- LOGIN
- MemberShip
- 2026-05-04 14:01:11
- Company
- 'Jemperli,' a PD-1 inhibitor immunotherapy lands in Big 5
- by Eo, Yun-Ho Jun 04, 2024 05:46am
- GSK Korea’s PD-1 inhibitor Jemperli (dostarlimab). 'Jemperli,' the first immunotherapy for endometrial cancer, has landed in Big 5 general hospitals. According to industry sources, GSK Korea’s PD-1 inhibitor Jemperli (dostarlimab) has cleared the Drug Committee (DC) of the nationwide medical institutes, including Samsung Medical Center in Seoul, Seoul National University Hospital, Seoul St. Mary's Hospital, Seoul Asan Hospital, and Sinchon Severance Hospital. After being listed for reimbursement in December, Jemperli is now readily available for prescription. The efficacy of Jemerli was demonstrated through cohort A1 analysis results of the GARNET study. GARNET was a multiple cohort, open-label study, including patients with recurrent or advanced solid cancer. Cohort A1 enrolled patients with recurrent or advanced dMMR/MSI-H endometrial cancer who have shown progression after platinum-based systemic chemotherapy. Notably, the size of Cohort A1 was the largest among PD-1 inhibitor monotherapy studies involving patients with dMMR/MSI-H endometrial cancer to date. The study’s primary endpoints were objective response rate (ORR) and duration of response (DOR), and these were assessed by blinded independent central review (BICR) according to the Response Evaluation Criteria Solid Tumors (RECIST). The analysis of 108 patients at 16.3 months, a median value of the follow-up period, Jemperli showed consistent anti-tumor activities and a manageable safety profile. The treatment group had ORR of 43.5%, and its DOR has yet to reach the median value. A disease control rate (DCR) of 55.6% was recorded, and 97.9% and 90.9% of the patients had treatment responses that continued for 6 months and 12 months, respectively. Meanwhile, an expanded indication for Jemperli in combination with platinum-based chemotherapy was approved for the first-line treatment of patients with advanced or recurrent DNA Mismatch Repair Deficient/Microsatellite Instability-High (dMMR/MSI-H) endometrial cancer. Jae-Hoon Kim, Professor of the Department of Obstetrics and Gynecology at Gangnam Severance Hospital, said, "Platinum-based chemotherapy has been used as the first-line standard therapy for advanced or recurrent endometrial cancer, but the patients had unmet needs due to poor prognosis, with the average of overall survival period being less than three years. Therefore, we have high hopes for the clinical significance of Jemperli for the first-line treatment."
- Company
- AbbVie’s Rinvoq is reimbursed for Crohn's Disease in KOR
- by Son, Hyung-Min Jun 03, 2024 05:49am
- Byong Duk Ye, Professor of Gastroenterology at Asan Medical Center, Rinvoq’s reimbursement has been extended to cover Crohn's disease and ulcerative colitis in Korea. With this reimbursement extension, Rinvoq became the first and only JAK inhibitor that is reimbursed to treat adults with moderate-to-severe Crohn's disease. The treatment has been shown high effect not only in controlling symptoms but also in mucosal healing, which is expected to increase its use. On the 31st, AbbVie Korea held a press conference at the Sofitel Ambassador Seoul Hotel in Jamsil to celebrate the reimbursement of Rinvoq for adult patients with moderate-to-severe active ulcerative colitis and Crohn's disease in Korea. Rinvoq is a Janus kinase (JAK) inhibitor developed by AbbVie and indicated for ulcerative colitis, Crohn's disease, atopic dermatitis, ankylosing spondylitis, and psoriatic arthritis. In Korea, the drug became reimbursable for the treatment of patients with moderate-to-severe ulcerative colitis who have had an inadequate response or intolerance to conventional therapies such as corticosteroids, 6-mercaptopurine or azathioprine, or for whom these agents are contraindicated. It is also reimbursable for the treatment of patients with moderate-to-severe active Crohn's disease (Crohn's Disease Activity Index (CDAI) of 220 or greater) who have had an inadequate response or intolerance to conventional therapies In addition to ulcerative colitis and Crohn's disease, RInvoq is covered for the treatment of moderate-to-severe active rheumatoid arthritis in adults, moderate-to-severe active ankylosing spondylitis in adults, and severe atopic dermatitis in adults and adolescents. Inflammatory bowel disease (IBD) is a chronic inflammatory condition characterized by abnormal immune responses in the intestinal tract and recurrent episodes of inflammation caused by both internal and external factors. Typical IBD describes 2 main conditions, ulcerative colitis and Crohn's disease. These disorders are characterized by recurrent gastrointestinal symptoms such as diarrhea, bloody