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- 2025-12-25 04:43:00
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- Ilaris reattempts reimb for its 13 patients in Korea
- by Eo, Yun-Ho May 23, 2022 06:06am
- ‘Ilaris,’ an ultra-orphan drug indicated for only 13 patients in Korea, is reattempting to be listed for insurance benefit. According to industry sources, Novartis Korea recently submitted an application to receive insurance benefits for its hereditary periodic fever syndrome treatment ‘Ilaris (canakinumab). This is the first attempt made by the company since it was denied reimbursement by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee in 2017. Among the various Hereditary Periodic Fever Syndrome conditions, the drug was approved in 2015 in Korea for the treatment of ▲Cryopyrin-Associated Periodic Syndromes (CAPS), ▲Tumor Necrosis Factor-Receptor Associated Periodic Syndrome (TRAPS), and ▲Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) and ▲Familial Mediterranean Fever (FMF) in patients who are unable to use colchicine (due to contraindication, intolerance or lack of efficacy). The drug demonstrated an improvement in quality of life and convenience in administration in CAPS patients (a type of Hereditary Periodic Fever Syndrome) with 6 doses a year but was unable to prove its cost-efficiency, being a drug for an ultra-rare disease. In fact, Novartis had first applied for its reimbursement in 2017 after the drug was approved in 2015, and the company did not make any further attempts at listing until now. With this delay, the dire need for a reimbursed treatment option has intensified among patients. An alternative option exists, but just for one phenotype of the Hereditary Periodic Fever Syndrome - the chronic infantile neurological, cutaneous and articular (CINCA) syndrome – that patients can receive through the Korea Orphan & Essential Drug Center. With expectations rising on increased coverage for severe and rare disease drugs with the inauguration of the new administration, whether Ilaris will see different results this time remains to be seen. Dae Chul Jeong, Professor of Pediatrics at Seoul St. Mary's Hospital, said, “We need to improve accessibility to rare disease treatments so that Hereditary Periodic Fever Syndrome patients are guaranteed the same treatment benefits as other rare disease patients in Korea.” He added, “We also need to provide social attention and support so that patients diagnosed with Hereditary Periodic Fever Syndrome could continue on their difficult treatment journey while maintaining the quality of life with their families.”
- Company
- Keytruda became a new breakthrough in the tx
- by May 23, 2022 06:06am
- MSD's Keytruda succeeded in applying Hodgkin's lymphoma benefit for the second time as an immuno-cancer drug. Takeda is considered the best option for Hodgkin's lymphoma treatment. It is evaluated as suitable as a new option by proving superiority through comparative clinical trials with Takeda's Adcetris. As of March 1, Keytruda was reimbursed as a second or more treatment if it recurred or progressed after self-hematopoietic stem cell transplantation (ASCT) in typical Hodgkin lymphoma, and a third or more treatment if self-hematopoietic stem cell transplantation is impossible. Yoon Deok-hyun, a professor of oncology at Asan Medical Center in Seoul, commented on the expansion of the benefit, "Keytruda showed superior effect than Adcetris in most Hodgkin lymphoma patients, so Keytruda will be used first unless it is an exception." Hodgkin's lymphoma is mostly young patients, with people in their 20s and 30s accounting for 80% of the total. Lymphoma can occur in T lymphocytes, which play an important role in regulating the immune system and fighting viral infections, and in B lymphocytes, which produce antibodies essential to fighting some infections. Hodgkin's lymphoma is a type of lymphoma that