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- 2026-03-17 02:03:10
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- Samsung Bioepis makes ₩199.1 bil in Q1
- by Chon, Seung-Hyun May 19, 2022 05:51am
- Samsung Bioepis is off to a smooth start this year with a sharp rise in its biosimilar sales. According to the Korea Financial Supervisory Service, Samsung Bioepis recorded ₩199.1 in Q1 sales this year, a 19.4% increase compared to the same quarter of the previous year. Also, the company’s net profit increased 11.5% to ₩31.9 billion. This is the largest amount of sales ever made by the company in the first quarter. However, compared to the ₩271 billion in Q3 and ₩221.8 billion in Q4 it had made last year, the growth rate seems to have slowed down somewhat. In Q3 last year, the company had recorded its largest-ever sales with the milestone it received with the approval of its biosimilars abroad. In August last year, the company’s Lucentis biosimilar ‘Byooviz’ that it developed received marketing authorization from the European Commission (EC) and from the U.S. Food and Drug Administration (FDA) a month later. The biosimilar products developed by Samsung Bioepis have continued to show strong growth abroad. Most of Samsung Bioepis’ sales are generated by overseas sales of its biosimilars. Samsung Bioepis had succeeded in commercializing biosimilars of 6 original products - Enbrel, Remicade, Herceptin, Humira, Avastin, and Lucentis. All its 6 products were approved in Europe, and 5 products less the Avastin biosimilar received marketing authorization in the US. The 5 biosimilars of Samsung Bioepis’ raised $292,300,000 (approx.. ₩350 billion) in sales in Q1 this year. This is a 2.5% YoY increase from the $285,100,000 made in Q1 last year. Biogen’s sales of Samsung Bioepis’ 3 autoimmune disease treatments recorded $194,300,000 (approx. ₩240 billion), and Organon also sold $98,000,000 (approx. ₩120 billion) with Samsung Bioepis’ 3 autoimmune disease treatments and 2 anticancer drugs. Samsung Bioepis’ biosimilars are sold abroad by its partners Biogen and Organon. Samsung Bioepis, which had been established in 2012, first generated sales of ₩43.7 billion in 2013. Its sales then reached ₩147.5 billion with the start of its full-fledged penetration of overseas markets with its biosimilars in 2016, and have continued to grow ever since. Samsung Bioepis has recorded cumulative sales of ₩3.484 trillion since its launch in 2012. The company has been accelerating market penetration with a series of biosimilar products recently. This year, the company plans to release its Lucentis biosimilar ‘Byooviz’ in the US market. Pursuant to a global license agreement entered into with Genentech, Samsung Bioepis will have the freedom to market the drug in the United States as of June 2022, i.e., before the expiration of Genentech’s applicable SPC (Supplementary Protection Certificate). The company has also been accelerating the expansion of its biosimilar pipeline in Korea as well. Samsung Bioepis received approval from the Ministry of Food and Drug Safety to market Lucentis biosimilar, ‘Amelivu (ranibizumab).’ Amelivu is the first Lucentis biosimilar to be approved in Korea. With Amelivu’s approval, Samsung Bioepis is now approved for a total of 6 biosimilars in Korea. The company had first entered the domestic biosimilar market after receiving approval for its ‘Enbrel’ biosimilar ‘Etoloce’ in 2015. In the same year, the company also received approval for its ‘Remicade’ biosimilar ‘Remaloce,’ and then for the ‘Humira’ and ‘Herceptin’ biosimilars ‘Adaloce’ and ‘Sampenet’ in 2017. Last year, it also acquired approval for its ‘Avastin’ biosimilar, ‘Onbevzi.’ Its competitor Celltrion has acquired approval for the biosimilars of Remicade, Herceptin, Mabthera, and Humira. The approval of Samsung Bioepis’ biosimilars in Korea is expected to lead to financial savings for the National Health Insurance. In principle, the Korean drug pricing system mandates the ceiling price of original drugs to be discounted by 30% compared to its price before patent expiry with the introduction of its biosimilars. Prices of original drugs and their biosimilars that are ‘items developed by Innovative Pharmaceutical Companies, equivalent companies, or domestic companies that have signed joint agreements with multinational pharmaceutical accompanies; or items that were first-ever approved in Korea; or items manufactured in Korea’ are ensured a price set at 80% of the original’s price before patent expiry. Avastin’s insurance ceiling price fell with the listing of Onbevzi last year. In October last year, the ceiling price for Avastin 0.1g/4mL fell 30% from ₩330,387 to ₩231,271. Price of Avastin 0.4g/16mL also fell 30% from ₩1,077,531 to ₩752,746. According to the market research institution IQVIA, Avastin’s sales fell 23.8% YoY in Q4 last year to record ₩22.6 billion. This was a 27.2% drop from the ₩30.9 billion made in just the previous quarter, Q3 last year.
