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- 2026-05-19 14:16:50
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- HPV vaccine market expands 55% midst COVID-19
- by An, Kyung-Jin Jun 07, 2021 06:06am
- The market for the vaccine to prevent cervical cancer has expanded by the greatest amount ever. The increased inoculation rate of the high-priced 'Gardasil 9' has led the total market growth. MSD, which owns two HPV vaccines - 'Gardasil' and 'Gardasil 9' - accounted for 97% of the total market, and boasted its overwhelming influence in the domestic market. According to the industry research institution IQVIA on the 7th, the HPV vaccine market size in Q1 of this year was 22.9 billion won. This was a 55.5% increase from the same quarter of the previous year and the highest-ever quarterly sales record. The COVID-19 outbreak had temporarily slowed down market growth in the first half of last year, but sales turned back upwards in the second half. Since then, the market has been breaking its own record for three consecutive quarters. Compared to the 11.6 billion won in Q1 of 2017, the market size has doubled in 4 years. The high-priced ‘Gardasil 9’ acted as a catalyst in the HPV vaccine’s market growth. In Q1, sales of MSD’s ‘Gardasil 9’ recorded 17.4 billion won, which was a 75.6% YoY increase compared to the 9.9 billion won of the same quarter last year. In the same period, MDS’s other HPV vaccine, ‘Garadsil’ sold 4.8 billion won. Although ‘Garadsil’ also showed a 19.0% YoY increase from the 4.1 billion won in Q1 last year, the market was completely overwhelmed by the surge in sales of ‘Gardasil 9.’ In the same period, GSK’s ‘Cervarix’ sales fell 12.0% in one year to record 0.7 billion won in Q1 this year. Among the three products authorized in the Korean HPV vaccine market, the other two, which are MSD products, account for 97.1% of the domestic HPV vaccine market. In other words, MSD has a monopoly over Korea’s HPV vaccine market. MSD has grasped the lead in Korea’s HPV vaccine market in 2016 with the government selecting ‘Gardasil’ and ‘Cervarix’ as products for Korea’s National Immunization Project, and MSD releasing its follow-up ‘Gardasil 9,’ in the latter half of the same year. After selling 2.5 billion won in the first year of its release, sales of ‘Gardasil 9’ grew rapidly to 15.1 billion won in 2017, and 20.9 billion won in 2018. Since becoming the market leader product in 2019, raising 40.5 billion won in sales, twice the amount compared to the sales of ‘Gardasil,’ it had continued its rise ever since. In Q1 this year, the market share of ‘Gardasil 9’ was 76.0%, which was three times than that of ‘Gardasil.’ ‘Gardasil 9’ is a human papillomavirus virus (HPV) vaccine that was manufactured by adding five HPV serotypes 31, 33, 45, 52, and 58 in addition to the four HPV serotypes 6, 11, 16, 18 already in ‘Garadasil.’ It is being distributed at a high price with the differentiation that it covers the most amount of HPV types among existing HPV vaccines. The cost of inoculation paid by the consumers varies by hospital, but a single shot of 'Gardasil 9' may at most be 100,000 won more expensive than ‘Cervarix.’ Nevertheless, the demand for ‘Gardasil 9’ among adults not subject to NIP increases. News that the vaccine can prevent other HPV-related diseases such as anal cancer, genital warts, premalignant lesion, in addition to cervical cancer had spread through word of mouth, and the ‘couple vaccination’ promotions in obstetrics and gynecology clinics have been increasing the number of male inoculations every year as well. Since last year, the vaccination age for HPV vaccines was expanded to 45 years, and the rate of reinoculations has also increased significantly. One other factor that may have lead to a sales surge in Q1, is the pre-supply orders from hospitals and clinics in preparation for the price hike announced by the pharmaceutical company. MSD Korea has raised the supply price of 'Gardasil 9' and 'Gardasil' by 15% from April this year, citing rising production input costs. MSD Korea has changed its domestic distributor for ‘Gardasil 9' and 'Gardasil' to HK Inno.N this year and has been conducting co-promotion with the company ever since.
