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- 2026-04-09 14:41:30
- Company
- Generic drugs occupy over 70% of tamsulosin market
- by Kim, Jin-Gu Aug 10, 2023 05:33am
- The share of generic drugs in the market for prostatic hyperplasia treatments that contain tamsulosin exceeded 70%. This is interpreted as an effect of the rapid rise in generic sales while the prescription performance of original products slowed down. One variable in this market is impurities. At the end of June, impurities were detected in some products, initiating voluntary recalls. However, as only one product made the voluntary recall, its impact on the overall market is not significant yet. Prescription of tamsulosin generics rise 18% in one year... market share exceeds 70% According to the market research institute UBIST on the 9th, the outpatient prescription market for tamsulosin single-agent prostatic hyperplasia treatments in 1H recorded KRW 107.2 billion. The market increased by 10% from KRW 97 billion in 1H last year. The growth of generic products in the market led to the expansion of the overall market size. In 1H this year, the combined prescriptions for tamsulosin generics amounted to KRW 74.9 billion, an 18% increase from the past year. On the other hand, prescriptions of the original product Harnal-D decreased by 3% from KRW 33.4 billion in 1H last year to become KRW 32.3 billion in 1H this year. Prescription Performance of Tamsulosin Drugs for BPH While sales of the original drug slowed down, sales of generics rose rapidly. As a result, the share of generics in this market exceeded 70% for the first time. The quarterly share of generics exceeded 50% in Q3 2018 and then expanded further to exceed 60% in Q2 2021. Then, in the second quarter of this year, it exceeded 70%. The share of generics in the market reached 70.2% in Q2 this year. Sales of Hanmi Tams·Taminal·Bearosin rise over 10%…sales of combo drug Duodart rise rapidly Prescription performance of most of the major generic products increased by more than 10% during the past year. Hanmi Pharm’s 'Hanmi Tams' and 'Hanmi Tams OD’ recorded the highest prescription performance among generic tamsulosin drugs in 1H this year. The combined prescription of the two products in 1H this year recorded KRW 19.2 billion, up 11% from the KRW 17.3 billion the two drugs had made in 1H last year. In particular, prescriptions of Hanmi Tams OD rose from KRW 4.6 billion to KRW 6.2 billion in one year, driving the growth of the entire product line. Hanmi Tams OD is an orally disintegrating tablet version of Hanmi Tams, which is a capsule formulation. In addition, the prescription performance of all products with half-year prescriptions that exceed KRW 2 billion increased by more than 10%. Sales of Genuone Science's 'Taminal' increased by 11% from KRW 3.7 billion to KRW 4.1 billion, and Daewoong Bio's 'Bearosin' increased by 25% from KRW 2.8 billion to KRW 3.5 billion. Prescriptions of DongKoo Bio&Pharma’s ‘Uropa,’ Celltrion Pharm’s ‘Tamsol (30%↑)', Kyung Dong Pharma’s ' Uronal (14%↑)', Dongkook Pharmaceutical’s ' Tarunal (26%↑)', Huons’s ' Tamlusindi (19%↑)' had also increased relatively greatly. One product that stands out is GSK’s ‘Duodart.’ Duodart is a combination of tamsulosin and another prostatic hyperplasia drug dutasteride. Prescriptions of Duodart had only reached KRW 0.9 billion in 1H last year, but sales had risen by more than 7 times in one year to KRW 6.7 billion. GSK released the product in Q1 last year. The variable that remains in the market is impurities. Last June, Huons voluntarily recalled some lot numbers of its Tamlusindi. This was a voluntary recall made to address concerns related to the detection of excess N-nitroso tamsulosin impurities. However, the voluntary recall was limited to Huons. No cases of voluntary recall have been reported since then. In the current situation, the impact of the impurity issue is not expected to be significant. Specifically, how much the impurities will affect the overall tamsulosin market may be revealed at the end of this year.
