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- 2026-04-11 03:01:27
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- Avodart, Real World Data
- by Dec 28, 2022 05:48am
- GSK's large-scale real-world clinical results of Avodart, a treatment for prostatic hypertrophy, which marks the 13th anniversary of its launch in Korea, have been released for the first time. Based on actual field data, the company expressed its ambition to further strengthen Avodart's position in early hair loss treatment.LEAD clinical trials are the first RealWorld study conducted to evaluate the long-term clinical usefulness of Avodart in Korean male hair loss patients. It was compared with Finasteride, the two major mountain ranges for oral hair loss treatment. 600 patients participated in five general hospitals in Korea, including Inha University Hospital and Gangdong Kyung Hee University Hospital, and the average analysis period reached 3.4 years. In particular, the Korean Hair Loss Type Classification Act (BASP) developed by the Hair Institute for data analysis with the domestic medical staff was applied. The accuracy of the evaluation was improved by using the Korean classification method, not the Western classification method, which is difficult to apply to Koreans. Dr. Gary Ong, general manager of GSK Global Dermatology Medical, who led the LEAD clinical trial, said, "This study confirmed that Avodart is more effective in treating male hair loss based on Korean classification," adding, "M-shaped hair loss is the part that patients care the most, and Avodart showed good results compared to Finasteride." LEAD clinical results showed that Avodart had a significantly higher cumulative number of patients with improved symptoms compared to Finasteride in most types of hair loss. In M-shaped hair loss, which is most common in Korean men, the proportion of patients with improved symptoms was 86.0% for Avodart and 45.5% for Finasteride, showing a difference of more than 40%p. The improvement rate of hair growth was also about twice as high in the Avodart group as in the Finasteride group. A common misconception about Avodart is that it has higher side effects than Finasteride, which inhibits only type 2 by inhibiting both type 1 and type 2 of 5-alpha reductase. As a result of the Real World study, Avodart showed only a similar level of adverse reactions to Finasteride. Dr. Gary Ong said, "As a result, Avodart was more effective, and safety was similar. "I think the results of this study not only help reduce misunderstandings and prejudices about Avodart but also help doctors make more appropriate decisions when prescribing it in real life," he explained. Based on the results of the first Real World, GSK set a goal of further enhancing Avodart's position as a primary treatment in the Korean hair loss market. This is because there is still a high perception that finasteride is used first in the early stages of hair loss and Avodart is used after further progress. Dr. Gary Ong said, "This study broadens the path to prescribing Avodart as a primary treatment. Male-type hair loss is a progressive disease, so you need to start treatment as soon as possible to get better results in the long term, he stressed. In order to achieve this goal, GSK Korea has recently increased its marketing staff. BM Kim Hwan-geun, who joined Avodart marketing two months ago, said, "Avodart has maintained the top prescription for oral male hair loss treatment from the fourth quarter of 2020 to the second quarter of 2022, and real-world data for 600 Koreans will have a positive impact on Avodart's prescription expansion." "Avodart started as a latecomer amid fierce competition and showed double-digit growth every year," said BM, in charge of Avodart. As it is expected to grow further in the future, two managers will join us in marketing, he said. "We will try to make Avodart the epitome of hair loss treatments next year."
