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- 2025-12-24 06:33:40
- Policy
- SCD's Eylea biosimilar was approved for phase III trials
- by Lee, Tak-Sun Sep 07, 2020 06:12am
- Eylea by BayerSCD Pharm has been approved for a phase III clinical trial of a biosimilar for Eylea (Aflibercept, Bayer), a macular degeneration treatment for the third time in Korea. In June, it was approved for the third phase III clinical trial following Samsung Bioepis and Amgen. It is noted who will succeed in commercialization first in Korea. On the 2nd, the MFDS approved the multinational phase III clinical trial protocol of 'SCD411' applied by SCD Pharm. This clinical trial is a phase III randomized, double-blind, parallel group, multicenter trial that compares efficacy, safety, tolerability, pharmacokinetics, and immunogenicity between SCD411 and Eylea in new vascular age-related macular degeneration test subjects. As a multinational clinical trial, the total number of subjects is 560, and 75 in Korea will be recruited. The test is conducted at Samsung Medical Center, Ajou University Hospital, and Asan Medical Center in Seoul. It is the third phase III clinical approval of Eylea biosimilar this year. On June 11th, Samsung Bioepis, and on June 29th, Amgen's biosimilar was approved by global CRO, Parexel Korea. Eylea, along with Lucentis, is the most used macular degeneration treatment in the world. Macular degeneration is the #1 cause of blindness in the elderly, and there is high demand for medicines. Eylea recorded ₩46.8 billion in sales based on IQVIA last year. SCD Pharm was approved by the US FDA for a phase III clinical trial of Eylea biosimilar in May. The company has announced a plan to release the product in 2023 after applying for approval the next year after going through phase III clinical trials.
- Policy
- The MFDS supports ₩25.6 billion for COVID-19
- by Lee, Tak-Sun Sep 04, 2020 06:53am
- The MFDS has established a budget of ₩25.6 billion next year to support the commercialization of COVID-19 vaccines and K-quarantine products. The MFDS announced on the 2nd that the government budget for 2021 has increased by ₩45.2 billion (8.1%) from ₩559.2 billion this year to a total of ₩604.4 billion. The budget for 2021 includes that ▲ securing food safety for consumers to become healthier ▲ strengthening the management of medicines and medical devices that patients can rest assured ▲ building a preemptive safety foundation for the future. In particular, it announced that it will provide a solid foundation for safety against the post-coronavirus by supporting domestic development, commercialization, and rapid supply of vaccines with high dependence on imports, and to closely manage hygiene and nutrition to small daycare centers that do not have the obligation to hire nutritionists to ensure the safety of children's meals. In detail, a drug design-based quality by design (QbD) model was developed (₩3.2→5.2 billion) for the establishment of a pharmaceutical smart factory, and the 'Advanced Biopharmaceutical Regulatory Science Center' was operated (₩900 million) and a long-term tracking investigation system (₩2.9 billion). In addition, the MFDS explained that it will expand support for the commercialization of innovative medical devices and establish a management system (₩100 million →₩1.2 billion) and technical support for the commercialization of in vitro diagnostic medical devices (₩400 miliion → ₩900 million). In addition, it plans to implement patient-centered safety management of medical products by preparing the basis for evaluation of next-generation medical products (R&D, ₩4.1 billion) using big data produced in medical fields. The MFDS added that it will reinforce national testing equipment and built a BSL3 laboratory (₩700 million→₩4.5 billion) to quickly supply COVID-19 related vaccine and treatment in Korea and will expand support for the operation of Hwasun 'Vaccine Safety Technology Support Center' (2→₩5.8 billion) to improve the domestic vaccine self-sufficiency rate. In addition, to support the development of K-quarantine products, a laboratory dedicated to the quality and performance of in vitro diagnostic medical devices (₩1 billion) was installed, and research on approval/examination evaluation technology for quarantine products such as COVID-19 treatments, vaccines, and masks (R&D, ₩4.4→ 6.9 billion), and it has announced that it will start a business (R&D, ₩3.1 billion) that will lead the biohealth industry. The MFDS announced that when the government budget for 2021 is finalized in December of this year through the parliamentary deliberation process, it will promptly and actively promote next year's major projects, including national tasks, as a vision for 'safe food and medicine, healthy citizens'.
