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- 2026-05-08 20:11:20
- Policy
- Permission is increasing prior to the end of PMS
- by Lee, Tak-Sun Jun 04, 2020 10:41pm
- Hanmi's RosuzetEven before the end of PMS (Post marketing surveillance), a lot of new items have been approved through a contract production contract with the original company. Since PMS system in Korea is also provided with the data protection function of the original drug, it is possible to apply for a license for the same ingredient after PMS expires. However, as more and more original companies share item data in order to expand commissioned production, market competition is intensifying even before PMS. According to the industry on the 3rd, 18 new drugs (6 companies) were approved for the hyperlipidemic complex (Rosuvastatin and Ezetimibe) on the 29th of last month. New products have been released in about 3 years since December 2017. The first licensed item for this formulation is Hanmi's Rosuzet. Rosuzet was approved in June 2015. Subsequently, by December 2017, 84 additional drugs with the same ingredients were approved. All of these items, including Rosuzet, are drug for data-based re-evaluation, and were granted PMS until June 7, 2021, in recognition of the new combination of the two ingredients. During this period, the vendor of the item should conduct a post-marketing investigation on a certain patient. If post-marketing investigation is mandatory, data protection rights are also granted to prevent the generic drug of the same ingredient from applying for permission during the PMS period. As expected, until June 7, 2021, the same ingredient generic cannot apply for permission. However, 18 items that received this new license were commissioned and produced by the original PMS-granted original company and shared data, making it possible to enter the market. In 2016, it was approved through Ajou Pharm, which has been approved for Cretrol. Imported original companies do not increase their competitors. However, these days, domestic companies often share it with competitors even though it is a drug that has been granted exclusive rights. As for the sustained-release tablet of the indigestive drug, Mosapride citrate, PMS expires on June 29th, but 50 items of the same ingredient have already been approved. The original company, Daewoong Pharmaceutical, was granted permission to share data and produce it in consignment. Telmisartan, Amlodipine besylate The hypertensive complex Telmisartan-Amlodipine besylate complex also ends PMS on October 30th, but only 30 items have been approved this year. This is because Ildong Pharmaceutical, one of the original companies, is a consigned product. This trend is accelerating in recent years as the calculation of consignments aimed at rapidly entering the market and pharmaceutical companies seeking to increase profits by expanding commissioned production. However, pharmaceutical companies that maintain the No. 1 market share are not happy with the addition of competitors. These are Hanmi Pharm, which owns Rosuzet, and Yuhan, which has a dominant share of Duowell (Telmisartan-Amlodipine besylate) and Gastin CR (Mosapride citrate sustained release tablet). Industry officials said, "This is a result of a combination of Korean development situations driven by lucrative items."
- Policy
- Labeling will be promoted on product packaging
- by Lee, Tak-Sun Jun 04, 2020 06:14am
- In the future, it is expected that pharmaceutical companies carrying out bioequivalence tests will be separately labeled on generic drug packaging. In addition, policy initiatives are being undertaken to strengthen the global competitiveness of generic drugs, such as finding ways to disclose generic companies on a manufactory basis. The MFDS announced on the 1st that it is planning to draw the final plan through the public-private consultative body to strengthen the international competitiveness of generic drugs by this month. The public-private consultative body, which strengthens the international competitiveness of generic drugs, has been in operation since April, consisting of about 50 people from the pharmaceutical industry, academia, medical experts, patients, and consumer groups. The tasks for which the public-private consultative body came up with the final plan are: ▲ Conduct bioequivalence test, strengthen drug labeling and information disclosure ▲ Develop bioequivalence test evaluation indicators and disclose evaluation results ▲ Establish a generic drug database for each ingredient. First, among generic drugs, the number of bundled products that are entrusted and manufactured by companies that have not already conducted a bioequivalence test directly is increasing. Therefore, it is necessary to promote a method of labeling the product, such as the name of the pharmaceutical company that actually conducted the bioequivalence test. In particular, the MFDS explained that it is also considering ways to bundle generic drugs with the same bioequivalence test as a factory standard, and to disclose the information through the MFDS website and prescription preparation system. It means that bioequivalence tests are conducted on generic drugs, and products that are manufactured directly and products that have been granted product approval through consignment manufacturing are released together. The MFDS will also develop bioequivalence quality assessment indicators and disclose the evaluation results. It is a plan to increase the quality level and reliability of generic drugs by preparing quality evaluation indicators and transparently disclosing the evaluation results so that they can evaluate the quality level of generic drugs. The MFDS said that the analysis of the effect of the actual use stage after marketing, the MFDS in the bioequivalence test results indicates the ratio (The closer to 1 means the same) of the generic drug (test drug) to the original drug (control drug), the frequency of side effects after the generic drug is marketed may be an example for the quality evaluation index. In addition, the generic drug, which is manufactured by entrusting the entire process, will also clarify the responsible relationship between trustees, such as entrusting quality control obligations to consigned companies and strictly managing quality management of consigned companies. In addition, the establishment of a generic drug database for each ingredient will be promoted. In response, the MFDS will explain the current status of generics by ingredient in English so that overseas buyers and distributors can identify them to support the global advancement of generic drugs, and will also provide them to international organizations such as the World Health Organization (WHO). An official from the MFDS said, "We plan to prepare a plan to improve the specific system so that the contents under the agreement can be carried out normally in the public-private consultative body, and to prepare and announce a detailed action plan for the improvement method by the end of June."
