Soliris (eculizumab). The follow-on drug was authorized by the U.S. Food and Drug Administration (FDA) in December 2018, and European Medicines Agency (EMA) in July 2018. The South Korean health authority approved of the drug on May 21, 2020. The upper limit pricing on Soliris is at 5,132,364 won per vial (30 ml), costing a patient approximately 400 million won a year for administering three vials biweekly. Meanwhile, Ultomiris administers maintenance load once every eight weeks for two weeks after the initial load. The long interval in administration would help lowering the cost per patient even if it is priced similarly to Soliris. However, Handok would win the reimbursement only if it accepts a pricing lower than the DREC’s evaluated price, as it proposed a pricing higher than what DREC evaluated as. All six items containing daptomycin—either approved as domestically manufactured or imported as a complete product of Cubicin authorized in 2003 by an American-based Cubist Pharmaceuticals in 2003—also applied for the listing but received conditional approval.
- Company
- Antihypertension Zofenil and Adalat Oros to halt supply
- by Mar 09, 2021 06:24am
- Zofenil (zofenopril calcium) tablet and Adalat Oros (nifedipine) 60 mg tablet that had shortage issues are ultimately ceasing the supply. On Mar. 5, pharmaceutical distribution industry source reported Menarini Korea has informed of halting the supply of an antihypertension drug Zofenil in 7.5 mg, 15 mg and 30 mg doses. Menarini Korea explained the reason behind halting the drug supply and stated, “The drug composition amended by the manufacturer does not agree with the South Korean regulation, therefore the new version of the drugs cannot be imported to South Korea.” Without further import, the company is to supply the drug until the outstanding stock is depleted. The company commented, “The supply suspension was decided abruptly. A limited stock of the product would be supplied regardless of bulk order amount.” An angiotensin converting enzyme (ACE) inhibitor Zofenil was first approved in South Korea in 2010. Although it was once the best-selling ACE inhibitor in Italy, Zofenil had its label revised due to adverse reaction like dry cough and some of the batches failed to pass solubility testing. And recently, the manufacturer’s delay in shipment impeded the supply of 7.5 mg dose. Bayer’s headquarter has apparently decided to permanently cease the supply of an antihypertension drug Adalat Oros 60 mg tablet. The drug has been out of stock for a long time due to the maintenance work at the German factory. Initially, the company promised to resume supplying the drug, but the headquarters’ decision has been made otherwise. Currently, the Health Insurance Review and Assessment Service (HIRA) grants the healthcare reimbursement when multiple doses of Adalat Oros 30 mg tablet are prescribed. However, the reimbursement listing term was extended to coming July 31, because of the permanent supply suspension on the 60 mg dose. The company said the listing after July 31 would be informed after negotiating with HIRA. The pharmacies around South Korea have been complaining of shortage in Adalat Oros 60 mg tablet frequently occurred since 2017.
- Company
- Mercilon's sales fell 16%
- by Kim, Jin-Gu Mar 08, 2021 06:20am
- The OTC oral contraceptives market is fluctuating. Sales of Mercilon and MYVLAR, the existing No. 1 and 2 items, declined significantly for each reason. Sales of new products such as Senseday and Daon succeeded in establishing a very stable market. The cause of the change in the market is the change of vendor and the launch of new products. Mercilon and Alesse's sales have changed in the last two years, and Yuhan and Ildong launched their own items and joined them as generic companies. Another reason is the long-term out-of-stock and the resulting base effect. As MYVLAR sold out for more than a year, sales of Melian and Minulet increased. ◆Mercilon ↓16%·Alesse ↓15% & ↑ sales of Senseday and Daon According to the drug market research agency IQVIA on the 8th, last year, Alvogen Korea Mercilon posted the most sales among OTC oral pre-contraceptives last year. Mercilon's sales last year were ₩7.7 billion. However, compared to ₩9.1 billion in 2019, it has decreased by 16%. From 2018 (₩9.9 billion), sales declined for the second consecutive year. It is analyzed that the change of the retailer and the addition of generics have had an effect. Mercilon, which is owned by Alvogen Korea, has been sold by Yuhan since May 2016. However, the sales contract ended in May 2019. It was sold by Chong Kun Dang instead of Yuhan. Unfortunately, sales have been falling since Chong Kun Dang took over the sales. Mercilon, which had quarterly sales of the second half of ₩2 billion until the second quarter of 2019, declined to the second half of the ₩1 billion from the third quarter of 2019. In the pharmaceutical industry, intensifying competition due to the addition of generics is also affecting the decline in sales. In recent years, generics have been released in the oral contraceptive market. The most representative product is Yuhan's Senseday. Yuhan released Senseday as its own item after ending the sale of Mercilon. Senseday posted ₩1.3 billion in sales last year. It quickly rose to fourth place. It is analyzed that Alesse, the third-largest item in the market, was also affected