- Company
- Samsung Bioepis’s Lucentis biosimilar approved in Korea
- by Lee, Seok-Jun May 18, 2022 10:42pm
- Samsung Bioepis became the first company to receive approval for a Lucentis biosimilar in Korea with ‘Amelivu (ranibizumab).’ Lucentis is a treatment developed by Genetech for ophthalmologic diseases such as macular degeneration and macular edema. With Amelivu’s approval, Samsung Bioepis is now approved for a total of 6 biosimilars in Korea. The company is selling 3 types of autoimmune disease treatments that treat rheumatoid arthritis, etc – ‘Etoloce (Enbrel similar),’ ‘Remaloce (Remicade similar),’ and ‘Adaloche (Humira similar)’ – with Yuhan Corp. Its other two drugs, which are anticancer drugs ‘Sampenet (Herceptin similar),’ and ‘Onbevzi (Avastin similar)’ are sold jointly with Boryung Pharmaceutical. Amelivu’s approval in Korea holds significance in two ways. On the surface, Amelivu will be entering the domestic Lucentis biosimilar market worth 30 billion won as the ‘first drug’ introduced to the market, and will be able to gain market dominance before its competitor, Chong Kun Dang’s ‘CKD-701’ as its review is still in process. From a broader perspective, the approval may act as momentum in penetrating overseas markets. In addition to Korea’s approval this May, Amelivu has been approved in August and September last year in Europe and the US, which allows the company to accumulate real-world prescription data on the drug in various countries. Acquisition of such actual prescription data may facilitate easier approval in other countries in the future. Also, the accumulated evidence (data) can also contribute to the creation of a virtuous cycle that leads to an increase in actual prescriptions in global markets such as the US and Europe. Amelivu’s approval in each country is also directly related to the future of Samsung Bioepis. The company has been recently expanding its business to ophthalmology, endocrine system, and blood diseases. In ophthalmology, in addition to Amelivu, Samsung Bioepis has completed a Phase III trial of its biosimilar for Eylea(SB15), the drug that has been bisecting the market for macular degeneration with Lucentis. An official from Samsung Bioepis said, “We can now expand our business to ophthalmic disease treatments in earnest with our approval of Amelivu in various countries.” Global clinical trial on 705 patients Meanwhile, Amelivu was approved in each country based on the large-scale Phase III study. Samsung Bioepis conducted a global Phase III study comparing SB11 (Korean brand name: Amelivu) with the original from March 2018 to December 2019 in 705 patients with wet (neovascular) AMD. Analysis of the 634 patients among the 705 that continued to receive treatment up to week 52 showed that Amelivu was equivalent (non-inferior) to the original in terms of its efficacy, safety, pharmacokinetics, and immunogenicity. Based on the results, Samsung Bioepis received marketing approval for the drug in Europe in August, in the US in September, and in Korea this May. SB11 will be sold under the brand name ‘Byooviz’ in Europe and the US by Biogen, and its marketing partner and release date in the Korean market is yet unknown. Pursuant to a global license agreement entered into with Genentech, Samsung Bioepis will have the freedom to market the drug in the United States as of June 2022, i.e., before the expiration of Genentech’s applicable SPCs, and elsewhere in other territories after the expiration of Genentech’s SPCs. Increasing macular degeneration market… Epis preoccupies market The blockbuster macular degeneration treatments are ‘Lucentis’ and ‘Eylea.’ Lucentis’s patent is set to expire in July 2022 in Europe, and June 2020 in the US. In the case of Eylea, its patent is set to expire in May 2025 in Europe and in June 2023 in the US. Lucentis is currently sold by Roche and Novartis and has raised 4.4 trillion won in global sales last year. Samsung Bioepis is the first company in the world to receive marketing approval for a Lucentis biosimilar and is competing with European countries including Germany and Sweden in the global market. In Korea, Chong Kun Dang has also conducted a Phase III trial on domestic patients and is being reviewed by the Ministry of Food and Drug Safety. An industry official said, “Samsung Bioepis developed its biosimilar for the two major AMD treatments Lucentis and Eylea in time of their patent expiry. In the case of Lucentis, the company will be able to gain market dominance as it owns the ‘premium’ of being the first approved in Europe, the US, and Korea.”
