- LOGIN
- MemberShip
- 2026-05-19 14:16:50
- 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.”
- Policy
- It's necessary to go through the social consensus
- by Lee, Jeong-Hwan May 28, 2021 06:08am
- It is argued that conflicts between doctors and pharmacists were not be resolved despite government intervention in order to legislate for the activation of the generic substitution, and that they should go through the social consensus process that took place at the time of the separation of prescribing and dispensing. They say that citizens, doctors, pharmacists, and the government should come up with an agreement together because they are divided between doctors and pharmacists and repeatedly make unyielding claims. In particular, the formation of a social consensus is inevitable because the issue of "prescribing active ingredient" is in conflict with the revitalization bill of the generic substitution. The MOHW held a meeting of the KMA, the KHA and the Korean Pharmaceutical Association on the 26th, but failed to agree. Eventually, the first subcommittee of the National Assembly's Health and Welfare Committee reviewed the agenda for revitalizing the generic substitution, which broke down the agreement between doctors and pharmacists. Therefore, the National Assembly reviewed legislation to activate the generic substitution. In 1999, the KMA and the Korean Pharmaceutical Association agreed on a generic substitution and the same level of social consensus that the agreement council had worked on in order to implement the separation of prescribing and dispensing. Furthermore, the bill, which changes the name of the system from generic substitution to "same active patient dispensing" and extends pharmacists from doctors to the HIRA's DUR system, suggests that there is a serious conflict between the division of prescribing and dispensing. It is unreasonable for doctors and pharmacists to simply try to resolve the same active dispensing, separation of prescribing and dispensing bill, which affects social consensus, with parliamentary legislation. "From a doctor's point of view, changing a generic substitution to a same active ingredient dispensing is perceived as generic prescribing. In particular, the generic substitution is a system that is deeply related to the separation of prescribing and dispensing. "If the bill is passed right now, it will be a problem. "How many doctors will agree to the bill that the National Assembly or the government hastily decided without an agreement?" "The general substitution issue is not a matter that can be proposed by a member of Parliament from a pharmacist and decided unilaterally by the National Assembly. "We need to discuss more issues that have differences of opinion between professions." Professor Lee Jae-hyun of Sungkyunkwan University of Medicine said, "The perspective of the generic substitution depends on whether it is a job problem between doctors and pharmacists or a drug inventory problem at pharmacies.If looking at as a matter of doctors and pharmacists to operate a a social consensus on the impossibly difficult. Regardless of the generic substitution, doctors and pharmacists had different opinions," he said, adding, "In terms of pharmacy drug inventory, we can find common ground." The arrangement of a list of local prescriptions was agreed upon at the time of the separation of prescribing and dispensing. "It depends on which issue we focus on." An official from the Korean Pharmaceutical Association said, "The idea of a generic substitution as an active ingredient prescribing is too contradictory. "The goal of the bill is to secure the finances of health insurance and promote national benefits by increasing the use of drugs already licensed through biological equivalence tests," he said. "The general substitution sub-consultation ended without reaching an agreement, and theMOHW plans to report the details to the National Assembly." "It is not a matter of conflict between professional organizations, but a policy that the government should decide for the sake of the people." The official said, "The Ministry of Health and Welfare agreed to a clause that would expand the scope of post-notification. "It is time for the National Assembly to pass even a partial passage of the extension of post-notification clause," he said. "I think the Korean Pharmaceutical Association should join the discussion in that the formation of a social consensus is a division of preservation and dispensing revaluation." But it's going to take too long.
- 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.
