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- 2026-05-17 05:43:52
- Policy
- Following Kymriah, Zolgensma is also about to be reviewed
- by Lee, Tak-Sun Feb 09, 2022 06:09am
- Jang Yong-myung, executive director of HIRA development, briefing with reporters at Korea Special Press Association on the 8th So-called "one-shot treatments" that treat specific rare diseases with one administration are speeding up the reimbursement. Following Kymriah, which treats blood cancer such as leukemia and lymphoma, Zolgensma (Onasemnogene Abeparvovec), which treats a rare disease called SMA, is also set to be reviewed by HIRA's Drug Reimbursement Evaluation Committee. These drugs were difficult for patients to access because of their high price instead of high therapeutic effects, but if they are reimbursed, the burden of drug prices is expected to be relieved. Jang Yong-myung, executive director of HIRA Development, said at the Korea Special Press Association meeting on the 8th that Zolgensma will deliberate on the Drug Reimbursement Evaluation Committee to evaluate the adequacy of medical care benefits. Zolgensma is a drug that can treat spinal muscular dystrophy with a single dose. Spinal muscular dystrophy is a fatal rare genetic disease in which muscles are gradually contracted due to deficiency or mutation of normal SMN1 genes, and if not treated, 90% of SMA type 1 dies before the age of 2 or requires permanent respiratory aids. More than 30% of SMA type 2 patients can also die before the age of 25, requiring lifelong treatment. Zolgensma replaces genes that can prevent SMA progression, so it is expected to improve the quality of life of patients and their families as it can be fundamentally treated only once in a lifetime with intravenous administration. It is an ultra-high-priced new drug worth about 2 billion won, and it is too expensive for patients to handle, so being paid is the only hope for patients and their families. Accordingly, the solution found by the insurance authorities allows pharmaceutical companies to refund the amount paid to patients who was not effective. Executive Director Jang said, "Kymriah and Zolgensma are one-shot treatments that expect therapeutic effects from single administration, but there is a limit to proving cost effectiveness through existing evaluation methods due to high price and long-term uncertainty." "In the case of Kymriah, all patients who have been administered will be obligated to collect patient conditions for a certain period of time, and according to the results of the patient-level performance evaluation, pharmaceutical companies will refund a certain amount of money after administration," he explained. He also said, "If we claim more than a certain amount, we will pay on the condition of a contract that returns all excess amounts," adding, "We will be subject to risk-sharing revaluation after the fourth year of registration." Kymriah passed the Reimbursement Evaluation Committee on the 13th of last month under these conditions. As the adequacy of benefit has been recognized, it will now be possible if negotiations between the NHIS and pharmaceutical companies proceed smoothly. The HIRA plans to evaluate the adequacy of benefit in the same way as Kymriah or Zolgensma. Novartis applied for a decision on medical care benefits for Zolgensma in May last year and is currently being reviewed by the HIRA. It has been collecting opinions from the society since July last year, and at the end of last year, an expert advisory meeting was held to discuss clinical usefulness. At the end of January, the Drug Benefit Standards Subcommittee also reportedly set the benefit criteria. Executive Director Jang said, "Zolgensma is also considering a therapeutic performance-based refund mechanism to overcome the limitations of proving uncertainty and cost-effectiveness about long-term effects, just like Kymriah, as a drug that is effective with one administration."