stools, and abdominal pain that significantly interfere with daily life, due to which patients who have been unsuccessfully treated have been expressing a dire need for effective new treatment options. In clinical trials, RInvoq has demonstrated rapid symptom control as well as mucosal healing. In a Phase III trial studying its effect in ulcerative colitis, Rinvoq demonstrated significant improvements in histologic-endoscopic assessments, including endoscopic improvement, histologic improvement, and histologic-endoscopic mucosal improvement over placebo. In the two induction studies, RInvoq demonstrated endoscopic improvement at week 8 in 36% and 44% of patients, compared with the 7% and 8% shown in the placebo arm of the two studies, respectively. In the maintenance studies, up to 62% of the patients treated with Rinvoq for 52 weeks achieved endoscopic improvement. The onset of clinical response occurred as early as Week 2 in the induction therapy study, with a higher percentage of patients achieving clinical response at Week 2 in the Rinvoq treatment arm compared to the placebo arm. Rinvoq also demonstrated significant improvements in endoscopic endpoints, including endoscopic response and mucosal healing, compared to placebo In a Phase III trial on Crohn's disease, In two induction studies, endoscopic response rates were 35% and 46% at Week 12, compared with 4% and 13% in the placebo group. In the maintenance studies, RInvoq also improved endoscopic response and remission over placebo. Byong Duk Ye, Professor of Gastroenterology at Asan Medical Center, said, “If inflammatory bowel disease is not treated properly, complications such as fistulas and perforations can occur, and the risk of colorectal cancer can increase. Many treatments have been introduced to the field, but they have been lacking in terms of mucosal healing and ease in administration." "Rinvoq has shown high efficacy in mucosal healing as well as symptom control in clinical trials. Also, its once-daily dosing is convenient for the patients. We are excited to be able to provide patients with a more effective treatment option with the reimbursement extension. Rinvoq is a drug that has also been verified in the real world."
- Company
- 'Dupixent,' the final stages of reimb expansion for children
- by Eo, Yun-Ho Jun 03, 2024 05:48am
- Sanofi Korea’s Dupixent (dupilumab) Dupixent is about to enter the last hurdle of expanding insurance reimbursement coverage for young children. According to industry sources, the Ministry of Health and Welfare (MOHW) has recently ordered drug pricing negotiations for Sanofi Korea’s Dupixent (dupilumab). Consequently, a tug-of-war between the government and Sanofi is about to start. Dupixent is covered by reimbursement for severe atomic dermatitis over the age of 6 years. If it completes the drug pricing negotiations and secures expanded reimbursement, prescriptions will become available to infants six months and above. This indication was approved in South Korea in November 2022. There have been talks about the unmet needs of Dupixent’s reimbursement expansion toward young children. Notably, the Severe Atopic Dermatitis Association (SADA) issued a statement urging the coverage of Dupixent for young children aged 6 months to younger than 6 years with severe atopic dermatitis. 85-90% of atopic dermatitis manifests symptoms at the age of five, and for severe cases, the disease persists until adulthood and relapses. However, treatments approved for children under the age of five are limited to topical treatments, and the patients with symptoms uncontrolled with topical treatments have limited treatment options due to long-term skin retractions and infection risks. Meanwhile, Dupixent demonstrated its efficacy towards young children through the LIBERTY AD PRESCHOOL Phase 3 trial. This study evaluated the efficacy and safety of Dupixent in patients aged 6 months to younger than 6 years with atopic dermatitis who have inadequate responses to topical treatment. At 16 weeks, 28% of patients treated with Dupixent in combination with topical corticosteroids (TCS) showed a score of 0 or 1 point in the Investigator's Global Assessment PN-Stage (IGA PN-S), demonstrating a significant improvement in atopic dermatitis compared to 4% of the placebo group. Consequently, it met the primary efficacy endpoint. Furthermore, 53% of patients accomplished EASI-75, the secondary endpoint, in the Dupixent plus TCS combination therapy group, significantly higher than the 11% in the placebo group. Dupixent plus TCS combination therapy also improved the WSI-NRS (Worst Scratch and Itch Numerical Rating Scale) score by 49.4% compared to the placebo group’s 2.2%, demonstrating significant improvements in the common symptom of itchiness in atopic dermatitis.