- Company
- Patent dispute over Entresto's patents continue
- by Kim, Jin-Gu Aug 10, 2023 05:33am
- Pic of Entresto The patent dispute over ‘Entresto (sacubitril/valsartan),’ a chronic heart failure treatment with an annual prescription of more than KRW 40 billion, has been ongoing for over 2 years now. Novartis, the company that owns the original drug, is actively pursuing a defense strategy against generic companies' patent challenges. Novartis appealed after losing the 1st trial, and three cases are being tried in the second trial. Some of the results are expected to be pronounced next month. According to industry sources on the 8th, Novartis filed a trial revocation litigation against Hanmi Pharm and Elyson Pharm regarding Entresto’s salt·hydrate patent (10-1549318). After losing to generic companies in the Intellectual Property Trial and Appeal Board (1st trial), the company filed an appeal to the Patent Court of Korea against the ruling. Due to Novartis' appeal, the number of patent disputes in the second trial increased to 3. In addition to the salt and hydrate patents, Novartis and generic companies are in dispute in the Patent Court of Korea the crystalline form patent (10-1432821) and composition/use patent (10-0984939) of Entresto. Entresto is protected by 6 patents: ▲salt and hydrate patent that expires in November 2026, ▲use patent that expires in July 2027, ▲crystalline patent set to expire in September 2027, ▲composition patent set to expire in November 2028 (10-1700062), ▲another composition patent set to expire in January 2029 (10-1589317), and ▲a use patent set to expire in 2033 (10-2159601). Among the 6 patents, generic companies have succeeded in nullifying or avoiding 2 patents. The results of the two were finalized after the generic companies won the first trial and Novartis did not file an appeal. In the case of the use patent that expires in 2033, the patent was listed after generic companies applied for marketing authorization of their generics. The generic companies have also succeeded in winning against Novartis in the first trial for the other 3 patents as well. However, Novartis chose to appeal and proceed to the Patent Court of Korea for all 3 cases. The Patent Court of Korea announced that it will make a ruling on the crystalline patent on the 14th of next month. This means that the outline of the second trial rulings regarding the Entresto patent dispute will be revealed next month. After this ruling, the other 2 rulings are expected to be made until next year. If the party that loses the 2nd trial decides to go on to the Supreme Court, the Entresto patent dispute is likely to be prolonged to more than 4 years. Since 2021, generic companies have been filing trials against Entresto's patents. Starting with Elyson Pharm, about 10 companies including Hanmi Pharm, Chong Kun Dang, and Daewoong Pharmaceutical jumped into the dispute. Meanwhile, according to the market research institute UBIST, Entresto's outpatient prescriptions amounted to KRW 42.5 billion last year. Entresto has shown rapid growth in the market, increasing prescription sales by nearly KRW 10 billion every year. Its prescription performance, which recorded KRW 5.5 billion in 2018, increased to KRW 14.3 billion in 2019, KRW 22.4 billion in 2020, then to KRW 32.4 billion in 2021.
- Policy
- MOHW to expand ‘approval-assessment-negotiation’ project
- by Moon, sung-ho Aug 09, 2023 05:49am
- With the pilot project for the parallel operation of the ‘approval-assessment-negotiation linkage’ system that was implemented to shorten the drug reimbursement process in full swing, additional drugs are expected to be selected for the project in 2H this year. This is because the health authorities started a demand survey to select additional candidates for the pilot project in the second half of the year. Therefore, industry interest is rising on which items will additionally benefit. Pic. MOHW, HIRA, and NHIS have been operating the pilot project for the parallel operation of the ‘approval-assessment-negotiation linkage’ system this year According to industry sources on the 3rd, the Ministry of Health and Welfare, Health Insurance Review and Assessment Service, and National Health Insurance Service are planning to expand the operation of the ‘approval-assessment-negotiation linkage’ pilot project in 2H this year. The health authorities have been promoting a pilot project that included the parallel operation of the approval, benefit evaluation, and drug price negotiation system. The system was implemented to address the issue of how long and complicated the process for the reimbursement of high-priced rare diseases is. The authorities prepared a system that simultaneously operates the whole approval to reimbursement and drug price negotiation process. President Suk-Yeol Yoon had pledged to expedite the listing of ultra-high-priced drugs and expand reimbursement during his presidential campaign. Accordingly, the health authorities recently selected the neuroblastoma treatment Qarziba Inj (dinutuximab, Recordati) and the progressive familial intrahepatic cholestasis treatment advanced Bylvay (odevixibat, Ipsen) as priority candidates for its pilot project. Qarziba Inj, which is manufactured by the Italian pharmaceutical company Recordati, is being supplied by the Korea Orphan & Essential Drug Center in Korea. The drug is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months and above. Bylvay is indicated for the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis. The drug received FDA approval in 2021. In Europe, the drug was approved to treat patients from the age of 6 months with progressive familial intrahepatic cholestasis. The French pharmaceutical company Ipsen had acquired Albiero which owns Bylvay earlier this year. The health authorities are now planning to select additional candidates for the project through a demand survey in 2H this year. The drug currently being discussed is 'Pluvicto (lutetium (177Lu) vipivotide tetraxetan), Novartis' prostate cancer drug. Also, Cablivi (caplacizumab), Sanofi's acquired thrombotic thrombocytopenic purpura (aTTP) treatment, is also being considered as a candidate. An industry official who requested anonymity, said, “The pilot project will be conducted in 2H 2023 to minimize the registration period for drugs that have proven superior treatment effects for patients with no appropriate treatment and a life expectancy of less than 1 year. The authorities will select candidates for the pilot project in 1H and carry out the project in 2H.” He added, “A demand survey may be conducted for Novartis’s ‘Pluvicto’ and Sanofi’s ‘Cablivi’ in 2H this year. The drugs subject to the project need to go through the MFDS’s Global Innovative products on Fast Track (GIFT), so the GIFT system is also being extended.”
