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- 2026-05-04 00:25:54
- Policy
- Qarziba’s reimb standard has been set before approval
- by Lee, Tak-Sun May 31, 2024 05:51am
- The reimbursement standard has been set for Qarziba (dinutuximab, Recordati Korea), which was designated as the 1st drug for a “Pilot Project for Integration of Product Approvals, Reimbursement Coverage Reviews, and Drug Price Negotiations,” even though it has not yet received approval from the Ministry of Food and Drug Safety (MFDS). Qarziba is used for treating neuroblastoma in young children over 12 months. The Health Insurance Review and Assessment Service (HIRA) held the 4th Cancer Disease Review Committee (CDRC) meeting 2024 on May 29 and announced this review result. Qarziba was considered for a review as a novel drug. It has been assigned to a “Pilot Project for Integration of Product Approvals, Reimbursement Coverage Reviews, and Drug Price Negotiations.” The process for product approvals, reimbursement coverage reviews, and drug price negotiations are being conducted concurrently. The MFDS has completed the safety and efficacy review and is currently processing the product approval. Even though the drug has not yet received product approval, a reimbursement standard has been set because it was designated as part of a pilot project. The CDRC set the reimbursement standard for this drug for young children over 12 months with ▲ A high-risk neuroblastoma who had received bone marrrow removal therapy and a stem cell transplantation therapy after showing partial adverse reactions following chemostheray ▲Recurrent and refractory neuroblastma. The CDRC review results for Qarziba, nexatin inj plus Loicosodium inj plus FU inj Choongwae, nexatin inj plus Xeloda tab, and Trisenox Inj plus Vesanoid Soft Cap. At the meeting, CDRC also approved a reimbursement expansion proposal for nexatin inj plus Loicosodium inj plus FU inj Choongwae or nexatin inj plus Xeloda tab. Additionally, the CDRC passed a reimbursement expansion proposal for Trisenox Inj plus Vesanoid Soft Cap. The committee also considered opinions by the Korean Academy of Medical Sciences and drafted a reimbursement standard improvement proposal reflecting current clinical settings. The reimbursement standards have been set for anticancer therapies for treating gynecologic cancer (2 items), breast cancer (1 item), esophageal cancer (1 item), and urological cancer (2 items). The HIRA stated that it has considered the opinions of the Korean Medical Association and the Korean Academy of Medical Sciences regarding reimbursement standards and is proactively pursuing a review to improve pharmaceuticals, activities, and treatment materials through communication with the medical industry and academics. For anticancer therapy, the CDRC’s task force team reviewed 6 items. As a result, reimbursement standards have been set for anticancer therapies for treating gynecologic cancer (2 items), breast cancer (1 item), esophageal cancer (1 item), and urological cancer (2 items). The CDRC delivered partial approval of Lutathera inj use coverage, limiting to application by clinics. Additionally, the CDRC approved reimbursement for the use of Lutathera inj use, limited to application by clinics, exceeding the standard approval.
- Policy
- MFDS approves the orphan drug 'Pluvicto' for prostate cancer
- by Lee, Hye-Kyung May 31, 2024 05:51am
- The Ministry of Food and Drug Safety (MFDS) approved The Ministry of Food and Drug Safety (MFDS) stated that on May 29th, it has granted approval of the orphan drug 'Pluvicto inj (Lutetium(177Lu) Vipivotide Tetraxetan)' for the treatment of prostate cancer. Pluvicto is imported by Novartis Korea. It is a radioligand therapy comprised of radioisotope Lutetium(177Lu), which binds to prostate-specific membrane antigen (PSMA), commonly expressed in prostate cancer, delivering therapeutic radiation to prostate cancer, leading to cell death of cancer cells. Pluvicto inj has been approved for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and ‘taxane‘-based chemotherapy. The MFDS stated that in June last year, it has designated Pluvicto inj as the '6th Global Innovative products on Fast Track (GIFT)' and expects to provide a new treatment opportunity for prostate cancer patients who cannot receive conventional therapies. The MFDS said, "We will continue to make efforts to expand treatment opportunities for rare and refractory diseases by ensuring the expedited distribution of medications with proven safety and effectiveness based on our expertise in regulatory science.”