is believed to have originated from B lymphocytes. In Korea, it accounts for about 5% of all lymphoma. Hodgkin's lymphoma has a high cure rate. In the case of local weapons, more than 95% of them are completely cured. However, about half of the high-risk groups of advanced stage patients suffer recurrence. Overall, it shows a recurrence rate of more than 20%. Patients who recur or fail to comply with treatment with cocktail therapy represented by ABVD consider autologous hematopoietic stem cell transplantation. The cure rate during transplantation is reported to be about 50%. However, the treatment of patients who cannot be transplanted or recur after transplantation still remains a homework. Professor Yoon said, "Self-hematopoietic stem cell transplantation is like high-dose chemotherapy, so patients who do not respond to chemotherapy cannot try it. This is one in three. In addition, about 20% of all patients are elderly or in poor systemic condition, so they cannot withstand transplants. The homework was how to treat these patients and those who recur after transplantation. Adcetris is the drug that contributed to improving their survival rate. It was a drug that combined strong anticancer drugs with antibodies targeting cancer, and it was effective not only in recurrent patients, but also in post-transplantation maintenance therapy and first-line treatment in high-risk groups." Although Adcetris has become the most effective drug for treating recurrence patients, many patients still experience recurrence with a 5-year progression-free survival rate of 20%, Professor Yoon said. At this time, Keytruda emerged as a new option by expanding the indication to Hodgkin's lymphoma. In particular, Keytruda first demonstrated superiority through a direct head-to-head comparison with Adcetris in phase 3 KEYNOTE-204. In this clinical trial, the risk of disease progression and death in the Keytruda group was 35% lower than that of the Adcetris group, and the median duration of progression-free survival was 13.2 months, showing a significant improvement compared to the control group (8.3 months). The objective reaction rate of the Keytruda group was 65.6%, and one in four showed complete remission. The median value and quality of life of the reaction duration were also significantly improved compared to the Adcetris group. Professor Yoon said, "When I used Keytruda at the treatment site, the quality of life of the patient increased due to its resistance, and it was convenient for patients as they only had to come once every three weeks without hospitalization. There was little hematological toxicity, he said. "Keytruda recorded a progression-free survival rate of 30-40% at the time of three years, which was higher than any other treatment." Since March, Keytruda benefits have been applied to Hodgkin's lymphoma, and treatment patterns at the treatment site have also changed. Professor Yoon said, "Based on the comparative clinical results, Keytruda can be considered first in almost all patients. If it is not an exceptional case, such as accompanying autoimmune diseases, we will use Keytruda first, he said. "Keytruda can be an important breakthrough in recurrent patients." Of course, Keytruda is not the perfect solution. Due to clinical design, Keytruda treatment is difficult to exceed two years. The reaction rate is high, but the rate of complete remission is 25%, which is also limited to achieving the goal of "complete recovery." However, Professor Yoon highly predicted the possibility of immuno-cancer drugs in Hodgkin's lymphoma, given that various clinical trials are underway beyond the effects of existing treatments. He said, "It is clear that immuno-cancer drugs will play a more role in the future as several clinical trials are currently underway in Hodgkin's lymphoma, including post-transplantation maintenance therapy and primary treatment therapy, including Keytruda."