- Company
- Shionogi applies to trademark its COVID-19 treatment
- by Kim, Jin-Gu May 17, 2022 06:02am
- With the domestic trademark application for the COVID-19 treatment that is being jointly developed by Shionogi Pharma and Ildong Pharmaceutical nearing completion, Shionogi Pharma and Ildong Pharmaceutical are speeding up preparations to commercialize its drug in Korea in the second half of this year. Shionogi submitted a trademark application for XOCOVAAccording to the Korean Intellectual Property Office on the 7th, Shionogi Pharma recently submitted an application for 6 trademarks including ‘Xocava.’ The trademarks were registered for ▲ antiviral drugs ▲ drugs for human use ▲ drugs for medical use ▲ animal drugs, etc. In addition to ‘Xocova,’ Shionogi submitted trademark applications for ‘Zocovea,’ ‘Zocovaty,’ ‘Xovished,’ ‘Xocovetti,’ and ‘Vyveclis.’ The KIPO review for the trademarks is complete, and the names are undergoing an objection submission period. Industry prospects are that these are brand names of ‘S-217622,’ the COVID-19 treatment that is being jointly developed by Shionogi Pharma and Ildong Pharmaceutical. The same names are known to have been already trademarked in Japan. Therefore, one of the names above may well be the brand name of S-217622 when Ildong Pharmaceutical applies for its emergency use approval to the Ministry of Food and Drug Safety in the near future. Ildong Pharmaceutical expects to commercialize S-217622 by the second half of the year. If Shionogi Pharma receives conditional approval for S-217622 in Japan, the company plans to use the approval as a basis with the domestic Phase IIb clinical trial results to apply for its emergency use approval in Korea. An official from Ildong Pharmaceutical said, “Shionogi Pharma has completed the Phase IIb trial for S-217622 and submitted an application for its conditional approval to the Japanese government. The company expects the conditional approval to come within the third quarter of this year. We plan to apply for emergency use approval in Korea after the results come out in Japan.” He added, “After we receive emergency use approval in Korea, we will receive technology transfer from Shionogi and start full-scale production. We have completed preparations and are ready to start production as soon as we receive the technology transfer." Ildong Pharmaceutical has been jointly developing S-217622 with Shionogi Pharma since November last year. Shionogi Pharma is in charge of the global trials in other countries and Ildong is in charge of the trials in Korea. The patient size for the domestic Phase IIb trial is set at 200, and at 400 for the Phase III trial. Patient enrollment for the domestic Phase IIb trial is known to be complete. S-217622 inhibits the 3CL protease that is essential for the replication of SARS-CoV-2. The oral COVID-19 treatments currently approved in Korea are Pfizer’s Paxlovid (ritonavir·nirmatrelvir) and MSD’s Lagevrio (molnupiravir). If commercialized, S-217622 may be listed as the third oral COVID-19 treatment to be approved in Korea.
- Company
- Pharmaceutical exports fall 19% this year
- by Kim, Jin-Gu May 17, 2022 06:02am
- Pharmaceutical exports from January to April last year were found to have fallen 19% from the same period in the previous year. According to the Korea Customs Service on the 16th, pharmaceutical exports from January to April this year have recorded $2,191,880,000 (approx. ₩2.81 trillion). This is a 19% decrease from the $2,689,820,000 (approx. ₩3.45 trillion) accrued last year. In the same period, the amount of imports increased 42% from $2,534,920,000 (approx. ₩3.25 trillion) to $3,603,450,000 (approx. ₩4.62 trillion). With exports greatly reduced and a surge in imports, the trade balance of pharmaceuticals, which recorded a surplus in the same period last year, turned to a deficit. From January to April this year, the trade balance of pharmaceuticals recorded a deficit of $1,411,570,000 (approx. ₩1.81 trillion). By each country, exports to the US and Italy surged. Exports to the US recorded $217,070,000 (approx. ₩280 billion) this year, a 77% increase from the $122,330,000 (approx. ₩160 billion) in the same period of last year. In the same period, exports to Italy jumped from $23,380,000 (approx. ₩30 billion) to $156,570,000 (approx. ₩200 billion) this year. On the other hand, exports to Germany fell from $1,010,270,000 (approx. ₩1.3 trillion) to $192,910,000 (approx. ₩250 billion). Germany had been Korea's largest exporting country for pharmaceuticals for the past 3 years from 2019 to last year. Exports to Japan also fell 15% from $161,250,000 (approx. ₩210 billion) to $146,170,000 (approx. ₩190 billion). In China, sales dropped by nearly half from $84,770,000 (approx. ₩110 billion) to $45,310,000 (approx. ₩58 billion).