- Policy
- DREC and Cancer Committee to convene more on-paper meetings
- by Lee, Hye-Kyung Sep 03, 2020 06:29am
- The South Korean government is to alleviate on-paper deliberations related regulation for the first threshold of pharmaceutical reimbursement listing—the Drug Reimbursement Evaluation Committee (DREC) and Cancer Deliberation Committee. The Health Insurance Review and Assessment Service (HIRA) preannounced partially revised managerial regulation on the committee that loosens and amends on-paper review regulations. Relevant public opinions would be accepted until Sept. 7. HIRA regularly convenes DREC meeting on every first Thursday of a month, and Cancer Deliberation Committee has scheduled eight meetings for the rest of the year. Amid COVID-19 pandemic, however, DREC and Cancer Committee meetings were postponed or delayed the decision making on drug reimbursement listing due to the regulation limiting on-paper review to two consecutive times. As a result, patients and pharmaceutical companies’ complains have snowballed. Accordingly, HIRA has decided to alleviate the on-paper review regulation stipulated in DREC and Cancer Committee managerial regulations. The current regulation stipulates, ‘a deliberation can be conducted on-paper, in case of urgent or non-critical case, but the on-paper review and deliberation cannot be conducted more than two consecutive times.’ The newly revised regulation would allow on-paper review and deliberation ‘in case the committee chair decides an in-person meeting cannot be convened for urgent or unavoidable reasons, or more than one-third of the registered committees have requested for on-paper deliberation with the attached No. 9 template.’ HIRA official stated, “The on-paper deliberation related regulation would be alleviated to efficiently operate the committees,” and “the revisions were made based on similar regulations in other Expert Evaluation Committees.” When finalized, the latest amendment aims to improve the continuity of tasks such as drug listing or reimbursement expansion, when in-person review is unfeasible due to a threat to public health like COVID-19.
- Policy
- Celltrion's COVID-19 antibody treatment phase I completed
- by Lee, Tak-Sun Sep 03, 2020 06:27am
- The MFDS announced on the 1st that the COVID-19 antibody treatment drug Celltrion is developing has completed phase I clinical administration and is currently under review of phase II/III trial plans. The MFDS announced the progress of the COVID-19 treatment and vaccine clinical trials in the explanatory data. Celltrion's new drug (CT-P59) for neutralizing antibody therapy (CT-P59), has been administered in phase I clinical trials in healthy people, and plans for phase II/III clinical trials are currently under review. Celltrion is recruiting patients with approval for a phase I clinical trial in the UK as well. The 'Plasma Fractionation Treatment' developed by GC Pharma, which was approved for a phase II clinical trial on the 20th of last month, is scheduled to conduct a clinical trial for patients with COVID-19 symptoms within 7 days from September at 6 hospitals including Samsung Medical Center. Specifically, plasma fractionation therapy will be administered to 15 patients per group at low, medium, and high doses in addition to the existing treatment for pneumonia patients identified by imaging diagnosis, patients 70 years of age or older, and patients with underlying diseases over 60 years of age. According to the MFDS, there are currently 22 clinical trials approved in Korea (20 treatments, 2 vaccines). Of these, 5 treatment clinical trials have been completed, and a total of 17 clinical trials currently in progress (15 treatments, 2 vaccines) In addition, 12 clinical trials are being conducted by pharmaceutical companies, and 5 clinical trials are being conducted by researchers. The MFDS announced that it is in the process of prompting national shipment approval with the aim of supplying approximately 30 million seasonal flu vaccines, up 20% from last year, in preparation for the simultaneous outbreak of seasonal flu and COVID-19. Through this, it plans to ship more than for 26 million people before September 22, when the NIP program starts in earnest.
