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- 2026-04-15 15:34:46
- Policy
- The MFDS released the minutes of the Advisory Meeting
- by Lee, Tak-Sun Mar 02, 2021 06:25am
- The Central Pharmaceutical Affairs Review Committee, a legal advisory body of the MFDS, also found that there was a controversy over the AstraZeneca (AZ) COVID-19 vaccine, which has been delayed for vaccination for 65-year-olds. It is administered to adults over the age of 18, including those over 65, but there was an opinion that the elderly should specify that "the vaccination should be carefully decided" in the precautions for use. However, no conclusions were drawn, including the recommendation of the MFDS’ Vaccination Committee to discuss whether to be vaccinated at the age of 65. The MFDS released the minutes of the Advisory Meeting of the Central Pharmaceutical Affairs Review Committee on the approval of the AZ COVDI-19 vaccine on the 4th. The AZ COVDI-19 vaccine was approved for vaccinations over the age of 18, subject to future US clinical data submission as advised by the Central Pharmaceutical Affairs Review Committee on the 10th. However, it stated in the precautions for use that the use for the elderly over the age of 65 should be carefully decided. It was the reason for the lack of clinical data if limited to 65 years of age or older. In addition to the efficacy and effect, which are the most important paragraphs in the permit, the indication was set to be 18 years or older, so that the elderly 65 years or older can also be included. The Central Pharmaceutical Affairs Review Committee also debated whether or not to allow vaccinations for seniors over 65 years of age. The majority opinion was that the vaccine should be made available to people over 65. One member said, "The supply of other vaccines may not be available because the supply timeline of other vaccines is tight. It should be allowed to reduce concerns about severe morbidity in the elderly." Another member also said, "Pregnant women are limited, but for people over 65 years of age, limiting as a matter of effectiveness should be considered differently." He said, "In consideration of the vaccine supply, it would be better to allow it to be 18 years of age or older, and that the effect may be inferior to 65 years of age or older. But there were also objections. One member argued that "the vaccine is not approved because it has a good immune response, and the effect in the elderly is unknown." He added that it is necessary to include restrictions on the use of 65 years of age or older. Another member argued, "It is reasonable to wait for the results of the US clinical trial, not to deny that there is a benefit to the patient, but to consider the impact of the US clinical trial results." At this meeting, it was not easy to gather opinions on whether or not to be vaccinated over the age of 65. When the first agenda was discussed, when a single proposal was not prepared, other agendas were discussed and discussed again. Eventually, the chairman made a single proposal, stating that "there was a considerable compromise of opinions" and "let's give the elderly an opportunity to use it." However, One member also said, "It's different from saying that people over 65 are not recommended until there is additional evidence." In addition, there was an opinion that amendment was proposed as "there is insufficient data on the effect, so it must be carefully determined until the effectiveness is verified." In response, the MFDS argued that "until the effectiveness is verified" may require additional explanation as to whether the effectiveness has not been verified." An official from AZ said, "It was conducted according to the clinical trial plan, and it is judged that it showed safety and efficacy in research subjects including 65 years or older." "The results of the analysis of US data are expected to be released at the end of April, and the efficacy data for the elderly in the UK is 55%, and the P-value is similar to that of young adults with a P-value of 0.005, and is being monitored by UK regulators." Regarding the additive and chimpanzee adenovirus controversy, "Polysorbate 80 is an additive used in other vaccines and has a good safety profile," he said. "The PEG used in mRNA vaccines was associated with anaphylaxis reactions." He said, "The chimpanzee adenovirus was strategically selected for a virus that has not been immune to existing immunity, and it was evaluated on a large scale in other clinical trials such as tuberculosis, Ebola, HIV, and malaria vaccines, and there was no safety concern."