- Policy
- Insurance price ceiling reeval negotiations to end on Aug 18
- by Lee, Tak-Sun Aug 09, 2023 05:49am
- The pricing negotiations for items subject to revaluations of their insurance price ceiling in Korea are taking place from the 4th to the 18th of this month. The negotiations are expected to be completed within the deadline as the National Health Insurance Service has been discussing the measures with pharmaceutical companies in advance. Therefore, the adjusted drug price will be announced on the 1st of next month after the results of the negotiations are reported to the Health Insurance Policy Deliberation Committee at the end of this month. According to the NHIS on the 8th, the Ministry of Health and Welfare issued a negotiation order on a total of 12,800 items by 206 companies that received insurance price ceiling reevaluations. Although 16,000 items were known to have received reevaluations, items that had already completed negotiations and were adjusted accordingly were excluded from the negotiations. The Generic Drug Division of the Pharmaceutical Benefits Department of NHIS plans to divide the companies subject to negotiation into 3 types and complete the negotiations by the 18th. HIRA had received data from pharmaceutical companies until last February and conducted a re-evaluation on the price ceiling of subject drugs. The first results were released in May after the results were reviewed by the Drug Reimbursement Evaluation Committee. After the results of the first evaluation were released, companies filed objections on 1,300 items, and the review results of the objections were finally deliberated by DREC on the 3rd. Afterward, HIRA transferred the results of the re-evaluation to NHIS. The NHIS had held discussions in advance with pharmaceutical companies before the main negotiations since last April and agreed on most of the terms of the negotiations. An NHIS corporation explained, "The pharmaceutical companies cooperated well with the NHIS during the preliminary discussion period and there seems to be no problem in completing the negotiations as scheduled." The reevaluation of the insurance price ceiling has been in progress to maintain or lower the upper limit set for insured drugs depending on whether or not the listed drugs meet the criteria for bioequivalence tests and DMF listing. Drugs that satisfy both requirements – DMF and self-bioequivalence tests – can maintain their price as is, and the price of those that only meet one of the requirements is adjusted to 85%, and those that meet none are adjusted to 72.25% of the previous price. Meanwhile, the 5,000 drugs subject to the second round of reevaluations by NHIS also submitted their data last month, and their review is expected to begin soon.
- Policy
- When will domestic COVID-19 Txs be officially approved?
