- LOGIN
- MemberShip
- 2026-05-07 14:20:47
- Policy
- Sotyktu, the world's first TYK2I, received domestic approval
- by Lee, Hye-Kyung Aug 04, 2023 05:38am
- The Ministry of Food and Drug Safety (Minister Oh Yoo-Kyung) approved BMS Korea's new plaque psoriasis drug 'Sotyktu 6mg' on the 3rd. Psoriasis is a chronic skin disease caused by immune abnormalities, and plaque psoriasis is the most common form. Sotyktu treats psoriasis by selectively inhibiting 'tyrosine kinase-2 (TYK2)' receptors related to inflammation and immune response by oral administration. The drug was approved by the US FDA in 2022 for use in adult patients with moderate to severe psoriasis who require systemic therapy or phototherapy. Sotyktu is the world's first and only TYK2 inhibitor approved for use and is the first oral drug available for moderate to severe psoriasis in 10 years. It is based on the comparative phase 3 POETYK PSO-1 and POETYK PSO-2 studies. This drug confirmed improved efficacy at 16 and 24 weeks after administration compared to the placebo and Otezla, and the clinical efficacy was found to last up to 52 weeks. This drug is expected to provide a new treatment opportunity for adult patients with moderate to severe plaque psoriasis who require phototherapy or systemic treatment. The Ministry of Food and Drug Safety said it would continue to do its best to expand treatment opportunities for patients by promptly supplying treatments whose safety and efficacy have been sufficiently confirmed based on regulatory science expertise.
- Policy
- Cancer immunotherapy Jemperli passes DREC review
- by Kim, Jung-Ju Aug 04, 2023 05:38am
- Jemperli GSK Korea’s immno-oncology latecomer drug ‘Jemperli (dostarlimab)’ has passed its first step to reimbursement in Korea. On the other hand, Koselugo (selumetinib), AstraZeneca’s new drug for pediatric patients with neurofibromatosis type 1 (NF1), received a redicussion decision, warning of a bumpy journey ahead. The Health Insurance Review and Assessment Service held its 8th 2023 Drug Reimbursement Evaluation Committee meeting and deliberated on the adequacy of reimbursement of 6 new drugs and made the decisions above. New drugs that were deliberated and deemed eligible for reimbursement include Jemperli and Ono Pharma Korea’s BRAF inhibitor for colorectal cancer, ‘Bratovi Capsule 75mg (encorafenib)’, and Roche Korea’s treatment for adult patients with neuromyelitis optica spectrum disorder (NMOSD), ‘Enspryng Prefilled Syringe (satralizumab)'. Among the drugs, Jemperli is the first drug in its class to be approved to treat adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) that has progressed on or following a prior platinum-containing regimen. BMS Korea’s ‘Zeposia Capsule 0.92mg‘ and ‘Zeposia Capsule Starter Pack 0.23mg/0.46mg (ozanimod hydrochloride) received a ‘conditional approval,’ allowing the drugs to proceed on to drug pricing negotiations with the National Health Insurance Service if the company accepts a price below the evaluated amount. These new drugs are indicated to treat moderate-to-severe ulcerative colitis (UC). AstraZeneca Korea’s Koselugo Capsule 10,25mg (selumetinib hydrogen sulfate) received a rediscussion decision. The drug is indicated to treat NF1 accompanied by plexiform neurofibroma, Koselugo had received a non-reimbursement decision by DREC in March last year, but attention had been rising on the possibility of it passing DREC review this time as the company immediately submitted supplementary data thereafter in May and a risk-sharing proposal this time. Although DREC did not decide to non-reimburse the drug this time, the industry predicts that it would take some time for Koselugo to receive reimbursement as DREC has temporarily postponed making a reimbursement decision on the drug. On the other hand, BMS Korea’s Reblozyl Inj 25,75mg (luspatercept) received a non-reimbursement decision. Reblozyl was designated an orphan drug in 2021 in Korea and is used to treat ▲ myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T) and ▲anemia in adult patients with beta-thalassemia who require regular red blood cell (RBC) transfusions.