- Policy
- Abbott’s Lipidil NT 145mg listed with reimbursement
- by Lee, Tak-Sun Dec 27, 2022 06:10am
- The original developer of the hyperlipidemia treatment fenofibrate will be releasing a 145mg product that can be taken on an empty stomach. This is the second drug to be released, following Yuhan Corp. As such, the two products are expected to compete fiercely in the market next year. According to industry sources on the 26th, Abbott Korea’s Lipidil NT (fenofibrate 145mg) will be listed at a ceiling price of KRW 339 from the first of next month. The price has been set the same as Yuhan Corp’s Fenowell Tab 145mg. The Health Insurance Review and Assessment Service decided for Lipidil NT’s price to be set at the same level as Yuhan Corp.'s Fenowell Tab 145mg was the only identical drug available and its price had already been adjusted to 53.55% of the original’s price. Although Lipidil NT had been listed later than Yuhan’s drug, its entry is expected to receive attention for being produced by Abbott, the original fenofibrate drug developer. Fenofibrate 160mg tablets are currently mainstream in the market, and the drugs recorded KRW 165 billion in outpatient prescriptions (UBIST) last year. The current market leader, GC Corp’s ‘Lipidil Supra,’ is also a 160mg strength tablet. Lipidil Supra has been developed by Abbott. However, the 160mg tablets have the inconvenience of needing to be taken with the main meal due to absorption issues in the stomach. On the other hand, gastrointestinal absorption of the 145mg tablets are absorbed quicker, and therefore can be taken with or without meals. As the new strength supplemented the shortcomings of existing products, there have been prospects that prescriptions will shift to the 145mg formulation with their release. Due to this element, a fierce competition is expected in the market with Yuhan Corp when Abbott releases Lipidil NT Tab The industry believes the result between the two companies will depend on how well Yuhan Corp preoccupied the market for the 5 months since its reimbursement listing in July this year. However still, it is analyzed that Abbott may quickly absorb the market as the original maker, even though it is the latecomer in the market. If GC Corp, which has already been targeting the domestic market in partnership with Abbott, adds on its support, Lipidol NT’s penetration rate in the market may accelerate further. GC Corp has also been approved for a 145mg product. Its product is Neofeno Tab. The product is being manufactured by Yuhan Corp upon consignment, but unlike Yuhan Corp, the company has not applied for reimbursement. Accordingly, there has also been analysis that GC Corp will collaborate with Abbott in marketing Lipidil NT, just like for Lipidil Supra.
- Company
- Samsung BioLogics did not receive 45.5 billion won
- by Dec 27, 2022 06:10am
- Cytodyn Main Pipeline (Data = Cytodyn)Samsung BioLogics has been in conflict with U.S. bio company Cytodyn over the past year to pay for commissioned production (CMO). Conflicts have continued for a year as Cytodyn is overdue the promised cost of the biopharmaceutical CMO. Late payments more than doubled from $13.5 million (17.2 billion won) in January this year. According to the U.S. Securities and Exchange Commission on the 26th, Cytodyn told Samsung BioLogics in a third-quarter report that the balance of overdue payments related to Leronlimab CMO was $35.7 million. Cytodyn is an American bio company that is developing AIDS, cancer, non-alcoholic fatty hepatitis (NASH), and COVID-19 candidates. In May 2019, Samsung BioLogics signed a contract with Leronlimab CMO for AIDS treatment. At that time, the minimum guarantee amount for the contract was $31 million (39.5 billion won). The minimum guarantee amount increased to $50.22 million (64 billion won) through a change in contract terms in July 2020. It is a contract that guarantees sales of $246 million (313.7 billion won) by 2027 through the production of commercial products if the license is successful. Cytodyn said Samsung BioLogics should pay $35.7 million in arrears. (Data = US Securities and Exchange Commission) Leronlimab is a fully humanized IgG4 monoclonal antibody treatment that targets CCR5 used in the process of the virus penetrating T cells as a mechanism to suppress cell infection of the HIV virus. Clinical trials for severe COVID-19 patients were also conducted through drug re-invention, but there was no significant difference from the placebo group in terms of efficacy. The payment conflict erupted when Cytodyn did not pay $13.5 million (17.2 billion won) to Samsung BioLogics at the end of last year. Samsung BioLogics sent a written notice to Cytodyn earlier this year demanding payment. According to the disclosure, the balance of arrears increased to $38.1 million as of May 31. As of August 31, it was slightly reduced to $35.7 million. The overdue balance seems to have decreased as some of the payments were made. Cytodyn said, "We will make reasonable efforts to fix serious violations. If we do not make reasonable efforts during the correction period, Samsung BioLogics can terminate the contract," and explained, "Cytodyn management is continuously discussing with Samsung BioLogics to solve the problem."