- Policy
- Korea-US gov't pledge to strengthen biohealth cooperation
- by Lee, Jeong-Hwan May 31, 2024 05:51am
- The Korean government has decided to strengthen cooperation with the U.S. Department of Commerce in the field of telemedicine and digital health, including non-face-to-face medical treatment. CareLabs and Lulu Medic, Korea’s leading healthcare platforms including domestic non-face-to-face treatment applications, Teladoc, the No. 1 telemedicine provider in the U.S., and Baxter, a global healthcare company, had the opportunity to present their major business achievements to the two governments. At 8 a.m. (KST) on the 30th, the Ministry of Trade, Industry and Energy (MOTIE) announced that it held the 'Korea-US Telemedicine Showcase' with the U.S. Department of Commerce via video. The showcase was held to enhance mutual understanding of the digital health and telemedicine industries in the two countries and explore ways for cooperation. The MOTIE assessed that the digital health industry is expected to continue to grow due to the rapidly aging population and improved quality of life. In particular, the ministry said that mobile app-based non-face-to-face medical treatment is gaining commercial results. The showcase was jointly organized by MOTIE, the U.S. Department of Commerce, digital health associations from both countries and 30 promising digital health companies from both countries. Among associations, the Korea Digital Health Industry Association (KoDHIA) from Korea and the American Telemedicine Association (ATA) from the U.S. attended the event. By company, CareLabs and Lulu Medic, Korea’s leading healthcare platforms including domestic non-face-to-face treatment applications, and Teladoc, the No. 1 telemedicine provider in the U.S., and Baxter, a global healthcare company, presented their major business results and future plans. The MOTIE plans to strengthen all-around cooperation in the bio industry, including pharmaceuticals, medical devices, and materials, parts, and equipment industries, through 'Bio USA 2024,' which will be held from the 3rd to the 4th of next month. A MOTIE official said, "We are promoting policies such as supporting the commercialization of products and services and fostering human resources to create a digital health industry ecosystem. Building on the telemedicine showcase we held this time, we plan to continue our bilateral digital health cooperation.”
- 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.
- Policy
- Research on reforming post-management of pharmaceuticals
- by Lee, Tak-Sun May 30, 2024 05:50am
- The government has initiated research on developing a comprehensive reform of post-insurance management of pharmaceuticals. This research was part of the 2nd Comprehensive NHI Plan, announced earlier this year. According to industry sources on May 29th, a policy initiative reporting session was held to announce the start of the research on post-insurance management of pharmaceuticals. As part of the 2024 initiative plan for the 2nd Comprehensive NHI plan, which was announced last month, policy initiative research will be conducted to develop a comprehensive reform of post-insurance management of pharmaceuticals. This plan aims to effectively manage the cost of pharmaceuticals as part of a mid-to-long-term strategy. The research will include the current state of the post-insurance management program, accomplishments, comparisons to foreign countries, and suggestions for improving the program to suit South Korean settings. The MOHW announced that the research will start in May and be completed by December. The Korea Institute for Health and Social Affairs (KIHASA) will conduct the research under a contract with the MOHW. "The research aims to develop a comprehensive reform of the post-insurance management of pharmaceuticals, including the Health Insurance Review and Assessment Service (HIRA)’s reevaluation of reimbursement appropriateness and the National Health Insurance Service (NHIS)’s Price-Volume Agreement (PVA) program," a government official explained. “Therefore, the MOHW, the HIRA, and the NHIS officials have joined the reporting session.” Earlier this year, there were talks of a possible reevaluation of comparisons to foreign pharmaceutical pricing following the research on the comprehensive measures for post-insurance management of pharmaceuticals. However, it appears that there are plans to separately pursue the reevaluation of comparisons to foreign pharmaceutical pricing this year. When the research report is available at the end of this year, there will be a discussion on systemization next year.