- Company
- Prescriptions of pseudoephedrine rise 35% in 1H
- by Chon, Seung-Hyun Aug 04, 2023 05:38am
- The prescription market for ‘pseudoephedrine,’ which continues to show an unstable supply and demand in the market, has expanded significantly. Despite the end of the pandemic, demand for the drug has increased significantly due to the increase in flu and cold patients. Accordingly, the need to raise the insurance price ceiling for the low-priced drug is being raised to increase production. According to the market research institution UBIST, outpatient prescriptions of the single-agent pseudoephedrine had been KRW 3.3 billion, up 35.3% YoY. Prescriptions of pseudoephedrine had increased 20.5% YoY to reach KRW 1.6 billion in Q1, and then 53.1% YoY to record KRW 1.7 billion in Q2 this year. Pseudoephedrine is used for common colds, paranasal sinusitis, upper respiratory allergies, etc. It is a prescription drug that is widely prescribed to cold patients. Quarterly outpatient prescriptions of single-agent pseudoephedrine (Unit: KRW 0.1 billion, Data:UBIST) Although the market size for pseudoephedrine had not been large, its demand has surged recently. Quarterly prescriptions of single-agent pseudoephedrine had been below KRW 1 billion from Q2 2020 to Q3 2021. However, after 7 quarters in Q4 2021, prescriptions exceeded KRW 1 billion and then rose to KRW 1.7 billion in Q4 last year. By Q2 this year, pseudoephedrine prescriptions had increased 149.9% from Q2 2020. In 2020 and 2021 the pseudoephedrine market was directly affected by COVID-19 and caused the market contraction. The number of patients with infectious diseases such as flu and colds had decreased sharply after the spread of COVID-19 due to strengthened personal hygiene management such as washing hands and wearing masks, and shrinking related treatment markets. However, the demand for pseudoephedrine increased significantly with as many as hundreds of thousands of confirmed COVID-19 cases pouring out every day from the end of 2021. The recent increase in pseudoephedrine prescriptions seems to be not only due to confirmed COVID-19 patients but also due to the increase in cold and flu patients. This year, the number of flu patients had continued to exceed the epidemic standard until June. According to the Korea Disease Control and Prevention Agency, the number of suspected influenza patients per 1,000 outpatients dropped from 52.5 in the first week of 2023 to 11.7 in March. However, the number of suspected flu cases rose again from April. For 6 consecutive weeks from the 17th week (fourth week of April) to the 22nd week last week of May), the number of suspected influenza patients per 1,000 outpatients continued to be over 20. This greatly exceeds the flu epidemic standard of 4.9 set by the KDCA. The supply shortage of pseudoephedrine is being prolonged. Its demand has soared in a short period, but due to limited production, supply is not keeping up with the demand. The Korean Pharmaceutical Association is working with the Korea Pharmaceutical Distribution Association and related pharmaceutical companies to ensure an even supply of single-agent pseudoephedrine. The KPA has been receiving online orders from pharmacies for Samil Pharma’s ‘Sudafed Tab’ or Kolon Pharmaceutical’s ‘Cosue.’ Pharmacies can order one of the two, and the KPA has been supplying one or two packer vials (500 tablets/vial) of the drug to each pharmacy. The low price of pseudoephedrine is another reason why companies cannot easily increase production of pseudoephedrine. According to the Health Insurance Review and Assessment Service, seven single-agent pseudoephedrine 60mg are listed for reimbursement in Korea, and their insurance price ceiling is a mere KRW 23. Of the 7, 6 products were listed at KRW 23 and 1 at KRW 20. If the supply shortage continues, the industry suggested that there may be a need to raise its drug price like acetaminophen. The Ministry of Health and Welfare raised the insurance price ceiling of 18 acetaminophen 650mg items by up to 76.5% in December last year. The insurance price limit for 650mg acetaminophen, which was only KRW 43 to 51 before then, was raised to KRW 90. The government made an unprecedented decision to raise the price of all acetaminophen products unilateraly when pharmaceutical companies expressed reluctance to increase production due to the drug’s poor cost structure. However, it is a temporary increase that will be adjusted to KRW 70 from December this year. Pharmaceutical companies had promised to increase production of acetaminophen in line with the price hike.