- Company
- Xospata can be prescribed at general hospitals
- by Eo, Yun-Ho Feb 26, 2021 06:26am
- Acute myeloid leukemia treatment Xospata can be prescribed at general hospitals. According to related industries, Xospata (Gilteritinib), a drug for acute myeloid leukemia (AML) of Astellas Korea, has passed the drug committee (DC) of SNUH and SMC, and is also in progress at other major hospitals nationwide. This drug has already been prescribed in the U.S. and Japan since 2018, obtained European EMA approval last month, and was approved as an orphan drug in Korea in March last year. The effectiveness of Xospata has been demonstrated in a phase 3 clinical ADMIRAL study. In the ADMIRAL test, overall survival (OS) was 5.6 months in other chemotherapy groups, compared to 9.3 months in Xospata group. In addition, the 1-year survival rate was 17% for other chemotherapy groups and 37% for Xospata group. Side effects that occurred in more than 10% of patients for 30 days after Xospata administration were anemia, increased ALT and AST, pyrogenic neutropenia, thrombocytopenia, constipation, fever, and fatigue. AML is the most common form of leukemia, accounting for 65% of adult acute leukemia. The incidence rate increases with age. AML is primarily treated by co-administration of 2-3 drugs such as Anthracycline. The problem is that even though the degree of complete remission, which drops less than 5% of leukemia cells after the first chemotherapy, reaches 50-70%, up to 50% of them recur. Many pharmaceutical companies are working hard to develop new drugs. An official of The Korean Society of Hematology said, "It is important to reduce the number of cancer cells in the early stages of AML. We are looking forward to the emergence of an option that can be prescribed to elderly patients and patients who cannot apply the induction method." Janssen's Dacogen (Decitabine) is currently being prescribed as the primary treatment for elderly patients with AML.
- Company
- Prolia's sales amounted to ₩75.1 billion in 4 years
- by Kim, Jin-Gu Feb 26, 2021 06:26am
- ProliaAmgen's Prolia (Denosumab) ranked first in the osteoporosis treatment market. Amgen's Evenity (Romosozumab) is expected to start earning sales this year. Amgen, which has established a lineup leading to Evenity-Prolia in the osteoporosis treatment market, is expected to sustain high sales for some time. Most of the bisphosphonates, which had previously led the market, declined after the launch of Prolia. ◆Prolia's sales increased 59% in one year from ₩47.3 billion to ₩75.1 billion According to IQVIA on the 23rd, Prolia's sales last year amounted to ₩75.1 billion. Compared to ₩47.3 billion in 2019, it increased by 59%. Amgen released Prolia in Korea in November 2016. In October 2017, it became a reimbursement drug, but it was limited to secondary treatment and quarterly sales remained at the level of ₩2~4 billion. Sales began to increase in earnest as it expanded to primary treatment in April 2019. Sales from ₩4.9 billion in the first quarter of 2019 rose to ₩12.3 billion in the second quarter. The maximum insurance price has decreased by 12% from ₩215,678 (per vial) to ₩190,000. From the second quarter of 2020, it posted sales of ₩20 billion every quarter. In the second quarter, it was ₩20.5 billion, ₩20 billion in the third quarter, and ₩20.2 billion in the fourth quarter. In December of last year, Prolia's upper limit price was cut again. Because it sold too much. The MOHW cut the upper limit of Prolia by 6.5% from ₩190,000 to ₩170,650 on December 4 of last year according to the Price-volume agreement. It is analyzed that the expansion of benefits and strengthening of sales power contributed to the growth of Prolia. Amgen has been selling Prolia with Chong Kun Dang since September 2017. Amgen Korea is in charge of sales and marketing of Prolia in general hospitals and Chong Kun-dang in semi-general hospitals and clinics. ◆Forsteo, Bonviva, and Fosamax sales fell Most of the major osteoporosis treatments that were leading the market showed a decline in sales. Sales of Forsteo by Eli