- by Lee, Hye-Kyung Aug 08, 2023 05:30am
- Voices calling for the approval of domestic COVID-19 treatments are rising. Petitions and heated discussions are being made on the free bulletin board of the Ministry of Food and Drug Safety’s website for the marketing authorization and accelerated review of homegrown COVID-19 treatments. The items that are receiving attention on the yay or nay of approvals are Ildong Pharmaceutical’s ‘Xocova (ensitrelvir)’ and Hyundai Bioscience’s ‘Xafty.’ Xocova was developed by Japan’s Shionogi Pharmaceutical. Ildong Pharmaceutical conducted a domestic clinical trial for the drug. The drug was unable to receive EUA in Korea last year, and the company applied for official marketing authorization for the drug in January this year. However, 8 months have passed and the drug has not even been designated as a subject for expedited review until now. On this, an MFDS official said, "It is difficult to disclose specifics on why a certain drug’s EUA review is being delayed. In some cases, the pharmaceutical company is unable to make follow-up measures after the MFDS gives feedback like insufficient supplementary data after primary review. The reason may differ by individual drug.” In the case of Xafty, a new drug candidate for COVID-19, Hyundai Bioscience submitted the results of its Phase II trial on Xafty to the Korea Disease Control and Prevention Agency in April to request emergency use approval. According to Hyundai Bioscience, in a Phase II trial conducted on 300 patients, Xafty reduced the time to improvement of COVID-19 symptoms by 4 days compared with the placebo. In particular, the company stressed that niclosamide, the main active ingredient of Xafty, has a verified profile as it has been used as an insect repellent for 60 years around the world. Xocova applied for marketing authorization in January and and Xafty for EUA in April. With their results still unknown, voices urging for results have been rising through public petitions and MFDS’s online bulletin board. One person said, “It has been 6 months since Xocova applied for approval, and 3 months since the start of the EUA review for Xafty has started. Why hasn’t the government decided upon their approval or non-approval still? We’re talking about the same authorities that approved Paxlovid in only 7 days.” Another person wrote, "3 months have passed since the drug’s Phase II trial was completed, and the drug has not been granted the EUA still. This is contrary to the purpose of granting EUAs.” Another added, "It is ironic that we seek to become a pharmaceutical powerhouse with pharmaceutical sovereignty in this state. What is the reason for the delay in approval?”
- Company
- Chong Kun Dang/Cell Biotech, big match in the MicrobiomeCDMO
- by Nho, Byung Chul Aug 08, 2023 05:30am
- It is expected that CKD Bio and Cell Biotech will compete to expand the related market in the microbiome drug CDMO (Contract Development Manufacturing) field. According to the Korea Institute of Science and Technology Information, the global market for human microbiome is expected to reach 1,743.8 billion won in 2029 with a rapid average annual growth rate of 31% from the current 343.4 billion. The size of the domestic market is expected to grow from 8 billion won last year to 48 percent annually, reaching 25.9 billion won in 2029. Chong Kun Dang Bio was the first to identify the blue ocean potential and set out to preoccupy the market. CKD Bio continues to invest in clinical trials and commercialization of various microbiome treatments based on its microorganism-related R&D and manufacturing capabilities accumulated over the past 50 years. CKD Bio is believed to have signed a business agreement with KoBioLabs in 2015 for microbiome research and customized probiotics development and is developing and producing therapeutics to be used in preclinical microbiome trials. CKD Bio has been developing probiotics products, such as acquiring a patent for a culture technology that increases the stability of lactic acid bacteria in March 2016. In November of last year, it signed a CDMO contract with Bifido, an Amicogen affiliate, for BFD1R, a candidate for rheumatoid arthritis microbiome treatment. Candidate substance strain BFD1R is a new concept treatment that can treat rheumatoid arthritis by controlling the abnormal immune function of patients with rheumatoid arthritis and is securing indications related to various autoimmune diseases (Sjogren's syndrome, lupus, ankylosing spondylitis, etc.). Cell Biotech, which has 28 years of research know-how, entered into the CDMO business in earnest by signing a business agreement with Biomi last month to develop and commercialize microbiome-based microbial treatments. Joint projects are broadly classified into various forms of cooperation for the development of new microbiome drugs, such as ▲ manufacturing and quality control tests for clinical trials,▲ sharing materials for microbial treatment, ▲ and sharing experiences for IND approval. Based on its multistrain technology, BioMe has five new drug development pipelines, including BM111, an antibiotic-resistant bacterial infection treatment, and BM109, a cardiovascular disease treatment. Cell Biotech is developing PP-P8, a colorectal cancer treatment, based on its expertise in researching various functionalities of Korean lactic acid bacteria. Cell Biotech, in particular, invests around 10% of its sales in R&D every year and is actively developing new drugs. In the meantime, Cell Biotech has been hinting at a strategy to preoccupy the CDMO business of domestic microbiome-related pharmaceutical strains, such as securing strain mass production technology and directly constructing a biologic drug factory to directly supply new drugs necessary for clinical trials.