- Policy
- Ultomiris can be reimbursed with prior approval
- by Lee, Hye-Kyung Jun 07, 2021 06:06am
- Ultomiris (Ravulizumab), Handok's paroxysmal nocturnal hemoglobinuria (PNH) treatment, will be listed at ₩5,598,942 per bottle starting today (7th). The upper limit price for Soliris (30ml) is ₩5,132,364, so if 3 vials are administered every other week, about ₩400 million won is needed for a year. Ultomiris, on the other hand, can be administered at a maintenance dose every eight weeks from two weeks after the initial dose, which is expected to lower the annual dose per patient compared to Soliris. However, like Soliris, the pre-approval system is introduced, and health authorities check from before to after the administration. The HIRA recently conducted a "Guidance on Establishment and Announcement of Details on Pre-Approval of Ultomiris" and asked the head of the HIRA to apply for approval for use before administration. Medical institutions equipped with personnel, facilities and equipment prescribed by the criteria for madical benefits for hematopoietic stem cell transplantation may apply for prior approval of Ultomiris for patients with paroxysmal nocturnal hemoglobinuria (PNH). The pre-approval review will take place on Thursday the last week of the even month at the Ultomiris Subcommittee, which will be set up within the Medical Review and Assessment Committee. In the event that the Ultomiris subcommittee approves the reimbursed administration, it must be administered within 60 days from the date the medical institution is notified of the results of the deliberation. It must be reapplied if administered after 60 days. Ultomiris was approved by the U.S. Food and Drug Administration (FDA) in December 2018 and the European Medicines Agency (EMA) in July 2018 and obtained an item license on May 21, 2020. Handok applied for insurance registration as of August 31 after the permit, and the HIRA submitted it to the Pharmaceutical Benefits Advisory Committee as of March 4 this year to determine that it would be appropriate to accept it below the weighted average price of alternative drugs. The Pharmaceutical Benefits Advisory Committee considered clinical usefulness to be inferior to Soliris, an alternative drug based on clinical trial results, but found it cost effective if Soliris' weighted average of ₩5,598,942 or less per bottle. As the company accepted it, it has agreed to ₩33 billion through negotiations with the NHIS on expected claims.
- Policy
- SK Bio regains license for 'SKYPneumo'
- by Lee, Tak-Sun Jun 07, 2021 06:06am
- SK Bioscience regained its license for its ‘SKYPneumo,’ the first-ever pneumococcal vaccine developed in Korea. This approval comes in less than a year since the company had withdrawn its license in October last year in the aftermath of losing a patent suit. On the 4th, the Korean Ministry of Food and Drug Safety (MFDS) approved SK Bioscience’s 13-valent pneumococcal vaccine, ‘SKYPneumo prefilled syringe inj..' The vaccine is used for infants six weeks to 6 months old and adults over 50 years of age to prevent pneumococcal disease. It was approved by demonstrating its non-inferiority to the existing vaccines in clinical trials. The MFDS designated the vaccine's re-examination period to June 3rd, 2025. SKYPneumo had been previously approved in July 2016. However, the drug was unable to enter the market after losing a patent suit to Pfizer’s Prevnar 13 which had been dominating the pneumococcal vaccine market. Prevnar 13 is also a vaccine to prevent pneumococcal diseases. SK Bioscience filed a suit claiming the invalidity of the composition and formulation patent of Prevnar 13. However, the Supreme Court rejected the claim in December 2018. Due to this ruling, the company was not allowed to sell SKYPneumo until 2026, when the patent for Prevnar 13 expires. Unable to meet the post-marketing surveillance and other requirements, the company had voluntarily withdrawn its license for SKYPneumo last October. It will be difficult for SK Bioscience to market SKYPnuemo as approved until March 2026, when the patent for Prevnar 13 expires. Therefore, the eyes are on whether SK Bioscience will succeed in avoiding the patent rights with a new strategy and be released in the market. Meanwhile, according to IQVIA, Pfizer’s Prevnar 13 sold 81.3 billion won in sales just last year.