- Policy
- The MFDS designated Mobocertinib as an orphan drug
- by Lee, Tak-Sun Jun 03, 2020 06:25am
- The MFDS (Minister Eui-kyung Lee) announced that Mobocertinib was newly designated as an orphan drug, and it announced on June 1 that target diseases were added for three types, such as Ipilimumab, designated as an orphan drug. An orphan drug is a drug that is used for the purpose of diagnosing or treating a rare disease, a drug that has no or no substitute drug, or is significantly improved in safety or effectiveness than a substitute drug, and has been designated by the MFDS. In order to support the development of treatments for rare and incurable diseases, the MFDS firstly authorizes orphan drugs and operates 'Orphan drug designation system' so that it can separately set data, standards, and conditions for approval according to the nature of the disease. The main announcement of this orphan drug designation was that Mobocertinib was designated for the treatment of patients with non-small cell lung cancer with epidermal growth factor receptor mutation, and Ipilimumab has been further designated for use in recurrent metastatic colorectal cancer in adult patients with DNA mismatch repair defects, etc. Also, Ixazomib was added to maintenance therapy of patients with multiple myeloma who received autologous hematopoietic stem cell transplantation, and Ravulizumab was added as a treatment for patients with atypical hemolytic uremic syndrome. Atypical Hemolytic Uremic Syndrome (aHUS) is a disease that occurs in blood clots in blood vessels, interferes with blood flow, destroys red blood cells, and causes hemolytic anemia. An official from the MFDS said, "The orphan drug designation is expected to help in the development of treatments for people with rare and intractable diseases., and will continue to develop policies to ensure patient care opportunities in the future."
- Policy
- Handok takes over Eisai’s Aricept license from Daewoong
- by Lee, Tak-Sun Jun 03, 2020 06:25am
- The Korean market license for the dementia treatment market leader Aricept (donepezil) has been transferred from Daewoong Pharmaceutical to Handok. Except for a few items, Handok is to manufacture the treatment in Korea. Daewoong Pharmaceutical has been importing active ingredient from a Japanese-based pharmaceutical company Eisai that developed Aricept and manufactured and supplied the finished product. Eisai Korea is in charge of the sales. On May 29, a pharmaceutical industry source reported Handok recently took over the Aricept license from Daewoong Pharmaceutical. The rights over five items including Aricept Evess 10 mg tablet, Aricept Evess 5 mg tablet, Aricept 10 mg tablet, Aricept 23 mg tablet and Aricept 5 mg tablet have been handed over. Daewoong Pharmaceutical would be the cosigned manufacturer of Aricept 5 mg tablet and Aricept 10 mg tablet, while Handok manufactures the rest. Meanwhile, Eisai Korea would maintain the license over Aricept 5 mg ODF and Aricept 10 mg ODF. Since the first approval won in 2000, Aricept’s license in Korea has remained with Daewoong Pharmaceutical. The partnership deal assigned the manufacturing to Daewoong Pharmaceutical and the sales to Eisai Korea. However, a slight change occurred in the deal as Eisai has decided to ink a joint sales deal with Chong Kun Dang. And now the license has been transferred from Daewoong Pharmaceutical to Handok. Technically, the shift in license ownership means Deawoong Pharmaceutical has ended the close relationship it had with the original Aricept. Regardless, the Korean company already owns a donepezil generic Dimenpezil tablet, which five items under the brand name so far have received approval since 2018. On the contrary, Handok with the new deal would expand its revenue source. According to pharmaceutical market research firm IQVIA, Aricept has generated 65.6 billion won last year. Eisai Korea’s official statement informed the pharmaceutical distribution industry of Aricept labeled with the new Handok product code valid from June 1, due to the change in manufacturer. Eisai also explained the healthcare reimbursement on Daewoong Pharmaceutical-manufactured Aricept products can be claimed until Nov. 30, 2020.