- Policy
- Novavax vaccine passed the national lot release procedure
- by Lee, Hye-Kyung Feb 09, 2022 06:09am
- 840,000 doses of Nuvaxovid PFS, a Novavax vaccine, have been released in the national lot. The MFDS (Minister Kim Kang-rip) announced on the 8th that SK Bioscience has approved 840,000 Nuvaxovid PFS manufactured in Korea for the first time. Nuvaxovid PFS, which was approved for shipment to the country this time, is a vaccine manufactured in a way that has already been used for hepatitis B and cervical cancer vaccines. The vaccine can be immediately inoculated with a PFS-typed single injection that contains one dose per vaccine without dilution or subdividing, and the MFDS expects people to be vaccinated conveniently, such as being used for visits by elderly and severely disabled people. National Lot Release refers to a system in which the state comprehensively evaluates the results of the inspection test and the results of the manufacturer's manufacturing and testing for each manufacturing unit (lot) before the vaccine is distributed on the market. The MFDS verified the manufacturer's test method from 2021 for the national lot release of Nuvaxovid PFS, established its own test method, introduced equipment such as enzyme analysts, reviewed the manufacturing and test data for 840,000 times, and decided to release the national lot. As a result, Potency assay and content assay were conducted to confirm that the product was not contaminated by conducting sterility tests and endotoxin tests, and quality test data issued by the manufacturer's quality assurance manager were reviewed to produce consistent quality. The MFDS said, "We will continue to do our best to ensure that quality vaccines are stably supplied by quickly and thoroughly verifying the COVID-19 vaccine introduced in Korea." Information on the national lot release of the COVID-19 vaccine can be found on the COVID-19 vaccine and treatment information (www.mfds.go.kr) on the representative website of the MFDS.
- Company
- Famotidine market triples 2 years after ranitidine issue
- by Chon, Seung-Hyun Feb 09, 2022 06:09am
- The H2 receptor antagonist market had fluctuated with the ban of the ranitidine ingredient in antiulcer drugs. The gap made by the exit of ranitidine initially shrunk the market into nearly half its size. Famotidine enjoyed the most reflective benefits with its market size increasing nearly threefold after the ranitidine impurity issue. Also, nizatidine, which also experienced an impurity issue, recently showed strong growth. According to the market research institution UBIST on the 8th, outpatient prescriptions of H2 receptor antagonists last year recorded ₩151.8 billion, an 11.2% increase from the previous year. This is the first time in 3 years the market showed year-on-year (YoY) growth. H2 receptor antagonists such as ranitidine, famotidine, nizatidine, lafutidine, roxatidine, and cimetidine are used for gastric and duodenal ulcers and reflux esophagitis. The H2 receptor antagonist market had significantly shrunk for two consecutive years since recording ₩346.5 billion in prescriptions in 2018. Its prescription market shrunk 60.6% in two years to record ₩136.5 billion in 2020. The market took a hard blow with the ban of its leading ingredient, ranitidine. In September 2019, the Ministry of Food and Safety decided to ban sales of all products containing ranitidine due to an excessive amount of a carcinogenic substance, ‘n-nitrosodimethylamine (NDMA),' being detected in the products. At the time, prescriptions of ranitidine-containing pharmaceuticals had accounted for 77.7% of the H2 receptor antagonist market, bringing in ₩269.2 billion in prescriptions in 2018. Although the H2 receptor antagonist market took a hard blow with the exit of ranitidine, the market has been making a rebound recently with the increase in prescriptions of other ingredients of the same class. Outpatient prescriptions of H2 receptor antagonists other than ranitidine recorded ₩151.7 billion last year, an 11.2% increase from the previous year. This is more than twice an increase from the ₩77.2 billion made by the same ingredients in 2018, before the ranitidine impurity issue. Among the ingredients, the famotidine market has shown the strongest growth. Prescriptions of famotidine recorded ₩60.5 billion last year, an 8.9% growth from the previous year. Compared to the ₩13.7 billion made in 2018, its market expanded by over threefold in three years. In 2018, famotidine’s sales had been on a downward trend, showing a 44.4% decrease YoY. However, its sales took an upward turn with the exit of ranitidine from the market. Famotidine had only accounted for 4.9% of the market in 2018, but its share surged 39.9% last year. Dong-A ST’s Dong-A Gaster drove the growth. Dong-A Gaster sold ₩12.5 billion last year, a fourfold increase from the ₩3.1 billion 3 years ago. Nizatidine, which had once been embroiled in impurity issues, has also shown strong growth. Nizatidine’s prescriptions recorded ₩46.1 billion last year, which is a 32.9% increase from the previous year. Also, its sales expanded 50.0% in two years from the ₩30.8 billion in 2019. The MFDS had suspended sales of 13 nizatidine products in October 2019 due to excessive level of impurities detected in the products. The industry’s