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- 2026-04-11 06:00:35
- Policy
- Some companies give up negotiations to recover Strepto
- by Lee, Tak-Sun Nov 11, 2022 05:51am
- Some pharmaceutical companies with the anti-inflammatory enzyme Streptokinase-streptodornase have conveyed to the NHIS that they are not willing to negotiate. Currently, about five of the 37 pharmaceutical companies subject to negotiation are known to have given up negotiations. However, as the end of the negotiations approaches, more pharmaceutical companies are likely to give up negotiations. According to the industry on the 9th, some pharmaceutical companies of Streptokinase-Streptodornase are giving up negotiations with the NHIS and accepting the deletion of benefits. Last month, the HIRA conducted a re-evaluation of the drug and decided to suspend the evaluation for one year only for items that were agreed to be recovered according to the results of the clinical re-evaluation, although there was no benefit adequacy. The clinical re-evaluation will end next year after submitting a result report. Accordingly, the NHIS is negotiating with pharmaceutical companies to recover salaries according to the results of clinical re-evaluation until the 14th. Pharmaceutical companies that have not reached an agreement in the redemption negotiations will be deleted due to a lack of benefit adequacy depending on the results of the revaluation. Some pharmaceutical companies are believed to have judged that the deletion of benefits is better. This is because if the recovery ratio is high and the clinical revaluation fails, the profit from product sales will also fall significantly. As a result, it is judged that it may be more profitable to close the business at all by deleting benefits. In the ongoing redemption negotiations, the NHIS and pharmaceutical companies are reportedly divided over the redemption rate. The NHIS sticks to more than 20% and pharmaceutical companies to less than 20%. Therefore, some predict that it will be difficult to conclude the negotiations by the deadline of the 14th of this month. Some predict that the delay in negotiations may be more disadvantageous for pharmaceutical companies as the Ministry of Health and Welfare may no longer issue a negotiation order and follow the HIRA opinion that there is no adequacy. As time goes by, there is a high possibility that more pharmaceutical companies will give up negotiations and accept the deletion of benefits. An industry official explained, "If a pharmaceutical company is disadvantaged in the negotiation for a refund, there is a high possibility that the pharmaceutical company with a small sales volume of the drug will choose to give up its business at all." The annual market size of Streptokinase-Streptodornase is about 35 billion won, which is not large. Among them, Hanmi Pharmaceutical's Mucorase and SK Chemicals' Varidase are said to be leading the way, so these pharmaceutical companies are also leading the clinical re-evaluation and negotiations for recovery.
- Company
- Impinzi's indication is expected to be approved in Korea
- by Eo, Yun-Ho Nov 10, 2022 05:46am
- Impinzi is also expected to have options for treating immuno-cancer drugs in the area of biliary tract cancer. According to related industries, the Ministry of Food and Drug Safety is reviewing the expansion of biliary tract cancer indications of Imfinzi, an immuno-cancer drug before PD-L1 inhibition mechanism. Permission is possible as early as this year. Impinzi is drawing more attention in Korea as researcher-led clinical trials conducted by Oh Do-yeon, a professor of oncology at Seoul National University Hospital, played a leading role in adding indications. Impinzi's specific biliary tract cancer indication was validated through a TOPAZ-1 study with "conventional chemotherapy (Gemcitabine·Cisplatin, GemCis) in the primary treatment of local progressive or metastatic biliary tract cancer" and obtained approval from the U.S. FDA in September. The TOPAZ-1 study is a multinational, randomized, double-blind, and placebo-controlled phase 3 clinical trial in 685 patients with progressive biliary tract cancer that compared and evaluated the combination of Impinzi, which is added to the existing standard treatment "GemCis." It is also worth noting that in the TOPAZ-1 study, patient recruitment was conducted in 17 countries, including the United States, Europe, and South America, and about 55% of the total was registered in Asian countries including Korea, Thailand, Japan, and China. As a result of the study, the Impinzi combined group had a 20% lower risk of death than the placebo combined group. However, the extension of the median value of the total survival period was only 1.3 months compared to the control group. The most commonly reported side effects were anemia (48.2%), neutropenia (31.7%), and zones (40.2%). Potentially serious side effects were 62.7% in the Impinge combined group and 64.9% in the placebo combined group, suggesting that most side effects were due to chemotherapy in both groups. Impinzi's expansion of biliary tract cancer indication was made under Project Orbis, priority screening, and designation of rare drugs. AstraZeneca, a developer, is currently in the process of expanding its indication in many countries, including Korea, Europe, and Japan.