- Product
- “Immediately stop enforcing the Healthcare Data Act”
- by Dec 27, 2022 06:10am
- Five major healthcare associations in Korea have called for the discontinuation of the enforcement of the Healthcare Data Act. The Korean Pharmaceutical Association (President: Kwang-Hoon Choi), Korean Medical Association (President: Pil-Soo Lee), Korean Hospital Association (President: Dong-Seop Yoon), Korean Dental Association (President: Tae-Geun Park), Association of Korean Medicine (President: Joo-Eui Hong) issued a joint statement on the 23rd criticizing the government's enforcement of the 'Act on the Promotion of Digital Healthcare and Utilization of Healthcare Data.’ The associations criticized, “From the 23rd of last month, the 5 associations had asked the government to consult on the details related to healthcare data services with medical and pharmaceutical associations under the premise that ‘healthcare services should be designed around public safety and health rather than from an economical or commercial point of view.’ However, the Ministry of Health and Welfare has been pursuing legislation of the Act from an economic and commercial perspective without any prior consultation.” In other words, the associations agree on the purpose of the legislation in promoting public health and contributing to improving the quality of life. However, the issue is in how the actual act overlooks the importance of healthcare data, which is highly sensitive information, and the need to manage it more strictly than any other information. The associations pointed out, “What’s most important is to ensure that the primary essential element of healthcare - protecting the life and health of the people – is not infringed by secondary by-products such as promotion of the industry in the course of applying digital technology. However, the MOHW is allowing sensitive data, not only the public’s diagnosis results, treatment history but also genetic information and life-related information to be leaked outside of healthcare institutions based on individual intent without supervision from healthcare institutions.” They added, “This goes to show that the measures for the safe use of healthcare data that had been discussed in-depth in the health, medical, and pharmaceutical industry are not being reflected at all in the legislation. Although medical information is sensitive information that requires the highest level of security, the government plans to transmit it to a private company without obtaining consent from healthcare institutions, which are in charge of producing and managing such clinical medical information, in an electronic format that is vulnerable to hacking, etc.” Also, the associations explained that the act contradicts other laws including the Medical Service Act, Bioethics and Safety Act, Personal Information Protection Act, Copyright Act, Data Industry Act, etc., and therefore may likely cause national confusion. The associations said, “In conclusion, we agree with the legislative purpose of contributing to the improvement of national health and quality of life and fostering the digital and biohealth industry, but as the legislation and institutionalization of a system that emphasizes industry promotion over public value and disregards the issues of safety and efficacy, poses a serious threat to public health and protection of personal information. Therefore we strongly oppose to the enactment of the law and request the following 4 conditions be met to guarantee the rights of healthcare data generators, ensure fair value evaluation and protection of personal information, and minimize infringement on the public’s right to health.” The four conditions suggested by the association are: ▲as healthcare institutions are obligated to directly produce, process, manage and protect healthcare data, the government should guarantee the status and rights of healthcare institutions as the principal subject of healthcare data; ▲ the government should guarantee a reasonable right of refusal to healthcare institutions against the third party’s and one-sided personal right to request transfer as the current Act only imposes obligations on healthcare institutions and overlooks the fact that a leakage of the large amount of concentrated healthcare data in the process can lead to a national disaster; ▲ the information that can be subject to the right to request transfer should be limited to information provided by individuals to healthcare institutions; ▲the government should ensure mandatory participation of healthcare institutions and representatives of industry types to represent the voices in the field and industry when forming of various national data policy medical expert committees including the Healthcare Data Policy Deliberative Committee, and the Digital Healthcare Policy Deliberative Committee, etc.