- Company
- Antibiotic resistance is serious
- by Jung, Sae-Im Aug 04, 2023 05:37am
- Antibiotic resistance has been a global issue for several years. In 2016, the British government predicted that 700,000 people worldwide would die from antibiotic-resistant bacteria every year and that the death toll would reach 10 million by 2050 if no special measures were taken. In 2015, the World Health Organization (WHO) presented a 'global action plan' to prevent the occurrence and spread of resistant bacteria transcending borders and urged countries to prepare countermeasures and international cooperation. Carbapenem-type antibiotics, which have the most extensive antibacterial activity, are called the 'last choice', and the number of infections with strains resistant to these antibiotics is rapidly increasing. According to the Korea Centers for Disease Control and Prevention, the number of cases of carbapenem-resistant Enterobacteriaceae (CRE), which was classified as a second-grade infectious disease last year, increased by 31% from the previous year to 30,548. Compared to 2017, when there were 5717, this is a more than five-fold increase in five years. Activities of the Korean Society for Antimicrobial Therapy also focus on antibiotic management to reduce resistance. It is the institutionalization of so-called 'antibiotic stewardship' that uses antibiotics appropriately. As of 2020, antibiotic use in Korea was the 4th highest among 29 OECD countries. As a result of investigating the adequacy of antibiotic prescriptions in 75 domestic hospitals, more than 25% were evaluated as inappropriate. Kim Shin-woo, chairman of the Korean Society for Antimicrobial Therapy Kim Shin-woo, chairman of the Korean Society for Antimicrobial Therapy (Department of Infectious Diseases, Kyungpook National University Hospital), said in a recent interview with Dailypharm, “Antibiotic resistance has become a situation that cannot be resolved through infection control anymore.” There is a need for systematic institutionalization of education,” he stressed. He then asked for appropriate support to quickly introduce new drugs that have emerged as carbapenem alternatives such as Zerbaxa at an appropriate price and to develop domestically produced new drugs that can be supplied in Korea. - Cases of infection with carbapenem-resistant Enterobacteriaceae are rapidly increasing. How much do you feel on-site? = The level of feeling on the spot is serious. The problems typically pointed out in Gram-negative bacteria resistance are resistance in Pseudomonas aeruginosa, Acinetobacter resistance, and Carbapenem resistance. Among them, Pseudomonas aeruginosa and Acinetobacter mainly cause problems in hospital environments, but carbapenem resistance has a greater ripple effect on the community than these and is more serious because resistance is developed in intestinal bacteria. CRE is a case where doctors do not respond even if they use carbapenem antibiotics, which are called 'last bastions', and colonization can lead to a real infection. If the CRE ratio in a person's bacteria increases, it causes various infections such as sepsis, which cannot be treated even with carbapenem. However, there is no monitoring, tracking, or reporting on this, so there is nothing that can be done even if the number of deaths increases. - Antibiotic resistance is a problem that has been pointed out for a long time. Why was the response delayed? = I think the biggest cause is not knowing the seriousness of antibiotic resistance. About 35,000 patients have died from COVID-19 in Korea, but it is not well-known that many people die every day from antibiotic resistance. There is also a famous prediction that by 2050, we will be in a post-antibiotic era, an era in which antibiotics are ineffective, with more deaths from antibiotic resistance than from cancer. Awareness of the term antibiotic stewardship is also very low. Medical institutions should be moved through continuous publicity and awareness improvement. -The Korean Society of Antimicrobial Therapy is citing institutionalization of the Antimicrobial Stewardship Program (ASP) as its top priority goal in the mid-to-long term. Why is Antibiotic Stewardship Institutionalization Necessary? =Antibiotic