- Company
- Thrombocytopenia treatment market rises as blue ocean
- by Nho, Byung Chul Jun 03, 2024 05:48am
- The prescription market for idiopathic (immune) thrombocytopenia treatments is expected to grow exponentially with the recent reimbursement standard extension granted in Korea. Until now, reimbursement for oral immune thrombocytopenia drugs has been limited to patients with immune thrombocytopenia who are refractory to corticosteroids and immunoglobulins after splenectomy or are refractory to corticosteroids and immunoglobulins and have medical contraindications to splenectomy. However, as of next month, the current reimbursement standards that require 'splenectomy' will be changed, and the oral drug will be available for use upon just the diagnosis of the disease, which is expected to expand the prescription market. Currently, Novartis' Revolade Tab (eltrombopag olamine) and Kyowa Kirin’s Romiplate (romiplostim) lead the market. The total market for both oral and injectable drugs is about KRW 15 billion based on last year's drug distribution results, and both treatments have been recording an upward-sloping sales curve. Revolade’s sales in 2020·2021·2022·2023·2024 1Q had been KRW7.5 billion·KRW 7.9 billion·KRW8.5 billion·KRW 9 billion·KRW 2.2 billion, respectively. Romiplate’s sales had remained in the KRW 1.3 billion to KRW 2 billion band from 2020-2021-2022, then grew 150% in 2023 to surpass KRW 5 billion. In 1Q 2024, its sales reached KRW 1.6 billion, closely following the performance of Revolade, which reached KRW 2.2 billion. In addition, JW Pharmaceuticals and Handok Pharmaceuticals are expected to receive approval for their Tavalisse (fostamatinib) and Doptelet (avatrombopag), which are new oral treatments for idiopathic (immune) thrombocytopenia in the third quarter of this year, further expanding treatment options. Immune thrombocytopenia is an autoimmune disease in which the body's immune system attacks platelets as foreign antigens. Serious bleeding has been reported in 9.5% of affected adults, and the patients are at 1.3 to 2.2 times higher risk of death due to cardiovascular events, infectious diseases, and serious bleeding than the general population. Also, at least half of the patients experienced fatigue and decreased mental, emotional, and physical health, as well as reduced quality of social functioning. The disease can affect many aspects of the lives of patients and their families, rendering school, work, relationships, and sometimes even daily life difficult.
- Company
- Growing DME market…new drugs clinical trials·biosimilars
- by Son, Hyung-Min May 31, 2024 05:52am
- Korean pharmaceutical companies are challenging the market for diabetic macular edema treatments with oral formulations. Handok and Curacle confirmed effects in clinical trials for oral diabetic macular edema treatments. Because only injectables are available in the market, oral formulations can have a competitive edge because of their convenience of administration. Furthermore, Korean pharmaceutical companies are set to compete in the market with biosimilars to Eyelia. According to industry sources on May 29th, positive results were secured from novel candidate product RZ402’s Phase 2 trials for diabetic macular edema conducted by Rezolute, Handok’s related company. This novel candidate drug works by inhibiting the overexpression of plasma kallikrein, which participates in blood coagulation. Handok owns RZ402’s marketing rights in South Korea. Diabetic macular edema (DME) is a diabetes complication that affects the central area of the retina, leading to vision deterioration and disorder. DME is a disease with damaged retinal vasculature due to increased blood glucose levels, resulting in macular fluid leaking. Conventional DME treatments are vascular endothelial growth factor (VEGFR) inhibitors, including Eylea, Lucentis, Beovu, and Vabysmo. Treatments offering the convenience of administrarion are leading the market. The intervals of administration of Eylea, the top-selling drug in the market, have been extended from once every two months to up to five months, and that of Vabysmo, an emerging competitor, can be administered once every four months. RZ402 is being developed as an oral formulation, and therefore, it has the advantage of differentiating from other treatments. This novel candidate product secured positive results from recently disclosed phase 2a trials, increasing its potential for commercialization. This research evaluated the efficacy and safety of RZ402 monotherapy (50 mg, 200 mg, 400 mg) and enrolled 94 patients with DME patients who had no prior experience with injectables or had limited therapies. The clinical results demonstrated that the RZ404 200 mg treatment group had the most improved edema, while there was no change across dosages. For the safety profile, no significant adverse reactions compared to the placebo were observed. Since the AZ402 200 mg treatment group had the most significant effect, this dosage will serve as the reference for future clinical 2b trials. Curacle, a Korea-based bioventure company, is developing an oral DME treatment CU06. The top-line results of clinical Phase 2a trials demonstrated no significant changes regarding the central subfield thickness, measured as CU06’s primary endpoint. However, significant improvements were observed in baseline in best-corrected visual acuity (BCVA), which was the secondary endpoint. In clinical trials, CU06 improved the patients’ word reading assessments within three months of administration. At 12 weeks, CU06 100, 200, and 300mg administration improved BCVA by up to 1.9, 2.5, and 2.2 letters, respectively. Notably, 300 mg treatment in the vision below 0.5 patient group improved BCVA by up to 6.6 letters at 16 weeks. Curacle signed a technology transfer licensing of CU06, excluding Asia, with Théa Open Innovation in October 2021. However, the company recently was notified of the return. Despite having the license returned, Curacle plans to continue the follow-up development since CU06 demonstrated clinical potential. Biosimilars are expected to be released…competition intensifies A significant number of Eyelia biosimilars are expected to be released. A significant number of Eyelia biosimilars are expected to be released in addition to novel oral formulations. Consequently, the competition in the market for DME is expected to intensify. Samsung Bioepis and Samil Pharmaceutical launched Afilivu, an Eyelia biosimilar, in the Korean market earlier this month. Afilivu was approved in February and completed reimbursement listing last month. In addition to these two companies, Sam Chun Dang Pharm successfully developed an Eyelia biosimilar, and Celltrion and Alteogen are also conducting clinical trials. Roche’s novel drug Vabysmo has been covered by insurance since last October and launched in the market. Vabysmo inhibits VEGF and inhibits angiopoietin-2 (Ang-2) to recover vasculature stabilization. It has the advantage of an extended effect. Vabysmo can be administered once every four months. Vabysmo’s global market sales closely match Eyelia’s. In two years of its launch, Vabysmo generated KRW 3.56 trillion in sales in the global market last year, which is over half of Eyelia’s KRW 7.8 trillion. Bayer, Eyelia’s developer, also recently introduced a high-dose formulation to defend the market. Bayer launched a product four times higher in dose than the previous 2 mg and extended the injection interval up to once every five months. Since Novartis’ Lucentis, Beovu, and Lucentis biosimilar are also seeking opportunities to expand sales, the competition in the market is expected to intensify.