- Company
- Union Korea Pharm agrees to export 8 drugs to Jurabek
- by Lee, Seok-Jun Aug 08, 2023 05:30am
- Union Korea Pharm signed an agreement to export 8 types of drugs with its Uzbekistan partner, Jurabek Laboratories. According to the company on the 7th, the 8 export items include the company’s representative antibiotics and injections such as Atrasen Tab, Serokfen Tab, Uni-Minoxidil Tab, Atorvan Tab, Kefodon Inj, and Amikacin Inj. The local pharmaceutical company, Jurabek Laboratories, will bear the product registration and marketing costs in Uzbekistan. Jurabek plans to expand sales to neighboring countries in Central Asia (Kazakhstan, Tajikistan, Turkmenistan, etc.). in the future. Union Korea Pharm established a joint venture with Jurabek in May last year. Due to the time required to establish the plant and manufacturing facilities, the companies decided to cooperate by exporting drugs produced in Korea first. The 8 items exported this time are a part of the agreement. Byung Ha Back, President and CEO of Union Korea Pharm, said, “We will increase our presence in the global market based on the excellent quality of our products that are recognized around the world.” Union Korea Pharm achieved a surplus for the first time in three years last year, powered by increased sales of its antibiotics and cold medicines and improved profits and losses structure due to the normalization of utilization rates of its new plant. The company’s total sales exceeded KRW 60 billion for the first time. Analysts predict that the new plant (Munmak Plant 2) that the company invested KRW 30 billion on will drive the company’s performance in the future. The Munmak Plant 2 has secured 2.5 times the production capacity of Plant 1 and owns two lines for injection manufacturing (30 million ampules/year) and one line for solid drugs (500 million tablets/year). After receiving GMP certification in 2H 2021, the company has been increasing the plant’s utilization rate since 2022. More than KRW 100 billion in new sales could be generated when the second plant is fully operated. As of the end of last year, the plant's utilization rate was 80%. At the end of Q1 this year, the rate rose to 85%, and the rate is expected to rise to 90% by the end of this year.
- Company
- Immuno-anticancer drugs have brought us closer
- by Jung, Sae-Im Aug 08, 2023 05:30am
- Product photos of Opdivo (left) and Keytruda Immuno-anticancer agents are active in early lung cancer. Following 'Opdivo (Nivolumab),' which obtained the indication for adjuvant therapy before surgery for the first time, 'Keytruda (Pembrolizumab)' is also seeking to expand its scope as adjuvant therapy before and after surgery. The data shown by immuno-anticancer drugs in early lung cancer were surprising. When chemotherapy and CCRT were used, 'pCR', which was seen in 1 or 2 out of 100 patients, increased more than 10 times. In the case of Opdivo, a pCR of 24% was recorded in CheckMate-816 phase 3, significantly improving the 2.2% of the chemotherapy alone group. At 3 years, EFS was 57%, exceeding the control group's 43%. Keytruda also had an event-free survival rate of 62.4% at 2 years, which was significantly higher than that of the control group, 40.6%. The mPR and pCR ratios were 30.2% and 18.1%, respectively, demonstrating a greater improvement than the control group of 11% and 4%. Lee Se-hoon, a professor of hemato-oncology at Samsung Seoul Hospital, said in a recent interview with Daily Pharm, "If Opdivo caused a 'frenzy' as an adjuvant therapy before surgery, Keytruda gave the answer that it is helpful for patients to use immuno-oncology for a certain period after surgery." “We are now able to take a step closer to the goal of complete cure with immuno-oncology,” he said. Lee Se-hoon, professor at Samsung Seoul Hospital The effects of immuno-anticancer drugs shown in clinical trials are being reproduced in the actual field. Professor Lee explained, "When Gefitinib, the first EGFR-targeted anti-cancer drug, came out as a fellow in the past, I was very surprised that the prognosis of patients improved significantly. I am feeling the emotions I felt then once again as I look at adjuvant therapy before and after immuno-anticancer drug surgery." He said, "The professors of the Department of Pathology were also surprised to see that there were so many 'cancer-free' cases when they did a PET scan after immuno-anticancer treatment. Not only did the pathological CR increase, but I felt that the overall response improved." If Opdivo showed significant improvement in adjuvant therapy before surgery for the first time, Keytruda could improve the prognosis even for patients who have not reached complete pathological remission if they use immuno-anticancer drugs for one more year as adjuvant therapy after surgery. Proven. While the Opdivo study used only adjuvant therapy before surgery and there was no follow-up treatment after surgery, Keytruda's KEYNOTE-671 study used up to 4 cycles of Keytruda + chemotherapy on patients before surgery and performed Keytruda alone after surgery. The design was designed to use up to 13 cycles of therapy. Opdivo EFS and pathological pCR data (source BMS) As a result of analyzing EFS, the primary endpoint, according to pathological complete remission status, EFS improved regardless of whether or not complete remission was achieved. Patients who did not achieve pCR by administering immuno-anticancer drugs before surgery and administered Keytruda after surgery reduced the risk of disease recurrence, progression, or death by 31% compared to the control group. Professor Lee said, "I knew that immunotherapy before surgery would be of great help from the Opdivo study, but there was no answer for postoperative treatment. Because the clinical design was designed to use Opdivo only as an adjuvant therapy before surgery, Treatment was a situation where clinicians had to take care of themselves, so everyone was interested in how to treat patients who did not achieve complete remission.” The Keytruda study provided answers to questions raised in the clinical field. Professor Lee said, “I was convinced through the KEYNOTE-671 study that the use of immuno-anticancer drugs after surgery is helpful even in the group that did not show pCR,” and “If you look at the EFS graph, the group that did not achieve pCR used Keytruda. You can see that the graph is clearly wider than the group that did nothing." EFS trend following pathological complete remission with Keytruda (data ASCO) There are many aspects to be discussed about adjuvant therapy before and after surgery of immuno-anticancer drugs that have just begun to be used in the field. Representative examples include use in patients with major mutations such as EGFR and ALK, and screening of patients who may experience difficulty in surgery with little improvement when using immuno-anticancer drugs before surgery. However, he said, it is self-evident that immuno-anticancer drugs are being used for early lung cancer and are getting closer to the goal of a complete cure. Professor Lee said, "The title of the 'ASCO' session, which included the KEYNOTE-671 research presentation, was 'The Promise of Neoadjuvant Immunotherapy Across Solid Tumors'. As in the usual case, this study was not included in the lung cancer session. Here, preoperative adjuvant immunotherapy for lung cancer You can notice the meaning of therapy. It means that immuno-anticancer drugs have begun to actively intervene in the goal of complete recovery with adjuvant therapy before surgery. I am happy to think that it has shown a major change in the cancer treatment paradigm."
- Policy
- The price of 6 items of Choline alfoscerate is cut
- by Lee, Tak-Sun Aug 08, 2023 05:30am
- Despite the government's decision to limit reimbursement, the brain function-improving drug Choline Alfoscerate continues to come out with price cuts due to increased usage. It was found that 6 Choline Alfoscerate items were included in the PVA type Da negotiations this year as well. According to the industry on the 7th, negotiations were conducted as Gliatamin drugs such as Gliatamin were included in the Type Da target this year. Choline Alfoscerate ingredient items that have been negotiated are Ahn-gook Kanoa Soft Cap., Korea Prime Pharmaceuticals Gria Soft, Daewoong Bio Gliatamine Soft Cap, and Gliatamine. They negotiated for the number of claims in 2022 to exceed the PVA Type Da standard. Criteria for each type is when the claim amount for the calculated drug increased by 60% or more from the previous year's claim amount or increased by 10% or more and the increase amount was 5 billion won or more. In the case of Ahn-gook Kanoa, the number of outpatient prescriptions based on UBIST was 6.8 billion won in 2022, up 68% from the previous year, Korea Prime Pharm. Gria’s sales were 29 billion won, up 17% from the previous year, and Daewoong Bio Gliatamin’s sales increased by 5% to 115.6 billion won. Kanoa and Gliatamine had their drug prices reduced last year as PVA. The use of Choline alfoscerate continues to increase despite the decision to reduce benefits in 2020. In September 2020, the government decided to allow reimbursement for Choline Alfoscerate drugs only for dementia patients and apply selective reimbursement by applying 80% patient copayment for the remaining indications. Specifically, 'secondary symptoms and degenerative or degenerative brain organic mental syndrome due to cerebrovascular defects: memory loss and confusion, disorientation due to decreased motivation and spontaneity, decreased motivation and spontaneity, and decreased concentration' in patients diagnosed with dementia It was agreed that reimbursement would be recognized for administration and 80% patient copayment would be applied to prescriptions other than the accreditation standards. The implementation has been suspended as related pharmaceutical companies filed lawsuits for suspension of execution and cancellation of benefit reduction. Since then, even the indications have been reduced in the process of clinical re-evaluation planning, but the amount of prescriptions in the field has not decreased. Even last year, the Choline Alfoscerate preparation Chongkundang Gliatirin Soft Cap. 10 items, including original drugs, were included in the PVA target, and the drug price was reduced.
