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- 2025-12-26 08:58:12
- Company
- Astellas notified distributors, Betmiga cannot be returned
- by Kim, Jin-Gu Jun 01, 2021 06:11am
- BetmigaConfusion in pharmacies is expected to continue for a while over the lowering of the drug Betmiga (Mirabegron), an irritable bladder treatment. The pharmaceutical industry and the outpatient pharmacies predict that it will take at least a year for the drug price to be finalized. According to the pharmaceutical industry and pharmacies on the 28th, Astellas Pharma Korea Betmiga PR will be lowered from the 1st of next month. This is because Chong Kun Dang and Hanmi Pharmaceutical succeeded in overcoming patents and released generic. The MOHW has announced that it will lower the upper limit of the original Betmiga from June 1 following the release of generic drugs. However, it is highly likely that Betmiga's drug prices will not be reduced. Astellas disobeyed the second trial's ruling, and the case went to the Supreme Court. Astellas lost the second trial of Betmiga's use-and-crystal patent dispute with 11 companies, including Hanmi, on January 22 this year. Astellas filed an appeal with the Supreme Court on March 3. At the same time, it is said that it filed an injunction with the administrative court to suspend the execution of the drug price notice. Since the related case has not yet been finalized, it is a request to postpone administrative disposition until the Supreme Court ruling is made. This is why Astellas notified distributors of "nonreturnable" and "non-settle balance" by saying, "There is no reduction in drug prices in June." In fact, the same thing happened earlier in the patent dispute surrounding Eliquis. BMS, the original company, maintained an insurance upper limit of ₩1,185 per party by dragging the case to the second trial and applying for an execution suspension of drug prices at the same time, even though generic was released after the first trial was lost. When the second trial was lost, the MOHW warned of a drug price cut, but the BMS applied for an execution suspension of the drug price cut as it dragged the case back to the third trial and eventually the insurance upper limit price was maintained. The case was overturned in the third trial and eventually BMS succeeded in delaying the drug reduction until September 2024. It took about two years for the final sentence (April 8, 2021) to be made after the third trial was held in the Eliquis case (May 3, 2019). Considering this, the pharmaceutical industry and pharmacies predict that it will take at least a year to reach a final conclusion on the reduction of Betmiga prices. Unlike the first and second trials, the Supreme Court does not disclose the date of the sentence to the public. This explains that the company's non-returnable measures and the pharmacy's confusion over them will continue for more than a year. However, there is a possibility that the conclusion may be unusually early. The Supreme Court will decide within four months whether to deal with the case in earnest from the second trial. This is called the discontinuity of trials period, and if the Supreme Court judges that the hearing is unnecessary, the second trial will be finalized before October. "Astellas submitted a statement of grounds of the final civil application," a pharmaceutical industry source said. "We expect a new claim to be made in the Supreme Court, which is different from the second trial," he said. "We believe that the possibility of disccontinuity of trials is low at the moment." For Bayer's new oral anticoagulant Xarelto (Rivaroxaban), the situation is different from that of Betmiga. Bayer is also said to have applied for suspension of execution in the government's disposition to lower drug prices because the lawsuit has not been completed. However, Bayer was defeated in the Supreme Court in December last year. The Supreme Court dismissed Bayer's appeal and sent it back to the Patent Court. Xarelto's prices are likely to remain until the Patent Court has reached the conclusion of the remand trial. In general, the period of judgment is shorter than that of the Supreme Court for destruction and repatriation. This means that the chaos in the pharmacy disappears more than in the case of Betmiga.