- Policy
- MFDS & FDA have different NDMA’s follow-up measures
- by Lee, Jeong-Hwan Jun 02, 2020 09:13pm
- The domestic pharmaceutical industry has pointed out that the MFDS and the US Food and Drug Administration (FDA) have made unusually different follow-up measures over NDMA detection Metformin. The MFDS caused an immediate and irreversible damage to pharmaceutical companies by disposing of manufacturing and sales prohibition along with the full recovery of items before the detection of impurities exceeding the standards, but FDA did not enforce the prohibition of sales other than the recovery of the existing distribution volumes. Some pharmaceuticals explain that there are aspects that minimize damage to the pharmaceutical industry through delicate regulation. In particular, about the cause of NDMA detection, the MFDS ordered the pharmaceutical companies to submit a compulsory order within three months, but the FDA also cooperated with the pharmaceutical company to find the cause of detection. .According to the pharmaceutical industry on the 1st, 22 pharmaceutical companies that detected NDMA above the reference level in Metformin are in the voluntary recovery process according to the recommendation of the MFDS .Nonetheless, the pharmaceutical industry is focusing on the differences between the MFDS and the FDA in responding to the NDMA crisis .22 companies holding 31 items that have been confirmed to have exceeded the standard have been affected by the withdrawal of their drugs from the pharmaceutical prescription market since The items detected by the MFDS were recovered and production·sale suspensions were announced on the 25th of last month .Compared to Valsartan or Ranitidine in the past, the number of items was small, so the damage to the entire pharmaceutical industry was minimal, but pharmaceutical companies such as JW Pharma and Hanall, which sold about ₩10 billion a year as a single item, were barred from selling for a day .So how did the MFDS and the FDA take other follow-up measures ?The MFDS, instructed the pharmaceutical company to verify the NDMA detection drug manufacturing process The MFDS went through the review of the Central Pharmaceutical Affairs Review Committee and announced further restrictions on the manufacture, sale and prescription of Metformin exceeding its own standards .It is mandatory to submit manufacturing process verification data that NDMA is no longer detected in the company's Metformin within 3 months until August 31 .Specifically, ▲ Process variables that can affect NDMA production ▲ NDMA generation possibility review data due to the effect between Metformin and other ingredients (main ingredients and other additives) ▲ Storage conditions tests such as acceleration and harshness and packaging and container review ▲ Preventive and corrective measures to prevent NDMA from occurring in the manufacturing process in the future or to be adjusted within the maximum allowable capacity per day ▲ Variability of NDMA detection between manufacturing numbers is the scope of verification data .As a result, 22 pharmaceutical companies were forced to focus on making NDMA process data along with recovering the total amount of their medicines scattered at the prescription sites such as medical institutions and pharmacies .It has long since been removed from physician's prescribed list .This is because the patient's sensitivity to NDMA is greatly increased, and sales are immediately banned .FDA has taken the lead in identifying the cause .Inspection by batch prior to manufacturing and sales ban. The pharmaceutical industry claims that unlike the MFDS, the FDA began to work with pharmaceutical companies to determine the cause, when and where NDMA was detected .In particular, even for items that detect impurities above the reference level, the pharmaceutical system view that FDA decides to recover the total amount of the existing distribution volume, while allowing subsequent distributions to be distributed immediately after the NDMA inspection before shipment rather than immediately stopping manufacturing and sales .In fact, according to a press release issued by the FDA on Metformin’s NDMA, the FDA ordered all Metformin to be tested for NDMA exceedingly, and each batch was individually inspected before shipment to the market, so that it would not be regulated for manufacturing and sales below the reference value .FDA has instructed not to market and report the detection of excess detection only for batches that exceeded the acceptance threshold .There is no immediate sale ban except voluntary recovery, even if NDMA is excessively detected in the collected items .Experts argue that these regulatory differences affect the pharmaceutical industry .It is explained that NDMA detection will result in market exit because the drug will be removed from the market immediately if the sale is prohibited due to excessive detection .In response to this, there is an opinion that the MFDS, like the FDA, requires a delicate regulation to prohibit the sale of detection batches by mandating NDMA inspection for each batch of Metformin for excess detection items .An official from the pharmaceutical industry said, "Unlike the MFDS, the FDA allows NDMA-detected items to be shipped consistently after inspection by batch .The items announced by the MFDSy have already been withdrawn from the prescription market .As a pharmaceutical company, the damage is severe .The official said, "If the MFDS applied batch-by-batch regulations like the FDA, 22 pharmaceutical companies would not have been accused of damaging prescription sales or immoral pharmaceuticals from the public." "The regulatory gap created by the FDA's recognition of the possibility that NDMA could be over-detected at any time and in any drug."