analysis was that the permit to sell the nizatidine products that were not found to have impurity issues had allowed the products to enjoy reflective benefits from the ban of the ranitidine ingredient. Nizatidine had ranked third in the H2 receptor antagonist market after famotidine and lafutidine but then jumped to rank second with the surge in its prescriptions. Prescription of lafutidine products recorded ₩36.1 billion last year, a 2.3% increase from the previous year. This is also an 11.5% increase from the ₩16.8 billion 3 years ago. Although its growth had slowed down somewhat recently, its overall market size had grown significantly since ranitidine’s exit. Sales of roxatidine products had also nearly doubled from ₩2.6 billion in 2018 to ₩5.1 billion last year. The only major H2 receptor antagonist ingredient that did not enjoy reflective benefits from the ranitidine ban was cimetidine. Prescription of cimetidine products fell to ₩3.9 billion, a 75.2% drop from 3 years ago. Such reduction in prescriptions is analyzed to have been due to the prolonged unavailability of key products that arose due to disruptions in the supply of its raw materials.
- Company
- Can the Antigen Rapid Test be widely used?
- by Choi-sun Feb 09, 2022 06:09am
- Although they are concerned about the transition to the COVID-19 test system, which adds the Antigen Rapid Test to the current PCR test, opinions are divided as they argue that this is only a concern. Unlike the initial virus that occurred in Wuhan two years ago, mutant viruses such as Omikron have a lot of detection in the body, so the Antigen Rapid Test can play a sufficient role, but they are still concerned. According to the medical community on the 28th, concerns and expectations were simultaneously confirmed by the medical association over the government's transition to the COVID-19 test system. The COVID-19 test method includes PCR tests that amplify and test genes and Antigen Rapid tests that use the principle of antigen detection by immune responses after virus infection. PCR (rRT-PCR, qRT-PCR), which collects secretions by inserting cotton swabs into the nostrils, has more than 98% accuracy and 100% specificity, and PCR through saliva reaches 92% sensitivity and 100% specificity. Although the accuracy is high, the results can be confirmed one to two days after the test, considering the time required for genetic testing and sample transfer. On the other hand, the Antigen Rapid Test has a sensitivity of 90% or more and a specificity of 99%. The Antigen Rapid Test is used at a time when the amount of virus in the body is high to obtain more accurate results, and when used at a time when the amount of virus is low, false negative results are likely to be derived. GCMS's Antigen Rapid Test "GENEDIA W COVID-19 Ag" The sensitivity of 80% means that 80 out of 100 samples confirmed positive by genetic testing are tested positive, but 20 are incorrectly tested negative. However, the Antigen Rapid Test has the advantage of being able to determine whether or not to be infected immediately when rapid results are needed in the field. The KSLM is concerned about the government's transition to the inspection system Sung Heung-seop, director of infection control at The KSLM, said, "We have built up to 850,000 test capabilities a day with PCR, but it is difficult to understand why it was approved as a test method even though experts pointed out the low sensitivity of rapid antigen testing several times." He pointed out, "The fact that the accuracy of the rapid antigen test is more than 90% is the value when the virus emission is at its maximum level from 3 to 5 days after the onset of symptoms." The argument that the test system needs to be changed is also convincing as antiviral drugs that are directly linked to the prognosis were introduced in the early stages of administration. Unlike the early Wuhan virus, the late mutation that led to Delta and Omicron is characterized by strong propagation power due to the large amount of viruses. 99% of new confirmed patients in the U.S. are infected with Omicron, and more than 50% of them are currently infected with Omicron in Korea, and have already become the dominant species. Kang Yoon-hee, a specialist in diagnostic testing, explained, "Before delta mutations, there were certainly not many detection of viruses in the body, but the situation changed rapidly due to mutations." Specialist Kang Yoon-hee explained, "The lower the Ct value, the higher the amount of virus emitted, the more sensitive the sample was 81%, and most of the ohmicron mutations were less than 23%." Studies on the subject of changes in the sensitivity of antigen testing and relative accuracy with PCR are also accumulating.A comparative test of the Antigen Rapid Test and PCR conducted by researchers at Johns Hopkins Bloomberg School of Public Health (JHSPH) such as Andy Pekosz was released in November last year. The study compared the two test methods by collecting upper respiratory samples from 251 people 7 days after the outbreak of COVID-19. As a result, the positive prediction value of the Antigen Rapid Test was 90%, higher than 70% of rt-PCR. Based on this, the researchers judged that "antigen testing can be a better factor for people with a high risk of having a highly contagious virus."