Lilly, which occupied the first place in the market before the launch of Prolia, fell 21% from ₩21.7 billion in 2019 to ₩17.1 billion last year. Sales of bisphosphonate treatments declined similarly. In the case of Bonviva and Bonviva plus by Handok, the total sales decreased by 5% from ₩14 billion to ₩13.3 billion. The sales of Fosamax by MSD also decreased by 16% from ₩14.3 billion to ₩12.2 billion, and sales of Daewoong's Zoledronic acid fell 21% from ₩14.1 billion to ₩11.2 billion. Excluding Amgen's treatment, Hanmi's RaboneD rose in sales. SERM-based treatment, RaboneD (Raloxifene/Cholecalciferol), increased sales by 7% from ₩8.5 billion in 2019 to ₩9.1 billion last year. ◆Amgen's Evenity From this year, Evenity will enter a new competitive drug. Evenity, a follow-up to Prolia by Amgen, were reimbursed in December of last year. Evenity is a bone-forming agent with dual effects of promoting bone formation and inhibiting bone resorption. Amgen is planning Evenity's positioning strategy in the order of Evenity→Prolia. Amgen has conducted clinical trials for Evenity in a sequential dosage method. In patients with high risk of fracture, after taking Evenity to prolia, and for additional treatment for 12 months, the Evenity-prolia treatment group lowered the risk of new vertebral fractures by 75% compared to the placebo-prolia treatment group. Evenity has recorded sales of around ₩1 billion after its release in December 2019, even though it was before benefits. Evenity's total sales last year was ₩3.8 billion. Amgen expects that sales will start in earnest from this year following the application of the benefits at the end of last year. Amgen also sells Evenity with Chong Kun Dang as well as Prolia.
- Company
- Cancer Committee passes Korean-made new drug Leclaza
- by Eo, Yun-Ho Feb 25, 2021 06:24am
- A Korean-made new drug Leclaza passed the first threshold to receive the National Health Insurance (NHI) listing. A pharmaceutical industry source reported the Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee has approved of the NHI reimbursement on Yuhan Corporation’s Leclaza (lazertinib), a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) like Tagrisso (osimertinib), on Feb. 24. With the current swift processing, the Drug Reimbursement Evaluation Committee (DREC) and the National Health Insurance Service (NHIS) pricing negotiation procedure would also be processed quickly. Leclaza is highly likely to be listed with a refund type risk sharing agreement (RSA) Leclaza was cleared for marketing in South Korea on Jan. 18. In just about a month time, the Cancer Deliberation Committee, considered as the biggest barrier to anticancer treatment seeking for the NHI coverage, passed the new drug. Considering a novel anticancer treatment generally takes about four to five months to be deliberated by the Cancer Deliberation Committee after applying for the reimbursement, the Leclaza processing speed has been exceptional. A related academic society also seems to be supporting Leclaza for the NHI coverage. The Korean Association for Lung Cancer submitted a statement to urge the health authority to approve the healthcare benefit on Leclaza. The society claimed, “The NHI reimbursement should be granted on lazertinib, as it has demonstrated acceptable level of safety and low cardiac toxicity. Moreover, the severity of the disease demands the treatment with coverage, urgently.” Leclaza was authorized as a first-in-class second-line treatment in EGFR T790M mutation-positive patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), who has been treated with EGFR-TKI previously. The drug approval was cleared based on the Phase II clinical trial (therapeutic exploratory trial) outcomes conducted in South Korea, but with a condition to conduct a post-marketing Phase III trial (therapeutic confirmatory trial). Currently, first-generation AstraZeneca’s Iressa (gefitinib) and Roche’s Tarceva, second-generation Giotrif (afatinib) and Vizimpro (dakomitinib), and a third-generation AstraZeneca’s Tagrisso are prescribed to patients as EGFR TKI.