- Policy
- Will expedited listing be possible within the year?
- by Lee, Tak-Sun Nov 10, 2022 05:46am
- The implementation of the measure that allows expedited listing for serious disease treatments is expected to be deferred somewhat. Although the government started the opinion collection process with the goal of implementing the measure in November, government officials see the measure to be implemented at the end of December at the earliest. According to industry sources on the 9th, the Health Insurance Review and Assessment Service and the National Health Insurance Service made a preannouncement on the proposed amendment to regulations that reduce the listing period of drugs related to life-threatening conditions and started the opinion collection process. The amendment contains plans to reduce the reimbursement review period of treatments for life-threatening conditions by 60 days through concurrent operation of reimbursement evaluation and pricing negotiations. Under the amendment, HIRA’s drug reimbursement evaluation period is set to be reduced from 150 days to 120 days, and the NHIS’s drug pricing negotiation period from 60 days to 30 days. Severe and rare disease treatments and PE exemption drugs are eligible for the expedited listing. The NHIS and HIRA will share data during HIRA’s review process and prepare a prior consultation process so as to establish a financial sharing plan. For this, HIRA decided to amend the ‘Regulation on the standards and procedures to evaluate the eligibility of reimbursement of drugs’ and the ‘Detailed evaluation standards for drugs subject to negotiations such as new drugs, etc,’ and the NHIS to revise the drug pricing negotiation guideline, with the common goal of implementing the measures in November. However, it is now November and the opinion collection process is now complete, but the amended regulations have not been announced yet. The industry believes that the implementation is being delayed due to a delay in the review of HIRA's regulations, and preparations for revision of drug price negotiation guidelines on NHIS's part are complete. HIRA’s proposed amendments to its regulations are now being discussed with the MOHW after completing the opinion collection process. Some are speculating that HIRA's delay may be due to amendments being made to address the criticism that arose regarding drugs eligible for pharmacoeconomic evaluation exemptions. In the proposed amendment to the regulations that are under review, the government added a clause allowing PE exemption for ‘drugs used to treat pediatric patients that are therapeutically equivalent or has no available treatment option and demonstrates improvement in quality of life or is otherwise approved by the committee.’ The industry has been voicing opposition to the system, saying that the amendment narrows the pathway for PE exemptions rather than expanding it. The Korean Research-based Pharmaceutical Industry Association had issued a statement, pointing out that “Drugs that fall under Item 2(a) and 2(b) that have difficulty generating evidence were eligible for PE exemptions even if they were not used to treat a ‘small number of’ patients. However, the amended regulation mandates the ‘small number’ condition to be met. This will only reduce the scope of eligible subjects. This rather reduced the scope of eligibility.” The same had been raised as an issue at the NA Audit. Rep. Sun-Woo Kang of the Democratic Party of Korea pointed out that the proposed system rather reduces the scope of eligible drugs by changing the standard of 'a small number of patients' that had been an ‘OR’ clause for PE exemptions into a requirement.” However, HIRA explained through a written response that “The ‘small number of patients’ standard is not absolute and drugs are evaluated for PE exemption through committee deliberations in consideration of the severity of disease, etc.” HIRA added that the ‘drugs used by pediatric patients’ mean drugs whose main indication is applied to pediatric patients, and recommended that companies prove the ‘meaningful improvement in quality of life’ through the use of Multi-Attribute Utility Instrument (MAUI) and that the drugs will be evaluated through committee deliberations in consideration of the characteristic of each disease. As such, there is an opinion that the implementation of the system is being delayed in order to revise the relevant regulations due to constant issues raised by the pharmaceutical industry and the National Assembly. An industry official said, “As the measure needs to be concurrently applied by HIRA and NHIS, implementation of the expedited listing system will inevitably be delayed if either side is less prepared. Therefore, it seems unlikely that the amendment will be implemented in November, and most are expecting the amendment to be applied at the end of December at the earliest.”