- Policy
- Focus on the possibility of NovaVax vaccine booster shot
- by Lee, Tak-Sun Feb 08, 2022 05:55am
- Experts expressed great interest in the cross-vaccination use of the vaccine during the Novavax COVID-19 vaccine screening process approved in Korea on the 12th of last month. This is because Novavax is likely to be used for additional vaccinations, so-called booster shots, in a situation where most people have been vaccinated with different types of vaccines. However, the MFDS said that among the clinical data submitted by the company, there is a lack of valid data for cross-vaccination, and that cross-vaccination can be considered only when basic vaccination permission is given priority. Such information is recorded in the minutes of the Central Pharmaceutical Affairs Council released on the website of the MFDS on the 7th. Novavax was approved in Korea under the product name Nuvaxovid PFS on the 12th of last month. SK Bioscience receives technology transfer from Novavax and manufactures the vaccine from the undiluted solution to the finished product. It is the first gene recombination vaccine licensed in Korea, and is the fifth approved COVID-19 vaccine after AstraZeneca, Janssen, Pfizer, and Moderna. After the MFDS' self-examination, it was finally approved through a verification advisory group composed of experts, the Central Pharmaceutical Affairs Council, and the final inspection committee. Among them, the Central Pharmaceutical Affairs Council has the greatest impact on vaccine licensing. Fifteen external experts and eight officials from the MFDS attended the Central Pharmaceutical Affairs Council meeting held at 2 p.m. on the 6th of last month in the headquarters of the MFDS in Osong. Experts who attended that day asked about the evaluation of related efficacy, saying that the Novavax is likely to be used for additional vaccinations (booster shots) with the majority of Koreans receiving the existing vaccine. The MFDS said, "The difference between this applied vaccine and the existing one is a single-use PFS, and if it is not used within the deadline after opening as a multi-use vial, it should be discarded." The MFDS also said, "It is also advantageous in terms of compliance with administration as a vaccine for gene recombination platforms that have already been commercialized." Since the company announced plans to develop adolescents and additional vaccinations, the MFDS expressed expectations for youth use with low vaccination rates. In response, a member of the committee asked, "Is there any study conducted as an additional vaccination for vaccines on other platforms in foreign countries?" and the MFDS replied, "According to data released in the UK, additional vaccinations were made for companies D and B." The MFDS explained, "When additional vaccinations were given to those who completed the basic vaccination of Company D, they showed a higher immune response than those who received the virus vector vaccine." However, the MFDS said, "After deciding whether the safety and effectiveness of the applied vaccine can be recognized in terms of permission, the quarantine authorities will decide whether to use it by reflecting the current situation." The MFDS also stressed, "Additional vaccinations can be reviewed only when permission for basic vaccinations is decided first." Nevertheless, at the meeting, some suggested that an additional phrase "need to check cross-vaccination data later" is needed for Novavax permits. The MFDS replied, "In some cases, normal cross-vaccinations can be confirmed through the published results of other research institutes such as universities, and it is difficult for the company to submit all of them." As a result, the committee agreed to approve the Novavax as "for use twice every three weeks for those aged 18 or older," but did not conclude separately regarding cross-vaccination. Meanwhile, the Novavax is expected to begin vaccination for unvaccinated patients at each hospital and clinic soon after approval from the MFDS.