- Company
- Beovu can be prescribed at general hospitals
- by Eo, Yun-Ho Jun 01, 2021 06:11am
- AMD treatment Beovu became available in general hospitals with insurance coverage. According to related industries, Novartis Korea's Beovu (Brolucizumab), which has been registered since April, passed drug committees of more than 30 medical institutions including Seoul National University Hospital and Sinchon Severance Hospital. Wet AMD treatment Beovu, in combination with VEGF-A, is a mechanism that inhibits neovascular expression and retinal effusion, administered once a month for the first three months and once every three months. Beovu's efficacy has been demonstrated through two three-phase clinical trials HAWK and HARRIER studies compared to Eylea (Afribercept). Clinical studies of 1,817 patients with macular degeneration related to the age of 50 and older demonstrated noninferiority compared to controls at 1 year (48 weeks) in BCVA (Best-Corrected Visual Acidity) changes, the primary evaluation index. Beovu also demonstrated that the proportion of patients with improved maximum corrective vision (BCVA), which is a secondary evaluation index, by more than 15 letters, was also non-equivalent compared to the control group at week 48. (HAWK study: 34% Beovu group, 25% Eylea group; HARRIER study: 29% Beovu group, 30% Aflibercept group) Furthermore, patients with intra-retinal fluid (IRF)/sub-retinal fluid (SRF) were also significantly lower in the Beovu group, showing superior improvement over controls. Kang Se-woong, an ophthalmologist at Samsung Medical Center, said, "AMD is a disease that can be blind within two years without proper treatment and requires active and effective treatment from the beginning. "Beovu, which is effective not only in improving vision but also in improving the retina, which causes direct degeneration of the macula, will be covered by insurance benefits and will be able to provide patients with effective treatment options." "In particular, as Beovu allows us to maintain a longer, three-month treatment interval than conventional treatment, it is expected that the burden of treatment and the possibility of discontinuation of treatment will be reduced in AMD, where continuous treatment is important," he added. AMD, one of the top three causes of blindness in the elderly population aged 65 and older, is a disease in which vision is degraded due to the metamorphosis of the macular region in charge of vision. Macular degeneration is caused by structural changes and damage to the retina and macula by leaking effluent or blood from abnormally produced blood vessels (new blood vessels). As it is a disease that causes vision loss and blindness, the main treatment goal of Neovascular (Wet) Age-Related Macular Degeneration is focused on improving vision, and anatomical changes should also be considered for effective treatment.
- Company
- Pacenra(Fasenra) can be prescribed at the general hospitals
- by Eo, Yun-Ho May 31, 2021 06:02am
- The severe asthma treatment "Pacenra" is available at general hospitals. According to related industries, Pacenra (or Fasenra, Benralizumab) of Astra Zeneca Korea has passed drug committee (DC) of medical institutions such as Samsung Medical Center, Seoul National University Hospital, Seoul National University Bundang Hospital , Ajou University Hospital, and Wonju Severance Christain Hospital. Pacenra is approved for use as an additional treatment in adult patients with severe anaerobic asthma if it is not properly controlled by conventional treatment, and is then administered once every four weeks for the first three months. One of the reason for asthma management is to reduce the risk of asthma deterioration. Pacenra is an anti-eosinophil, humanised afucosylated, monoclonal antibody (IgG1, kappa). It binds to the alpha subunit of the human interleukin-5 receptor (IL-5Rα) with high affinity and specificity. The IL-5 receptor is specifically expressed on the surface of eosinophils and basophils. The absence of fucose in the Fc domain of benralizumab results in high affinity for FcɣRIII receptors on immune effectors cells such as natural killer (NK) cells. This leads to apoptosis of eosinophils and basophils through enhanced antibody-dependent cell-mediated cytotoxicity (ADCC), which reduces eosinophilic inflammation. According to the SIROCCO study of 1,205 patients with severe asthma worldwide, including 122 Korean patients, the annual asthma exacerbation rate compared to placebo was reduced to 45% in once-four weeks and 51% in once-eight weeks. In addition, another clinical CALIMA study confirmed that the annual asthma exacerbation rate compared to placebo decreased by 36% in the once-in-a-week group and 28% in the once-in-eight-week group, significantly reducing the annual asthma exacerbation rate in the placebo group. In both studies, the change in FEV1 (1-second forcing capability) compared to baseline was measured, and consistent improvement over placebo was shown. In order to evaluate the long-term safety and efficacy of Pasenra in patients with severe anacid, there was no significant difference compared to placebo in the SIROCCO study and BORA study, a 56-week safety assessment extension study of 1926 patients participating in CALIMA study. Asthma, meanwhile, is associated with an unexpectedly high mortality rate. The death rate of hospitalized patients due to asthma is about one-third, and the cost of asthma-related patients requiring emergency treatment or hospitalization accounts for more than 80% of the total asthma-related costs. In particular, eosinophilic inflamination is present in 50% of asthma patients, which can cause poor lung function, worsening asthma, and increased exacerbation rates. Despite proper ICS therapy, patients with eosinophilic inflamination asthma with high levels of eosinophil are often not managed by conventional therapy such as ICS-LABA therapy, which is life-threatening due to pain caused by symptoms and frequent deterioration of diseases.