- Company
- Keytruda leads sales for the 9th consecutive quarter
- by Chon, Seung-Hyun May 23, 2022 06:06am
- MDS’s cancer immunotherapy Keytruda has again topped the rank in pharmaceutical sales this year. Its increase in sales has been reduced somewhat due to the price cut disposition that followed Keytruda's reimbursement expansion, still, the drug was able to maintain its lead for the 9th consecutive quarter. Also, new drugs from multinational pharmaceutical companies, such as Plavix, Opdivo, Prolia, and Dupixent showed strength this quarter. According to the market research institution IQVIA on the 20th, Keytruda made the most among pharmaceuticals in Korea in the first quarter of this year, recording sales of ₩40.4 billion. Although the amount has decreased 8.4% YoY, still, the drug was able to maintain its overall lead. Keytruda is an immune checkpoint inhibitor that inhibits PD-1 (programmed death 1) proteins expressed at the surface of activated T cells, thereby inhibiting its binding to PD-L1 and activating the immune system to treat cancer. The drug, which was first released in March 2015, is currently approved for 18 indications in 14 cancer types in Korea, including melanoma, lung cancer, and head and neck cancer. Keytruda’s sales had first remained in the ₩3 billion range but started soaring after the drug was approved for insurance benefit as a second-line treatment for non-small cell lung cancer. Its sales exceeded ₩10 billion in Q1 2018 and then exceeded ₩30 billion in Q2 2019. In Q1 2020, the drug outsold the then-lead Lipitor and rose to the top that it maintained for 9 consecutive quarters until now. The reduction in sales of Keytruda this year is considered to be due to Keytruda’s price cut. Keytruda’s insurance ceiling price had fallen 25.6% with its reimbursement expansion to first-line treatment of NSCLC in March this year. Although sales had reduced somewhat due to the price cut, its rise in sales is expected to continue to surge due to the expanded scope of reimbursement. Sales of the hyperlipidemia treatment Lipitor recorded 2nd place with ₩38.5 billion in Q1 this year, making a 9.7% YoY increase. The sales gap between Keytruda and Lipitor had been nearly ₩9 billion in Q1 last year, but this gap was reduced to ₩1.9 billion with the slower rise in Keytruda’s overall sales this year. Lipitor (atorvastatin) is a hyperlipidemia treatment that was released by Pfizer Korea in 1999. Although its insurance price fell to half after patent expiry and the fierce competition created by the 100 or more generics, the drug continues to exert its strong influence in the prescription drug market. Viatris Korea, which was launched in November 2020 through a merger between Global Pfizer’s business division Upjohn and the global healthcare company Mylan, is in charge of its sales. Sanofi’s antiplatelet Plavix recorded 3rd place with its sales increasing 37.7% YoY to record ₩26.8 billion in Q1 this year. Plavix’s patent had also expired in 2007, despite the 100 or more generics that entered its market in the past decade, the drug is still recording high growth. Also, new drugs released by multinational pharmaceutical companies have made the ranks and have shown high growth. Sales of Sanofi’s atopic dermatitis treatment Dupixent rose 77.0% YoY to record ₩23.9 billion in Q1 this year and newly entered the Top 10. Dupixent is the first targeted biologic for the treatment of moderate-to-severe atopic dermatitis that is not well controlled with prescription topical therapies or cannot use topical therapies. It selectively inhibits interleukin-3 and interleukin-4 proteins, which are known causes of adult atopic dermatitis. Sanofi Genzyme received marketing authorization for Dupixent in March 2018 for the treatment of moderate-to-severe atopic dermatitis in adults and released the drug in August of the same year. Although its initial performance was not up to par, its sales surged with its reimbursement approval for severe atopic dermatitis in January 2020. Dupixent’s sales, which had been only ₩3.3 billion in Q1 2020, increased over fourfold in a single year to record ₩13.5 billion in Q1 last year and exceeded quarterly sales of ₩10 billion. The drug has been recording sales in the ₩20 billion range since Q3 last year. Sales of Ono Pharmaceutical’s cancer immunotherapy Opdivo (nivolumab) also increased 43.5% YoY to record ₩25.1 billion in Q1 this year. Amgen’s osteoporosis treatment Prolia and MSD’s HPV vaccine Gardasil 9 also showed high growth with a 25.9% and 39.2% respective YoY increase in sales. Among new homegrown drugs, HK Inno.N’s gastroesophageal reflux disease (GERD) drug K-CAB’s sales rose 25.2% YoY to record 25.1 billion in Q1 this year and ranked 5th among the most-sold prescription drugs in Korea this quarter.