stewardship is to reduce the misuse and abuse of antibiotics and lower the rate of resistant bacteria. When antibiotic resistance develops, infection control and antibiotic stewardship to prevent the spread of resistant bacteria and the spread of legally infectious diseases must go hand in hand. As in Korea, there is no need to reduce the use of antibiotics in a situation where fee-for-service, high access to medical care, and an increase in the number of elderly people exist. It is easy to use antibiotics even for colds and to use for 3 days for 1 or 2 weeks. Therefore, an organization that monitors antibiotic use and gives feedback is essential. - Specifically, how to operate ASP =The Korean government is making phase 1 and phase 2 measures (national antibiotic resistance management measures) for antibiotic resistance. Institutionalization of antibiotic stewardship is needed in earnest. If there is no system, execution will not follow. A system must be in place so that medical staff can accept feedback on why antibiotics must be managed and used sparingly, and why antibiotics are used a lot. In general, an ASP team consists of a multidisciplinary team led by an infectious disease physician, a pediatric infection specialist, and a pharmacist specializing in infection, together with other departments (information computing team, clinical microbiology, medical quality control, infection control room, etc.). In developed countries where the system is being operated first, nurses are often included in the number of dedicated personnel. In overseas cases, large hospitals use a system that monitors antibiotics prescribed by doctors and supports prescriptions, checks the contents of prescriptions electronically, controls them when necessary, and gives feedback. -Zerbaxa is a new drug that can reduce the use of carbapenem antibiotics. It seems important to use new antibiotics well. = Recently developed antibiotics are trying to prove their therapeutic effect on pneumonia such as complicated urinary tract infection, complicated intra-abdominal infection, ventilator pneumonia, and hospital-acquired pneumonia. Zerbaxa has won these indications. If Zerbaxa can be used regardless of whether or not ESBL is produced, the use of carbapenems can be reduced. However, if the cost of using a new drug is high, carbapenem, which costs relatively less, will be used. Of course, if the use of Dr. Jeo increases, there are concerns about tolerance. Because Dr. Jeo has not yet been widely used, information on tolerance is lacking.
- Policy
- Animal drugs can be manufactured at human drug factories
- by Kang, Shin-Kook Aug 03, 2023 05:35am
- The manufacture of veterinary drugs are now allowed at manufacturing facilities that manufacture human drugs. The Ministry of Agriculture, Food and Rural Affairs recently announced the legislation of an amendment to the ‘Decree on the Facility Standards for Veterinary Pharmacies and Manufacturers, Importers, and Retailers of Veterinary Drugs’ and will be collecting industry opinion until September 4th. According to the amendment, in order to minimize the impact on the existing industry, the products that can be manufactured at human drug manufacturing facilities are limited to those for companion animals. In addition, among the active pharmaceutical ingredients that have been approved for human use in Korea, those that have not been approved for animal use before August 31, 2023, can be manufactured until the expiry date. However, 22 ingredients that have been approved for both human and veterinary use are allowed for use in manufacturing drugs for companion animals. The amendment will take effect immediately after promulgation. The Ministry of Agriculture and Food and Rural Affairs said, "We seek to ease the burden of redundant investment that is required for the establishment of a separate manufacturing facility for veterinary drugs by enabling human drug manufacturers to produce drugs for companion animals using existing facilities." The goal of the amendment is to develop and produce high-value-added veterinary drugs and grow the domestic veterinary drug industry qualitatively and quantitatively through coexistence with existing veterinary drug manufacturers.”