- Company
- Adtralza becomes the 2nd reimbursed biological drug for AD
- by Son, Hyung-Min May 31, 2024 05:52am
- Jiyoung Ahn, Professor of Dermatology at the National Medical Center LEO Pharma Korea has launched Adtralza (tralokinumab) as the 2nd biologic drug in the atopic dermatitis market and is on its way to take on Dupixent. LEO Pharma has been emphasizing that Adtralza has a longer dosing interval after 16 weeks compared to existing therapies and is relatively cheaper, reducing the cost burden for patients. On March 30, LEO Pharma held a press conference at the Grand Hyatt Hotel in Seoul to celebrate the reimbursed launch of Adtralza. Adtralza is a biological drug that selectively targets interleukin-13 (IL-13). The drug is being reimbursed for the treatment of chronic severe atopic dermatitis in adults and adolescents from the 1st of this month. IL-13 is a key cytokine that causes signs and symptoms of atopic dermatitis, including immune dysregulation and skin barrier dysfunction, and is overexpressed in affected skin and is known to be correlated with the severity of the disease. The launch of Adtralza adds a biologic treatment option for atopic dermatitis alongside Sanofi's Dupixent, which inhibits IL-4 and IL-13. Adtralza is reimbursable for the treatment of chronic severe atopic dermatitis in adults (18 years and older) and adolescent patients (12 years to 17 years of age) whose condition has remained symptomatic for at least 3 years and meets one of the following conditions: ▲patient received at least 4 weeks of topical therapy (at least moderate-potency corticosteroids or calcineurin inhibitors) as a first-line treatment but was unable to adequately control their condition, followed by at least 3 months of systemic immunosuppressive agents (cyclosporine or methotrexate) that did not result in a 50% or greater reduction in Eczema Area and Severity Index (EASI) or was unable to continue their use due to side effects’ or ▲Patients has an EASI of 23 or greater prior to Adtralza use. Adtralza’s clinical efficacy and safety were confirmed through four Phase III ECZTRA 3 and ECZTEND trials. The ECZTRA 3 trial compared Adtralza to placebo in patients 18 years of age and older with moderate-to-severe atopic dermatitis who had not responded adequately to prior topical therapy or requires systemic therapy. The primary endpoint of the trial was the Investigators' Global assessment score of 0 (clear) or 1 (almost clear) and EASI 75 (75% improvement in Eczema Area and Severity Index)at week 16. Trial results showed that the rate of patients who achieved EASI 75 at Week 16 was 56.0% in the Adtralza group, which is a clinically significant improvement compared with the 35.7% in the placebo group. Also, 38.9% in the Adtralza group achieved IGA (Investigator’s Global Assessment) 0/1 at week 16, compared with 26.2% in the placebo group. Results from the ECZTEND study, which evaluated the long-term efficacy of Adtralza, showed that 84.5% of patients had an EASI-75 at 4 years of Adtralza treatment. Adtralza was also effective in patients with difficult-to-treat head and neck atopic dermatitis. In particular, Adtralza had the advantage of being dosed once every 4 weeks after week 16, ensuring ease of administration for the patients. Jiyoung Ahn, Professor of Dermatology at the National Medical Center, said, “Although the symptoms of atopic dermatitis may not seem serious, the itching and pain that patients experience can interfere with sleep and other daily life activities. Although there are many treatment options available on the market, the number of patients with atopic flare-ups continues to increase, so various treatment options are necessary, We are excited about the increased treatment options that the launch of Adtralza brings to us healthcare providers and patients." Dong Hun Lee, Professor of Dermatology at Seoul National University Hospital, said, “Adtralza is convenient because it can be administered every 4 weeks at the discretion of the physician for patients with clear or nearly clear skin after 16 weeks of treatment. Also, its reimbursed price is lower than its competitors, which will reduce the financial burden borne by the patients."
- Company
- Delay after delay…When will Phesgo be reimb in Korea?
- by Eo, Yun-Ho May 31, 2024 05:51am
- The biobetter breast cancer treatment ‘Phesgo’ is facing a tough road to insurance coverage in Korea. Roche Korea’s subcutaneous fixed-dose combination injection Phesgo (pertuzumab, trastuzumab) that combined ‘Perjeta’ and ‘Herceptin’ has passed the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee review in August last year. After reporting to the Drug Reimbursement Evaluation Committee review, Roche started negotiations with the National Health Insurance Service regarding the supply and quality control obligations for Phesgo but had made no progress. The 60-day deadline for negotiations has already passed, and no agreement has been reached in the extended negotiation period. It has now been 10 months since the CDDC review. As a biobetter that is an improved version of an existing drug, Phesgo’s drug price negotiations were