- Company
- LG Chem's Humira biosimilar applies for domestic permission
- by Dec 27, 2022 06:10am
- A researcher at LG Chem is looking at the data.(Source: LG Chem)LG Chem announced on the 23rd that it has applied for permission for Humira biosimilar LBAL items to the Ministry of Food and Drug Safety. Indications include rheumatoid arthritis, psoriatic arthritis, axillary spinal arthritis, adult Crohn's disease, psoriasis, ulcerative colitis, Betchett enteritis, and meningitis in adults. In addition, children (6 to 17 years old) have Crohn's disease, idiopathic childhood arthritis, and childhood plate psoriasis. LG Chem was approved on May 27, 2016, for a phase 3 clinical trial to evaluate the equivalence of LBAL and Humira in patients with active rheumatoid arthritis who responded inappropriately to Methotrexate. After registering the first target on June 23, 2016, the last target visit was completed on February 1, 2018. LG Chem confirmed equivalence in the LBAL and Humira groups as clinical results. In the safety sector, the incidence of adverse reactions (AE) was similar in the LBAL and Humira groups. The incidence of significant adverse reactions (SAE) was 8.3% in the LBAL group and 4.7% in the Humira group, showing no significant difference. There was no adverse reaction that resulted in death. LBAL is a biosimilar developed in a high-concentration formulation like Humira. It is a product that improves patient convenience by removing citrate that can cause pain to patients. An official from LG Chem said, "We expect to provide patients with more options for treating autoimmune diseases through the previously released Eucept and LBAL."
- Policy
- Darzalex succeeded in renewing his contract with RSA
- by Kim, Jung-Ju Dec 26, 2022 06:07am
- Darzalex, a treatment for multiple myeloma by Janssen Korea, has succeeded in negotiating a contract renewal with the NHIS. As a condition for renewal of the contract, the drug price was reduced by 2% by content, and RSA plans such as refund rate and cap were also set. According to the industry, the Ministry of Health and Welfare will push for a revision of the "drug benefit list and upper limit table," which includes Darzalex price cut, based on the renewal of the RSA contract between the NHIS and the company. This drug is used to treat multiple myeloma, which failed to treat at least three treatments, including proteasome inhibitors and immunomodulatory agents, and the alternative drug is Dexamethasone which is listed in all of the A77 countries (the United States, France, Germany, Italy, Britain, Switzerland, and Japan). When the RSA-applied drug approaches the expiration of the contract period, the NHIS evaluates the clinical usefulness and cost-effectiveness of the drug in advance. Based on the results, the corporation and pharmaceutical companies renegotiate RSA negotiations on the reduction price, expected claim amount, refund rate, and cap. The drug succeeded in signing its first RSA contract with the NHIS on April 8, 2019, as a Refund with Expenditure Cap, and was set to expire in early April next year. The company conveyed its intention to renew the contract to the NHIS, and renegotiated with the NHIS from September 23 to the 24th of last month after the NHIS review. As a result, the drug price by content was reduced by 2%. The NHIS expected to cut the drug price to 2% compared to the existing upper limit, which is expected to reduce the budget for health insurance. The time to apply the cut price is April 8th next year.
