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- 2026-05-11 21:25:27
- Opinion
- [Reporter’s View] Asthma drugs await reimb discussions
- by Eo, Yun-Ho Feb 14, 2023 05:48am
- The asthma drugs that had long remained unreimbursed since their approval has resurfaced at the table for discussions, but the situation has not improved much from before. The government and the companies are seemingly unable to reach a consensus on the appropriate drug price. Three asthma biological drugs that were developed at similar periods - Nucala (mepolizumab), Cinqair (reslizumab), Fasenra (benralizumab) – have finally started their reimbursement listing process 3 years after being approved in Korea, but had difficultly making progress ever since. As interleukin-5 antagonists, the drugs reduce levels of blood eosinophils, a type of white blood cell that is involved in the development of asthma exacerbation. At the time of their approval, the drugs received attention for being an effective treatment option that had not been available before. However, no other asthma biodrug has been reimbursed since the reimbursement approval of Novartis Korea’s ‘Xolair (omalizumab)’ in 2020. Although all the drugs were introduced for ‘asthma,’ the indication and other specifics for the three drugs differ from Xolair. However, as Xolair was considered the comparator of the 3 drugs from the government’s perspective, the government’s suggested price had been unacceptable on the biodrug companies’ part, which brought a halt to the reimbursement process. Xolair itself had also been reimbursed 13 years after approval. Although there had been controversy over the holdout tactic it may have implemented, the long time and turmoil that the company had undergone until its reimbursement should be adequately considered. Regardless of the right and wrongs on either part, the time has passed and discussions have now resumed. It is time for both sides to make the effort to push the discussions through. The pharmaceutical companies must have had a reason and a purpose for deciding to go through the reimbursement process for the items again. Even without reference to their launch status in other countries, it is evident that the companies would have made a consensus internally on an acceptable level. Although the government also has to consider the limited amount of resources, the government should also fully look into the history and value of the drugs before carrying on the dialogue. Also, attention will be focused on whether any of the three drugs show differing results.
- Company
- “5 of 10 TNF-αis prescribed last year were adalimumab”
- by Kim, Jin-Gu Feb 14, 2023 05:48am
- On the 13th, the healthcare big data analysis service Evidnet released the results of its analysis on the prescription data of 10 general hospitals nationwide last year. According to the results, ‘adalimumab (Humira)’ was the most frequently prescribed TNF- α inhibitor last year. Evidnet analyzed and announced 18,371 prescription data on TNF-α inhibitors from 10 general hospitals nationwide by indication and component last year. According to Evidnet, the most prescribed TNF-α inhibitor was adalimumab, which accounted for 50.7% of all prescriptions last year. Next was infliximab (Remicade) at 20.2%, followed by etanercept (Enbrel) at 15.1%, then golimumab (Simponi) at 14.0%. By indication, TNF-α inhibitors were most prescribed for ankylosing spondylitis, which accounted for 50.7% of all prescriptions, followed by rheumatoid arthritis (19.5%), Crohn's disease (13.0%), ulcerative colitis (5.7%), uveitis (5.3%), psoriasis (3.5%), then others (4.1%). by ingredient, etanercept (18.3%) and infliximab (16.4%) were prescribed the most for ankylosing spondylitis. In rheumatoid arthritis, adalimumab (46.0%), etanercept (30.2%), then golimumab (16.4%) were prescribed the most. On the other hand, for Crohn's disease, the most prescribed substances were infliximab (54.2%) and adalimumab (45.7%). For ulcerative colitis, the most prescribed were infliximab (47.5%), adalimumab (32.2%), and golimumab (20.3%).
- Company
- Forxiga's patent war ended after eight years
- by Kim, Jin-Gu Feb 13, 2023 05:59am
- The Supreme Court sided with Generic in the dispute over Forxiga patents for SGLT-2 inhibitor-based diabetes treatment. Patent challengers will be able to release generics early after April 7. The Supreme Court's special second division ruled in the morning of the 2nd that AstraZeneca would dismiss the appeal in an appeal filed against 17 companies, including international drugs. Forxiga is protected by two substance patents. The first substance patent (10-0728085) expires on April 7, 2023, and the second substance patent (10-1021752) expires on January 8, 2024. In March 2015, 17 companies, including Kukje Pharmaceutical, filed a trial for invalidation of the second substance patent. In the first trial, generic companies won. In August 2019, the Patent Tribunal made a trial decision on the establishment of the claim. AstraZeneca objected. The patent court, which is the second trial, also sided with generic companies. The Patent Court ruled against the plaintiff in October 2020. The Supreme Court also sided with generics following the first and second trials. This effectively ended the eight-year patent dispute. The ruling will allow patent challengers to release Forxiga generics early after April 7, 2023, when the first substance patent expires. Generics have already overcome all the remaining patents. Generics won the first trial in August 2020 and even received generic for exclusivity. This means that SGLT-2 inhibitor-based generics will pour into the diabetes treatment market after April.