- Product
- Discontinued muscle painkillers in heavy demand
- by Kim JiEun Aug 03, 2023 05:35am
- The aftermath of some pharmaceutical companies’ tricking pharmacies into believing ‘there is not much stock available for order’ An ironic situation has occurred where a drug that pharmaceutical companies have given up manufacture and sales of due to the inability to demonstrate its effect is in heavy demand at pharmacies. On the 1st, in drug online malls used by pharmacists, many muscle pain relievers that are fixed-dose combinations of chlorzoxazone 250mg + acetaminophen 300mg, are out of stock, or can only be ordered in small quantities. The issue arose after it was recently confirmed that pharmaceutical companies that manufacture and distribute related products voluntarily withdrew their products or did not apply for renewal of the product licenses. The stock shortage occurred because some pharmacies are trying to stockpile the drug to sell within the expiration date as the pharmaceutical industry as well as the pharmacist society believe the drug will be naturally removed from the market. As pharmaceutical companies have voluntarily withdrawn or did not apply for renewal within the deadline, pharmacies can only sell those in stock until the expiry date of the currently distributed products. According to pharmacists, most of the muscle pain relievers that contain chlorzoxazone 250mg + acetaminophen 300mg are used at pharmacies and the combination is one of the steady sellers at pharmacies. As a result, some pharmacies trying to stock as much as possible and sell the product until possible. In addition, the fact that some pharmaceutical companies implemented a sales policy of “imminent closing” had also partially affected the out-of-stock phenomenon of related products. In the case of pharmaceutical company A, immediately after applying for voluntary withdrawal of related products, it sent a text message to pharmacists using its online mall to encourage them to order related products. A sales representative of the pharmaceutical company encouraged pharmacies to buy the product, sending the message that “manufacture will be discontinued and the current stock is our last. Those in stock can be sold until the expiration date. Therefore, it would be good to order as much as possible.” It is known that the number of orders that can be ordered per pharmacy has been limited to 300 for each specific time, but orders poured in in a very short period of time. Some pharmacists said it was regrettable that over-the-counter products with certain ingredients, which are in constant demand in pharmacies, are being removed. It seems necessary to look at the overall situation to see if the system is being excessively applied or whether related pharmaceutical companies are being complacent.” A pharmacist in Seoul said, “Most pharmacies have one or two products with the combination, and the demand for them is quite high, it is unfortunate that relevant products are being withdrawn from the market. It seems that the related pharmaceutical companies need to look at the overall situation to see if they are being complacent.”
- Company
- Variable for contract renewal for joint sales
- by Kim, Jin-Gu Aug 03, 2023 05:35am
- HK inno.N r, up 17% in about a year after the launch. HK inno.N sold alone, no commission share, profitability improved as more sold Expiration of the joint sales contract with Chong Kun Dang at the end of the year, will it affect renewal negotiations? HK inno.N K-Cab OD tablets accounted for 17.0% of the total prescription performance of this product. HK inno.N's K-Cab joint sales contract with Chong Kun Dang is about to expire at the end of this year. The increase in the proportion of prescriptions for OD tab, sold exclusively by HK inno.N, is expected to act as a variable in determining conditions such as the sales commission rate in the process of contract renewal negotiations between the two companies. According to HK inno.N on the 2nd, the outpatient prescription amount of K-Cab in the second quarter was 38.4 billion won, up 20.0% from 32 billion in the same period last year. Kcab is currently sold in the form of film-coated tablets and OD tabs. Oral disintegrating tablets accounted for 16.3% of total prescription sales in the second quarter. This means that Kc-ab OD tab's prescription sales in 2Q reached 6.3 billion. HK inno. N released the OD tab in May last year. In 2Q09, the prescription portion of OD tabs was 4.2%. Since then, it has rapidly expanded its share to 7.8% in the third quarter, 10.2% in the fourth quarter, 12.9% in the first quarter of this year, and 16.3% in the second quarter. The proportion of prescriptions increased to 17.0% in June. The prescription portion of OD tabs, which stood at 11.8% in January, increased by more than 5.0%p in half a year. If this trend continues, it is expected to expand to more than 20% within the year. OD tab is also contributing greatly to expanding the prescription record of all K-Cabs. Since the second quarter of last year, prescriptions for film-coated tablets have been somewhat stagnant at 