- Policy
- Janssen to import Ultracet as Hyangnam factory closes
- by Lee, Tak-Sun Jun 02, 2020 06:09am
- As Janssen Korea is closing down its Hyangnam factory next year, the locally manufactured pain reliever Ultracet fast-acting tablet (acetaminophen plus tramadol hydrochloride) would be imported, instead. However, the extended release tablet form of the drug, developed in Korea, would be manufactured by Handok. A pharmaceutical industry source reported that the Ministry of Food and Drug Safety (MFDS) has approved the imported Ultracet tablet on May 21. The imported tablet is manufactured in Janssen’s factory in Italy. It shares the same substance and dose as ‘Ultracet Tablet Janssen Korea’ approved in Korea in 2001 for export. The company explained, “The fast-acting tablet would be imported as the Hyangnam factory would be shut down.” However, Handok is apparently taking over the manufacturing license over Ultracet extended release (ER) tablet and Ultracet semi-ER tablet, which were developed by Janssen Korea in 2010 and 2012, respectively. The two drugs release the effect slower than the fast-acting tablet, which reduce the dosage regimen. The company official commented about the extended release tablet and said, “It is unclear when the manufacturing transfer would be completed.” So far in the year, Janssen Korea has announced Invega ER tablet, Topamax springkle capsule and Jurnista slow release tablet would be imported, instead of locally manufacturing them in Hyangnam factory. In 2018, Janssen Korea has announced the Hyangnam factory would stop operating in 2021. The factory was opened in 1983.
- Policy
- The emergency introduction of Remdesivir was confirmed
- by Lee, Tak-Sun Jun 02, 2020 06:09am
- 정은경 중앙방역대책본부장The government urgently introduced Gilead's 'Remdesivir' as a cure for COVID-19. Accordingly, the MFDS is planning to go through a special import procedure. Eun-kyung Jung, Head of the Central Disease Control Headquarters, said at the regular briefing on the 29th that the Central Clinical Committee on 28th suggested the need for the introduction of Remdesivir. Accordingly, the Central Disease Control Headquarters plans to apply for the special import (emergency introduction) of Remdesivir from the MFDS in response to the opinion of the Central Clinical Committee. The Committee evaluated that Remdesivir is safe and effective in the treatment of COVID-19 pneumonia, and that it is necessary to medically introduce Remdesivir in the absence of an alternative antiviral agent. In addition, it is said that the need for Remdesivir is given to patients with severe pneumonia from COVID-19 infection and who require oxygen treatment. The dosing period is about 5 days, and it is extended for 5 days depending on the patient's condition. However, the need for monitoring for effects or side effects is mentioned. Remdesivir is a drug that is currently undergoing clinical trials in Korea. The MFDS can import special drugs under the pharmaceutical affairs law at the request of the KCDC for drugs not approved for domestic use. If special import is recognized, it is possible to enter and use the imported items in Korea without the approval procedure. Pediatric Kaletra syrup, currently used to treat COVID-19, has also undergone this procedure. "Currently, there is not so much supply or production of drugs, so we plan to cooperate with related ministries as much as possible to secure drugs," said Jung. "It seems difficult to tell about the time now."