- Company
- Samjin-Pin to co-develop new targeted protein degrader
- by Lee, Seok-Jun Nov 10, 2022 05:46am
- Samjin Pharm announced on the 9th that it had signed a strategic Memorandum of Understanding (MOU) with the new drug developer Pin Therapeutics to develop a radical and improved treatment for cancer and fibrosis. Under the MOU, Samjin Pharm will conduct a comprehensive study on the targeted protein degrader (TPD) candidate to assess its efficacy, toxicity, formulation, and CMC. Pin Therapeutics will study its structural design and conduct screening on the drug. Pin Therapeutics is a new TPD drug developer that was established in 2017. Through collaboration with ‘PinUS,’ its 100% US subsidiary, the company has been conducting research and development at a global level. In addition to individual pipelines that degrade specific proteins, the company is also securing platform technology to overcome technical limitations in the field of TPD. New TPD therapies are a next-generation new drug development platform that can specifically degrade target proteins using the Ubiquitin-Proteasome system (UPS), which is one of the natural protein degradation systems in cells. TPD drugs fundamentally degrade and remove the pathogenic proteins whose function had been only inhibited with conventional small molecule inhibitors. It is a superior therapeutic modality compared to existing small molecule inhibitors in terms of efficacy and target selectivity. Sumin Lee, head of Samjin Pharmaceutical’s research center, said, “The TPD technology is expected to become a game changer in the field of new drug development as it can target more than 80% of the pathogenic proteins that could not be controlled by existing small molecule compounds.”
- Opinion
- [Reporter's view] COVID-19 demand has disappeared
- by Nov 10, 2022 05:45am
- The boom of pharmaceutical companies, which had benefited from COVID-19, has subsided since the third quarter. Representatively, Roche Group suffered a sharp drop in sales of diagnostic kits and treatments in the third quarter. Roche Group supplies Actemra and Ronapreve, a treatment for COVID-19, and Roche Diagnostics manufactures a COVID-19 diagnostic kit. In the third quarter of this year, Actemra fell 42% year-on-year. Ronapreve's sales also shrank by 36%. Sales of Roche Diagnostics' COVID-19 diagnostic kit, which introduced the first COVID-19 diagnostic kit at the time of the outbreak of COVID-19, also fell sharply. Roche believes that it is no longer possible to benefit from COVID-19 from the third quarter. Roche CEO Severin Schwan said, "COVID-19 demand completely disappeared in the third quarter." It was judged that sales related to COVID-19, which had been on a roll until the end of last year, would not continue this year. Pfizer and Moderna's COVID-19 vaccine sales have also peaked in the fourth quarter of last year and have been on the decline in the first quarter of this year. Although the two companies were the fastest to respond to the COVID-19 mutation among the developers of the COVID-19 vaccine, a drop in sales was inevitable. Overall, the need for vaccination was lowered as the fatigue level of vaccination increased and the severity rate decreased as the coronavirus mutated. The situation of domestic pharmaceutical companies, which benefited from the COVID-19 vaccine and diagnostic kits, is similar. SK Bioscience, which focused on the production of COVID-19 vaccines, saw its sales and operating profit fall 59% and 79% in the third quarter, respectively. The company gave up the flu vaccine, which was its main source of sales, to produce the COVID-19 vaccine. It has also succeeded in developing the first domestic COVID-19 vaccine but has not yet led to profits. Domestic diagnostic kit companies, which recorded all-time sales with COVID-19 diagnostic kits, are also expected to receive sluggish report cards in the second half of the year. The only companies that still benefit from COVID-19 are Pfizer and MSD, which have developed COVID-19 treatments, and pharmaceutical companies that manufacture cold medicines. They are mainly companies that supply treatments for patients with mild COVID-19. In fact, SK Bioscience is considering resuming the production of flu vaccines next year. This is a measure to prepare for a decrease in the production of COVID-19 vaccines. Pfizer is expanding its sales excluding COVID-19-related sales as its existing flagship products are on a roll. However, market concerns are increasing for diagnostic kit companies that have seen the COVID-19 vaccine as the only source of sales or have excessively expanded sales to COVID-19. Countries have supported COVID-19-related diagnosis, prevention, and treatment at the government level, but the situation is expected to change next year. The United States and Japan are already considering charging COVID-19 vaccines or treatments. The loss of government support means that related companies will find it difficult to generate as many sales as they do now. It remains to be seen whether pharmaceutical and bio companies, which have benefited from the COVID-19 special for about two years, will be able to quickly prepare new growth engines.