- Company
- The global competitiveness of new drugs depends on
- by Nho, Byung Chul May 23, 2022 06:06am
- Public opinion on the realization of the preference for new drugs developed in Korea is rising ahead of the announcement of the results of research services on drug prices support policies for innovative pharmaceutical companies in line with the international trade order. The research service, which took place for five months from December last year to this month, is handled by Professor Park Mi-hye of Sungkyunkwan University with the order of the KHIDI, and is scheduled to be published as a report in June and July. The background of the research is due to the feasibility review of the MOHW's written inquiry of last year's parliamentary audit in the absence of subordinate laws due to trade issues, although the Pharmaceutical Industry Promotion Act was revised ('18.12). While positive results are expected, the core background and contents of the research service are expected to present support measures consistent with pharmaceutical company innovation and insurance finances, establish enforcement ordinances related to Article 17-2 of the Pharmaceutical Industry Promotion Act, and raise and resolve trade issues. New drug price preferential treatment at the new drug registration evaluation stage As a preference for drug prices for innovative pharmaceutical companies that can avoid trade issues demanded by the industry, first, a new drug price preference target (a new drug performed in phase 3 clinical trials in Korea) is established at the new drug registration evaluation stage. In the negotiation stage, innovative pharmaceutical companies are raising the current weighted average price of 90% to 100% for new drugs developed through phase 3 clinical trials in Korea, focusing on promoting R&D will and securing predictable marketability. Other preferential measures include improving the selection criteria for alternative drugs (excluding patent expired drugs from alternative drugs), accumulating a discount on drug prices during the patent period (deferred application), applying it after patent expiration, and reflecting the cost data of innovative pharmaceutical companies in Korea at the negotiation stage. The global innovative drug preferential treatment system was introduced temporarily between 2016 and 2018, and K-Cab and Olita have benefited from the suspension of development, but it has been virtually private due to the issue of non-compliance. Preferential conditions were the world's first domestic licensed or domestic production, joint development or social contribution between domestic and foreign companies, domestic clinical performance (phase 1), innovative pharmaceutical companies, or equivalent companies. Since 2018, all five requirements such as proving clinical usefulness, such as new mechanisms or substances, alternative treatments, extension of survival, rapid licensing in the United States or Europe, and rare disease treatments or anticancer drugs have been met, causing reverse discrimination against domestic history. Therefore, the industry believes that if innovative pharmaceutical companies omit ▲ economic evaluation, the highest A7 adjustment price or the highest alternative drug price will be reasonable, ▲ ICER when submitting PE data, and ▲ if PE data are not submitted, the maximum price of alternative drugs will be added by 10%. For new drugs similar to clinical usefulness, the lower of the amount between the weighted average price of substitute drugs and the weighted average price of substitute drugs × (100/53.55) (but in the case of new drugs, the highest price of substitute drugs can be recognized). The KPBMA said, "We plan to adopt the Pharmaceutical Bio Innovation Committee's policy, which will be established in the future, to encourage R&D, as well as secure new drug powerhouses and global entry points."
- Company
- COVID-19 exports to Australia↑123 times in a year
- by Kim, Jin-Gu May 23, 2022 06:06am
- In the January-April period, exports of medicines to Australia surged more than 100 times compared to the same period last year-on-year. In the pharmaceutical bio industry, it is interpreted that the moderna vaccine produced by Samsung BioLogics was exported to Australia in earnest, leading to an increase in total exports. Exports to Germany, which was previously the largest exporter, fell by one-fifth in a year. Exports to China and Japan also fell sharply. As the COVID-19 crisis enters a calming phase, analysts say changes are coming to major drug exporters. ◆Export to Australia 3.4 billion → 420 billion won in a year, 95% of them are vaccines According to the Korea Customs Service on the 17th, exports of medicines from Korea to Australia from January to April this year were 325.1 million dollars. Compared to $2.65 million (about 3.4 billion won) between January and April last year, it increased 123 times in a year. Until the middle of last year, Korea did not export much medicine to Australia. Before August last year, it was around 2 million dollars per month. It was in September last