0.7 billion, 30.6 billion won, 32.2 billion won, 31.1 billion won, and 32.1 billion won. Compared to the second quarter of last year, it increased only by 1.5 billion won (4.8%) in one year. OD tab's sales increased significantly with 1.3 billion won, 2.6 billion won,3.7 billion won, 4.6 billion, and KRW6.3 billion. Compared to the second quarter of last year, it increased by 4.9 billion won (366%) in one year. It is an analysis that the OD tab is driving the overall growth of K-Cab prescriptions. An increase in the prescription portion of the OD tab is directly linked to improving the OD tab's profitability. In the case of existing film-coated tablets, they were jointly sold with Chong Kun Dang upon release. In the pharmaceutical industry, it is known that HK in no.N pays Chong Kun Dang a sales commission in the upper 20% range. On the other hand, OD tab is sold by OD tab alone. As sales commissions are not paid separately, the profitability of HK inno.N improves as the number of prescriptions increases. HK inno.N signed a joint sales contract with Chong Kun Dang in 2019. The contract expires at the end of this year. It is known that the two companies are currently discussing whether to renew the contract. In the pharmaceutical and investment industries, it is highly likely that the two companies will sign an extension contract at the level of readjusting sales commission rates and incentives. In this situation, the expansion of the prescription portion of the OD tab, sold exclusively by HK inno.N, is expected to have a significant impact on determining specific negotiation conditions. As OD tab prescription performance expands, HK inno.N's bargaining power is expected to increase. Unlike at the time of release, HK inno.N's sales network has been significantly expanded, and K-Cab awareness in front-line hospitals and clinics has also greatly improved. In addition, it is an analysis that HK Innoen is proving its own sales power by producing good results in the single sale of OD tab.
- Company
- Rise of 4-drug combos in hypertension/hyperlipidemia Tx mkt
- by Kim, Jin-Gu Aug 03, 2023 05:35am
- The growth of 3-drug combinations has slowed down in the hypertension/hyperlipidemia combination drug market. After recording double-digit YoY growth every quarter until the first half of last year, the spurt has slowed sharply since the end of last year. On the other hand, the 4-drug combinations that newly entered the market are rapidly expanding their influence. Prescription sales of Hanmi Pharm’s Amosartan XQ, which is leading the growth of 4-drug combinations, are expected to exceed KRW 10 billion in annual prescriptions. Brakes pulled on the growth of 3-drug combos…rate of growth reduced According to the market research institution UBIST, the outpatient prescription market size for 3-drug combo treatments that contain ARB+CCB+statin had reached KRW 15.3 billion in Q2. This is a 5% increase from the KRW 14.5 billion in Q2 last year. Although the market size expanded compared to the same period last year, the growth rate has slowed significantly recently. Sales of the 3-drug combination that contains ARB+CCB+statin for hypertension and hyperlipidemia have been marking double-digit growth until the first half of last year. Especially in 2020, the market has expanded rapidly. Prescriptions more than doubled every quarter, compared to the same period last year. In 2021, the market continued to grow, expanding by more than 30% every quarter. However, the growth slowed significantly since the second half of last year. In Q3 last year, the market size increased by only 8% YoY. From the Q4 of last year to Q2 of this year, the quarterly growth rate of prescriptions fell to 5%. Prescription performance of combo therapies for hypertension and hyperlipidemia It took just one year from Q4 2019 to Q4 2020 for the prescription scale of the 3-drug combination of ARB+CCB+statin for hypertension and hyperlipidemia to expand from KRW 5 billion to over KRW 10 billion. On the other hand, it took two and a half years to increase the size from KRW 10 billion to KRW 15 billion. The prescription size of the market, which had been around KRW 10.8 billion in Q4 2020 expanded to more than KRW 15 billion only in Q2 this year. Sales of most of the major products also showed a slowdown. Boryung Dukaro (fimasartan + amlodipine + rosuvastatin) posted KRW 4 billion in prescriptions in Q2. This is virtually no change from what it had made in Q2 last year. Hanmi Pharmaceutical’s Amosartan Q (losartan + amlodipine + rosuvastatin) and Daewoong Pharmaceutical’s Olomax (olmesartan + amlodipine + rosuvastatin) even showed a decline in prescription performance. For example, prescriptions of Amosartan Q which had been KRW 2.9 billion in Q2 last year, slightly fell to KRW 2.8 billion in one year. Sales of Olomax had also fallen from KRW 2.3 billion to KRW 2.2 billion. Prescription performance of major three-drug combo treatments for hypertension and hyperlipidemia Will sales of the 4-drug combos surge like the 3-drug combos...Sales of Amosartan XQ rise 75% in one-year Unlike the 3-drug