- Policy
- We will do our best to compensate for Paxlovid side effects
- by Lee, Jeong-Hwan Nov 10, 2022 05:45am
- Director Oh Yoo-kyung (Photo = Provided by the National Assembly Professional JournalistsOh Yoo-kyung, head of the Ministry of Food and Drug Safety, said she would focus on budget and legislation to compensate for side effects and damage relief for drugs approved for emergency use for the treatment of COVID-19. Oh Yoo-kyung said she will immediately process the patient's compensation as soon as the results of the side effect review of the emergency use approved drug are released. This is an answer to the question of pending issues of Choi Hye-young, a member of the Democratic Party of Korea, at the plenary session of the National Assembly's Health and Welfare Committee on the 7th. Representative Choi Hye-young pointed out that there is no national damage compensation track for side effects that occurred after the administration of oral treatments for COVID-19 such as Paxlovid and emergency use approved drugs. In fact, the side effect damage relief system is currently in operation only for drugs that have obtained official marketing permission based on the Pharmaceutical Affairs Act. Representative Choi said, "The administration rate of oral medicine for COVID-19 tripled from February to August. As the administration rate increases, the number of abnormal cases caused by the treatment taken increases, she said. "The drug has no legal basis for compensation for damage." Representative Choi said, "There are two screening procedures for emergency approval drugs, and even if the compensation is decided, there are no financial resources," adding, "We have submitted a bill to solve this problem." She said, "Please try to pass the bill and show your initiative in explaining the need for the bill and budget at each office of lawmakers." She responded to Choi's criticism that she would speed up budget and bill work. Director Oh said, "We are currently actively trying to revise related laws quickly. We are also trying to secure the budget, she said. "The Korea Pharmaceutical Safety Management Agency is receiving counseling for victims' damage compensation so that damage compensation can be paid as soon as the budget is secured." "We will push ahead with it quickly," she said.
- Company
- The number of reimbursed drugs is the lowest in 33 months
- by Chon, Seung-Hyun Nov 09, 2022 05:47am
- The number of medicines listed on the health insurance benefit list is the smallest in about three years. New-entry drugs have decreased significantly due to the price reorganization of generic drugs and joint development regulations. The size of the reimbursed drug has been greatly reduced due to the reorganization of items such as microbial or unclaimed deletion of drug benefits. Prior to the reorganization of the drug price system, reimbursed drugs exploded, but they are rapidly recovering to the previous level. According to the HIRA on the 8th, a total of 23,604 drugs were registered as of the 1st of this month. It decreased by 1,057 in a month from 24,661 in the previous month. The health authorities delete drugs that have not claimed insurance benefits in the past two years or have not reported production or import performance for three years from the payroll list. The number of medicines has been on a steady decline since it hit 26,527 in October 2020. It has decreased by 2,923 in the past two years and one month. This means that there have been 2,923 more withdrawals or exits from the market than new entries into health insurance benefits over the past two years. In November 2018, the number of reimbursed drugs was recorded at 26,689, but in October 2020, the number increased by 5,838 in a year and 11 months to 26,527. During this period, new entries overwhelmed the number of withdrawals from the market, with the size of salary-listed drugs