- Company
- ‘Competitors eye Eylea due to its many benefits’
- by Jung, Sae-Im Aug 08, 2023 05:30am
- The fact that many companies are concentrating on the development of Eylea biosimilars is proof of the many advantages owned by Eylea. We plan to continue to make known the strengths of Eylea while developing new products to continue to deliver on our patient and HCP-centric treatment strategy.” Sangok Suh, Head of the Specialty Medicine business unit at Bayer Korea said so regarding Eylea’s off-patent strategy during an interview with DailyPharm. Sangok Suh, Specialty Medicine BU Head, Bayer Korea The anti-VEGF inhibitor Eylea is regarded as the long-standing powerhouse in the field of macular degeneration. The drug has been solidifying its lead in the market ever since it was approved in Korea in 2013. According to the market research institution IQVIA, Eylea’s annual sales reached KRW 80.4 billion last year. This is a 14% increase over the previous year. Even in the 10th year of approval, the drug has been showing off its unwavering potential, recording double-digit growth. However, like all other new drugs, Eylea is also facing challenges from competitors. This year, the first new bispecific antibody drug for macular degeneration, ‘Vabysmo’, was introduced to Korea, and the domestic patent for Eylea is set to expire in January 2024. Although no direct competition has been made between the two, changes are expected to arise at the end of the year. Vabysmo received conditional approval from the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee in July. The committee deemed the drug’s reimbursement adequate if the company accepted a price lower than the evaluated price. Therefore, if the drug pricing negotiations progress without issues, the drug is expected to be listed in 2H this year. In addition, domestic pharmaceutical and bio companies have been applying for the approval of their biosimilars that target Eylea’s patent expiry. Celltrion, Samsung Bioepis, Sam Chun Dang Pharm, and Alteogen are nearly at the end of developing their Eylea biosimilars. The imminent challenges are set to inevitably complicate the marketing strategy for Eylea. In this changing environment, Suh expressed her determination to stick to the basics. Suh plans to further appeal to the strengths of Eylea, the drug that had established the T&E(Treat&Extend) treatment regimen as a standard treatment in the field of macular degeneration. Eylea was the first drug that allowed patients to adjust their treatment interval according to the patient's condition using the T&E regimen. Suh said, “Eylea has been at the forefront of change in macular degeneration treatment trends over the past 10 years. It has contributed to establishing anti-VEGF treatment as the standard of care and established a personalized treatment environment for patients by demonstrating the efficacy of flexible injection intervals. We wanted to raise awareness of the disease itself break the ‘'macular degeneration leads to blindness’ formula, and create an environment where patients receive early treatment for the disease.” As the representative macular degeneration treatment, Eylea has shown steady growth in Korea. Recently, the prefilled syringe formulation has been newly introduced, reducing the preparation time for drug administration, and enabling a more efficient and convenient treatment experience for the patients. The prefilled syringe formulation can be used with reimbursement for all indications approved for the existing Eylea 2mg formulation. Regarding the challenges being made by biosimilar companies, Suh said, “That in itself is proof of the many advantages owned by Eylea. Although we won’t be able to prevent the price cuts made on our drug due to the introduction of its biosimilars, we are confident that competitivity-wise, the market is still in favor of the original. Biosimilars usually make a bid at the market with their lower price. However, in the case of Eylia, we have a program in place that reimburses a certain level of expenses for diabetic macular degeneration, which takes care of about half of the patient's burden. Therefore, patients can enjoy the ‘cheap price’ benefit offered by the biosimilars while using the original drug. The clinical data and trust that Eylea has built over the past 10 years is a barrier that biosimilars cannot easily break down. Based on this, Suh emphasized that the company’s best defense strategy will be to focus on the unmet needs of patients and HCPs. Suh said, “The Eylea team needs to contemplate how to address the unmet needs of patients and HCPs to ultimately create a better treatment environment for the patients. That is the best defense strategy. We will work to make Eylea more widely available for various retinal diseases, including diabetic retinopathy, retinal vein occlusion, etc.