by the change of sales location. Alesse's sales last year were ₩1.8 billion, down 15% from ₩2.1 billion in 2019. Ildong was in charge of distribution and sales of Alesse. However, the sales contract ended in December 2019. Currently, it is known that Pfizer is in charge of direct sales. Ildong released Daon and Baraon as their own products after ending the sale of Alesse. This is the same strategy as Yuhan launched Senseday. The two products launched in the second quarter of last year generated total sales of ₩700 million. Daon entered the 7th place in the market in its first year of launch. ◆Last year's sales of zero, Melian and Minulet sales increased due to prolonged sales of MYVLAR Dong-A's MYVLAR, which was in second place until 2019, continues to be sold out. MYVLAR has been out of stock since the second half of 2019. Accordingly, sales from ₩3.9 billion in 2018 decreased to ₩2.7 billion in 2019, and last year, as inventory was exhausted, it decreased to less than ₩10 million. Bayer's overseas plant, which supplies the product, was relocated, resulting in a disruption in production. Not only MYVLAR, but also Minivlar & Melian were sold out. Fortunately, supply of Melian has resumed, but MYVLAR and Minivlar are still out of stock. Dong-A focused on selling Melian, which had normalized supply, as a substitute for MYVLAR. It is ranked second in the market with ₩1.8 billion in sales last year. However, MYVLAR is still out of stock. MYVLAR has generated sales of around ₩1 billion each quarter, while Melian's sales are limited to around ₩500 million despite Dong-A's sales power. Pfizer's Minulet received the most due to the sold-out of MYVLAR. Minulet's sales last year were ₩700 million, an increase of 119% from ₩300 million in 2019. Minulet, like MYVLAR, contains ethinylestradiol 0.03mg and gestoden 0.075mg. Minulet is the only product sold in Korea.
- Opinion
- [Reporter’s Eye] Needs transparency in Cancer Committee
- by Eo, Yun-Ho Mar 08, 2021 06:20am
- The cases of healthcare reimbursement expansion on novel drug in South Korea has plummeted last year. The drug use has diversified but the actual use volume has not been increased. A survey on pharmaceutical reimbursement status found the increase in reimbursement expansion for each item in 2020 compared to 2019 has plunged by 70 percent, and by 75 percent for each indication. The figure includes the reimbursement expansion in off-label use as well. In 2019, total 107 items had their coverage expanded. However in 2020, only 35 items succeeded expanding the coverage. 104 indications had their coverage expanded in 2019, whereas it was only 30 indications last year. Regardless of the drop in expanded coverage, the number of coverage expansion application was not so different in 2020 compared to 2019. The biggest cause of the drop seems to be the COVID-19. Respective reimbursement deliberation committees including the Health Insurance Review and Assessment Service (HIRA) Drug Reimbursement Evaluation Committee (DREC) and Cancer Deliberation Committee had to postpone their meetings multiple times, which is an essential step prior to reimbursement listing. To improve the situation, the South Korean government alleviated the related regulation and allowed on-paper review from September. But besides the COVID-19 pandemic, some of the pharmaceutical industry associates point out the reimbursement expansion barrier has gotten higher over the year. The fingers are pointing at the Cancer Deliberation Committee. Originally, specialist doctors used to discuss the practicality of the drug by reviewing the drug’s clinical efficacy. But from last year, the committee started to also evaluate the financial impact of a drug. Since last year, the Cancer Deliberation Committee became the impossible river to cross. More and more drugs are pending for reimbursement expansion due to the committee. Some company goes as far as to submit a pharmacoeconomic analysis to the committee. It is possible, that many companies could have been too greedy with the pricing or had so many clinically ineffective drugs specifically in last year. But the issue is transparency. Currently, the Cancer Deliberation Committee does not disclose the result. The applicant company sometimes finds out about the listing close to the effective date. The DREC was like that in the past. An applicant company had to either pull their strings to confirm the result immediately after each meeting or wait for healthcare news media to publish an article on it. The companies continued to file complaints and now the DREC results are disseminated to news media with clear reasoning behind the decision. The same old situation is occurring within the Cancer Deliberation Committee. As the Cancer Committee started reviewing the financial impact, the number of cases where a drug is rejected by DREC after passing the Cancer Committee has drastically dropped. Basically, the Cancer Committee is playing the role of DREC. It is clear the Cancer Committee has to disclose all result clearly as DREC has. Only when the Cancer Deliberation Committee provides the clear reason behind the disapproval, a company can be reprimanded for its greediness or seek for the middle ground. While COVID-19 is an emergency state to be handled carefully, the South Korean health authority should not forget the cancer patients are also waiting desperately.