- Policy
- The MFDS is pre-reviewing a combination of Mifegyne
- by Lee, Jeong-Hwan Feb 25, 2021 06:23am
- The MFDS announced that it is in the process of applying for a preliminary review of the combination drug Mifepristone(generic for Mifegyne) and Misoprostol. The MFDS has also initiated a guideline for safe use of abortion pill and is also planning to collect opinions from experts such as gynecologists and women's groups. On the 24th, the MFDS made this announcement in a written inquiry by Nam In-soon, a member of Democratic Party of Korea and the National Assembly's Health and Welfare Committee. She inquired about the current status of domestic screening along with the efficacy and safety of Mifegyne in use in 74 countries around the world. The MFDS replied that it is being used after individual safety and efficacy evaluations along with each country's health care environment. The MFDS announced that it is confirming the application for a preliminary review of Mifepristone & Misoprostol. In other words, some domestic pharmaceutical companies are preparing for marketing permission for abortion pills. Preliminary review is a system in which the standards for preparing data required for drug marketing approval are reviewed in advance prior to formal marketing approval. All of the Mifepristone·Misoprostol combination drugs that have been requested for preliminary review are drugs used overseas as abortion pills. Mifepristone, generic for Mifegyne, is a drug that prevents fetal growth. Many foreign countries are using it, but it was not imported into Korea. Misoprostol induces uterine excretion, and is used in the treatment of gastric duodenitis in Korea. It means that in order to use it as an abortion pill in Korea, it is necessary to expand the indications to change the permission matters such as indications and dosage. The MFDS announced that it has also begun to establish guidelines for safe use of abortion pill. In addition, the MFDS said that it would prepare abortion pill-related policies through a procedure for collecting opinions from experts in various fields such as obstetricians, gynecologists and women's organizations. By referring to overseas prescription cases, even if they are not obstetricians, it is expected that doctors who have completed certain training can prescribe prescriptions. The MFDS said, "We have initiated a preliminary review of Mifepristone·Misoprostol. We will also prepare guidelines for safe use. We will thoroughly verify the safety and effectiveness of the product so that the drug can be used based on the doctor's accurate diagnosis." The MFDS said, "If there is a request for an evaluation to expand the indications of Misoprostol, we will conduct safety and efficacy evaluations." It added, "When establishing related policies with abortion pills, we will consider a plan to expand accessibility together with safety."
- Policy
- Can Pfizer Vaccine be vaccinated immediately after arrival?
- by Lee, Tak-Sun Feb 24, 2021 06:03am
- On the 3rd, KIM Kang-lip, head of the MFDS, announced the approval of the special import of COVAX-Pfizer 117,000 doses of Pfizer's COVID-19 vaccine supplied by the COVAX Facility will arrive in Korea on the 26th, and attention is focused on whether vaccination is possible immediately. COVAX Facility's Pfizer vaccine is highly likely to greatly simplify the assay method, as it is introduced in Korea through a special import rather than a domestic official license. The MFDS is known to be planning to discuss this with the KCDA in the near future. According to the MFDS and the KCDA on the 22nd, consultations will be held soon to test the Pfizer vaccine supplied from COVAX. The MFDS approves national lot release by conducting an inspection for quality verification on vaccines that have been approved for the product. It is a national lot release system, which is to verify the efficacy and safety of the vaccine before the government releases the lot. The previously approved AstraZeneca vaccine was also approved for lot release through this system on the 17th. The lot release of this vaccine was comlpeted in 20 days. However, there is insufficient evidence for the Pfizer vaccine supplied by COVAX to undergo a national lot release. The MFDS announced on the 3rd that it would verify the Pfizer vaccine through a separate test plan while deciding on a special import. There is currently no basis for national lot release obligations for special import drugs. It is highly likely that the MFDS will go through a minimum screening procedure in consultation with the KCDA and take measures to enable immediate vaccination. According to the verification method, vaccination on the 27th, which is proposed as a target, may be delayed. In a briefing for approval of the special import of COVAX Pfizer's vaccine on the 3rd, Kim Kang-lip, head of the MFDS, said, "If the domestic supply is confirmed and a test report for the quantity is secured through COVAX, we will discuss the quality verification method with the KCDA."