- Policy
- Botulinum Toxin is poorly managed
- by Lee, Jeong-Hwan Jun 07, 2021 06:05am
- Poor management of some domestic botulinum strains has been detected. Illegal circumstances have also been detected, including analysis of strains' sources and characteristics, security management of fungus handlers, illegal acquisition of strains, and suspected cases of false separation reports. Authorities are planning to jointly come up with measures to strengthen safety management of bio pathogens, including botulinum bacteria. On the 3rd, the KDCA announced the results of an all-in-one survey of 24 botulinum-bearing institutions, including Botox producers' acquisition of botulinum strains and illegal transactions. The KDCA conducted a written survey of 24 institutions from December 2 to 11 last year and conducted an on-site survey of 11 institutions from February 3 to March 4 this year. As a result of the investigation, insufficient management was confirmed, including analysis of the source and characteristics of strains, security management of bacteria handlers, illegal acquisition of strains, and suspected cases of false separation reports. Inspection items included permission to possess germs, separation and movement of germs, violations of the Biochemical Weapons Act, detailed copies of experimental notes, interviews with fungal separators, and results of the agency's security system. Botulinum toxins are highly likely to use bioterrorism, which requires strict management, but it has been revealed that there is a lack of human security management system to prevent illegal transactions and exploitation. Suspicions of strains exploitation have been raised through the transfer of some handlers, but problems have also been identified without legal grounds to identify the list of handlers and the status of transfers. There was no regulation on the reasons for disqualification, such as the definition and scope of handlers and criminal experience, so there was even a blind spot for management. In addition, there was no mandatory regulation for record preparation and management, including research notes that record the entire process of research and development, and genetic information on pathogens such as the entire sequence was excluded from the management list. Of the seven institutions that conducted on-site surveys to check whether bacteria were separated, five institutions were not prepared experimental notes by date and experimental process, and two institutions were confirmed to lack experimental notes. It has been confirmed that strains of some institutions reported to be separated in Korea are very similar to those of the United States. Specifically, the problematic strains had a genetic sequence consistency of 99.99% or more with the U.S. strains. While trying to determine the source of botulinum, there were also suspected violations of genetically modified organism and methods for prevention of infectious diseases related to safety management of pathogens. A total of four violations of the law, including two suspected violations of mobile reporting, one violation of genetically modified organism development and approval of experiments, and one suspected false separation report. In consultation with related ministries and the National Assembly, the KDCA plans to revise related laws, including the mandatory submission of strains to test records of bio-terrorism infectious disease pathogens, handler management, and bio-terrorism pathogen data (DB). It will also push for mandatory recording and management, such as preparing research notes and diaries for experiments and production processes related to bacterial handling. The government plans to investigate and analyze overseas cases so that it can check the criminal history and mental history of handlers and introduce the disqualification of handlers in accordance with domestic conditions. The goal is to prevent false reports and illegal transactions by making it mandatory to submit strains if they have bioterrorism pathogens such as botulinum bacteria. It will also quickly respond to bioterrorism by establishing an analysis of the entire sequence of bioterrorism pathogens, genetic diversity analysis, and molecular epidemiological in the event of bioterrorism. In addition, the government will prepare methods and procedures necessary for establishing and implementing security measures for fungal handling agencies to prevent exploitation, outflow, and deviant behavior of strains. "Botulinum, which produce neurotoxins that are fatal to humans, can pose a serious risk to people's health in the event of bioterrorism and accidents," Jeong Eun Kyeong, commissioner of the Korea Disease Control and Prevention Agency (KDCA) said. "We will compensate for the deficiencies in the bioterrorism pathogen management system confirmed by the investigation and strengthen safety management," she said.
- Policy
- Improvements to exempted calculation of psoriasis are urged
- by Kim, Jung-Ju Jun 07, 2021 06:05am
- #iThe registration for exempted calculation of severe psoriasis is just a year away. Patients have pointed out the difficulties and problems of the system. The point is that there are many unequal and unreasonable conditions, so the system should be improved to ensure quality before re-registration. The Korea Organization For Patient Group issued a press release today (3rd) calling for new and re-registration of special cases for severe psoriasis and improvement of the system. Psoriasis has been included in this list since June 2017. However, the government is applying exempted calculation only for "severe injuries" rather than all psoriasis. At the time, the NHIS estimated that out of a total of 1.5 million psoriasis patients, about 22,000 had severe psoriasis. Four years after the application of the special calculation case, only about 4,500 patients have been registered, and patient groups have called for improvement. The Korea Organization For Patient Group pointed out that compared to other immune diseases such as spondylarthritis ankylopoietica, Crohn's disease, and rheumatoid arthritis, the new registration period and baseline conditions for severe psoriasis are strict, which is equivalent to about 17,500 severe psoriasis patients. They also pointed out, "The fact that the existing treatment, which has been effective in treatment at the time of the five-year re-registration standard for calculation, has been set as a condition for re-registration adds to the difficult situation of psoriasis patients." This organization urged to apply the same special system for exempted calculation of severe psoriasis as ▲spondylarthritis ankylopoietica, Crohn's disease, and rheumatoid arthritis, and,▲it also urged the withdrawal of unreasonable criteria for discontinuing drugs under treatment when re-registration of special cases of calculation after 5 years. The Korea Organization For Patient Group emphasized, "These standard issues have lost equity compared to other diseases, and the pain and difficult situation of patients with severe psoriasis have not been properly identified, so they must be withdrawn."