- Company
- Sales of Gaviscon and Strepsil continue to be sluggish
- by Kim, Jin-Gu May 31, 2021 06:01am
- Gaviscon & StrepsilsSales of Gaviscon and Strepsils have been sluggish for five years since Reckitt's boycott. It is shown that sales of two products decreased by 46% and 74% respectively in first quarter compared to before boycotting. Competitive items are found to benefit from the long-term sluggishness of the two products. According to IQVIA, a pharmaceutical market research company, Strepsil's sales in first quarter of last year were ₩600 million. The figure is down 74% from ₩2.2 billion in the first quarter of 2016, just before the boycott of the entire Reckitt product began in earnest. The boycott of Reckitt products began in earnest after the second quarter of 2016. At that time, the humidifier disinfectant incident caused a lot of controversy, and as public opinion deteriorated sharply, it spread to a boycott of the entire product. The company changed its name from Oxy Reckitt to Reckitt, but it was not enough. Strepsils was ranked first in the sore throat treatment market with quarterly sales of about ₩2 billion before the boycott. However, since the boycott began in earnest, it has only generated ₩600 million to ₩1.2 billion in sales so far. Competing products are enjoying reflective benefits due to Strepsil's sluggishness. The representative product is Boryung's Younggaksan. Immediately after the boycott, it beat Strepsils and became the No. 1 item in the market. Its quarterly sales are about ₩2 billion. Since the fourth quarter of last year, sales have risen significantly on the basis of COVID-19 prevention issues. Its sales in fourth quarter of last year are ₩3.5 billion and its sales in first quarter of this year are ₩4 billion. In the case of Gaviscon, the company generated ₩2.3 billion in sales in the first quarter of 2016, just before the boycott began, but has since maintained sales of around ₩1 billion. Its sales in first quarter of this year are ₩1.2 billion. In five years, it has fallen by 46%. Gaviscon's rival, Yuhan's Almagel, has seen a modest rise in sales since the boycott. Its first quarter sales were ₩3.2 billion and it was the highest ever. Another competitor, Boryung's Gelfos, had sales similar overall to those before the start of the Gaviscon boycott. Its first quarter of this year's sales were about ₩2.4 billion. Analysts say that the sluggish sales of Gaviscon & Strepsils are due to the company's passive advertising and marketing activities. In fact, Reckitt Benckiser had been actively advertising and marketing both products before the boycott began. According to the KFAA's Advertising Information Center statistics, Reckitt Benckiser was included in the top 100 advertisers, spending ₩2.2 billion as of January 2016, but has disappeared since 2017.
- Company
- Keytruda, passed the committee except for lung cancer
- by Eo, Yun-Ho May 31, 2021 06:01am
- According to the industry, yesterday (26th) the HIRA's Cancer Drugs Benefit Appraisal Committee recognized the appropriateness of immuno-cancer drug Keytruda (Pembrolizumab)'s ▲ bladder cancer 2nd or higher ▲ typical Hodgkin lymphoma solo therapy that recurred after 3rd treatment. In fact, NSCLC, Non-small Cell Lung Cancer's indication of primary solo and combined therapy failed to pass the Cancer Drugs Benefit Appraisal Committee on the eighth challenge. This is likely to make it virtually difficult to expand the benefit of Keytruda's indications of lung cancer. It has been discussing the benefit expansion since September 2017. It's been almost four years now. The biggest challenge at the time was the "burden of pharmaceutical companies for the initial third cycle of medication," which the government presented as a condition for expanding the benefit to pharmaceutical companies with immuno-cancer drugs. Roche, a company with "Tecentriq(Atezolizumab)" which was generic at the time, accepted the proposal, and failed to accept two types of PD-1 inhibitors, including Keytruda and "Opdivo(Nivolumab)." The MSD then repeatedly proposed and revised compromises. The final discussion was in August last year. At that time, the Cancer Drugs Benefit Application Committee held off because it believed there was a lack of compromise. The HIRA then resubmitted the financial contributions discussed at the Cancer Drugs Benefit Appraisal Committee to MSD in September of the same year, demanding a revision. MSD submitted the revised bill a month later and handed it over to the Cancer Drugs Benefit Appraisal Committee for discussion. Eventually, the introduction of the Cancer Drugs Benefit Appraisal Committee was delayed, and the MSD persuaded the government directly by the new CEO Kevin Peters, but the answer was NO. There may be a reason, but even the failure of third-generation EGFR TKI 'Tagrisso' (Osimertinib) and Keytruda in April, the expansion of the benefits of the first treatment for lung cancer is facing difficulties.