- Policy
- GC Pharma-Moderna-KCDC ink COVID-19 vaccine contract
- by Lee, Jeong-Hwan Mar 08, 2021 06:20am
- GC Pharma has officially announced it would supply the COVID-19 vaccine developed by Moderna. The decision is made for the vaccine distribution deal signed between the multinational company and the Korea Disease Control and Prevention Agency (KDCA).. On Mar. 4, GC Pharma (President Heo Eun-cheol) stated it would distribute 40 million doses of an American-based Moderna’s COVID-19 vaccine. The company elaborated the decision was made to support the government’s goal by supplying the vaccine at the right timing, immediately after the South Korean authorization procedure. Previously, KDCA said the 40 million doses of Moderna’s COVID-19 vaccine would be imported to the country from the second quarter. The decision was made based on the contracts signed between GC Pharma and Moderna, and GC Pharma and KDCA. The vaccine developer and the health authority would support GC Pharma in processing the local authorization process and take in charge of the local distribution. President Heo Eun-cheol of GC Pharma commented, “We are proud to be able to cooperate with the government and Moderna to supply the vaccine to the people. As controlling the infectious disease is the top priority task for a pharmaceutical company, GC Pharma is seeking various means to prepare for COVID-19 and other prospective public health emergency based on the capability and experience the company has been accumulating.”
- Company
- Pantogar's Sales cut in half
- by Mar 08, 2021 06:19am
- OTC hair loss treatment by Merz, Pantogar, was delayed in import, and sales were cut in half. According to the pharmaceutical industry on the 4th, import of Pantogar has been temporarily suspended from the middle of last year due to changes in overseas manufacturing sites. It was sold out as Pantogar's domestic distribution was stopped. Pantogar is out of stock at major online pharmaceutical shopping malls. This caused Pantogar's sales to plummet. According to the pharmaceutical market research firm IQVIA, Pantogar sales decreased 53.8% from about ₩1.3 billion in 2019 to ₩600 million last year. Pantogar's competitors include DongKook's Pansidil and Hyundai's Minoxyl. Pansidil beat Pantogar with number one in sales. An official from Huhpharma, who is in charge of distribution of Pantogar in Korea, said, "We cannot import due to the change of the factory last year, but The stock remains until May. It will be normalized within the year."
- Policy
- Amivantamab designated as a rare drug
- by Lee, Tak-Sun Mar 08, 2021 06:19am
- Janssen's Amivantamab, which is promoting joint development with Yuhan's non-small cell lung cancer treatment Leclaza, has been newly designated as an orphan drug. The MFDS announced that it will newly designate five drugs, including Amivantamab, as orphan drugs, and announce additional target diseases for three drugs, including 5-Aminolevulinic acid HCl. Orphan drugs are used for the purpose of diagnosing or treating rare diseases. It is a drug that has been designated by the Minister of Food and Drug Safety with no alternative drugs or with improved safety or efficacy than alternative drugs. Amivantamab has been designated as a treatment for non-small cell lung cancer with an epidermal growth factor receptor (EGFR) exon 20 insertion mutation. In order to support the development of treatments for rare and incurable diseases, the MFDS is operating an orphan drug designation system that allows rapid approval of orphan drugs according to the characteristics of the disease. An official from the MFDS said, "The designation of an orphan drug is expected to help in the development of treatments for people with rare and intractable diseases." It said, "We will continue to formulate policies to guarantee patient treatment opportunities in the future."