year that there were signs of full-fledged change. It exported 6.5 million dollars (about 8.3 billion won), more than three times more than usual. In November, it increased further to $12.74 million (approximately 16.3 billion won) in November. From December last year to February this year, it recorded more than 90 million dollars per month. In particular, in March, it reached its highest point by exporting 130.21 million dollars over a month. Exports in March were higher than annual exports of $126 million last year. Monthly exports in April have fallen again to $349 million. The pharmaceutical bio industry is paying attention to the fact that exports of medicines to Australia are concentrated in vaccines. Exports of vaccines (HS code 3002.41) to Australia from January to April amounted to $314.36 million, accounting for 97% of all drug exports to Australia. For the rest, it is maintained at the previous year's. It is explained that Moderna vaccines produced by Samsung BioLogics were exported to Australia. Yeonsu-gu, Incheon, is the only region in the country where vaccine exports have soared during this period. It is the area where Samsung BioLogics is located. ◆81% of Germany, the largest pharmaceutical export country in the past. "The base effect of panic buying" Exports of medicines to Germany plunged by one-fifth compared to the same period last year. In the January-April period of this year, exports of medicines to Germany amounted to 192.91 million dollars, down 81% from 1.010.27 billion dollars during the same period last year. Until last year, Germany was Korea's largest exporter of medicines for the past three years. Last year alone, 1.76922 billion dollars of medicines were exported to Germany. The pharmaceutical industry interprets that the rapid spread of COVID-19 in Europe has led to a decrease in drug exports to Germany. In the early days of the spread of COVID-19, exports of medicines increased as Germany and other European countries competed to stock up on essential drugs, and the opposite situation is taking place this year when COVID-19 calms down. Exports of medicines to Germany, which were $521.31 million in 2019, increased 3.5 times to $1.856.97 billion in 2020, the first year of COVID-19. Last year, it recorded a slight decrease of $1.76922 billion. In the process, the proportion of drug exports to Germany also increased significantly. Germany accounted for 14.1% of all drug exports in 2019, but soared to 26.9% in 2020. It decreased slightly to 21.8% last year, and fell to 8.8% from January to April this year. ◆47% decrease in China and 15% decrease in Japan In addition to Germany, exports of medicines to China and Japan also decreased significantly in a year. In the January-April period, exports of medicines to China amounted to $45.31 million, nearly half of $84.77 million in the same period last year. Exports to Japan also fell 15.2% from 161.25 million dollars to 136.68 million dollars in a year. In the case of the two countries, it is analyzed that the decrease in local demand for medicines has affected the decrease in exports.
- Company
- The standard of Xospata is very disappointing
- by Eo, Yun-Ho May 19, 2022 05:51am
- Insurance benefits for the new leukemia drug Xospata have been applied, but clinics are expressing regret. Acute Myeloid Leukemia (AML) treatment Xospata has been reimbursed since March. Looking at the benefit criteria of this drug, remission-induction therapy is recognized in patients with FLT3 mutant acute myeloid leukemia who are refractory to conventional treatment or can transplant homologous hematopoietic stem cells. Considering the preparation period for the transplantation of homologous hematopoietic stem cells, additional administration of 2 cycles is required only if the transplantation of homologous hematopoietic stem cells is approved in advance. Xospata's administration is limited to up to 4 cycles. In general, when the drug administration cycle is limited in the benefit standard, it is based on the design of clinical research of the drug or authoritative overseas guidelines. Blood cancer treatments such as Besponsa and Blincyto have limitations on benefit administration, all of which are based on evidence. In the case of Xospata, there is no specific reason to limit the dosage cycle. According to Xospata's ADMIRAL study, it was designed without any limitation on the administration period, and the NCCN guidelines recommend it as "Category 1" without any limitation on the period. Lee Je-hwan, chairman of the Korean Society of Hematology, said, "I'm not sure why the four-cycle restriction was made. Currently, Xospata benefits are recognized in A7 countries such as the United States and the United Kingdom and Canada without restrictions on the treatment cycle, he said. In addition, "targeted treatments such as Xospata are virtually difficult to prescribe unless they are reimbursed." If the treatment period is limited, it will have a great adverse effect on the patient's treatment," he stressed.
- Company
- 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).