- Company
- ‘No-show vaccines’ as the way out of COVID-19
- by An, Kyung-Jin May 28, 2021 06:08am
- J, who works as a medical representative in A Pharmaceuticals, has been struggling with his smartphone for 3 hours. J had finished his lunch early to try and reserve the no-show vaccines. However, both the Naver and Kakao applications on his phone were not working. Even after the server was restored, both maps were full of ‘0’s. He expanded the search area to all of Seoul and renewed the page several times. One hospital popped up, but the 10 shots that were available immediately turned to 0 as he pressed the reservation button. Dispirited, he pressed the notification services in various nearby hospitals, then put down his smartphone According to industry sources on the 27th, pharmaceutical companies have been internally encouraging vaccination with the ‘no-show vaccines’ to their employees. By hastening the vaccination of their employees, the companies sought to reduce group infections and normalize their business activities that have shrunk down due to the prolonged COVID-19 pandemic. In other words, the companies are seeing the leftover vaccines as an exit strategy-the fastest way out of the COVID-19 pandemic. One year and three months have passed since the World Health Organization (WHO) declared the 'COVID-19' pandemic. Industry’s fatigue is accumulating with the repeated ups and downs in the prescription drug market. Medical representatives who were unable to conduct normal sales activities for nearly a year since the entry into clinics and hospitals were restricted are at the end of their tether. The prescription drug market has not shown signs of recovery after the social distancing level was raised at the end of last year. With pressure for sales performance rising, the atmosphere in the companies for MRs to receive COVID-19 vaccinations as soon as possible’ have been tacitly created. If the number of vaccinated employees increase, the companies could reduce the proportion of telecommuters and boost sales activities that have been shrinking. ▲ Hospitals that have remaining vaccines in the whole Seoul area on the afternoon of the 27th, after the reservation of no-show vaccines have started (Source: captured screen of Naver and Kakao no-show vaccine reservation page) The COVID-19 vaccination response task force made the decision to disclose the information on leftover vaccines to the public in a bid to minimize the waste of COVID-19 vaccines. AstraZeneca’s COVID-19 vaccine can inoculate up to ten people per one vial, but once opened, the vial must be used within six hours or be discarded. Until now, people who wish to receive the vaccine had to directly call the commissioned medical institutions and put their name on a waiting list. A search and real-time reservation function was developed as a pilot program so that people could search for leftover vaccines through the Naver and Kakao map platform from 1 p.m. on the 27th, and will be operated for 2 weeks. As the reservation for ‘leftover vaccines,’ or no-show vaccines started at 1 p.m. on the 27th, pharmaceutical MRs were busy attempting reservations of the vaccines. However, it was difficult to find success stories in the Seoul area. An MR from A pharmaceuticals said, “I did the authentication process in advance and was fully prepared to reserve the no-show vaccines, but I also failed. Our Kakaotalk chat room was busy all day with the talk about reserving no-show vaccines. Other than those who had reserved vaccines in advance in noncapital regions like Busan, none of my colleagues were able to succeed in making the reservations.” The situation does not only apply to MRs. Attempts to reserve the no-show vaccines have increased greatly among pharmaceutical employees working at manufacturing plants and research sites. These employees who hold manufacturing and research duties at the pharmaceutical companies are those that can cause enormous damage to the company in the case of shutdowns. The opinion is that by completing inoculation, the employees can be free from the risk of becoming the first infected in their companies. Also, the ‘incentive’ policy to ease restrictions for those vaccinated with COVId-19 is seen to have had some influence on raising interest in the no-show vaccine. An employee from a plant at B Pharmaceuticals said, “No formal instructions were given, but most of my colleagues have already listed their names on the waiting list for leftover vaccines. Many have already completed their first vaccinations. As more and more colleagues joining in for the reservation, we have applied for the reservation at a nearby hospital and are awaiting their notification.”