- Company
- EUSA Pharma establishes subsidary in Korea
- by Eo, Yun-Ho Feb 08, 2022 05:55am
- The UK-based pharmaceutical company EUSA Pharma is entering the Korean market. According to industry sources, EUSA Pharma established the Asia Pacific Regional Headquarters in Korea and launched its Korean subsidiary, EUSA Pharma Korea. EUSA Pharma is a global specialty pharmaceutical company that focuses on rare and incurable diseases that were established with funding support from a leading life science investor EW Healthcare Partners. The company is currently a multinational pharmaceutical company that has branches in Europe, the Middle East, Africa, the United States, South America, the and Asia Pacific region, and recorded sales of 130 million euros as of June 2021. Its leading product is ‘Sylvant (siltuximab),’ a Multicentric Castleman‘s Disease treatment that is being distributed by Janssen Korea in Korea. Sylvant is being listed and prescribed with reimbursement from February 2018. Also, Yeon Jae Lee was appointed General Manager of the Asia Pacific region and Korean subsidiary. Lee is a seasoned professional in the pharmaceutical industry, who served in various posts at Novartis Korea, Daewoong Pharmaceuticals, and as the Country Head of UCB Korea and the Head of Rare Blood Disorders at Sanofi-Aventis Korea. Meanwhile, the Italian pharmaceutical company Recordati confirmed the deal to acquire EUSA Pharma at the end of last year. As the acquisition process is expected to be completed within the first half of this year, Whether EUSA Pharma will be maintained in its current form remains to be seen.
- Product
- Defective tablets of Lipitor were found
- by Kim JiEun Feb 08, 2022 05:54am
- (left) A case of powder mixing in 90 tablets of 20 mg of Lipitor at the end of last year, and (right) a broken drug was recently found in the same product Defective drugs have been found one after another in Lipitor, one of the most frequent prescription drugs, requiring caution when preparing. According to a pharmacist in Seoul on the 3rd, a defective tablet was recently found in a bottle of Lipitor again following November last year. The pharmacist said he found a suspicious substance while charging the drug to ATC in November last year. A broken tablet came out of the medicine container, and the manufacturing number of the drug in which the problem was found is 100005333068. The pharmacist said he could not confirm whether the number of tablets was insufficient due to other drugs that had already been charged, as he found in the process of filling ATC with drugs. The pharmacist estimated that foreign substances were mixed during the manufacturing process. The problem is that more than two months after this happened, defects were found again in the same product recently. One of the tablets was broken into half. The pharmacist saw that the tablet was broken during the distribution process and looked at the medicine container again, but did not find any remnants of the broken tablet. The manufacturing number of the packaging, where the defective drug was found this time, is 180164582867. The pharmacist said, "I think the powder was mixed before the drug was made into tablets," adding, "As defective drugs were found one after another in the same drug, I thought it was necessary to check whether there was a problem in the manufacturing process." This pharmacist said, "It's famous original medicine". He added that he doesn't readily understand that such a defective drug is found. Pfizer said a precise confirmation process is needed for related content. As related information has been received, the government plans to take action through a pharmacy to confirm the drug in question. A company official said, "There have been no cases of defective drugs such as powder mixing or tablet damage in Lipitor, especially similar cases in related lot numbers," adding, "We need to collect related drugs and check them accurately." In the case of refining damage, we regularly check whether the amount set during the production process meets the set acceptance standards such as the presence or absence of refining abnormalities, but it is possible that we have not been able to completely distinguish the damage control during the packaging stage, in the case of powder mixing cases, additional confirmation is needed, he added.