expanding by 28.2%. In the 22 months from November 2018 to October 2020, the number of salary-listed drugs decreased compared to the previous month only once on November 8 and December 2019. In other words, the remaining 21 months have all increased the size of salary-listed drugs compared to the previous month. During this period, the average number of unproduced and unclaimed drug benefits was deleted twice a year, but the number of new entries was higher. The number of times listed drugs has decreased from the previous month 16 times in 25 months from October 2020 to this month. Since August last year, the number of drugs listed has decreased for six consecutive months. Currently, the number of drugs listed has fallen to 25,694 in February 2020, the lowest in 33 months. It is analyzed that the overall number of listed drugs has continued to decline as the speed of the health authorities' continuous arrangement of reimbursed drug items has advanced to the new entry. Recently, the number of new generics has decreased significantly. According to the Ministry of Food and Drug Safety, the number of Rx drugs licensed from January to October this year was 942, an average of 94 per month. Last year, 1,603 Rx drugs were licensed, recording an average of 134 per month, down 41.2% in a year. Compared to the 2,616 Rx drug licenses (218 per month on average) in 2020, it has fallen to less than half in two years. The number of Rx drug permits was 1,562 in 2018, recording an average of 130 per month, but in 2019, it soared to an average of 350 per month. Since then, it has been gradually decreasing. It is analyzed that the number of permits for generic drugs, which account for the largest proportion of Rx drugs, has decreased. The reorganization drug price system, which took effect in July 2020, focuses on maintaining the 53.55% upper limit of the current original drug before the expiration of the patent only when generic products meet both the direct performance of BA Test and the use of registered raw materials. The reorganized drug price system includes a stepped drug price system in which the upper limit decreases as the registration period is delayed. If more than 20 generics are listed in the specific ingredient market, the upper limit of newly listed items will be up to 85% of the existing lowest price. It is analyzed that the approval of the manufacturing consignment generic for the entire process has decreased significantly due to the structure in which the drug price drops significantly if pharmaceutical companies do not develop the generic themselves and perform BA tests. Some say that the regulation on joint drug development, which took effect in July last year, has promoted the decline in generic permits. The revised Pharmaceutical Act, which was passed at the plenary session of the National Assembly in May last year, limits the number of IMDs and generics that can be approved as a single clinical trial. If all manufacturing processes are manufactured the same with the same prescription and manufacturing method at the same manufacturer as the pharmaceutical company that directly conducted the BA test, the use of BA data will be limited to three times. This means that only four generics can be licensed with one BA test. Clinical trial data can also be agreed on up to three items other than medicines by direct pharmaceutical companies. In the past, when certain pharmaceutical companies received generic permits through BA test, dozens of pharmaceutical companies often received consignment generic permits with the same data, but joint development regulations made it impossible to "unlimited generic replication." It is analyzed that pharmaceutical companies received generic permits indiscriminately regardless of marketability before tightening regulations, and there are many cases that lead to market withdrawal without sales performance.