- Policy
- Pfizer's non-steroidal eczema, under phase III in Korea
- by Lee, Tak-Sun Jun 01, 2020 06:20am
- A non-steroidal ointment that can be used for eczema in children is under clinical trial for domestic introduction. Pfizer's Crisaborole is a drug sold in the United States under the name of 'Eucrisa' after it was approved by the US in 2016. The MFDS approved a multinational clinical trial phase III for Pfizer’s Crisaborole on the 29th of last month. This clinical trial is aimed at verifying the efficacy and safety of 2% of Crisaborole ointment in Asian children and adult subjects (over 2 years of age) with mild to moderate eczema. Of the 510 subjects, the total number of domestic patients is 120. If safety and effectiveness are proved through this clinical trial, it is expected that the drug approval process will be conducted in Asia, including Korea. Eczema is a symptom of itching and dry skin, which usually starts in early childhood. the cause of the disease is still unknown, but it is said to be affected by genetic factors and environmental factors. Topical steroid ointments are used to moisturize the skin and suppress itching. However, the side effects of steroids are thinning the skin and there is a risk of infection, so long-term use should be avoided. Crisaborole is a non-steroid, and is a new ointment that can be used for eczema in the PDE-4 (phosphodiesteras). PDE-4 drugs that maintain immune homeostasis by increasing the release of inflammatory mediators include CDPD treatment, Daxas and psoriasis treatment, Otezlar, the first ointment to treat pediatric eczema. Accordingly, it is expected that the release of Crisaborole will act as an alternative to steroid ointments. Crisaborole was approved by the United States FDA in December 2016 for children over 2 years of age and adults with eczema. Recently, clinical trials have been conducted to lower the age group so that it can be used by children over 3 months of age. It is reported that there are about 950 thousand eczema patients in Korea, which is increasing every year. Treatment for non-steroidal eczema exists in Korea, but it is likely that attention will be focused on the introduction of Crisaborole in that it is rare for ointments that can be used in children.
- Policy
- Mabthera coverage extended and Strensiq newly listed
- by Kim, Jung-Ju Jun 01, 2020 06:20am
- Healthcare reimbursement would be granted on AbbVie Korea’s adult psoriasis treatment Skyrizi prefilled syringe (risankizumab) and Handok’s rare disease treatment Strensiq Injection (asfotase alfa) with new reimbursement standards. Korea’s Ministry of Health and Welfare (MOHW) announced the finalized changes in the revised Healthcare Reimbursement Standard and Method would be effective from June 1. ◆Skyrizi prefilled syringe: A new detailed standard of healthcare reimbursement would be established for the risankizumab injection based on the existing biological therapy options for psoriasis treatment. The coverage on the treatment would be granted to patients (age over 18) with chronic (expressed for over six months) psoriasis at a severe level, who qualify all following conditions—showing symptoms of plague psoriasis on 10 percent and more of their body surface area; scoring 10 or higher on Psoriasis Area and Severity Index (PASI); and demonstrating no reaction despite receiving UVB phototherapy for over three months or cannot maintain the therapy due to adverse reaction. However, those patients who cannot receive both photochemotherapy (PUVA) and UVB phototherapy should qualify following conditions—showing symptoms of plague psoriasis on 10 percent and more of their body surface; scoring 10 or higher on PASI; and demonstrating no reaction to three months of or longer administration of methotrexate (MTX) or cyclosporine, or cannot maintain the therapy due to adverse reaction. If the patient shows reduction of PASI by 75 percent or more after taking the treatment for 16 weeks (three doses), the coverage status is maintained for another six months. The PASI would be evaluated every six months and the coverage would be maintained if the patient shows the initial evaluation result. Risankizumab was added as an alternative option of TNF-α inhibitors like adalimumab, etanercept and infliximab or guselkumab, ixekizumab, secukinumab and ustekinumab have added risankizumab with the new reimbursement approval. ◆ Strensiq 40 mg/ mL injection and other: Handok’s Strensiq injection (asfotase alfa), the only enzyme replacement therapy indicated to treat infantile- and juvenile-onset hypophosphatasia (HPP). The injection would also be listed from June 1 for patients with infantile- and juvenile-onset HPP, who started treatment before the age of 19. Accordingly, provisional approval procedure and other reimbursement standards were added to manage careful use of the treatment with standard of initial administration and suspension. A patient with