- Policy
- IND for AK-216 (Vildagliptin) by Alvogen Korea was approved
- by Lee, Tak-Sun Sep 03, 2020 06:27am
- Galvus by NovartisAlvogen Korea is launching a phase III clinical trial of Vildagliptin, a diabetes treatment of DPP-4 inhibition. It is entering phase III in 9 months after approval of clinical trial I in November of last year. However, the effectiveness with Metformin, not monotherapy, are verified. While generics for Galvus are aiming for an early release through a patent challenge, it is noteworthy whether they will fall into an ambush On the 31st of last month, the MFDS approved the Phase III Clinical Trial Protocol (IND) for AK-216 (Vildagliptin) by Alvogen Korea. Type of AK-216 is known as a sustained-release tablet taken once a day. Currently, the original drug Novartis' Galvus 50mg requires a total of 100mg twice a day. AK-216 is expected to improve patient convenience by reducing the dosage. This clinical trial demonstrates the efficacy and safety of Vildagliptin SR tablet (AK-216) compared to Vildagliptin (Galvus) when Vildagliptin is administered concurrently to patients with type II diabetes who have insufficient blood sugar control with Metformin alone. It is conducted for comparative evaluation. It is scheduled to be conducted at the Asan medical center in Seoul for 356 patients in Korea. Currently, the material patent of Galvus 50mg is scheduled to expire on March 4, 2022. Ahn-gook and Hanmi succeeded in invalidating 187 days at the Intellectual Property Trial and Appeal Board through a request for invalidation of an extension of the duration, laying the foundation for launching from August 30 next year. However, the decision of the Patent Court, which can be called an appeal trial, is scheduled soon, so the outcome cannot be predicted. In addition, Hanmi has devised a strategy for splitting indications, but it was canceled after the Intellectual Property Trial and Appeal Board dismissed the claim in July. Alvogen's sustained-release tablet is expected to complete phase III clinical trials in line with the expiration of the material patent. Even if Ahn-gook and Hanmi launch generic for Vildagliptin in advance, it is likely that the preoccupation of Alvogen's product will be less affected. Alvogen has been using a strategy to supply developed IMD to other companies through licensing out. Accordingly, it is expected that Vildagliptin SR tablet will receive attention from the various pharmaceutical companies. Galvus recorded an outpatient prescription amount of ₩8.7 billion last year according to UBIST.
- Policy
- 2021 MOHW budget KRW 90.15 tln--KRW 131 bln on COVID-19
- by Kim, Jung-Ju Sep 03, 2020 06:27am
- South Korea’s Ministry of Health and Welfare (MOHW) has finalized next year’s budget plan with 90 trillion won. The state funding for National Health Insurance (NHI) has been raised to 9.5 trillion won. 131.4 billion won was allocated on providing support on R&D seeking COVID-19 treatment and vaccine. Moreover, the state-led new drug R&D program’s budget has increased by 15.1 billion won, and pharmaceutical industry development support was increased by 1.1 billion won to 16.1 billion won. MOHW stated on Sept. 1 that 90.15 trillion won, with 9.2 percent increase compared to this year, has been appropriated for the 2021 budget plan to mainly enhance public health risk response capacity, expand public medicine facility and improve platform for the ‘Inclusive State.’ The government’s projected overall expenditure in 2021, passed by the Cabinet meeting on Sept. 1, would grow by 8.5 percent from this year to 555.8 trillion won. Within the budget plan, MOHW’s projected overall expenditure is to reach 90.15 trillion won, with 9.2 percent increase from this year. The projected figure would take up 16.2 percent of the overall government expenditure. ◆Enhancing public health risk response capacity—R&D on infectious diseases: The government has allocated budget to assist developing COVID-19 treatment and vaccine, and to upgrade equipments for infectious disease control. Total budget of 131.4 billion won, consisting of 62.7 billion won on treatment and 68.7 billion won on vaccine, were finalized. Additionally, 16.5 billion won would be injected for upgrading infectious disease control equipment and testing kit, and developing relevant technology. .The budget was approved for the use of building R&D infrastructure responding against novel infectious diseases like COVID-19 .The government has cleared a budget of 5.2 billion won to continue projecting severity of prognosis and developing treatment through analyzing clinical data from confirmed COVID-19 cases .5.8 billion won was approved to operate antiviral pharmaceutical test lab, while the budget for operating public vaccine development and support center has been expanded from 5 billion won to 13.6 billion won .Also, a budget of 3.3 billion won was given to constructing facility and laboratory infrastructure for the National Infectious Disease Research Institute .