expected to go smoothly at first, but the government was more concerned about its fiscal impact than expected and made additional demands to Roche. The good news is that both the government and the pharmaceutical company are willing to reimburse the drug, so it is possible that the parties will reach a negotiation in the future. In the case of ‘Nexviazyme (avalglucosidase alfa),’ which was the first case of preferential pricing granted to a biobetter drug, the process to its reimbursement listing took 5 months. It remains to be seen how long the tug-of-war between the government and Roche, which began last year, will continue. Phesgo was recognized for its innovation in improving patient convenience and reducing treatment time by changing the IV-injected Herceptin and Perjeta into a fixed-dose subcutaneous injection and was named the first biobetter approved for cancer in Korea. Metastatic HER2-positive breast cancer patients who had received maintenance therapy with IV Herceptin and Perjeta injections every three weeks may reduce their administration and monitoring time by 90% from the 270 minutes (90min+180min) to 20 minutes (5min+15min) when switching to Phesgo. Also, as Phesgo is a subcutaneous formulation injected in the thigh rather than into the veins, it can reduce blood vessel and nerve damage that can be caused by repeated intravenous injections. These benefits of Phesgo could prove to be useful amid the current healthcare disruptions. However, delays in the process, which could have been listed as early as the end of last year, have left Phesgo a pie in the sky. The NCCN guidelines state that Phesgo can be used in the place of Perjeta and Herceptin, In fact, in the UK, 90% of patients treated with Herceptin and Perjeta switched to Phesgo within a year after its launch. Therefore. If listed, a significant number of patients receiving Herceptin-Perjeta treatment are expected to switch to Phesgo as well. In 2016, the government announced a plan to provide preferential pricing for biosimilars and biobetters, which are improved versions of already approved biopharmaceuticals, that have contributed to the improvement of Korea’s healthcare. In the case of biobetters (chemical drugs), considering the difficulty in developing compared to improved new drugs (synthetic drugs), it was decided to calculate it at 100-120% of the drug price of the development target product (original, etc.), and Nexviazyme became the first drug to benefit.
- Company
- Over 50,000 ppl signed 2nd petition for Trodelvy’s reimb
- by Eo, Yun-Ho May 30, 2024 05:50am
- The second petition calling for the insurance reimbursement of the breast cancer drug 'Troldelvy (sacituzumab govitecan-hziy)' has again garnered over 50,000 signatures. This is the second petition filed after the first in January that garnered 50,000 signatures. Patients are growing increasingly desperate, as 3 months have passed with little news heard on Troldelvy’s reimbursement progress. Unfortunately, with the 22nd National Assembly currently in session, it is unlikely that the agenda will be reviewed by the relevant committee. The petitioner, who described herself as a Stage IV triple-negative breast cancer (TNBC) patient on the petition board, wrote, "My tumor is growing too fast. I'm stage IV, and I beg the government to give me the chance to live," she wrote, stressing the need for Trodelvy’s reimbursement. However, no news has been heard of on its review at the DrugReimbursement Evaluation Committee stage since it passed the Health Insurance Review and Assessment Service's Cancer Disease Review Committee in November last year. Gilead Sciences' triple-negative breast cancer drug Trodelvy is an antibody-drug conjugate (ADC) that consists of a monoclonal antibody that binds to the cell surface antigen Trop-2 and ‘SN-38,’ a TOP1 inhibitor payload. The drug received approval from the Ministry of Food and Drug Safety in May last year to treat adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received at least two prior systemic therapies, including at least one prior therapy for metastatic disease. Trodelvy is the only non-cytotoxic chemotherapy approved as a second or higher line of treatment for the entire TNBC patient population that has demonstrated an improvement in overall survival, but the cost-effectiveness evaluation remains a major hurdle to reimbursement. However, there is hope as another ADC, ‘Enhertu (trastuzumab deruxtecan),’ which was reimbursed in April, was recognized for innovativeness and applied a beneficial ICER from the government. Therefore, it will be interesting to see whether any progress will be made in Trodelvy's reimbursement amid the growing patients’s requests. Meanwhile, Trodelvy’s clinical efficacy was confirmed through the Phase III ASCENT study. In the study, Trodelvy significantly reduced the risk of death by 49% compared with a treatment of physician’s choice (TPC) in patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. Also, the Trodelvy arm showed a 57% improvement in progression-free survival (PFS). These effects were observed regardless of the patient’s brain metastasis status.