- Imported new Tylenol to be listed for reimb from Jan
- by Lee, Tak-Sun Dec 26, 2022 06:07am
- Tylenol 8 hours ER Tab that had been manufactured and sold in Korea. J&J will be importing the product for sale from JanuaryThe new Tylenol 8 hours ER Tab will be listed for reimbursement. The insurance price of Tylenol products has been raised to address the imbalance in supply and demand. With the listing, the existing domestically manufactured products will be removed from the reimbursement list. Unlike the previously listed products, the newly listed products are imported, and the insurance ceiling price has been set at KRW 90, which is the highest price among same-ingredient products. According to industry sources on the 25th, Tylenol 8 hours ER Tab, which is being sold by Johnson & Johnson Korea, will be listed for reimbursement from January next year. The product has been imported from Canada and Indonesia. The drug has been approved by the Ministry of Food and Drug Safety in January this year. With the reimbursement approved for the new product, the previous Tylenol 8 hours ER Tab that had been manufactured by Janssen Korea will be removed from the reimbursement list. The product had been set to be removed from the reimbursement list in March with a 6 month claims grace period after its license withdrawal in January in line with the shutdown of the Hyangnam plant. However, in consideration of the shortage of supply and inventory, the grace period for reimbursement had been extended until December upon request of the company. Its drug price had been raised from KRW 51 to KRW 90 after pricing negotiations. This is the highest price among the same ingredient products. As the pricing raise negotiations were made proportionate to the supply volume, the highest increase in price for the drug implies that its supply volume may also be the greatest. The new product’s ceiling price was set at KRW 90. The company, therefore, will be importing that many Tylenol products. However, with China withdrawing its COVID-19 lockdowns, demand for acetaminophen has been rising greatly, raising concerns over whether the imported amounts will arrive properly. The concerns have been rising further with increasing reports on how Chinese tourists are stockpiling cold medicines in Korea and Japan.
- Policy
- Dong-A ST’s Forxiga prodrug Dapapro 5mg listed for reimb
- by Lee, Tak-Sun Dec 26, 2022 06:07am
- Following the reimbursement listing of the 10mg formulation of Dapapro Tab, the first follow-on drug of the antidiabetic SGLT-2 inhibitor Forxiga that had been developed by Dong-A ST, the 5mg lower-strength formulation of the drug is also soon to be listed with reimbursement. When listed, Dapapro Tab 5mg will be the only dapagliflozin drug to be reimbursed and will have the potential to exclusively take over the market. Reimbursement of the original Forxiga 5mg has been removed from the list. According to industry sources on the 23rd, Dong-A ST’s Dapapro Tab 5mg will be listed at an insurance ceiling price of KRW 456 per tablet. Dong-A ST had already launched Dapapro Tab 10mg with reimbursement for KRW 684 per tablet starting this month. This was the first Forxiga latecomer to be listed for reimbursement. Other Forxiga latecomers can only be released after the original drug’s patent expires in April. Therefore, the company is expected to make every effort to preoccupy the market before the entry of its competitors. Dong-A ST was able to release its product before patent expiry because its product is a prodrug that has a different chemical structure from the original. However, once absorbed, the structure changes and the drug shows the same effect as the original. Dong-A ST was able to invalidate 917 days added to Forxiga’s substance patent through its prodrug strategy, with the court ruling in favor of Dong-A ST in the passive trial to confirm the scope of the patent that was filed against Forxiga’s substance patent. However, the final winner of the patent suit is yet to be determined as there is a high possibility that AstraZeneca, the patent holder, will appeal. However still, DongA-ST decided to release Dapapro Tab 10mg to preoccupy the market. The Dapapro Tab 5mg that will soon be listed will also be released to the market. Moreover, DongA-ST’s Dapapro Tab 5mg is the only 5mg formulation to be reimbursed. The original Forxiga 5mg Tab had been removed from the reimbursement list in October 2018. As the 5mg strength is the recommended initial dose for patients who have not been treated with drugs for diabetes before in combination with metformin, it is expected to be quite well used in the market. However, AstraZeneca is focusing on the main dose, 10mg strength of dapagliflozin. This is why its combination drugs containing 5 mg of dapagliflozin, Xigduo XR Tab 5/500mg, and Xigduo XR Tab 5/1000mg still remain reimbursed. Therefore, Dong-A ST will be on its own in the dapagliflozin 5mg market until AstraZeneca’s patent expires in April next year. However, dozens of dapagliflozin follow-on drugs are expected to pour in after patent expiry. In addition, Daewoong Pharmaceutical is also aiming for an early release of its SGLT-2 class new drug 'Envlo Tab.’ Therefore, competition among domestic companies in the SGLT-2 inhibitor market will intensify after April. Therefore, from Dong-A ST’s perspective, the next four months will serve as an important period for them to measure the drug’s performance.