- Policy
- NA prepares bill to prevent 'price cut lawsuit' gimmicks
- by Lee, Jeong-Hwan Jun 04, 2021 06:06am
- A bill to prevent pharmaceutical companies from filing administrative suits for the purpose of evading or delaying drug price cut dispositions made by the government is expected to be introduced at the National Assembly. The bill will prevent the recurrence of cases similar to the suspended execution of drug price cuts ruling for the brain function enhancer choline alfoscerate, which has been a hot issue since last year’s NA audit. An official from Woni Kim’s office of the NA Health and Welfare Committee explained, “The avoidance of drug price cuts and reimbursement suspensions by companies is an issue that every Health and Welfare Committee member should pay attention to. We are preparing to amend relevant laws.” Woni Kim’s office is not the only place preparing a bill. The bill will aim to recover the reimbursed benefits paid to drugs during the period that the price cuts were avoided using the suspension of execution when the pharmaceutical company that filed the administrative lawsuit in objection to the government’s price cut disposition loses the suit. The key is to impose a penalty and exercise the right to indemnity when a pharmaceutical company deliberately pursues a lawsuit to cancel or delay the government’s justifiable drug price cut disposition. Of course, the bill will also include a provision that compensates for the damage suffered by pharmaceutical companies during the litigation period if the government's unjustifiable drug price cut is proven in court after a pharmaceutical company wins the lawsuit. Also, retroactive application of the bill is also being reviewed in consideration of the fact that many drugs including choline alfoscerate are in litigation to cancel their price cuts. The issue of health insurance finances wasted due to objections to price cut dispositions has been an agenda discussed for many years including at last year’s audit. At the NA audit last year, NA Health and Welfare Committee members Insoon Nam and Jaekeun In of the Democratic Party of Korea had appealed the need to amend the laws, criticizing the cancelation and injunction suit filed by choline alfoscerate makers whose reimbursement reduction and price cuts were set. They pointed out that the administrative suits or suspension of execution filed for the drug price adjustment disposition are being used as a means to preserve or make profit for pharmaceutical companies, or that it is causing unreasonable loss of health insurance finances. In had said that an estimate of 150 billion won of health insurance finances was lost in three years from 2018 to 2020 due to the abuse of drug price reduction cancellation lawsuits by pharmaceutical companies. An official from a member’s office of the NA Health and Welfare Committee said, “Several ruling party members in the committee agree to the validity of such a bill and are coordinating the bill with the Ministry of Health and Welfare. Legislation of this bill requires careful examination in retrospective application, enforcement date, and the supplementary provisions, as the issue on choline alfoscerate is still ongoing.” The official added, “Some have criticized that the drug price reduction cancellation lawsuit and injunctions are being abused as marketing tools by pharmaceutical companies to minimize damage from such price reductions. The Ministry of Health and Welfare and the National Health Insurance Service also agree on the need for the bill, so we expect that a bill will be proposed soon.”