- Company
- NA bill to guarantee labor succession following M&A
- by May 28, 2021 06:08am
- A bill that guarantees the succession of labor relations in changing businesses such as mergers or business transfers is being promoted. With the introduction of such a bill soon expected, eyes are on whether and how the pharmaceutical industry will also be affected by the bill. In particular, the bill is expected to pull the brakes on the unilateral notifications given by multinational pharmaceutical companies that undergo frequent mergers and divisions. Ok-Joo Song (Democratic Party of Korea), member of the Environment and Labor Committee of the National Assembly, submitted the ‘Act on the protection of workers changing business, etc.’ as a representative, which is the first bill to stipulate the succession of labor relations following changes in business, such as corporate spinoffs, merger, and changes in subcontractors. Specifically, the business owner must undergo consultation processes with the labor representative before the change of business, and notify the workers subject to succession, and stipulates the worker's right to refuse succession and right to object. Also, the bill contains measures to prevent the existing employment rules and working conditions from changing unfavorably with an individual worker’s consent during changing business and restricts layoffs from the change of business. In the case where a change of business happens, the collective agreement made between the previous company and labor union is to be succeeded as well. In particular, the bill stipulates the laws of labor succession and protection take precedence over other laws. On the background for proposing such a bill, Song said, “There has been criticism that the current system lacks legal stability as the succession of labor relations left to the interpretation of the court. The EU has guidelines on change of business that stipulate labor succession as a principle. The proposed bill intends to provide significant protection to workers that may be left unstable due to changes in the workplace by stipulating the succession of labor relations following change of business.” The bill was proposed as a result of the group dismissal of cleaning workers that happened at the LG Twin Tower, however, it is expected to have a significant impact on the pharmaceutical industry as well. In particular, multinational pharmaceutical companies have been seeing much labor-management conflict due to frequent mergers and split-ups. For example, Pfizer spun off its off-patent business to a separate corporation, Pfizer Upjohn, and then combined with Mylan only 2 months after the division and renamed the company to Viatris. MSD has also spun off its women’s health·off-patent drug·biosimilar business with Organon. Takeda Pharmaceutical also acquired Shire and sold off its primary care business (chronic disease business) in the Asia-Pacific region. In the process, many employees have suffered labor instability, worried that they might be notified to move to the spin-off or become subject to voluntary retirement due to redundancies. Protests were led by labor unions opposing the unilateral decisions made by companies. With mergers and divisions expected to continue at the global level, similar issues are expected to continue to arise. The problem is that there is no law stipulating the succession of labor relations following changes of business under the current law and relies solely on case law precedents. Workers have difficulty exercising their ‘right to refuse transfers,’ and in reality, cannot assert their rights to refuse relocation during labor negotiations. If the bill is passed, the consultation process between the company and workers would play an important role in the sale or mergers of its businesses. Labor consultant Kyung-Rak Kim of the Daesang Labor Law Firm said, “The bill will make it mandatory for the management to undergo a consultation procedure with worker representatives in advance in the process of making corporate changes such as mergers, business transfer, or divisions. The bill stipulates the right to refuse succession or raise objections of workers in the process. If the bill is passed as it is, it will be able to provide significant protection to workers in the process of corporations’ reckless business changes."
- Company
- Olumiant's indication for atopic dermatitis has expanded
- by May 28, 2021 06:08am
- Lilly's Olumiant (Baricitinib) is the first Korean JAK inhibitor to acquire atopic dermatitis. Lilly Korea announced on the 26th that Olumiant received approval from the MFDS to expand its indications to treat secondary or severe atopic dermatitis in adult patients subject to systemic therapy on the 24th. Olumiant has acquired two indication for diseases, following severe active rheumatoid arthritis, which was previously recognized in Korea. Atopic dermatitis is a chronic inflammatory disease that is typical of itching. This causes scratching, leading to worsening skin inflammation and skin pain. In addition, the majority of patients suffer from itching and accompanying symptoms such as sleep disorders and poor quality of life, and mental symptoms such as stress and depression due to apparent skin lesions. JAK inhibitors contain inflammatory cytokines, which block inflammation, pain and cell activation. Olumiant, a selective inhibitor of JAK1 and JAK2, has confirmed the efficacy and safety of the drug on a combination of sole and local corticosteroid (TCS) administrations in three clinical studies. In particular, Olumiant has been shown to improve itching rapidly from day 2 of treatment, which seriously undermines patients' overall health and quality of life. Olumiant's recommended dose for treatment of atopic dermatitis is 4 mg once a day. It can be administered alone or in combination with TCS, and its effectiveness can be increased when administered in combination with TCS.