- Opinion
- [Reporter’s View] We don’t know the fate of rivoceranib
- by Kim, Jin-Gu May 30, 2024 05:50am
- On the 17th, The US Food and Drug Administration issued a complete response letter (CRL) for HLB and Chinese Jiangsu Hengrui Pharmaceuticals’ frontline camrelizumab plus rivoceranib as a treatment for those with unresectable or metastatic hepatocellular carcinoma (HCC). Immediately after the news broke, HLB's stock price plummeted. The stock price, which was KRW 95,800, hit the floor for two days in a row, halving to KRW 47,000. Its market cap evaporated by more than KRW 630 billion in 2 days. As investors had high expectations for the company, which once recorded the second-largest market cap on KOSDAQ, the disappointment was as great. However, its stock has since rebounded, especially on the 27th and 28th, rising by more than 10% for two consecutive days and recovering to the KRW 63,500 level. The analysis is that HLB's strong claim that the FDA's approval was only delayed due to the facility issue at Jiangsu Hengrui Pharmaceuticals and that there is no problem with its final approval, has brought back the investors' attention again. Interpretations of the companies’ CRL receipt had been mixed. Some have said that the FDA "denied" the approval or that the companies have "failed," while others say the approval was just "delayed" or "pending. There is no special meaning to a CRL. It doesn't mean that the possibility of an FDA approval is long gone or that your approval is assured. Receipt of a CRL literally means that the FDA has requested a supplement to the application. Of course, as HLB claims, many new drugs have crossed the FDA threshold after receiving a CRL. HLB and Jiangsu Hengrui Pharmaceuticals plan to reapply for the FDA’s approval. They plan to resolve the facility issues that were pointed out as the reason for the CRL and try again. The exact time of the reattempt was not disclosed, but the industry expects the companies to reapply 'soon.’ We cannot predict whether the reattempt will end a success or failure. While many factors favor a positive outcome, there are also clear factors that point to a negative outcome. According to HLB claims, the CRL was unrelated to the efficacy and safety of the combination therapy. If so, this means that the combination therapy’s longest overall survival (OS) data compared to competing drugs is acceptable. In this case, the reapplication would only need to address the Jiangsu Hengrui Pharmaceuticals’ facility issues that caused the CRL. However, it is different if there are other causes besides the facility issue. In the past, the pharmaceutical industry has criticized the camrelizumab plus rivoceranib combination trial for not being double-blinded and for having a disproportionately large number of Asian patients. There are also other variables beyond the clinical and facility issues. One risk is that the US has been slow to approve new drugs from China for political reasons. The US recently passed the Biosecure Act, which actively restricts activity by Chinese pharmaceutical companies. Furthermore, the imminent release of clinical data of a potential competitor, the Opdivo plus Yervoy combination as a first-line treatment for liver cancer, also renders it difficult to be optimistic about the outcome. HLB Chairman Yang Gon Jin called the CRL a "double hit" for the company. However, it's too early to assess whether it's a double or a triple hit based solely on the FDA’s rejection or delay of approval. The ball hit by the HLB is still in flight. At this point, the ball could go over the fence or be out. Even if the FDA approves the product, the approval by itself would be hard to call a success. While it's clear that crossing the FDA's threshold is very difficult, it shouldn't be the ultimate goal. It’s as important to have a vision of how to commercialize the product after approval. So from various aspects, it is clear that it is too early to call rivoceranib a success or a failure, just based on the receipt of the CRL.
- 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.
- Policy
- MSD discontinues supply of Zostavax in Korea
- by Lee, Hye-Kyung May 30, 2024 05:50am
- MSD Korea has announced that it will discontinue the domestic supply of the shingles vaccine Zostavax in Korea. According to the Ministry of Food and Drug Safety, MSD reported the suspension of Zostavax to the Ministry of Food and Drug Safety on Monday. The last batch is expected to be delivered within September, but the supply period is subject to change depending on market demand. Zostavax is a shingles vaccine that was launched in 2013. It was the first live attenuated vaccine available in South Korea. According to the market research institution IQIVA, Zostavax generated KRW 22.4 billion in sales last year, which is half the KRW 55.9 billion it had posted in 2019. "The introduction of alternative shingles vaccines to Zostavax in 2017 has significantly reduced global clinical demand for Zostavax," explained MSD said in a statement. "We have decided to voluntarily discontinue the manufacture and supply of Zostavax in the global market in 2024." The company added that this decision has nothing to do with the quality or safety of the product and that the decision is based on a careful evaluation of the declining clinical demand for Zostavax due to changing market conditions and the availability of alternative vaccines. Alternatives to Zostavax include SK Bioscience's ‘SKYZoster’ and GSK's ‘Shingrix.’ "In the case of Zostavax, there are alternative shingles vaccines already available on the market," said MSD, adding, "We believe the market impact of this discontinuation will be minimal, so we are not taking any measures to facilitate supply." The last batch is planned for September 2024. "The supply period may vary depending on market demand," MSD said. "We will continue to ensure smooth supply and management of the last batch of Zostavax in Korea and any remaining product in the market, while diligently informing health authorities, relevant organizations, and healthcare providers about this decision and the processes that will follow to minimize disruption in the healthcare setting."
- 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.