- Company
- Sales in the herpes zoster market have halved in 2 years
- by An, Kyung-Jin Jun 04, 2021 06:06am
- Sales in the domestic shingles prevention vaccine market, which had been on the mend, fell again. In December last year, sales of two vaccines to prevent shingles fell as the vaccination rate fell in the wake of the third pandemic of COVID-19. According to IQVIA, a pharmaceutical research institute, the size of the vaccine market for shingles prevention in the first quarter was ₩10.9 billion, down 10.8% from ₩12.2 billion a year earlier. It is down 44.5% from ₩19.7 billion. The first quarter of last year was a time when the economy stagnated sharply as COVID-19 pandemic began around the world. South Korea's two vaccines for shingles prevention were competing, but sales fell to the lowest level. This year's sales declined from the first quarter of last year, further slowing down. Two types of shingles prevention vaccines are being sold in Korea, including MSD's Zostavax and SK Bioscience's Sky Zoster. It was monopolized by Zostavax, but it continued to grow rapidly with the advent of Sky Zoster in late 2017. The successful shingles prevention vaccine market has worsened in the face of an unexpected infection crisis. Its fourth quarter sales increased to ₩27.9 billion and halved to ₩12.2 billion in the early stages of COVID-19 crisis. Although its second quarter sales recovered to ₩22.6 billion, but decreased again to ₩20.3 billion in third quarter and ₩17.3 billion in fourth quarter. Until the first quarter of this year, quarterly sales have fallen for three consecutive quarters, and have rarely recovered. The industry believes that the vaccine market for shingles prevention is more easily affected by factors such as the epidemic of infectious diseases than other drug markets prescribed for chronic diseases. Since it is a vaccine to prevent diseases, not treatments used in urgent situations, the inoculation rate will inevitably fall if patients avoid visits to medical institutions. The fact that the COVID-19 vaccination, developed by Pfizer and AstraZeneca since early this year, has also had some impact on the decrease in the number of other vaccinations. The market for adult vaccines is sluggish, with the exception of pneumococcal vaccines that benefited from COVID-19. Both Zostavax and Sky Zoster have drawn similar quarterly sales distributions since last year. Sales of Zostavax in the first quarter were ₩6.5 billion, down 10.9% from a year earlier. This is a 40.6% decrease from $10.9 billion (10.9 billion KRW) in previous quarter.Sky Zoster posted sales of ₩4.4 billion in the first quarter, down 10.6% from a year earlier. Compared to the previous quarter, it decreased by 30.6%. As sales of the two products showed similar ups and downs, market share was similar. Sky Zoster's share in the first quarter stood at 40.4%, no significant difference from 40.3% a year earlier. There is another variable in the domestic shingles prevention vaccine market. GSK reportedly applied to the MFDS for the approval of Shingrix earlier this year. Starting with FDA approval in 2017, Shingrix is a product that has been sold in major countries around the world. Demand was high enough to cause scarcity overseas. Market competition is expected to intensify if GSK starts selling Shingrix in Korea.
- Policy
- Humira's price cut 30% due to Adalloce Prefilled Pen listing
- by Kim, Jung-Ju Jun 04, 2021 06:06am
- Abbvie Korea’s lead product line Humira is facing an insurance price cut of 30%. This ex officio adjustment by the government is to be made due to the introduction of the two biosimilars earlier this year by Samsung Bioepis, including its Adalloce prefilled pen inj.. The Ministry of Health and Welfare (MOHW) is preparing to amend the 'drug benefit list and price ceiling schedule' to include such adjustments. Once the amendment is finalized, it will take effect from the 7th of this month. Humira is a biologic product approved for rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis, and Crohn’s disease, etc. Humira is facing price adjustments in Korea as Samsung Bioepis' biosimilar of this product, Adalloce Prefilled Syringe inj. 40mg and Adalloce Prefilled Pen inj. 40mg were listed in February. Under the Criteria for Decision or Adjustment on Drugs, the government may reduce the ceiling price of first-listed products, products with the same route of administration/ingredient/formulation, and those in the same class for mixed nutrient solutions to 53.55% of the original price when another company lists a drug with the same route of administration/ingredient/formulation. For narcotics and biologics, the price is adjusted to a 70% level. The MOHW ordered negotiations for Humira, under which the National Health Insurance Service (NHIS) and Abbvie Korea held negotiations from the 11th to 18th last month. However, the terms were not introduced or deliberated by the Health Insurance Policy Deliberation Committee as it missed the deliberation period. The price cuts will be at around 30% for each product in the Humira line. The MOHW is expected to make the final decision soon as the authorities believe that the price cuts are necessary for saving health insurance finances.