combos, the 4-drug combos that were newly introduced to hypertension/hyperlipidemia combination drug market are rapidly expanding prescriptions. In Q2 last year, the 4-drug combination of ARB + CCB + statin + ezetimibe posted a sales performance of KRW 3.2 billion in the outpatient prescription market. Compared to the KRW 1.5 billion it had posted in Q2 last year, this is a more than twofold increase. This is similar to when the 3-drug combination was first introduced to the market. Hanmi Pharmaceutical was the first to release Amosartan XQ (losartan + amlodipine + rosuvastatin + ezetimibe) and form the market. Then, at the end of last year, GC Biopharma and Jeil Pharmaceuticals released Rozetelpine and Telmican-Q, respectively, both of which are combinations of telmisartan, amlodipine, rosuvastatin, and ezetimibe. In January this year, Chong Kun Dang released Nuvorozet. Nuvorozet contains the same combination as Rozetelpine and Telmican-Q with only amlodipine replaced with amlodipine. The market is currently being led by Amosartan XQ. The drug had recorded prescriptions of KRW 2.7 billion in Q2 this year. This is a 75% increase from the KRW 1.5 billion in Q2 last year. Amosartan XQ recorded a combined prescription performance of KRW 5 billion in the first half of the year, and at this rate, the drug is expected to record more than KRW 10 billion in annual sales this year. Meanwhile, the two-drug combinations of ARB + statin are showing a gradual decline in prescriptions. In Q2 last year, the two-drug combination drugs recorded a combined prescription performance of KRW 20.9 billion. This is a 6% YoY decline. The combination sold the most in Q3 2021, accounting for KRW 23.3 billion, but has been downhill ever since with the introduction of the 3-drug combinations.
- Policy
- Countdown to the Prime Minister’s Biohealth Committee
- by Lee, Jeong-Hwan Aug 03, 2023 05:35am
- Expected to be completed before the regular session of the National Assembly this year. The work of establishing a pan-governmental control tower dedicated to fostering Korea’s biopharmaceutical and healthcare industries has entered the countdown. The Ministry of Health and Welfare, along with the Office of the Prime Minister, plans to revise the order for the establishment of the Biohealth Innovation Committee in the near future. Although the specific schedule has not been disclosed to the outside world, the National Assembly and the pharmaceutical industry expect that the order will be completed by the time the regular National Assembly opens this year in September and October. On the 2nd, an official from the Ministry of Health and Welfare explained, "We plan to complete the establishment of the Biohealth Innovation Committee as soon as possible through the revision of the directive rather than legislation." The domestic pharmaceutical industry, led by the Korea Pharmaceutical Bio Association, has repeatedly requested the government to establish a Pharmaceutical Bio Innovation Committee directly under the President's Office. During the presidential election, President Yoon Seok-yeol pledged to become a member of the Pharmaceutical and Bio-Innovation Committee directly under the president, and after the inauguration of the new government, he put forward a plan to establish a new organization under the Prime Minister. Jeong-suk Seo also proposed a bill that the Pharmaceutical Bio Innovation Committee, chaired by the Prime Minister, serves as an industrial control tower. However, the establishment of the Biopharmaceutical Innovation Committee is promoted not by legislation, but by the revision of the Prime Minister's Office order, and the scope was also determined to target the 'bio health' industry, not just the 'pharmaceutical bio' industry. Accordingly, the name of the organization to be established by the revision of the directive is also expected to be the Biohealth Innovation Committee. This is in line with the attitude the Ministry of Health and Welfare showed in the process of reviewing the National Assembly's Health and Welfare Committee's proposal for Seo Jeong-sook. At the time, the Ministry of Health and Welfare expressed the view that an organization was needed to nurture a wider range of areas, such as medical devices and digital healthcare, in addition to the biopharmaceutical industry, regarding the provision of 'upgrading under the Prime Minister's Office of the Pharmaceutical and Bio-Industry Innovation Committee' contained in the bill of Congressman Seo Jung-sook. The external and internal structure of the BioHealth Innovation Committee, which will be newly organized by the Yoon Seok-yeol administration, can be predicted in detail only when the revised order is released. An official from the National Assembly's Welfare Committee said, "The Ministry of Health and Welfare has expressed its position to create a biopharmaceutical innovation committee by revising the Prime Minister's Office directive without legislation, and the outline will be revealed sooner or later." It may not be necessary, but it remains to be seen whether the effectiveness will be equal."