- Company
- Pfizer's Benefix was approved as a prophylactic treatment
- by Feb 24, 2021 06:02am
- Pfizer Korea (CEO Dong-wook Oh) announced on the 22nd that Benefix (Recombinant Blood Coagulation Factor Ⅸ), a hemophilia B treatment, was additionally approved by the MFDS for an indication for routine preventive therapy administered once a week. For those over 12 years of age who are injecting Benefix, a dose of 100 IU/kg once a week is recommended to prevent long-term bleeding, and the dosage should be adjusted according to the patient's clinical response. Benefix is the first factor IX genetically modified hemophilia treatment that has been used for over 20 years for supplemental and prophylactic treatment of pediatric and adult hemophilia patients. Benefix can be injected according to the patient's characteristics and circumstances, including 3000 IU/kg. Not only the average dose of 40 IU/kg (in the range of 13 to 78 IU/kg) in clinical trials for conventional secondary prevention is administered every 3 to 4 days, as well as 100 IU/kg once a week. It is now possible to provide patients with a variety of treatment options. Previously, Pfizer confirmed the efficacy and safety of once-a-week prophylaxis in the Benefix 100IU/kg group through a clinical phase 3 extension study of the once-weekly administration for patients with severe hemophilia B, aged 12 to 65 years. The annual bleeding rate (ABR) was reduced by 94% compared to supplemental therapy, and nearly half (48%) of patients did not experience spontaneous bleeding. The median of the annual bleeding rate, including joint, muscle, and soft tissue bleeding, which hemophilia patients frequently experience during the weekly prophylaxis period, was 0. Even about one week after Benefix administration, blood levels exceeding the required baseline 2IU/dL were maintained (2.13-10.39IU/dL) in most patients (2.13-10.39IU/dL), resulting in a prolonged half-life. For the safety profile, no antibody production and allergic reactions, including the formation of blood clots due to high-dose administration, occurred in a study in which prophylaxis was performed once a week for 12 months. Jo Yeon-jin, executive director of Pfizer's Rare Disease Division said, "Benefix, which has been used for the past 20 years, has a variety of treatment options, including once a week for preventive therapy indications, and we are able to provide customized treatment for patients with hemophilia factor IX."
- Company
- Keytruda annual sales top the market for the first time
- by Chon, Seung-Hyun Feb 24, 2021 06:02am
- An immunotherapy Keytruda has topped the South Korean pharmaceutical market for the first time. Its outstanding effect confirmed in treating various cancer types have generated sales profit to dominate the market. Anticancer treatment Tagrisso and immunotherapy Humira surpassed the annual sales of 100 billion won. A pneumococcal pneumonia vaccine Prevnar 13 had its sales soaring amid the novel coronavirus infection (COVID-19) outbreak. According to the pharmaceutical market research firm IQVIA on Feb. 21, MSD marked the highest sales last year with Keytruda making 155.7 billion won. Keytruda pushed aside Lipitor and took over the first place making year-on-year growth of 24.8 percent. It is first time for Keytruda took the market leadership for the time since its launch in 2015. Immediately after the market release, Keytruda’s annual sales have remained around 10 billion won in 2016 and 2017, but the figure grew rapidly and hit 70 billion won in 2018. The demand on the drug has surged as the healthcare insurance coverage was granted from August 2017 as a second-line therapy treating non-small cell lung cancer (NSCLC). Keytruda sales in 2019 exceeded 100 billion won, and it was also the drug with highest sales revenue last year. Keytruda is an immune checkpoint inhibitor that blocks PD-L1 receptor from biding with PD-1 pathway on the surface of T-cell and activates immune cells to treat the tumor cells. The drug showed notable efficacy in treating over 30 cancer types including melanoma, lung cancer, head and neck cancer, stomach cancer and cervical cancer. The vastly wide range of indication eventually helped the drug to boost the sales. Moreover, the sales in AstraZeneca’s Tagrisso rapidly grew as well. Compared to the year before, Tagrisso last year grew by 34.5 percent and made 106.5 billion won. Approved for sales in South Korea in 2016, Tagrisso is a second-line treatment prescribed to NSCLC patients who developed tolerance in EGFR tyrosine kinase inhibitors (TKIs) like Iressa, Tarceva and Giotrif. The medicine is considered a third-generation treatment that overcame EGFR-TKI tolerance. After receiving the healthcare reimbursement from December 2017, the drug sales have been growing consistently in South Korea, where it exceeded over 100 billion won a year in just four years into the market. AbbVie’s autoimmune disease treatment Humira grew by 8.1 percent from the year before making 104.2 billion won last year, and exceeded the 100 billion won-line for the first time. A tumor necrosis factor-alfa (TNF-α) inhibitor Humira has the most