- Company
- Daewoong Nabota has obtained an item license in Singapore
- by Kim, Jin-Gu Feb 13, 2023 05:59am
- Daewoong Pharmaceutical announced on the 9th that its botulinum toxin "Nabota" obtained an item license in Singapore on the 20th of last month. The acquisition of Singapore permits was the first of its kind among domestic botulinum drugs, and Nabota has increased the number of licensed countries worldwide to 62. Nabota 100 units are approved by the Singapore Health and Science Agency (HSA). Daewoong Pharmaceutical applied for an item license in September 2021. Daewoong Pharmaceutical plans to release Nabota in Singapore in the third quarter of this year. Hypens Pharma Pte Ltd is in charge of local distribution and sales. Hypens Pharma is a subsidiary of the SGX-listed Hypens Group. Compared to other Southeast Asian countries, Singapore has a smaller botulinum toxin market. However, as the beauty and medical industries are developed with high national income, it is considered a strategic point for expanding the regional market. For this reason, it is expected to gradually expand to neighboring countries and increase brand awareness. Park Sung-soo, vice president of Daewoong Pharmaceutical, said, "Singapore has a great influence on the Southeast Asian beauty and medical industry," adding, "Not only is it meaningful in that it is the first botulinum toxin brand in Korea to obtain Singapore approval, but it is expected to accelerate Nabota's market expansion in Asia." Nabota is a botulinum toxin preparation that Daewoong Pharmaceutical released in Korea in 2014. It is the only FDA-approved in Asia as well as in Korea. As of February 2023, 62 countries, including the United States and Europe, are providing excellent beauty and treatment options, and Singapore is also expanding its global business by obtaining permission.
- Company
- Generic for Dukarb is coming soon
- by Kim, Jin-Gu Feb 13, 2023 05:58am
- According to the second trial decision of Dukarb on the 16th of this month, it is decided whether to release the core capacity at the same time. With Boryung Kanarb's generic set to be released next month, attention is focused on the second trial of the patent dispute, which is three days away. This is because the decision of the patent court determines whether to release the Dukarb generic core capacity at the same time. ◆Dukarb's generic will be released sequentially after registering next month's benefit According to the pharmaceutical industry on the 13th, the material patent of Boryung Kanarb expired as of the 1st of this month. In principle, a generic for Kanarb has become available. In addition, the remaining generics, except for the core capacity of Dukarb, which is protected by patents for composite compositions, will also be available. The drug that generics are paying attention to is Dukarb. Currently, 27 pharmaceutical companies have been licensed for 72 items of Dukarb generics with different capacities. No single-system Kanarb Generic has been licensed. They received permission for related products from December to January this year. He then applied for a salary registration with the HIRA. According to related regulations, Health insurance benefits will be announced two months after the date of application and will be applied as of the 1st of the following month. Since generic companies applied for salaries in December last year, it will be announced at the end of this month and the salaries will be applied from the 1st of next month. As a result, Dukarb generic is expected to be released sequentially after next month. Products from the four companies approved in December last year are expected to be released first on the 1st of next month, followed by products from the remaining 23 pharmaceutical companies on April 1. The pharmaceutical industry's attention is focused on the second trial of the Dukarb patent dispute, which is just three days away. This is because the ruling determines whether Dukarb's core capacity will be released simultaneously. Dukarb is protected by a patent that expires in 2031. However, the scope of this patent is limited to Dukarb 30/5 mg. Except for this capacity, the rest can be released after the 1st of next month regardless of the 2nd trial ruling. The key is the 30/5 mg product. If the patent court sides with Generic on the 16th of this month, Generic can release 27 items of Fimasartan and S-Amlodipine 30/2.5mg products simultaneously as other generics. In the case of S-Amlodipine, it is interpreted as half the dose of Amlodipine. The combination of Fimasartan and S-Amlodipine 30/2.5mg chosen by generics means that it is virtually the same drug as the original drug Dukarb's 30/5mg. If the court sides with Boryung in the second trial following the first trial, the timing of the release of the 30/2.5mg product by generics will be postponed. The product can be released only when generic companies win a reversal decision from the Supreme Court through an appeal or win a separate invalidation trial. If both methods fail, the capacity product may not be released until 2031, when the Dukarb patent expires. According to UBIST, a pharmaceutical market research firm, Dukarb's prescription last year was 46 billion won. Boryung explains that more than half of the performance comes from 30/5mg products, which are core doses.