- Company
- Entresto's outpatient prescriptions exceed ₩30 billion
- by Feb 08, 2022 05:54am
- Pic. of Entresto Sales of Novartis’ chronic heart failure treatment ‘Entresto’ exceeded ₩30 billion only 5 years into its release. In the midst of drug price cuts and domestic patent challenges, Entresto is seeking greater growth this year by expanding the scope of indications and reimbursement benefits. According to the market research institution UBIST on the 29th, outpatient prescription sales of Entresto recorded ₩32.3 billion, a 37.3% growth from the ₩23.5 billion made in the previous year. The product made such growth in only 4 years since its release in October 2017. Entresto is a first-in-class angiotensin receptor-neprilysin inhibitor (ARNI) that combines the angiotensin receptor blocker (ARB) valsartan and neprilysin inhibitor sacubitril. The drug may be used as an alternative to an angiotensin receptor blocker (ARB) or an angiotensin-converting enzyme (ACE) inhibitor in patients with left ventricular (LV) dysfunction in combination with other heart failure treatments. Entresto received marketing authorization in April 2016 and was officially launched with reimbursement in October 2017. Entresto’s explosive growth was well expected. The drug demonstrated its efficacy and safety in acute heart failure in addition to chronic heart failure, and academic societies in Korea and abroad recommend Entresto as a standard of care. Also, the American Heart Association recommended Entresto as the standard of care for heart failure with reduced ejection fraction (HFrEF). Until now, ACE or ARB inhibitors were mainly used in patients with chronic heart failure. Replacing this demand, Entresto quickly increased its share in the market. Its outpatient prescription sales, which started at ₩300 million in 2017, increased 20 times to ₩6.3 billion the next year. In 2019, its sales doubled once more to ₩15 billion, then rose to exceed ₩30 billion only 2 years since then. To slow down such growth, pharmaceutical companies in Korea have aggressively set out to challenge Entresto’s patent. 13 domestic companies including Hanmi Pharmaceuticals and Chong Kun Dang filed patent challenges last year. The Intellectual Property Trial and Appeal Board ruled in favor of the generic companies in the trial to confirm the passive scope of rights of Entresto’s crystalline patent. By overcoming the key patent among 5 of Entresto’s patents, the domestic generic companies are speeding up their challenges. Also, Entresto’s price will undergo additional price cuts. The Ministry of Health and Welfare is working to cut Entresto’s price by 6.6% as of February 1st under the ‘‘Amendment to the drug reimbursement list and reimbursement ceiling price table.’ Entresto is subject to pricing cuts under the ‘Use amount-price linkage-type B’ where a product whose use increased over 10% in an amount over ₩5 billion undergo price cuts. The price of Entresto, which was listed at ₩2,243 at the time of first listing, will be reduced to ₩1,910 through three pricing adjustments. Novartis plans to continue its strong growth by adding indications and expanding Entresto’s reimbursement standards. Its indication for HFpEF is one of the company’s key areas of interest. Although around half of all patients with heart failure suffer HFpEF, which is defined as a left ventricular ejection fraction of 40% or higher, no appropriate treatment had existed for the condition yet. Novartis demonstrated that Entresto can reduce the risk of hospitalization from heart failure and cardiovascular death through the PARAGON-HF trial. The UF Food and Drug Administration additionally approved the HFpEF indication for Entresto in January last year. In line with the added indication, Novartis is working to expand the scope of Entresto’s reimbursement to first-line therapy in HFrEF.