- Policy
- Zavicefta has been approved for domestic use
- by Lee, Hye-Kyung Dec 26, 2022 06:06am
- .The Ministry of Food and Drug Safety (Director Oh Yu-kyung) announced on the 22nd that it has approved Korea Pfizer Pharmaceutical's "Zavicefta 2g/0.5g (Ceftazidime/Avibactam)," a new antibiotic drug. This drug is a combination of Cefalosporin-based antibiotic Ceftazidime and avibactam, a newly developed beta-lactam inhibitor. Permitted efficacy and effect are ▲Infection treatment in the complex abdominal cavity for adults and children over 3 months old ▲Infection treatment in the complex urinary tract including nephritis for adults and children over 3 months old ▲Infection treatment in hospitals for adult patients over 18 years old. It is a drug developed by Zavicefta AstraZeneca and sold the development and copyright of the global market outside the U.S. in the low-molecular antibiotic business to Pfizer on August 24, 2016. The Ministry of Food and Drug Safety said, "We will continue to do our best to expand treatment opportunities to patients by quickly supplying treatments that have been sufficiently confirmed in safety and effectiveness based on regulatory science expertise."
- Policy
- Exclude Australia from the drug price reference country?
- by Lee, Tak-Sun Dec 26, 2022 06:06am
- Insurance authorities, which are seeking to expand drug reference countries from seven to nine from next year, are expected to exclude Australia from strong opposition from the pharmaceutical industry. It is said that the government has turned to a careful review after a meeting with the Vice Minister of Health and Welfare and the pharmaceutical industry held last week. The HIRA is expected to finalize the plan announced by internal regulations within this week and announce it soon. According to industries on the 22nd, there is a possibility that an amendment excluding Australia will be announced in the revised bill, which was announced by adding Australia and Canada to the drug price reference country. Earlier, the HIRA announced on the 21st of last month a revision to regulations on evaluation standards and procedures, including whether drugs are subject to concessionary benefits, including the U.S., Britain, Germany, France, Italy, Switzerland, and Australia. It will take effect on 1 January next year. The HIRA explained the revision, "We are using the adjusted price, which translates the drug price of seven foreign countries (A7), to evaluate the adequacy of new drug benefits, but we want to improve transparency and clarity and supplement its validity." When the revision was announced, the pharmaceutical industry strongly protested. In addition to the KPBMA, which represents domestic pharmaceutical companies, KRPIA, which has multinational pharmaceutical companies, issued a statement and made clear its opposition to the addition of Australia. Domestic pharmaceutical companies are concerned that the addition of Australia, which has low generic drug prices, could significantly lower the domestic generic drug price in the re-evaluation of registered drugs that reflect this. Foreign pharmaceutical companies are also strongly opposed to the revision that if Australia, which has low drug prices, is added, the price of new drugs will be lowered, further reducing patient accessibility. At a meeting with Park Min-soo, the second vice minister of the Ministry of Health and Welfare, pharmaceutical organizations, and CEOs of pharmaceutical companies on the 16th, the industry expressed concern about Australia's addition to the reference country. At the meeting, Vice Minister Park also said, "We will listen to the opinions of the field under the stance of increasing the sustainability of the health insurance finance and carefully look at ways to improve the system, including insurance drug price policies." It seems to have changed to a careful review. For now, the Ministry of Health and Welfare is said to have presented its revised opinion, and it is believed that it felt burdened to announce the existing plan as it is, conscious of the controversy within the HIRA. A senior HIRA official also said, "As the purpose of the amendment was to supplement the validity of the existing calculation formula, we are carefully considering ways that all stakeholders can accept." The HIRA is expected to draw up a final draft as early as this week and immediately announce the amendment without further notice.