number of indications among TNF-α inhibitors with 14 indications. Targeting such diverse patient group with the range of indications, the drug was able to maintain the high growth. In 2020, Keytruda, Lipitor, Avastin, Tagrisso and Humira were the five drugs that broke through the 100 billion won-line. All were developed by multinational pharmaceutical companies. Although Lipitor sales dipped by 4.9 percent and handed over the top place to Keytruda, it still made over 100 billion won and consolidated its strong presence in the market. Pfizer’s pneumococcal pneumonia vaccine Prevnar 13 generated 81.3 billion won last year and showed off an exceptional year-on-year growth of 64.8 percent. Prevnar 13 is a pneumococcal conjugate vaccine (PCV13) that prevents infection from 13 types of pneumococcal pneumonia (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F). The vaccine can be inoculated to all age group older than 6-week-old. Chong Kun Dang is in charge of distributing the vaccine for adult in South Korea, whereas the infant and children vaccine distribution is handled by Korea Vaccine. The market research firm analyzes Prevenar 13 has been showing consistent growth in sales over the years from 2016 through 2019 making 56.1 billion won, 49.1 billion won, 50.5 billion won and 49.4 billion won, respectively, but last year’s sales soared abruptly amid COVID-19. They evaluate the use of the vaccine in adults has leapt sharply as many were convinced by a number of experts claiming the vaccine can weakened the pneumonia symptoms induced from COVID-19, although it cannot prevent the pneumonia itself. Amgen’s osteoporosis treatment Prolia joined the top ten by making 75.1 billion won last year showing year-on-year growth of 58.6 percent. Released to the South Korean market in November 2016, Prolia is a biologic osteoporosis treatment directed against receptor activator of nuclear factor-κB ligand (RANKL), which interferes with the formation, activation, and survival of osteoclasts. The drug’s sales started taking off since it was listed for reimbursement in 2017 as a second-line treatment. And Prolia’s sales grew exponentially from 3.7 billion won in 2017 to 14.3 billion won in 2018. Also when it successfully expanded the reimbursement as a first-line treatment from April last year, the figure hit 47.3 billion won and it continued to soar last year as well. Experts point out the sales partnership with Chong Kun Dang has strengthened the growth. Meanwhile, none of South Korean companies had their product in the top ten. The influenza vaccines developed by GC Pharma and SK Bioscience both remarkably made 40 billion won each in last year’s fourth quarter. However, in last year as a whole, they respectively made 63.8 billion won and 51.5 billion won, and failed to list their names on the leader board.
- Policy
- IMDs for Champix are being commercialized
- by Lee, Tak-Sun Feb 24, 2021 06:02am
- IMDs of domestic pharmaceutical companies that challenge Champix (Varenicline Tartrate, Pfizer) are attracting attention. This is because film-type formulations with enhanced convenience and SR formulations are promoting commercialization. Although generic products have already been released, demand for IMDs is expected to remain high. According to the industry on the 19th, CTC Bio, Boryung, etc. are challenging Champix as a new formulation of smoking cessation treatment. CTC Bio applied for permission for a film-type formulation of Varenicline, the same active ingredient as Champix, for the first time in Korea in September last year. This product has a salicylate salt that is different from the original salt (Tartrate). Champix is a tablet type that is taken twice a day, and it should be taken with a sufficient amount of water after meals. Since the film type is taken by dissolving it on the tongue, it will be useful for patients who have difficulty swallowing tablets or have a reluctance to drink water. Boryung recently got approval for phase 1 clinical trial plan for BR9003. Although BR9003 is unknown, it is SR tablet type that has been changed from existing twice a day to once a day. The industry is evaluating Champix SR as a competitive drug against the original drug. SK chemicals applied for a patent for Varenicline SR in 2018. Varenicline formulations have a high solubility in water, resulting in rapid effects, but a disadvantage in that the effect doesn’t last. It is believed that SK Chemicals has secured a patented formulation technology that extends the duration of drug effects by replacing salts that release drugs slowly. Champix's patent ended last July. Korean pharmaceutical companies previously challenged the market with a strategy to avoid patents by changing salts, but they lost a patent lawsuit and had a brake on early launch. Champix was used as a drug to support smoking cessation projects initiated by the former President Park Geun-hye's government, and once rose to a mega blockbuster drug of ₩60 billion per year. However, it is analyzed that there is a high possibility of success if IMD with enhanced convenience comes out as it still has a large share of smoking cessation drugs.