- Company
- GC Pharma reinforces sales partnerships
- by Kim, Jin-Gu Feb 13, 2023 05:58am
- GC Pharma has been strengthening partnerships with pharmaceutical and biohealth companies in Korea and abroad by signing a series of copromotion agreements. After the company signed a copromotion agreement for GSK’s shingles vaccine ‘Shingrix’ at the end of last year, the company recently also signed an agreement to copromote Sanofi's anti-platelet agent ‘Plavix.' Also, earlier this year, the company expanded its sales agreement with BMS on selling the company’s hepatitis B treatment, ‘Baraclude.’ The industry interpreted this as the company’s move to diversify its business structure, focusing on blood derivative products and vaccines and securing a cash cow through external expansion. ◆Will copromote Shingrix and Plavis...expanded sales agreement for Baraclude According to industry sources on the 11th, GC Pharma has been jointly selling Sanofi’s anti-platelet agent Plavix (clopidogrel) from the first of this month. Under the copromotion agreement, GC Pharma is responsible for local sales, and Sanofi for sales at large hospitals. Plavix has been generating KRW 120 billion in the outpatient prescription market in Korea. According to the pharmaceutical market research institution UBIST, Plavix sold KW 117.6 billion last year, ranking fourth among all prescription drugs sold in Korea last year. (From the left) Shingrix, Plavix, Baraclude Also, the company had signed a copromotion agreement for GSK’s shingles vaccine Shingrix with GSK and Kwangdong Pharmaceutical and started joint sales of the drug in earnest in December last year. Shingrix has been gaining attention as a new premium vaccine in its area. It has shown a near 97% efficacy, twice higher than that of other existing shingles vaccines, and has demonstrated its long-term effect and safety. It had already raised KRW 2.26 trillion in sales in the global market in the first half of last year, which is near the KRW 2.70 billion that the vaccine had made in the previous year. Earlier this year, the company expanded its sales agreement for the hepatitis B treatment Baraclude with BMS. The company, which had previously jointly sold the product with BMS in the past, will exclusively distribute and sell the drug from this year. Therefore, the company will be selling the drug to all medical institutions including general hospitals in addition to local hospitals and clinics in Korea. Baraclude is a hepatitis B treatment that contains entecavir. The drug sold KRW 71 billion in prescriptions last year. Although its generic version has been released in the market after patent expiry, the original drug continues to exert an overwhelming influence in the market. Last year, it ranked second in sales in the market after Gilead Sciences Viread (KRW 89.5 billion). ◆Suceeds in joint sales of its self-developed Neulapeg·Shinbaro with domestic companies The company has also been strengthening partnerships with domestic pharmaceutical companies. GC Pharma has been adopting the strategy of jointly selling its self-developed drugs with domestic pharmaceutical companies. Neulapeg and Shinbaro are representative examples of such activity. Neulapeg is a treatment for Neutropenia that had been self-developed by GC Pharma. It is a biobetter product that is an upgraded version of the original drug, Kyowa Kirin’s Neulasta. It has improved purity and stability compared to existing treatments and reduced the drug’s half-life over existing drugs. GC Pharma has been jointly selling Neulapeg with Boryung Pharmacuetical until 2021, then with Jeil Pharmaceutical from last year. Its sales had surged during its partnership with Boryung Pharmacuetical. Its sales, which had been less than KRW 1 billion every quarter until 2018, surged to nearly KRW 6 billion in 2021 and exceeded that of the original version by Q4 2021. ◆ Strategies to fill the gap derived from non-sale of MSD vaccines + expanding business portfolio The domestic sales license transfer of the 3 MSD vaccines is pointed out as the background for GC Pharma’s recent moves. Until 2020, GC Pharma had been copromoting 3 of MSD’s vaccines: the shingles vaccine Zostavax, and cervical cancer (HPV) vaccines Gardasil 4 and Gardasil 9. Sales of the 3 vaccines reached KRW 106.1 billion in 2020. However, MSD changed its domestic copromotion partner for the three vaccines to HK inno.N in 2020. Since then, the company has been actively filling the gap that occured in its revenue by making new copromotion agreements. In the mid-to-long term, this is also in line with GC Pharma’s recent business structure diversification strategy. GC Pharma has recently been aggressively strengthening its prescription drug business. It plans to expand its business portfolio, focusing on existing blood derivative products and vaccines. Due to the heavily export-dependent nature of blood derivative products and vaccines, the disadvantage is that its sales are volatile depending on the overseas performance and period. This is why the company has established a mid-to-long strategy to expand its field to prescription drugs and secure a new cash cow.