- Policy
- Drug prices should be raised if RWD show high effect
- by Lee, Tak-Sun Nov 09, 2022 05:47am
- Jin Yong Lee, Director of HIRA Research Institute, is answering questions at the press briefing held on the 8t Jin Yong Lee, Director of the Health Insurance Review and Assessment Research Institute, expressed his personal view that the government should raise the prices of high-priced drugs that confirm improved outcomes with real-world data (RWD). Currently, the Health Insurance Review and Assessment Service conducts performance analysis for some high-priced drugs with RWD to manage NHI reimbursement expenditures. However, the purpose of the system is mostly in retrieving the reimbursed expenditures, and there is no mechanism established to allow drug price increases for better-performing drugs. However, Director Lee strongly expressed the need for a mechanism to increase the drug price as well as one to secure mutual trust with the pharmaceutical companies. Director Lee said so at the press conference that was held at The National Health Insurance Service’s Wonju headquarters with its press corps on the 8th. Director Lee is a former professor at Seoul National University Hospital who took office in August 2020 through an open position system, and his three-year term is set to be completed in August next year. HIRA’s reimbursement management model based on RWD has also been developed after Director Lee took office. The model allows for the government to apply reimbursement to high-priced drugs such as Kymriah and Zolgensma based on RWD. Therefore, the system contains a clause that regulates the companies to refund the reimbursed amount to patients that see no treatment effect. The RWD for the system is collected through data from actual claims and those used for prior approval of the drugs. However, Director Lee explained that a drug price increase is also necessary for high-priced drugs that show a high treatment effect. Lee had made the same claim at the 2021 Innovation Research Symposium,’ which was held under the theme of ‘Measures for establishing an RWD collection system to manage drug reimbursements.’ Lee said, “I still hold the same view (as the one I made at last year’s Innovation Research Symposium). It's my personal opinion, but I think that’s a kind of 'rule' to ensure mutual trust with pharmaceutical companies." He added, “From my experience, although it is difficult for drugs to receive a price increase through reevaluations, the possibility should be left open." However, Lee reiterated that it is just his personal opinion and that there is a high possibility that his claim will be agreed upon by only a few people. HIRA Research Institute has recently confirmed the difference in treatment effect according to the age of the patient through RWD analysis. In addition, the institute is conducting cost calculations after designing a pharmacoeconomic evaluation model to confirm the appropriateness of the listed drug prices. Lee said, “Use of RWD in analyzing drug effect and pharmacoeconomic evaluations will increase to improve access to high-priced drugs and for the management of NHI finances. Therefore, it is necessary to collect and continuously accumulate analysis results of various pharmaceuticals to derive more meaningful results.” The definition of high-priced drugs and measures for their reimbursement that was reported to the Health Insurance Policy Deliberation Committee in July was also one of HIRA Research Institute’s major achievements this year. Although there is no international consensus on the definition of high-priced drugs, the Institute defined the drugs as those that require price management and long-term effect confirmation due to high prices and uncertainty in effect. Also, to manage reimbursements, the institute planned to improve access by shortening the registration period, strengthening monitoring of treatment effects and safety, and securing the sustainability of NHI finances by strengthening financial management. Drugs subject to the measure were defined as drugs that are expected to bring long-term effects after a single treatment (one-shot treatment), drugs with annual financial spending exceeding KRW 300 million per person, and drugs with annual health insurance claims that exceed KRW 30 billion. Director Lee also expressed high expectations for the new administration’s plan to support treatments for pediatric patients and severe and rare diseases.
- Company
- Atozet market ↑40% in 1 year...Lipitor Plus leads generics
- by Kim, Jin-Gu Nov 09, 2022 05:47am