- Company
- Why MSD raised the price of Gardasil 9 for two years?
- by May 17, 2022 06:02am
- As MSD Korea raised the supply price of Gardasil 9, a cervical cancer vaccine, by 25% in two years, attention is being paid to the background. Some interpret the decision ahead of the application of Gadasil 9's health insurance benefits, which was President Yoon Seok-yeol's pledge, or an alternative to fill the sales gap due to the reduction of Januvia drug prices. According to MSD Korea on the 17th, the supply price of Gardasil 9 will increase by 8.5% from July 1st. This is the first measure in a year and three months following a 15% increase in April last year. The supply price of Gardasil 9, which was 106,300 won (excluding VAT) early last year, rose 15,945 won to 122,245 won in April of that year. With the decision to raise the price further this year, Gardasil 9 will be supplied at 132,636 won starting in July. Various interpretations have been made about the increase in Gardasil 9 for the second consecutive year of MSD in Korea. It then rose 25% in two years as the price was raised again in a year and three months. The average total inoculation cost of Gardasil 9 (three times), calculated as the average inoculation price per session (215,555 won), amounts to 631,665 won. Various interpretations are exchanged over the measure of raising Gardasil 9 for the second consecutive year by MSD Korea. In particular, the backlash was so strong that a national petition against a price hike appeared last year. This is why attention is focused on the background of pushing ahead with another increase in supply prices despite worsening public opinion. President Yoon promised to expand Gardasil 9 insurance when he was a candidate. The vaccines included in the existing National Essential Vaccination (NIP) are Cervarix and Gardasil. The pledge is to support free vaccination of Gardasil 9, which has a wider range of prevention. The scope of support will also be greatly expanded. It encompasses not only women aged 12 to 17, women from low-income families aged 18 to 26, but also women aged 9 to 45 and men aged 9 to 26, who are currently eligible for NIP. As a way for the government to support Gardasil 9, a plan to expand the scope of NIP and include Gardasil 9 or to provide health insurance benefits for Gardasil 9 is cited. Both measures are more likely to fall in price than before through bidding or drug price negotiations. This is the background of the interpretation that the supply price hike is a preemptive measure in preparation for the future reduction of Gardasil 9. It is also interpreted as a countermeasure to fill the sales gap caused by lowering drug prices of other drugs such as Januvia. MSD Korea asked to "trade off" in negotiations with the government to expand the primary benefit of non-small cell lung cancer of Keytruda, a blockbuster immuno-cancer drug. Instead of expanding Keytruda's benefit, it has decided to voluntarily cut drug prices for 15 items, including Januvia Family, which has an outpatient prescription of 171 billion won, from at least 3.2% to up to 77%. The opinion is that price increase of Gardasil 9 is a strategy to fill the sales gap caused by drug price cuts. In response, MSD Korea drew a line, saying, "The price increase of Gardasil 9 is the result of price adequacy evaluation." The company conducts a price adequacy evaluation of medicines at the global level every year, and this increase is only a result of the evaluation and has no other impact. It was also judged that the drug price cut would not hurt overall sales due to Keytruda's rise. The price increase is not limited to Korea, but also applied to other countries that supply Gardasil 9. While Gardasil 9 price hikes have only recently been carried out in Korea, the company also emphasizes that it has increased by an average of 5% every year in the United States. An official from MSD Korea said, "It is difficult to disclose specific evaluation criteria, but the policy of Gardasil 9 price has only changed, and there is no other impact."
- Company
- Prescription of CGRP migraine drugs to begin in earnest?