- Policy
- HPV vaccine expanded free vaccination for men and women
- by Lee, Jeong-Hwan Feb 08, 2022 05:54am
- It is estimated that about 200 billion won will be spent over the next five years to expand the national vaccination target of HPV vaccination to children aged 11 and 12 regardless of gender. Assuming that the target vaccination rate is 89%-100%, an annual average budget of about 40 billion won is needed. This is the result of Baek Jong-heon, a member of the National Assembly, entrusted with the cost estimation of some revisions to the Infectious Disease Prevention and Management Act proposed by the National Assembly's Budget Office on the 4th. Baek Jong-heon proposed a bill to expand the subject of HPV national vaccination (NIP) to children aged 11 and 12 regardless of gender. As a result of the cost estimation by the Ministry of Budget and Policy, a total budget of 2015 billion won to 210.5 billion won will be needed depending on the target vaccination rate. Specifically, the current HPV vaccine NIP is inoculating 12-year-old women. Accordingly, in the first year of implementation of the amendment, the cost of inoculation for 11-year-old women was estimated, and from the second year of implementation, the cost of inoculation for women was excluded from the estimation. The target vaccination rate was estimated by dividing it into two scenarios because the inoculation rate of 89.6% and 100% in 2020 were separately counted. The vaccine cost was 62,200 won for HPV4 at the public health center, reflecting the average increase in the number of vaccines over the past three years (2019-2021). As a result of the estimation, a total of 2015 to 210.5 billion won was estimated from 2022 to 2026 when HPV vaccinations were conducted for 11-year-old women and men aged 11 to 12 according to the revision of Baek Jong-heon. In the case of scenario 1 with an 89.6% vaccination rate, a total of 201594 billion won will be required for five years from 2022 to 2026, including 79.242 billion won in 2022 and 30.736 billion won in 2026. When the inoculation rate was estimated to be 100% scenario 2, it was estimated to be 210.512 billion won for five years from 2022 to 2026, including 88.439 billion won in 2022 and 30.787 billion won in 2026.
- Policy
- Generics for Bridion are being released one after another
- by Lee, Tak-Sun Feb 07, 2022 05:58am
- Generic drugs are being released one after another ahead of the patent expiration in April, with the drug Bridion (Sugammadex Sodium, MSD), which helps wake up from anesthesia during surgery. As the domestic market size of the drug alone is around 40 billion won, domestic generic companies are expected to aggressively target the market. According to the MFDS on the 6th, six generics of Sugammadex Sodium have been approved so far since Hanlim was first approved on December 29 last year. Bridion is a drug that directly acts on the relaxation of the muscles used for patient anesthesia and restores them to their original state. In patients over the age of 2, it is used in reverse of neuromuscular blocking induced by Vecuronium or Rocuronium. These are muscle relaxants used for patient anesthesia during surgery. Bridion, approved in Korea in October 2012, is also a new anesthetic antagonist drug that came out in 20 years. In particular, this drug is widely used because it can provide a stable surgical environment to medical staff in that it acts directly on muscle relaxants and acts within 3 minutes. Existing drugs were indirectly applied to muscle relaxation drugs, resulting in slow recovery of relaxed muscles. Bridion's rapid action not only enhances surgical stability, but also relieves concerns about muscle relaxation remaining after surgery. In particular, existing anesthetic antagonists have the advantage of being used even for patients with respiratory or cardiovascular diseases that are highly likely to have side effects. With this differentiation, Bridion is maintaining high growth in the domestic market. In the second quarter of last year based on IQVIA, its performance was 11.2 billion won. The drug, which recorded 39.1 billion won in sales in 2020, is said to have surpassed 40 billion won last year. Market sales were so high that other generic companies also paid attention early on. However, material patents are valid until April 12 this year. Since 2018, pharmaceutical companies such as Daewoong Pharmaceutical and Chong Kun Dang have been challenging patents, but all of them have been dismissed by the Intellectual Property Tribunal. As the patent expiration time is imminent, generic drugs are preparing to be released with permission. First of all, Hanlim was approved for the first generic under the product name Briturn on December 29 last year. In January, products from Sandoz Korea, BMI Korea, and Huons were approved. On the 4th, Boryung Pharmaceutical and Jeil Pharmaceutical were then approved by Huons for items that were commissioned. These generic drugs are expected to be released on the market from April 13, when patents are terminated. As it is such a large-scale drug in the market, expectations for sales performance are high, but the prevailing opinion is that it will be difficult to win the competition of the original drug. In the case of general hospitals that perform a lot of surgery, the reliability of original is much higher. It remains to be seen whether generic drugs will overcome this and set meaningful records in terms of market share.