- The atorvastatin and ezetimibe combination market has grown 40% in a single year. The cumulative prescription amount of related generics increased over twofold and drove the market growth. In particular, Jeil Pharmaceutical and Viatris Korea’s Lipitor Plus is rapidly increasing its influence in the market. Prescription sales of Lipitor Plus rose 4.6 times in one year and became the highest-performing product among all generics. ◆Prescipriton of Atozet generics rise 96% in a year…market share increases to 56% According to the market research institution UBIST on the 7th, the outpatient prescription sales of the atorvastatin and ezetimibe combination had reached KRW 51.1 billion in Q3 this year. This is a 39.8% increase from the KRW 36.6 billion made in Q3 last year. The original product in the market is MSD’s Atozet. Atozet’s prescriptions in Q3 this year were KRW 22.5 billion, rising 2.3% in one year. With sales of the original drug slowing down, the market growth is being evaluated to have been driven by the generics. Prescription of Atozet generics rose around twofold (96%) in one year, from KRW 14.6 billion in Q3 last year to KRW 28.6 billion in Q3 this year. The market share of atorvastatin and ezetimibe combination generics has been growing rapidly since their release in Q2 last year. Their prescriptions, which had amounted to KRW 6.9 billion in Q2, had risen to KRW 14.6 billion in Q3, and KRW 19.3 billion in Q4. In Q1 this year, the generics made KRW 22.1 billion, exceeding sales of the original version (KRW 21.4 billion). Its growth continued on since then to occupy 56.0% of the market in Q3. In Korea, 112 companies were approved to manufacture atorvastatin and ezetimibe combination generics. Chong Kun Dang first received approval for ‘Lipilouzet’, a combination drug that contains the same ingredients as Atozet in October 2020. In January of the following year, 21 companies received approval for their authorized generics of Lipilouzet. Authorized generics refer to already approved generic products with different packaging. The drugs were listed for reimbursement in April last year. Latecomer generics joined the competition in February. 88 companies received approval for Atozet generics then, which were listed for reimbursement in May last year, one year later than the authorized generics of Lipilouzet. Among the companies, 83 are currently selling atorvastatin and ezetimibe combination drugs. ◆Lipitor Plus rises as the leading generic in the market despite low price Among the selling atorvastatin and ezetimibe combination generics, Lipitor Plus’s rapid growth is gathering attention. Pic of Lipitor PlusLipitor Plus’s Q3 prescription amount was KRW 3.7 billion, a 4.6 times rise from the KRW 0.8 billion it had made in Q3 last year. At the same time, the drug recorded the highest prescription performance among all atorvastatin and ezetimibe combination generics. Its cumulative prescription amount by Q3 this year is KRW 8.6 billion, and the analysis is that its annual prescription is highly likely to exceed KRW 10 billion this year. Lipitor Plus was released as an Atozet generic, not an authorized generic of Lipilouzet. Being listed a month later than the authorized generics of Lipilouzet, its price was set at a lower price than other generics. Based on the 10/10mg dose, the insured ceiling price of Lipilouzet is KRW 1,037, whereas the price of authorized generics of Lipilouzet is 85% of that at KRW 881, and Atozet generics 30% of that at KRW 637. In accordance with the reform of the drug pricing system in July 2020, the price ceiling of 20 of the 21 authorized generics that were listed at the same time as Lipilouzet was set at 85% of the highest price. This is because the drugs did not meet the requirement of “directly conducting a bioequivalence test”, one of the two requirements that need to be met to receive the highest ceiling price among generics. As the number listed identical products exceeded 20 by the time the Atozet generics were listed a month later, their price was set as the lower of the two - '85% of the price of the drug that did not meet the two requirements' or '85% of the previous lowest price’ - regardless of whether or not the two requirements were met. As a result, the price ceiling of Atozet generics was set around 30% lower than the authorized generics of Lipilouzet. Due to its low price, the sales performance of Lipitor Plus had not been good earlier in its release. In Q3 last year, its prescriptions had been lower than that of its competitors, such as Daewoong Pharmaceutical’s Litorvazet (KRW 1.7 billion), Boryung Pharmaceutical’s L50 (KRW 1.6 billion), Yuhan Corp’s Atovamibe (KRW 1.4 billion), HK Inno.N’s Zepitor (KRW 1 billion). Q3 prescription sales of major atorvastatin+ezetimibe generics However, Viatris and Jeil Pharmaceutical made a joint promotion agreement and rapidly increased prescriptions of Lipitor Plus. For Lipitor Plus, Viatris will be supplying the API of Lipitor, atorvastatin to Jeil Pharmaceutical, and the final product will be manufactured and produced by Jeil Pharmaceutical. The two companies will manage and jointly promote sales of the drug. The fact that Lipitor (atorvastatin), one of the main ingredients in Lipitor Plus, is still exerting much influence in the prescription field, positively influencing the sales performance of its follow-on, Lipitor Plus. Following Lipitor Plus, Daewoong’s Litorvazet sold KRW 3.6 billion, Boryung’s L50 sold KRW 2.4 billion, Yuhan Corp’s Atovamibe KRW 2.2 billion, HK.Inno.N’s Zepitor KRW 2 billion, and Ahngook’s Lipozet KRW 1.5 billion in Q3 this year. Quarterly sales of other products in the market were less than KRW 1 billion.