- InterView
- Leclaza's ASCO data is like a global champion
- by An, Kyung-Jin May 28, 2021 06:08am
- Cho Byung-chul, a professor at Yonsei UniversityThe response rate for 'Lazertinib+Amivantamab' is the same as when ESMO was announced? It's ridiculous. The data is incomparably more complete than it was 7 months ago. " Professor Cho Byung-chul (oncology at Yonsei Cancer Hospital) commented on Leclaza (Lazertinib) combined data. A number of questions have been asked since the opening of the American Society of Clinical Oncology (ASCO 2021) and some misinterpretations need to be corrected. Professor Cho will introduce the latest clinical results related to combined therapy of Leclaza and Amivantamab at the ASCO 2021 online conference on the 5th of next month. This is the follow-up announcement of CHRYSALIS 1b, which drew much attention at the European Oncology Society (ESMO 2020) last year. The purpose is to evaluate the response rate of 'Lazertinib+Amivantamab' combined therapy in patients with resistant non-small cell lung cancer. The published objective response rate (ORR) is 36%. Fifteen out of 45 Tagrisso-resistant patients reached a partial reaction (PR) that reduced the tumor size by more than 30%, and one showed a complete reaction (CR) that completely disappeared. Because ORR figures are the same as when ESMO 2020 was announced, it can be accepted as the same data. "Even if the ORR values are the same, the maturity of clinical data has completely changed," Professor Cho added. The key is the difference in follow-up periods. Data released at the time of ESMO showed a follow-up period of only about four months after medication. On the other hand, the tracking period of ASCO's announcement increased to 11.8 months. In other words, the same response rate was maintained even though the tracking period has more than doubled.The duration of the reaction in patients who responded to the drug administration was more than 10 months. When the concept of biomarker is combined, the reaction rate increases further. Eight out of 17 patients with EGFR and MET mutations, known as Tagrisso's most common cause of resistance, showed treatment responses, achieving ORR 47%. However, the absence of biomarkers does not mean that the response rate is low. Of the remaining 28 people whose biomarkers were not identified, eight showed tumor responses to combined Lazertinib+Amivantamab administration. In terms of ORR, it is 29%. "There is a group of patients who are good at responding to Lazertinib+Amivantamab combined therapy," Professor Cho said. "However, the data alone when there is no biomarker is far more competitive than the existing treatment." Previously, there were no lung cancer treatments that demonstrated a 30% response rate and a duration of 10 months in patients who failed Tagrisso treatment. For example, the most prescribed combination of Tagrisso and MET inhibitor Savolitinib is 30% response rate and 7.9 months response duration when only MET patients are selected. Professor Cho compared this data to boxing. It's nothing short of winning Mike Tyson.Treatment of non-small cell lung cancer, which has developed new resistance after Tagrisso administration, is quite difficult due to tumor heterogenicity. This means that the data has increased over a long period of tracking for cancer patients with such malignant conditions. Professor Cho said that there is a good chance that Lazertinib+Amivantamab combined therapy will be designated as a U.S. FDA innovative therapy (BTD) within this year. If similar levels of data are reproduced in Janssen's ongoing CHRYSALIS-2 clinical trial, FDA approval will not be long.
- Policy
- One-time ￦2 billion therapy Zolgensma to be soon approved
- by Lee, Tak-Sun May 27, 2021 05:56am
- Zolgensma (onasemnogene abeparvovec-xioi), a new gene therapy drug that attracted attention due to its high price of nearly 2 billion won per single shot, is soon to be approved in Korea. As a spinal muscular atrophy gene therapy, Zolgensma is also called a ‘one-shot treatment’ as only a single dose is required during a patient’s lifetime. As the drug is about to be approved, whether the drug will be allowed reimbursement is expected to be the key issue. On the 26th, industry sources said that the Ministry of Food and Drug Safety (MFDS) completed the safety and efficacy review for Zolgensma. The results are expected to be announced soon. Zolgensma was designated as an orphan drug in December 2018 but was not formally approved in Korea. The drug has gained much attention as a treatment for SMA that needs to be administered only once. SMA is caused by a defect or mutation in the SMN1 gene that leads to a deficiency of motor neuron protein. Without proper treatment, patients with SMA would need to depend on assistive devices and even result in death. When administered, For Zolgensma, an SMN1 gene is inserted inside a virus vector, which is then injected into the patient's body to induce the production of SMN1 protein. Various SMA treatments such as Spinraza (nusinersen, Biogen) and Evrysdi (risdiplam, Roche) have been recently released in Korea; however, the demand for the one-shot Zolgensma stays strong. The issue at hand is its price. The price of a single shot of Zolgensma is 2.5 billion won in the U.S. and 1.89 billion won in Japan. Experts say that the reimbursement standards in Korea are not sufficient to evaluate ultra high-priced drugs and that a new evaluation model needs to be designed for such drugs. In a forum held on the 13th, Professor Hye-Young Kang of the Department of Pharmacy at Yonsei University said, “The optimal plan for each country should be prepared in consideration of each country’s history, culture, and economy.” She continued, “Adopting a reimbursement model from other countries may be dangerous as we cannot fully implement or understand the details or backgrounds of the models used in other countries.” On this, Yoon-Seok Yang, head of the Division of Pharmaceutical Benefits at MOHW said, “We can apply the current risk-sharing agreement scheme to evaluate the reimbursement of Zolgensma.” Explaining that the drug may be evaluated under current reimbursement standards, he added that “However, the payment structure needs to be deeply considered.” Meanwhile, Novartis’s ‘Kymriah,’ another ‘one-shot treatment’ indicated for the treatment of acute lymphoblastic leukemia (ALL), was approved in March and is in the process of being evaluated for reimbursement.
- 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.