- Company
- Rx of Generics for Xarelto doubled in 1 yr
- by Kim, Jin-Gu Aug 02, 2023 05:25am
- Generics for Xarelto (Rivaroxaban) are rapidly increasing their prescription performance. In the first half of last year, prescription sales of 8 billion won were recorded, more than doubling in one year. On the other hand, the original product's prescription performance decreased by half during the same period. Generics for Xarelto, 3.9 billion → 8 billion won growth in one year, original cut in half According to UBIST, a pharmaceutical market research institute on the 1st, the number of outpatient prescriptions for rivaroxaban in Korea in the first half of last year was 23.8 billion won, down 29% from 33.5 billion won in the same period last year. During this period, Xarelto, the original product, decreased by 46% from 29.6 billion won to 15.9 billion won. Xarelto's quarterly prescriptions peaked at 16.3 billion won in the third quarter of 2021, then steadily declined. In particular, the drop has increased since the third quarter of 2022. Prescription sales, which were 14.8 billion won in the second quarter of last year, plummeted to 11.8 billion won in the third quarter. Analysts say that the drug price cut, which was delayed due to Bayer's administrative lawsuit and application for suspension of execution, took place at this time, leading to a sharp drop in prescriptions. Since then, Xarelto's prescriptions have steadily declined. In the fourth quarter of last year, prescription sales of 8 billion won fell below 10 billion won, and in the first and second quarters of this year, prescription sales were only 8 billion won and 7.8 billion won, respectively. Xarelto generics are expanding. In the first half of last year, Xarelto generics recorded a combined prescription of 8 billion won. Compared to 3.9 billion won in the same period last year, it more than doubled in one year. Generics for Xarelto first appeared in the second quarter of 2021. Then, they exceeded 1 billion won in the first quarter of 2022 and 2 billion won in the second quarter, respectively. In the fourth quarter of that year, it further increased to more than 3 billion won, and in the second quarter of this year, it recorded more than 4 billion won. In the process, the share of generics also steadily increased. In the second quarter of this year, generics accounted for 36% of the rivaroxaban ingredient market. Compared to 13% in the second quarter of last year, it has nearly tripled in one year. Analysts say that generics are succeeding in targeting the original. Among generic products, Chong Kun Dang's Riroxia, Hanmi Pharm's Riroxban, and Samjin Pharm's Riroxaban posted sales of over W1bn in 1H. Prescriptions for each product in 1H were 2.2 billion won for Riroxia, 1.5 billion won for Riroxban, and 1.3 billion won for Riroxaban. Lixiana announces 100 billion won per year, Pradaxa's sluggishness continues Among the NOAC products other than Xarelto, Daiichi Sankyo's Lixiana produced the highest prescription performance. Lixiana's prescription amount in the first half was 51.4 billion won, up 10% from 46.5 billion won in the first half of last year. If this trend continues, Lixiana is expected to generate more than 100 billion won in prescriptions by the end of this year. BMS Eliquis recorded prescription sales of KRW 38.3 billion in the first half. Compared to 35.8 billion won in the first half of last year, it increased by 7% in one year. Boehringer Ingelheim Pradaxa's slump is prolonged. Pradaxa's prescriptions in the first half of this year were 5.9 billion won. It decreased by 11% from 6.6 billion won in the first half of last year. Pradaxa's quarterly prescriptions fell below 4 billion won in the third quarter of 2020 and further decreased to less than 3 billion won in the second quarter of this year.