- by Eo, Yun-Ho May 17, 2022 06:01am
- CGRP-targeted migraine treatments are gaining better access as prescriptions. The first drug introduced is nearing insurance benefit listing and the second drug is landing in general hospitals. According to industry sources, the Calcitonin gene-related peptide (CGRP)-targeted migraine treatment ‘Emgality (galcanezumab)’ has passed deliberations by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee on the 12th. The latecomer ‘Ajovy (fremanezumab)’ also applied for insurance benefits earlier this year but was not set for deliberations in the recent DREC meeting. However still, Ajovy passed the drug committees (DCs) of Seoul Asan Medical Center and Sinchon Severance Hospital. If Emgality successfully receives reimbursement approval, Ajovy’s reimbursement would also be plausible with the pharmaceutical companies’ will. Both drugs are humanized monoclonal antibody drugs that bind to the CGRP ligand that plays a key role in inducing migraine symptoms to inhibit its binding to its receptor. Although the two drugs are of the same class, Severe migraine patients are approaching the drugs with different expectations due to their differences in dosage and administration, etc. Emgality can currently be prescribed in medical institutions nationwide, including the ‘Big 5’ that includes the Seoul National University Hospital and Sinchon Severance Hospital, as well as other institutions nationwide, such as the Kangbuk Samsung Hospital, Hallym University Dongtan Sacred Heart Hospital, and Nowon Eulji Medical Center. Meanwhile, Emgality’s approval was based on results of the EVOLVE-1 and EVOLVE-2 trials which involved 1,773 patients with episodic migraine (at least 4 to 14 migraine headaches days [MHDs] a month) for 6 months, and the REGAIN trial which involved 1,113 patients with chronic migraines (at least 15 headaches days per month with at least 8 MHDs per month) for 3 months. Results of the two trials on episodic migraine patients comparing the changes in MHDs per month over 6 months showed that, compared to baseline (Emgality group 9.2 days, placebo group 9.1 days), Emgality demonstrated efficacy over placebo in treating migraines. In the case of Ajovy, the drug comes in two formulations, one which is administered in a monthly dosage and the other that comes in a quarterly dosage that is administered every 3 months. The drug demonstrated its efficacy at the HALO EM/CM clinical trial that was conducted for 12 weeks on 2,000 episodic migraine (EM) and chronic migraine (CM) patients. In the HALO EM study that was conducted to verify the efficacy and safety of Ajovy in comparison to the placebo, Ajovy met the primary endpoint by significantly reducing the monthly number of migraine days in both the monthly and quarterly dosed groups. WonGu Lee, Professor of Neurology at Kosin University Hospital, said, “Unlike existing preventive treatments that required daily dosage, patients may manage their migraines with once-a-month injection with CGRP-targeted antibody drugs. The treatment cost remains an issue, however, we neurologists have high expectations for these drugs because the condition becomes easier to treat with more targeted therapies.”
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- Servier launches supply of new acute leukemia drug Oncaspar
- by Eo, Yun-Ho May 16, 2022 06:14am
- Servier Korea began supplying Oncaspar Lyophilized Inj, a combination treatment for "acute lymphocytic leukemia (ALL)" from the 10th. It was supplied through the rare drug center, but the license holder, Servier, was in charge of the supply, and insurance benefits have not yet been registered. Servier Korea is undergoing prescription procedures at major general hospitals to ensure that Rx for Oncaspar can continue smoothly as supplies to rare drug centers are exhausted. Acute Lymphoblastic Leukemia (ALL) treatment was approved by the MFDS as a rare specialty drug in February last year as a combination therapy with other anti-tumor drugs. Oncaspar is a drug that maximizes the half-life of drug circulation through PEGylation, dramatically reducing the frequency of administration to be administered once every 14 days compared to L-Asparaginease, which was previously administered once every other day. Considering that ALL has a high incidence rate, especially in pediatric patients, the improved method is expected to reduce the injection burden, physical pain, and hypersensitivity reactions of pediatric patients and patient guardians suffering from frequent anticancer injections. It is expected to have a positive effect on medical costs such as hospital visits or hospitalization for injection treatment. Oncaspar, which was first approved as a secondary treatment for ALL in the United States and Germany in 1994, was recognized as a primary treatment for ALL in the United States in 2006. Since birth in Europe in 2016, it has been approved as a combination therapy with other anticancer drugs in 18-year-old children and adult ALL patients. Oncaspar is primarily recommended in major international guidelines and treatment protocols such as NCCN and ESMO and Children's oncology group (COG) as a treatment for acute lymphocytic leukemia and is used in 62 countries. Servier Korea CEO, Melanie Loresry said, "We are happy to supply Oncaspar, an innovative treatment option, to patients suffering from ALL and hematologic oncologists. "This release reveals Servier's hope to better treat rare cancer and lead tumor treatment," he said.