- Company
- SGLT-2 diabetes medication is on the rise
- by Kim, Jin-Gu Nov 08, 2022 05:43am
- By product, AstraZeneca Forxiga and Xigduo are chased by Beringer Ingelheim Jardiance and Jardiance DuoThe market for diabetes treatments related to SGLT-2 inhibitors has grown by 16% in a year. Analysts say that the use of this drug in the diabetes treatment market is steadily expanding and that major drugs have recently added indications for heart failure treatment, leading to the expansion of appearance. In the first half of next year, Daewoong Pharmaceutical's new SGLT-2 inhibitor-based diabetes drug is expected to launch, which is expected to intensify competition in the market in the future. ◆SGLT-2 Diabetes Treatment Market Expanded by 15% According to UBIST, a pharmaceutical market research firm, the domestic SGLT-2 inhibitor market in the third quarter of this year was 44.6 billion won. It increased by 15% compared to 38.7 billion won in the third quarter of last year. The cumulative prescription amount increased by 16% from 109.6 billion won in the third quarter of last year to 126.6 billion won in the third quarter of this year. The SGLT-2 inhibitor market was formed in 2014 when AstraZeneca released Forxiga. Astellas Suglat was added in 2015, and Beringer Ingelheim Jardiance and MSD Steglatro were added in 2016 and 2018. With the addition of new drugs, the market has grown rapidly. In the first quarter of 2017, the quarterly prescription exceeded 10 billion won for the first time. It then surpassed 20 billion won in the fourth quarter of 2018, 30 billion won in the second quarter of 2020, and 40 billion won in the fourth quarter of last year. Analysts say that the use of complex drugs at the prescription site is expanding, driving the growth of the overall market. These combinations include AstraZeneca Xigduo and Beringer Ingelheim Jardiance Duo. It is a drug that combines Metformin with SGLT-2 inhibitors. Sugar and Steglatro have no combination. In the third quarter, the number of outpatient prescriptions for the single SGLT-2 inhibitor was 25.3 billion won in total for four products. It increased by 11% compared to 22.8 billion won in the third quarter of last year. During the same period, the total amount of prescriptions for the two combination products increased by 21% from 15.9 billion won to 19.3 billion won. Although the single market is still larger, the gap is expected to gradually decrease in that the complex is rapidly increasing its influence. The expansion of the prescription area to heart failure also positively affected the market growth. In July, the Korean Society of Cardiology issued a "complete revision of the 2022 Heart Failure Treatment Guidelines" and recommended SGLT-2 inhibitors as a major drug for the treatment of chronic heart failure regardless of the presence or absence of diabetes. The SGLT-2 inhibitors specified in the guidelines are limited to Jardiance and Forxiga, which have been based on clinical research. Following the revision of the guidelines, if health insurance benefits expand to heart failure, the market is expected to grow even more. Forxiga and Xigduo's total prescription amount in the third quarter of this year was 23.7 billion won. It increased by 14% compared to 20.8 billion won in the third quarter of last year. Jardiance and Jardiance Duo increased by 19% from 16.7 billion won to 19.8 billion won during the same period. Suglat and Steglatro recorded prescription performances of 800 million won and 400 million won, respectively, in the third quarter of this year. In terms of market share, Forxiga and Xigduo decreased by 1%p from 54% in the third quarter of last year to 53% in the third quarter of this year, and Jadiang and Jadiang Duo increased by 1%p from 43% to 44%. Suglat and Steglatro are insignificant at 2% and 1% respectively. Daewoong Pharmaceutical plans to release a new self-developed SGLT-2 inhibitor in the first half of next year. I applied for an item permit in April. Daewoong Pharmaceutical is expected to receive an item license this year. As Daewoong Pharmaceutical is building strong sales power in the diabetes treatment market, competition in the SGLT-2 inhibitor market is expected to intensify with the addition of DWP16001. Daewoong Pharmaceutical is jointly selling Forxiga and Xigduo, the No. 1 product in the SGLT-2 inhibitor market. In the DPP-4 inhibitor treatment market, another diabetes drug, Daewoong Pharmaceutical is also jointly selling LG Chem's "Zemiglo Series," the No. 1 product in the market.