- Company
- 11 years since global entry…K-biosimilars
- by Chon, Seung-Hyun May 29, 2024 05:45am
- The biosimilar products developed by Korean companies are actively tapping into the global market. Celltrion received approval for Remsima in Europe in 2013. Since then, Koran companies have successfully commercialized 15 products in Europe and 12 products in the United States for the past 11 years. Celltrion secured 11 approvals in Europe and the United States, and Samsung Bioepis accomplished 14 approvals. According to industry sources on May 27th, Celltrion and Samsung Bioepis’ biosimilars received three approvals from Europe and the United States. On May 24th, Celltrion received the European Commission (EC) approval for its Omlyclo, a biosimilar to Xolair. The official approval was granted in two months, after the company received an approval recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in March. Omlyclo is the first Xolair biosimilar to receive European approval. Xolair is a biosimilar antibody used for persistent allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic spontaneous urticaria. It recorded KRW 5 trillion in global sales last year. In Omlyclo’s global Phase 3 trials, which enrolled 619 patients with chronic spontaneous urticaria across six European countries, Celltrion demonstrated Omlyclo’s equivalent efficacy to the original medicine and confirmed a similar safety profile. In two years since receiving approval for Vegzelma, a biosimilar to Avastin, in 2022, Celltrion established an additional biosimilar pipeline. This year, Samsung Bioepis received approval for its biosimilar both in Europe and the United States. Samsung Bioepis received EC approval for Pyzchiva, Stelara’s biosimilar. The company received the final approval for Pyzchiva two months after receiving a positive review for approval from the EMA’s CHMP in February. Stelara, developed by Janssen, is prescribed for treating autoimmune diseases, including plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. It inhibits the activities of the immune response-associated inflammatory cytokine called interleukin (IL)-12 and 23. The annual global sales amount to approximately KRW 1.4 trillion. Samsung Bioepis added the product to its portfolio after receiving approval for Soliris biosimilar, Epysqli, in Europe in May last year. Samsung Bioepis received approval from the U.S. FDA for its Opuviz, a biosimilar to the macular degeneration drug Eylea. Eylea, developed by Regeneron Pharmaceuticals in the United States, is indicated for the treatment of wet (neovascular) age-related macular degeneration (AMD). Eylea’s global sales last year amounted to approximately KRW 1.3 trillion. This marks the approval of Samsung Bioepis’ biosimilar in three years, following the approval of Byooviz, a biosimilar to Lucentis, in 2021. Korean biosimilar products granted approvals in Europe and the United States. Celltrion’s Remsima, a biosimilar to Remicade, and others. Samsung Bioepis’ Benepali, a biosimilar to the autoimmune disease treatment Enbrel, and others. The current list of global entries by companies show that Celltrion has received six approvals in Europe and five approvals in the United States. Celltrion received the marketing authorization in Europe for its Remsima, titled ‘world’s first biosimilar antibody,‘ in August 2013. Subsequently, Celltrion received European approval for Truxima, a biosimilar to Mabthera, in 2017 and Herzuma, a biosimilar to Herceptin, in 2018. These drugs are immunotherapy for cancer. In November 2019, Celltrion received European approval for Remsima SC, a subcutaneous injection formulation of Remicade, and entered the market. Remsima SC is a biosimilar developed by Celltrion by changing the formulation of Remicade from intravenous (IV) to subcutaneous (SC) injection. In February 2021, Celltrion obtained European approval for its Yuflyma, a biosimilar to Humira. In August 2022, Celltrion obtained European marketing authorization for its Vegzelma, a biosimilar to Vystin. In 2016, Celltrion's Inflectra, a biosimilar to Remicade, became the first to pass the FDA approval gateway in the United States. In 2018, Truxima and Herzuma received FDA approval. In September 2022, Celltrion obtained marketing authorization for Vegzelma, a biosimilar to Avastin, from the FDA, and last year, Yuflyma, a biosimilar to Humira, also received FDA approval. In August last year, Celltrion received marketing authorization for Zymfentra, a subcutaneous (SC) formulation of the biosimilar antibody Remsima, as a novel drug. Samsung Bioepis accomplished eight approvals in Europe and six approvals in the United States. In January 2016, Samsung Bioepis began its global market expansion by obtaining approval for its Benepali, a biosimilar to the autoimmune disease treatment Enbrel, in Europe. In May of the same year, Samsung Bioepis also obtained marketing authorization in Europe for its biosimilar Flixabi, a biosimilar to the autoimmune disease treatment Remicade. In 2017, Samsung Bioepis received European approvals for its biosimilars to Herceptin, an immunotherapy for cancer, and Humira, an autoimmune disease medication. In 2020, the company successfully acquired European approval for its biosimilar to Avastin, and in 2021, it also received a marketing authorization for a biosimilar to Lucentis, an eye disease medication, in Europe. In May last year, Samsung Bioepis obtained marketing authorization from the EC for ’Episcli,’ a biosimilar to the orphan drug ’Soliris.’ Episcli is the first biosimilar developed by Samsung Bioepis in hematology. Soliris, developed by Alexion Pharmaceuticals, is a high-cost medication for refractory rare diseases such as paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). In April 2017, Samsung Bioepis received the first FDA approval in the United States for its Renflexis, a biosimilar to Remicade. In 2019, Samsung Bioepis received FDA approval for three biosimilars to Herceptin, Enbrel, and Humira. In January 2019, Ontruzant, a biosimilar to Herceptin, received marketing authorization in the United States, followed by Eticovo and Hadlima, biosimilars to Enbrel and Humira, in April and July of the same year, respectively. Samsung Bioepis obtained FDA approval for its Byooviz, a biosimilar to Lucentis, in the United States in September 2021. Koran companies have successfully commercialized 15 products in Europe and 12 products in the United States for the past 11 years, following Celltrion’s European approval for Remsima in 2013. The companies strengthened global targeting, entering over two products annually into the United States and Europe.
- Company
- Six pharmaceutical companies challenge the 'Esgliteo' patent
- by Kim, Jin-Gu May 29, 2024 05:45am
- Generic companies have claimed patent challenges against Boehringer Ingelheim’s combination therapy for diabetes, 'Esgliteo (empagliflozin+linagliptin).' It is the strategy of six companies, including Boryung, to launch their generics early by avoiding or nullifying the patent of this combination therapy, which contains SGLT-2 inhibitor and DPP-4 inhibitor ingredients. According to pharmaceutical industry on May 28th, the six companies, including Boryung, Dongkook Pharm, Aprogen, Korea Prime Pharm, and Daehwa, filed claims for passive trials to confirm the scope of a right involving the Esgliteo patent. These companies also filed a claim for a nullification trial for the same patent. In the case of a nullification trial, Genuonesciences has already filed a claim for a trial last month. Consequently, generic companies are challenging both avoidance and nullification of a single patent. Esgliteo is protected by the patent titled 'A pharmaceutical composition including glucopyranosyl-substituted benzene derivatives' until August 2028. However, this patent is not listed on the Ministry of Food and Drug Safety (MFDS) list. This strategy is similar to that of Boehringer Ingelheim, where Jardiance (empagliflozin) and Trajenta (linagliptin) were not patented. The companies challenging patents aim to launch their generics after either avoiding or nullifying the Esgliteo patent. Since they are challenging a single patent with two approaches simultaneously, the analysis indicates that they are eager to overcome the patent. The generic version of linagliptin is expected to launch after the Trajenta substance patent expires next month. If the companies successfully challenge Esgliteo patent, they can expand their portfolio of linagliptin-based combination therapy. The remaining hurdle is the possibility of an unregistered patent. Similar to the cases of Jardiance and Trajenta, there may be unregistered patents. The analysis suggests that the product approval is not affected by the remaining unregistered patent challenge, but there may be a patent infringement possibility when products are launched. Meanwhile, Esgliteo has the highest prescription sales among combination therapies, consisting of SGLT-2 inhibitor and DPP-4 inhibitor, for diabetes. According to market research firm UBIST, Esgliteo a generated prescription amount of KRW 2.7 billion. This is higher than KRW 2.2 billion of LG Chem’s 'Zemidapa (dapagliflozin+gemigliptin),' KRW 2.1 billion of AstraZeneca’s 'Qtern (dapagliflozin+saxagliptin),' KRW 600 million of CKD Pharm’s 'Exiglu S (dapagliflozin+sitagliptin),' and KRW 500 million of Dong-A ST’s 'Sugadapa (dapagliflozin+evogliptin).' Esgliteo generated KRW 2.5 billion this year in the first quarter, similar to last year’s annual prescription performance. The pharmaceutical industry anticipates that other generic companies may challenge the patent additionally because Esgliteo sales are rapidly increasing.