- Company
- Huons' local anesthetics export contract with FPI Canada
- by Kim, Jin-Gu May 16, 2022 06:14am
- CEO Yoon Sang-bae (left) and CEO FPI Lee Mangubat are taking a commemorative photo after holding a contract ceremony to export local anesthetics to Canada at the Pangyo headquarters in Seongnam, Huons on the 12thHuons announced on the 13th that it has signed an export contract with Canadian pharmaceutical company Formative Pharma Inc (FPI). Items signed an export contract are▲1% Lidocaine hydrochloride injection 5mL, ▲ 0.75% Bupivacaine hydrochloride injection 2ml, and ▲ 1% lidocaine hydrochloride injection 5mL vial. These items were obtained from April 2018 to May 2020 by the U.S. Food and Drug Administration (FDA). Huons plans to work with FPI to obtain permission from Health Canada. It is expected that it will be able to complete the license application by June and start local sales within the third quarter of next year. "The Canadian generic basic injection market is worth $712 million, of which Huons enters the aseptic injection market of $21 million to $25 million," said Lee Mangubat, CEO of FPI. "There are many opportunities as large pharmaceutical companies are suffering from continuous shortfalls due to financial difficulties." An official from Huons said, "If we enter Canada following the U.S., our position in the North American injection market will be stronger." "With this contract, we plan to discuss expanding items with FPI to target the Canadian generic aseptic injection market," he said. FPI is a pharmaceutical import company established in Ontario, Canada in 2018.
- Company
- The introduction of Biogen Aduhelm in Korea is also unclear
- by May 16, 2022 06:13am
- Biogen has decided to minimize the commercialization infrastructure of the Alzheimer's drug Aduhelm and focus on developing subsequent drugs. In fact, it is unclear whether Aduhelm, which is in the process of eviction, will be introduced in Korea. Biogen announced in its first-quarter earnings announcement on the 3rd (local time) that CEO Michel Vounatsos will resign due to responsibility for Aduhelm. CEO Michel Vounatsos will retire as soon as a successor is decided. At the same time, what attracts attention is the announcement that it will drastically reduce Aduhelm's commercial infrastructure. Biogen said it minimizes all infrastructure for Aduhelm's commercialization. In the previously announced $500 million annual cost reduction plan, it will save an additional $500 million. In fact, it is interpreted as a decision to give up the commercialization of Aduhelm. Biogen's move to give up Aduhelm is pointed out as the decisive background for the rise to the surface of the water, which is the restriction on the application of Aduhelm insurance by Medicare, a U.S. public health insurance. CMS in the U.S. made a final decision last month to apply insurance benefits only to patients who participated in clinical trials of Aduhelm. CEO Michel Vounatsos said in a performance announcement, "This decision is very disappointing as it virtually rejects Aduhelm from all Medicare subscribers." "As a result, Biogen will substantially eliminate commercial infrastructure for Aduhelm," he said. Aduhelm is also increasing the financial burden on the company. Biogen said it was negatively affected by $275 million in inventory amortization costs for Aduhelm and $45 million in idle capacity costs in the first quarter. Instead, Biogen plans to accelerate the development of follow-up drugs. The subsequent drug is another new Alzheimer's drug, Lecanemab. It is being developed jointly with Eisai and Biogen plans to begin the process for Lecanemab's acceleration approval this year. The pharmaceutical bio industry interprets that Biogen's decision has also made it unclear about the commercialization of Aduhelm in Korea. Biogen had already voluntarily withdrawn Aduhelm's application for European permission in April. After the EMA refused to approve Aduhelm in December last year, it reapplied for approval, but soon voluntarily decided to withdraw it. Biogen applied for Aduhelm from the MFDS in July last year. It is predicted that the MFDS, which has currently started the screening for Aduhelm, has possibilities to refuse the permission by referring to EMA's decision. However, Biogen expressed its original position, saying that it has not changed its domestic commercialization plan. An official from Biogen said, "We confirmed the decision of the global headquarters through the article, and there were no guidelines for commercialization in Korea."