- Product
- Tylenol's sales at convenience stores rose 125% year-on-year
- by Jun 04, 2021 06:06am
- Convenience stores are also benefiting from the shortage of outpatient pharmacies' Tylenol as vaccination begins in earnest.Tylenol sales at convenience stores designated as household medicine rose. Household medicine sold at convenience stores First of all, CU's Tylenol sales increased 125.5% year-on-year. According to sales from May 27 to May 31, when vaccinations for people aged 65 or older began in earnest, it increased 89.9% compared to the previous month (April 26 to 30), and it also increased 68.1% compared to the previous week (May 20 to 24). In the case of Seven-Eleven convenience stores, sales of Tylenol increased 23.3% compared to the previous month, especially sales from the 27th to 30th increased 99.6% from the same period last month. In the case of GS25 convenience stores, Tylenol sales rose 41.9% last month from a year ago and 38.8% compared to the previous month, the survey showed. In some convenience stores, Tylenol is in short supply like pharmacies. "The number of consumers visiting Tylenol has increased recently," said CU convenience store owner in Seoul. Both Tylenol 500mg and Tylenol160 mg are out of stock, he said. "We only have children's syrup in stock at the moment." Meanwhile, the Gyeonggi Pharmaceutical Association criticized the government and the vaccination center's inexperienced administration for causing Tylenol shortage on the 1st and insisted that Tylenol should not be sold at convenience stores for a while as it is time to manage side effects.
- Product
- Korean Tylenol is in stock
- by Jun 04, 2021 06:05am
- "It doesn't have to be original Tylenol." Pharmacists have launched a counterattack in connection with the Tylenol shortage. As Tylenol has been out of stock for months to respond to consumers due to recommendations from vaccination centers and health centers, pharmacists are trying to immediately inform them of fever and painkillers. They started to improve consumer awareness by spreading the message that It doesn't have to be original Tylenol through pharmacies and SNS. First of all, pharmacist Lee Jung-chul, the author of "Alssulshinyak" told by dispensing brothers, recently posted a message on blogs and YouTube saying, "You don't have to stick to Tylenol after the vaccine against COVID-19." The pharmacist recognizes that "the painkillers available after COVID-19 vaccine are Tylenol unconditionally, but there is no need to insist on Tylenol." Tylenol is just one of many drugs made of Acetaminophen, and said, "There are many drugs made of the same Acetaminophen even if they are not Tylenol." Since Tylenol has become an issue due to its high recognition of many drugs with Acetaminophen, there is no problem in taking Acetaminophen, the same active ingredient as Tylenol, in situations where Tylenol is not easy to obtain. "About 10 to 20 consumers a day visit and ask for Tylenol," said pharmacist Lee Jung-chul. "It doesn't matter if it's Acetaminophen, but if patients don't understand or if the media or hospitals nominate Tylenol, they often think they can't do other drugs," he said. "I'm filming a video out of frustration, and I hope the message will be shared widely." The pharmacist explained, "In fact, the number of cases where people accept and buy other products is increasing if they use the 'Ask a Pharmacist' card news produced by the Korean Pharmaceutical Association." Tylenol-related notice attached to the entrance of a pharmacy in Incheon A pharmacist in Incheon recently attached a sign that Tylenol is out of stock and there's a stock of same active ingredient to the entrance of a pharmacy and a consultation desk. Tylenol is Acetaminophen formulations made by Janssen, a foreign company, under the notice, "If you take fever and painkillers after the COVD-19 vaccine, take Acetaminophen-based medicine." There are 80 items such as Suspen, Tramol, Tacenol, Nasphen, and Setopen," a notice said. The pharmacist said, "When asked repeatedly by consumers if they had Tylenol in stock all day, the voices of working pharmacists were hoarse. "It was like the public mask crisis in the past," he said. "We changed our sales strategy because of the release of good domestic drugs." In addition, pharmacists who run SNS channels such as blogs, Instagram, and YouTube are also participating in "Knowing About Acetaminophen Right away," explaining the types of Acetaminophen, how to take it, and alternatives. The Korean Pharmaceutical Association and the MFDS urgently produced posters and distributed them to pharmacies about the ridiculous situation of trying to buy only Tylenol at pharmacies despite the presence of a number of Acetaminophenes. Posters distributed by the Korean Pharmaceutical Association & the MFDS The Korean Pharmaceutical Association and the MFDS posted a poster saying, 'Relax if some items are out of stock. There are about 70 Acetaminophen formulations approved by the MFDS. Talk to a pharmacist' in the message.