- Company
- Daewoong & Dong-A succeeded in overcoming patent of Otezla
- by Kim, Jin-Gu May 27, 2021 05:56am
- Daewoong & Dong-A ST succeeded in avoiding one of two patents of Otezla (Apremilast), a psoriasis treatment drug worth ₩2.46 trillion in global sales. While Amgen, the original company, has yet to officially release Otezla in Korea, the two companies are on the verge of releasing generics early. According to the pharmaceutical industry on the 26th, the Intel Property Trial and Appeal recently ruled in a passive right-checking trial on Otezla's patent filed by Daewoong and Dong-A ST against Amgen. There are two patents, use patent, which expires in March 2028, and formulation patent, which expires in December 2032. The patents avoided by Daewoong and Dong-A ST are formulation patent that expire later. In addition to the two companies, Chong Kun Dang, Dongkoo bio, Mothers, Yuyu, Huons, and Cosmax have also filed for the same judgment, but no conclusion has been reached yet. Eight companies including Daewoong and Dong-A ST also filed for invalidation of the case against use patent. If Daewoong and Dong-A ST overcome use patent, they can release generics early after November 2023 when Otezla PMS expires. There is a possibility that Amgen will appeal against the verdict, and generic companies should also succeed in proving their biological equivalence with the original. Otezla is Amgen's global blockbuster psoriasis treatment. As of last year, it made $2.2 billion in global sales. In 2017, Celgene received a domestic license and challenged for the benefit, but the launch was delayed as it failed to be paid due to differences in opinions between insurance authorities and companies on prices. As Celgene was acquired by BMS in 2019, South Korea's release plan was delayed even more. Initially, BMS tried to have the copyright of Otezla, but the U.S. Federal Trade Commission (FTC) ordered the sale because it was concerned about monopolies. Eventually, BMS sold Otezla's copyright to Amgen. Amgen acquired global copyright for $13.4 billion. As a result, domestic copyrights were transferred to Amgen. Amgen is trying to negotiate with insurance authorities, but it is still said that it will not be easy to apply the benefit.
- Company
- AD drug ‘Dupixent’ records ￦13.5 bil. in Q1 with reimb.
- by An, Kyung-Jin May 27, 2021 05:56am
- Sanofi Genzyme’s biologic medication ‘Dupixent (dupilumab),’ which was finally approved for reimbursement after a long wait, is creating a sensation in the market. After receiving approval for its reimbursement in severe atopic dermatitis last year, sales of Dupixent rose steeply to exceed 10 billion won in the first quarter this year. With the indication expanded to pediatric patients earlier this year, its sales growth is expected to accelerate further. According to the market research institution IQVIA, sales of Dupixent recorded 13.5 billion won in the first quarter this year. This was a 306.2% YoY increase compared to the same quarter of the previous year, in which Dupixent recorded 3.3 billion won in sales. With the surging sales, Dupixent sold over 10 billion won in quarterly sales for the first time. Compared to the 1.5 billion won in 2019 Q1, the size of quarterly sales leaped ninefold in 2 years. Dupixent is the first targeted biologic developed for the treatment of moderate-to-severe atopic dermatitis that is not well controlled with prescription topical therapies or who cannot use topical therapies. It selectively inhibits interleukin-3 and interleukin-4 proteins, which are known causes of adult atopic dermatitis. Sanofi Genzyme received marketing authorization for Dupixent in March 2018 for the treatment of moderate-to-severe atopic dermatitis in adults and released the drug in August of the same year. However, its performance after the initial release was not up to par. Starting with a record of 0.2 billion won in Q3 2018, it exceeded 1 billion won in Q4; however, its quarterly sales since then remained in the 1 billion to 2 billion won range. Even in Q4 2019, it was not able to record 3 billion won and sales remained at 2.7 billion won. The non-reimbursed monthly cost of 2 million won (based on 2 doses/month) remained as a financial barrier for prescribing Dupixent. Sanofi Genzyme had applied for the reimbursement of Dupixent to the Health Insurance Reimbursement and Assessment Service (HIRA) in February 2019. However, the agenda was not chosen for deliberation by the Drug Reimbursement Evaluation Committee for 5 years due to its excessive drug price. However, in the same year, the government had decided to expand eligibility of the Risk-sharing agreement scheme, and Dupixent’s eligibility was recognized through the RSA track. After 2 months of pricing negotiations, the drug was finally granted reimbursement for severe atopic dermatitis from January last year. After the reimbursement approval, Dupixent’s sales soared. In 2020, Dupixent’s sales rose from 3.3 billion won in Q1 to 5.2 billion won in Q2, then to 7.1 billion won in Q3 and to 8 billion won in Q4. In total, Dupixent recorded 23.6 billion won in sales last year. This year, its sales already recorded 13.5 billion won in the first three months, and a new sales record is expected to be set this year. The industry expects the sales growth of ‘Dupixent’ to continue for the time being. In October last year, Sanofi Genzyme additionally released a ‘Dupixent’ 200mg formulation for adolescents weighing less than 60kg with moderate-to-severe atopic dermatitis. In addition, its indication extended to pediatric patients under 11 years of age since March. Dupixent’s indication now covers all atopic dermatitis patients aged 6 years or older.