- Company
- Can Jakavi be reimbursed for GvHD within the year?
- by Eo, Yun-Ho Feb 13, 2023 05:58am
- Whether reimbursement of ‘Jakavi’ be extended to cover Graft versus Host Disease (GvHD) is gaining attention. Novartis Korea submitted an application to extend reimbursement of its Jakavi (ruxolitinib) to GvHD immediately after receiving approval for the indication in May 2022. However, 8 months have passed and no progress has been made at the Health Insurance Reimbursement and Assessment Service’s level. Therefore, whether the agenda will be deliberated during HIRA’s Drug Reimbursement Evaluation Standard Subcommittee meeting that is expected to be held within the week is gaining attention. When considering the remaining review process, it may be difficult to extend the drug’s reimbursement within the year if HIRA does not complete evaluations by the first half of this year. GvHD is a potentially serious complication that may occur after allogeneic stem cell transplantation (allo-SCT). The donor’s T cells (the graft) view the patient’s healthy cells (the host) as foreign and attack and damage them, affecting various organs including the skin, the gastrointestinal tract, the liver, and the lungs. As symptoms can appear throughout the body, GvHD poses another challenge to patients who have survived allogeneic hematopoietic stem cell transplantations by affecting the patient’s quality of life. Steroids are used as standard first-line therapy, but unmet needs exist as no standard therapy exists in the second-line for the 50% of patients that fail treatment in the first-line. In this area, Jakavi arose as an option that can be used to treat patients aged 12 years and older with acute or chronic GvHD who have an inadequate response to corticosteroids or other systemic therapies. Hee-Jae Kim, the Chief Chair of the Korean Society of Blood and Marrow Transplantation (Professor of Hematology at the Catholic University of Korea), said, “Jakavi demonstrated superior effect in treating acute and chronic GvHD patients in clinical studies and has shown similar outcomes in the field, opening up new possibilities for patients suffering from lack of an appropriate treatment option” He added, “Treatment access to Jakavi has been restricted in Korea due to its non-reimbursement. A considerable amount of time has passed since its approval, and Jakavi’s reimbursement should be applied as soon as possible so as not to further increase the burden of the patients that have already suffered enough, from hematopoietic stem cell transplantation to GvHD.” Meanwhile, Jakavi has demonstrated its efficacy in the Phase III REACH2 trial. Results showed that the overall response rate with Jakavi at Day 28 was 62%, which was higher than the 39% that was achieved with the best available therapy (61/155) Also, the durable overall response was found to be nearly twice higher in the Jakavi group at Day 56 at 40% (34/155), compared with the 22% (61/154) in the control group.
- Policy
- MFDS prepares a cost-sharing plan
- by Lee, Hye-Kyung Feb 10, 2023 05:53am
- The Ministry of Food and Drug Safety plans to prepare measures to disperse risk responsibility in preparation for the occurrence of drug safety accidents such as unintentional impurity generation and mixed drugs. According to the 4th plan for drug safety management recently released by the Ministry of Food and Drug Safety, related industries such as pharmaceutical organizations and user organizations will be discussed to compensate for costs incurred in exchanging drugs. This is to come up with social sharing measures for costs incurred due to the exchange of drugs that are feared to be harmful as unintentional impurity accidents may continue to occur in the future following NDMA detection accidents such as Valsartan and Ranitidine. In 2021, according to the re-prescription, re-prescription, or exchange procedure prepared by the Ministry of Health and Welfare and related associations, the remaining amount of impurities produced by consumers can be re-prescribed, re-prescribed, or exchanged for normal products of the same drug at hospitals, clinics, and pharmacies. Hospitals and clinics have been charging pharmaceutical companies for the cost of re-prescribing and re-preparing impurities-producing drugs as normal manufactured products through the Korea Appraisal Board and the Health Insurance Corporation. However, 36 companies are responding to a lawsuit to confirm the absence of debt when the National Health Insurance Service requested 69 companies to make up 2.03 billion won for the loss of health insurance related to valsartan. At the time of the Valsartan impurity accident, the Pharmaceutical Affairs Act was revised, and after consultation between ministries through the Legislative Policy Council of the Ministry of Government Legislation, the Pharmaceutical Affairs Act was revised. Accordingly, the Ministry of Food and Drug Safety plans to provide legal grounds by reflecting on the discussions of the consultative body and the results of research services this year. When revising the Pharmaceutical Affairs Act, the goal is to prepare and revise sub-laws that set details such as applications for compensation for the operation of the Deliberation Committee for the calculation and collection of the cost compensation charges. The Ministry of Food and Drug Safety said, "We plan to establish a social safety net to protect public health and create a safe use environment for drugs by preparing measures to disperse risk in case of drug safety accidents such as unintentional impurity generation."