- Company
- Wet AMD tx new option to shorten Eyelea's minimum cycle
- by May 16, 2022 06:13am
- Bayer's macular degeneration treatment Eyelea took the lead in establishing an optimized treatment strategy for patients by shortening the minimum treatment cycle. It is evaluated that a new option was presented in macular degeneration treatment that determines the treatment cycle according to the patient's condition. According to the pharmaceutical industry on the 6th, Eylea's minimum administration interval has recently been shortened from 8 weeks to 4 weeks. Accordingly, medical staff can increase the treatment interval from at least 4 weeks to up to 16 weeks through monitoring after injection once a month for the first three months of treatment with Eyelea. As T&E therapy is widely used in macular degeneration treatment, the medical staff believes that there is room for reducing the minimum dose interval to address the unmet demand. T&E therapy is a method of monitoring patients after initial three-month treatment and adjusting the treatment interval. It is a widely used treatment method around the world by overcoming the shortcomings of the post-treatment method, such as PRN therapy, which is more efficient than fixed treatment cycles and continues treatment when symptoms worsen. Dailypharm listened to the meaning of changing minimum administration cycle of Eyelea through Director Jang Woo-hyuk. Director Jang served as a clinical doctor at the Wills Eye Institute at Thomas Jefferson University in Philadelphia and a professor at the ophthalmology department at Yeungnam University University. Director Jang Woo-hyuk Macular degeneration begins with dryness and progresses into habit. Dry macular degeneration is a stage in which only wastes accumulate in the retina. When waste accumulates and oxygen permeation becomes difficult, new blood vessels are created to forcibly supply oxygen. In the process, abnormal neoplasms bleed and exudates leak out. This stage is wet macular degeneration. Failure to receive proper treatment can lead to blindness. The number of patients with habitual macular degeneration is also rapidly increasing due to rapid aging. Director Jang said, "There are overwhelmingly many elderly patients in the clinical field. This is because aging is the biggest cause of wet macular degeneration. Environmentally Westernized eating habits and the increase in adult diseases are also affecting it, he explained. The most important goal of treating wet macular degeneration is to preserve vision that can maintain the quality of life. Therefore, it can be seen that the core of the treatment is to restore vision as much as possible with initial active treatment and then maintain vision at least with damage. The drug mainly used for treatment is an anti-VEGF injection. Representative treatments include Eylea and Lucentis, and recently Beovu has also emerged as new treatment options. The medical staff determines the drug according to the patient's condition because the medication cycle varies slightly from drug to drug. According to IQVIA, a pharmaceutical market research firm, Eyelea is the treatment that generates the most sales in Korea, recording sales of 70.5 billion won last year. In response to the recent reduction in the minimum administration interval for Eyelea to four weeks, Director Jang said, "There was clearly a need for injections at clinical sites at shorter intervals than eight weeks. Even after injection treatment every eight weeks, there are no signs of deterioration, no improvement, or persistent exudation causes vision to gradually decrease," he said. "In the past, in this case, we had no choice but to use off-label drugs or increase the dose, but even this was not very effective. The reduction of the minimum administration interval of Eylea to four weeks is a very welcome change," he said. Reducing the administration interval to 4 weeks mainly occurs in long-term treatment. This is because the drug's effectiveness decreases even if it is injected every eight weeks because of long treatment. "There are few patients who need to be treated every four weeks from the beginning. If resistance develops or the effectiveness of the drug decreases after a year or two of treatment, we will consider shortening the interval," he added. In order to perform only four-week intervals, anatomical examinations must show clear deterioration. There are still ambiguous situations where it is difficult to boldly apply the four-week interval. Director Jang explained, "This is the case when it continues to not deteriorate when it is done every eight weeks, or when there are findings of exudation in monitoring, it is better than eight weeks ago." He said, "At this time, medical staff tend to worry about reducing the interval to four weeks and then reducing the benefit. Since the four-week interval has not been long since it was applied, it is difficult to reduce it to four weeks unless there are clear deterioration findings," he said. Patients with good treatment effects are treated by widening the interval to a maximum of 16 weeks. According to Director Jang, about 20 to 30% of all patients show good treatment results, extending it to 16 weeks. "The longer the injection period is, the more patients are satisfied. There may be anxiety about watching without treatment for four months, but experience has shown that the symptoms rarely worsen severely among patients who have extended it to 16 weeks. If there is any recurrence, the interval will be reduced by two weeks again, he said.