- Company
- Market sales of Saxenda & Qsymia are the highest ever
- by An, Kyung-Jin Feb 23, 2021 06:11am
- Despite COVID-19 incident last year, the domestic obesity treatment market set a new record. the market sales of Qsymia and Saxenda, which is known for injectables to lose weight, expanded to the highest level ever. According to IQVIA on the 23rd, the domestic market for obesity treatments last year was ₩143 billion. It has achieved the largest scale ever, increasing 6.6% from the previous year. Compared to ₩96.8 billion in 2018, this is an increase of 47.7% in two years. Belviq (Lorcaserin), which had formed annual sales of ₩10 billion, was withdrawn due to safety issues at the end of 2019 and suffered a global recession due to COVID-19, but it recorded a new record in sales for the third consecutive year. NovoNordisk's Saxenda and Alvogen Korea's Qsymia led the expansion of obesity treatments. Last year, Saxenda recorded sales of ₩36.8 billion. Although it decreased by 13.6% from the previous year, the sales volume is the largest among obesity treatment drugs on the market. The market share based on accumulated sales last year was 25.7%, maintaining a gap of about 10%p. Saxenda is the world's first obesity treatment approved as an analogue of GLP-1 (Glucagon-Like Peptide 1). It is the same as Victoza (Liraglutide), which is prescribed for type 2 diabetics. It has enjoyed a boom over the past two years as a perception that it is relatively safe because it acts as the same mechanism as GLP-1 in the human body to suppress appetite and induce weight loss. Saxenda ranked first in sales of obesity drugs in the fourth quarter of 2018, the first year of its release, with sales of ₩5.6 billion. In the first quarter of 2019, it set a record of ₩10.5 billion in sales and ₩11.9 billion in sales in the third quarter of the same year. At that time, the market share of Saxenda reached 33.7%. Qsymia was released in the first quarter of last year with sales of ₩4.3 billion, and at the same time, it ranked second in sales of obesity drugs. Since then, sales rose sharply to ₩5.8 billion in the second quarter and ₩6.5 billion in the third quarter. Last year's cumulative sales of Qsymia were ₩22.5 billion, and the market share was 15.7%. In the fourth quarter of last year, the quarterly sales of both Saxenda and Qsymia decreased slightly, but the proportion of the total obesity treatment market accounted for 41.5% of the total sales among the 110 products. Qsymia is a combination of Phentermine/Topiramate, which Alvogen Korea obtained domestic copyright from Vivus in the United States in 2017. Alvogen Korea signed a joint sales contract with Chong Kun Dang at the end of 2019 and began marketing in earnest from the beginning of last year. The sales power of Chong Kun Dang and Alvogen Korea, which has the know-how to sell obesity drugs such as Furing and Furimin, created a synergy. Although Belviq was withdrawn, Qsymia, which contains relatively low psychotropic ingredient and can be prescribed for a long period of time, was released even though it is an oral drug. It is an analysis that it was able to continue unprecedented success in the obesity treatment market. Except for Saxenda and Qsymia, sales of other products were sluggish last year. Last year's sales of Daewoong's Dietamin were ₩9.2 billion, down 3.2% from the previous year. Until the fourth quarter of 2019, it was the second most-selling item after Saxenda, but sales decreased with the release of Qsymia. Huons' Hutermin (₩6.1 billion) and Alvogen Korea's Furing (₩5.1 billion) also decreased by 1.6% and 3.8% compared to the previous year's sales. It is observed that NovoNordisk, which has successfully developed generics, has not yet decided to release it in Korea and that competition between Saxenda and Qsymia will continue for the time being.