infantile-onset HPP would receive coverage when qualifying all following conditions—level of alkaline phosphatase (ALP) measures lower than normal range of the certain age and sex group but exceeds normal range of Pyridoxal-5’-phosphate (PLP); bone condition unique to HPP confirmed through radiograph prior to treatment; initial treatment received before the age of 19. The evaluation has to be conducted prior to the initial treatment, three and six months into the therapy, and clinical evaluation (height, weight, reparatory function, motor development stage, ambulatory function and pain) should be followed every six months from then on. The treatment has to be administered at a healthcare institute by principle, but self-administration would be allowed only when a properly trained patient demonstrates stable disease activity and no sign of adverse reaction. For a long-term prescription, a single dose is for maximum of four weeks. The patient also has to document ‘medication log’ to keep track of administration period and management for the responsible healthcare institute to follow. ◆ Lemtrada injection: Sanofi-Aventis Korea’s Lemtrada injection (alemtuzumab) indicated to treat relapsing remitting multiple sclerosis (RRMS) in adult patients is extending its reimbursement to cover third cycle for patients qualifying acceptable disease activity level after the second cycle. Patients, who have relapsed at least once, are eligible for the coverage if they meet two conditions out of following three; brain or spinal MRI detects new or enlarged T2 lesion, or new Gadolinium-enhanced lesion. ◆ Cyclosporine oral and injection and mycophenolate mofetil: The reimbursed indications are expanding for Cipol-N soft capsule and Sandimmun injection (cyclosporine), Cellcept capsule (mycophenolate mofetil), cyclophosphamides, Mabthera Injection (rituximab) and IV-Globulin SN injection (human immunoglobulin G). Specifically, the healthcare reimbursement would be granted for the off-label use of the drugs in immune tolerance induction as immunosuppressant to treat hemophilia A or B patients, if pre-approved by Health Insurance Review and Assessment Service (HIRA). The President of HIRA is stipulated to decide prerequisite conditions of the pre-approval, such as forming a committee, standard, procedure and method of the pre-approval. But the reimbursed off-label use of Pfizer Pharmaceutical Korea’s Benefix injection (Recombinant Blood Coagulation Factor Ⅸ) cleared is only for hemophilia B patients. ◆Desmopressin acetate and mirabegron: As Ferring Korea’s Nocdurna 25 μg sublingual tablet is to get listed, desmopressin acetate items exempted from reimbursement due to the revised standard would be stipulated. Also, the reimbursement standard for mirabegron would be revised with the listing of overactive bladder treatment by Hanmi Pharmaceutical, Mirabeg 50 mg SR tablet.
- Policy
- Hanmi, applied for permission for Xoterna's generic drug
- by Lee, Tak-Sun Jun 01, 2020 06:19am
- HanmiHanmi is expanding its inhaler business for respiratory diseases such as bronchial asthma and chronic obstructive pulmonary disease (COPD). In 2014, Fluterol, generic for GSK's asthma treatment was first introduced in Korea, and recently, the COPD treatment Xoterna (Korea Sandos) is also targeting the market. According to the industry on the 27th, Hanmi applied for the same ingredient as Indacaterol/Glycopyrronium on the 25th. This drug is a bronchodilator and is used as a maintenance therapy to relieve symptoms of chronic obstructive pulmonary disease. The inhalation method is to inhale by attaching a capsule-type inhalant once a day to a separate inhaler (Hanmi Heller). The original is Xoterna by Sandos under Novartis. Xoterna was licensed in May 2014. Based on IQVIA last year, sales amounted to ₩6.4 billion. Hanmi had earlier attempted a patent challenge. Last year, an invalidation trial was filed in a patent that is due to expire . Whether to enter the market will be determined based on the result of the request for the trial. So far, there have been few domestic inhalants. There are still many imported items in the market. Hanmi continues to challenge its domestic products. In 2014, it was the first domestic company to introduce Fluterol, a generic for the asthma treatment Seretide, and in 2015, it was granted Tiropium, generic for COPD treatment Spiriva. An inhaler device called 'Hanmi Heller' was also developed. However, the market performance is lower than that of the original drug compared to expectations. In the case of Fluterol, last year's sales amounted to about ₩1 billion. On the other hand, the original Seretide diskus recorded ₩12 billion. The size of global inhaler market is estimated at 40 trillion. Korea is also not small, with a size of 300 billion. According to the analysis, if localization is established in the market, which is one of the imported products, it can be a 'goose that lays golden eggs'.