- Policy
- MenQuadfi has entered the licensing process
- by Lee, Hye-Kyung Feb 10, 2023 05:53am
- MenQuadfi, Sanofi Pasteur's tetravalent meningococcal vaccine, is expected to be released soon. According to the pharmaceutical industry on the 7th, Sanofi Pasteur completed receiving product licenses from the Ministry of Food and Drug Safety, including clinical trials of MenQuadfi, a vaccine for meningococcal (A, C, Y, W) to prevent invasive meningococcal infections in children and adults over the age of 2. MenQuadfi is designed to induce high immune responses for four serum groups across a wide range of ages from 2 to 56 and was FDA-approved as the first and only tetravalent meningococcal vaccine in the United States using tetanus toxoid as a protein carrier in April 2020. FDA approval was based on clinical data from five double-blind, random, multi-organ, phase 2, and phase 3 trials conducted on 5,000 children and adults over the age of 2. Tests have shown that MenQuadfi-induced immune responses are inferior to other approved tetravalent meningococcal vaccines. Four clinical trials were conducted on those who have not been vaccinated against the meningococcal vaccine and one on those who have been vaccinated against the meningococcal vaccine. In a study of those who have not been vaccinated against the meningococcal vaccine, most (55.4-97.2%) were confirmed to have an immune response after 30 days of vaccination.
- Policy
- Rosuvastatin 2.5mg/Ezetimibe, Hanmi from Daewoong,& Yuhan
- by Lee, Tak-Sun Feb 10, 2023 05:53am
- Rosuzet 10/2.5 mg (left) and Daewoong Crezet 10/2.5 mg (right)The combination market, which combines low-dose (2.5 mg) Rosuvastatin + Ezetimibe, is fluctuating with the addition of large pharmaceutical companies. Yuhan Corporation will also join the market, which Hanmi Pharmaceutical first entered at the end of 2021, following Daewoong Pharmaceutical. As the market size is not expected to be small, competition between the three pharmaceutical companies is expected to intensify. According to the industry on the 9th, Yuhan received a license for Rosuvastatin 2.5mg + Ezetimibe complex developed by its affiliate Addpharma and received a license for Rosuvamibe 10/2.5mg on the 7th. Earlier, the original developer Addpharma has also licensed for Addrose 10/2.5mg in December last year. However, it is said that this product has not yet been applied. Rosuvastatin + Ezetimibe complex has become a trend in the treatment market for dyslipidemia. It is characterized by the combination of statins and Ezetimibe to increase the therapeutic effect. However, there has been a steady demand for low capacity due to the burden of existing statins. The Rosuvastatin 2.5 mg + Ezetimibe complex has the advantage of reducing side effects of high-dose statins such as diabetes-induced and muscular dystrophy while having a similar effect to a single drug, high-dose Rosuvastatin. Accordingly, it is becoming a new prescription option for patients with low and moderate-risk groups and elderly patients. Hanmi Pharmaceutical pioneered the market by launching Rosuzet 10/2.5 for the first time in Korea in December 2021. This product is known to have shown a blockbuster aspect as its monthly prescription (based on Ubist) has recently risen to about 1.4 billion won. Daewoong Pharmaceutical then joined the market by releasing Crezet 10/2.5mg in November last year. There is little difference in the drug prices of the two products. Rosuzet 10/2.5 mg is 751 won and Crezet 10/2.5 mg is 750 won. It's only a one-won difference. Yuhan is expected to be on the payroll list in May with permission this time. As the three pharmaceutical companies have a high market share in the Rosuvastatin+Ezetimibe combination market, market reactions are expected to be high. Last year, Rosuzet recorded 140.3 billion won, Crezet 25.8 billion won, and Rosuvamibe 66.8 billion won in outpatient prescriptions. They are expected to implement a strategy to maximize sales through the Rosuvastatin+Ezetimibe. Meanwhile, in addition to these three companies, other pharmaceutical companies such as NVP Healthcare are also said to have jumped into the development of Rosuvastatin 2.5mg + Ezetimibe complex. It is also leading to the development of Atorvastatin low-dose + Ezetimibe complex.