- Company
- Sales of EGFR anticancer drug Tagrisso have been put on hold
- by An, Kyung-Jin May 27, 2021 05:56am
- The market for EGFR lung cancer drugs has been put on hold. Sales of Tagrisso, a third-generation drug, have declined since its benefit. As new products emerge one after another, the market is expected to change within this year. According to IQVIA, a pharmaceutical research institute, the size of Korea's market for EGFR tyrosine kinase inhibitors (TKI) in the first quarter of last year was ₩35.5 billion, down 2.9% from ₩36.5 billion a year earlier. South Korea's EGFR-TKI market increased to ₩38.9 billion in sales in third quarter of last year as it continued to grow since first quarter of 2017, but fell for second consecutive quarter. EGFR-TKI is a targeted anti-cancer drug prescribed to patients with metastatic non-small cell lung cancer (NSCLC) accompanied by EGFR mutations. EGFR mutations are a very common mutant type observed in 30–40% of non-small cell lung cancers that account for 80–85% of lung cancer, occurring between exon 18 and exon 21. It is known that Asian markets, including Korea, China, and Japan, are larger because they are more popular than Westerners. EGFR-TKI, which is currently on the market in South Korea, includes first-generation drugs Iressa (Gefitinib), Tarceva (Erlotinib), second-generation Giotrif (Afatinib), and third-generation Tagrisso (Osimertinib). Among the five products, the total size of the market tends to depend on the sales of Tagrisso. Tagrisso's first-quarter sales rose 3.1% year-on-year to ₩24.4 billion. As of first quarter, Tagrisso accounts for 68.9% of all markets. It is maintaining a four-fold gap with Giotrif, the second-largest item in sales. AstraZeneca's Tagrisso was approved by the MFDS in May 2016 for "local progressive or metastatic non-small cell lung cancer patients with EGFR-T790M mutations confirmed after EGFR-TKI administration." It is prescribed as a secondary treatment for non-small cell lung cancer patients who have developed resistance after administration of the existing first and second generations of EGFR-TKI. Tagrisso's sales soared in December 2017 when it was covered by health insurance benefits as a secondary treatment. Tagrisso's sales, which started at ₩2.3 billion in the first year of release and stayed at ₩10.3 billion in 2017, jumped 5.8 times to ₩59.4 billion in 2018. Although it continued to grow rapidly with ₩79.2 billion in 2019 and ₩106.5 billion in 2020, it is not as good as it used to be recently. After setting its own record of ₩27.9 billion in sales in third quarter of last year, it continued to decline for two consecutive quarters. The decline in Tagrisso sales varies. Tagrisso was added to the primary therapy indication in Korea in December 2018, and the reimbursement process has been stalled for more than two years. Tagrisso, which is not covered by insurance, costs ₩217,782 per 80mg, more than ₩6 million a month. Even if it meets the standards, there are many patients who cannot be treated because of the cost burden.The release of generics also seems to have had some impact. Since last year, global clinical subjects have been actively recruiting third-generation EGFR-TKI Leclaza (Lazertinib) therapy developed by Yuhan. Pfizer's Vizimpro (Dacomitinib), a small but second-generation drug, also began to be prescribed late last year after being listed on the benefit. Sales of Giotrif in the first quarter of last year were ₩5.2 billion, up 10.1% year-on-year. This is its biggest sales since its launch in South Korea. The remaining EGFR-TKI sales are sluggish. First quarter sale of Iressa by AZ were ₩4.2 billion, down 29.9% from a year earlier. During the same period, Roche's Tarceva recorded ₩1.5 billion in sales, down 29.6%. Vizimpro's sales in fourth quarter of last year and first quarter of this year are still insignificant. Industries are predicting that changes in EGFR-TKI markets will also accelerate during second half of this year. It is observed that competition between the 3rd generation EGFR-TKI will intensify after the launch of the domestic new drug Leclaza (Lazertinib). Leclaza was approved by the MFDS in January as a treatment for patients with EGFR T790M mutations that had previously been treated with EGFR-TKI. The HIRA's Cancer Drugs Benefit Application Committee, which was held in February, has been properly assessed and negotiated between the Pharmaceutical Benefits Advisory Committee and the NHIS. It is predicted that sales will begin in earnest from the second half of this year after completing the registration process quickly.
- Policy
- Combination vaccine Priorix-tetra by GSK has been revoked
- by Lee, Tak-Sun May 27, 2021 05:55am
- The final license will be revoked because GSK's licensed combination vaccine "Priorix-tetra" did not submit the review data in November 2013. The vaccine is the first MMRV vaccine in Korea to have chickenpox prevention added to existing measles, rubella, and infectious mastitis. However it seems that GSK has not been able to actively respond to the cancellation as demand in Korea has decreased. The MFDS ordered GSK's Priorix-tetra to be revoked on the 17th. It will take place as of June 1st. This product is a live virus vaccine mixed with measles, mumps, rubella and chickenpox, and was approved by the MFDS in November 2013. In particular, it was comfortable because the existing MMR vaccine combined with chickenpox prevention requires a second injection. However, there was not much demand for MMRV vaccines because the NIP separately designated MMR vaccines and chickenpox vaccines. Furthermore, GSK's MMR vaccine Priorix is included in the NIP. Priorix has been co-sold by SK Bioscience since this year. It seems that the company did not actively respond even if the MFDS requested unfulfilled reexamination data. This is because it believes that it will be difficult to increase demand in the future. Eventually, the vaccine disappeared from the domestic market after seven years of approval.