◆Preparing for the future health and welfare—fostering K-Bio: MOHW has decided to expand R&D and financial investment on infectious disease, regenerative medicine, data, and new drug .The ministry’s major healthcare R&D budget plan allocated 791.2 billion won for next year, increasing 49.9 percent compared to 527.8 billion won in 2019 .Innovative new drug R&D support would be also provided to nurture Korean-made new drug development .15.1 billion won would be injected to push state-led new drug development, covering candidate medicine discovery to commercialization .Meanwhile, 3.3 billion won would be assigned to state-led new anticancer treatment development .The ministry budgeted 6.8 billion won on training specialists on bioprocessing and AI-basis new drug development and clinical trial .More specifically, 3 billion won on training Korean National Institute for Bioprocessing Research and Training (NIBRT) consultant and instructor, 2.1 billion won on biopharmaceutical specialists, 1 billion won on training and promoting AI-basis new drug development and 700 million won were drawn up for the budget .A separate budget plan for promoting regenerative medicine, backed by the Advanced Bio Act, was set .From basic science research like induced pluripotent stem cell (iPSC) technology for regenerative medicine to developing advanced biopharmaceuticals, rare disease treatment clinical research and relevant R&D would be operated according to the new legislation .Particularly for the regenerative medicine R&D, a budget of 10 billion won on regenerative medicine clinical study, and 6.4 billion won on pan-government regenerative medicine R&D program were set .A big data platform would be built to incorporate public institute data, genome and medical data for the technological innovation in biohealth .And 60.2 billion won would be spent on pan-government medical device R&D program covering from R&D to clinical trial, approval and commercialization .A budget of 5.3 billion won was set for healthcare professionals to conduct clinical evaluation and receive training to use Korean-made medical devices .◆Expanding public medicine: MOHW expanded the state funding for the support on improving medical safety net through NHI coverage enhancement .The publicness of regional medical center would be strengthened as well .The government plans to enhance the infectious disease response capacity of regional medical centers and to expand regional healthcare institutes (from 12 to 15), and provincial healthcare institutes (from 15 to 35) .Also, some of the budget was allocated for the preventive healthcare program, or so-called ‘Korean New Deal.’ As a pilot program, MOHW would expand healthcare centers subject for preventive healthcare program through ICT devices (Bluetooth blood pressure monitor, and blood glucose monitor) currently set as 30 to 80 sites .The healthcare center’s customized healthcare support program via mobile app for high-risk patients with chronic disease would incorporate 160 sites with 20 more sites than this year .Additional human resources for the program would be dispatched as well .◆The Inclusive State—healthcare reimbursement: The government plans to increase the overall NHI reimbursement per beneficiary, currently set at 6.50 trillion won, to 7.23 trillion won with 11.2 percent increase .And by cooperating with NHI, the ministry would continue to enhance healthcare coverage .
- Policy
- HIRA clears all Strensiq pre-approvals from July
- by Lee, Hye-Kyung Sep 02, 2020 06:18am
- Handok’s rare disease treatment Strensiq injection (asfotase alfa) passed the preliminary approval review and processed the first reimbursed administration. Listed for healthcare reimbursement as of June 1, Strensiq is a third drug to be required to receive pre-administration approval for a reimbursed use of the drug. Soliris injection (eculizumab) and Spinraza (nusinersen) are the other drugs required to pass the pre-approval. . Health Insurance Review and Assessment Service (HIRA) Healthcare Review and Assessment Committee has approved of granting reimbursement on two cases that applied in July .Strensiq’s maximum pricings for all doses are set at 806,964 won (12 mg), 1,210,446 won (18 mg), 1,882,916 won (28 mg), 2,689,880 won (40 mg), and 5,379,760 won (80 mg) .Handok has signed the Korean market sales right deal over Strensiq with the U.S.-based company, Alexion on Nov .17, 2016 to strengthen their strategic partnership first made through Soliris .Strensiq is indicated as an enzyme replacement therapy treating bone related symptoms in patients with infantile-onset hypophosphatasia (HPP) .A patient with infantile-onset HPP would receive coverage when qualifying all following conditions—level of alkaline phosphatase (ALP) measures lower than normal range of the certain age and sex group but exceeds normal range of Pyridoxal-5’-phosphate (PLP); bone condition unique to HPP confirmed through radiograph prior to treatment; initial treatment received before the age of 19 .A clinical evaluation (height, weight, reparatory function, motor development stage, ambulatory function and pain) has to be conducted prior to the initial treatment, three and six months into the therapy, and every six months from then on .The pre-approvals were respectively deliberated on male children aged four and six .The four-year-old was diagnosed with HPP eight days after the birth, and started using Strensiq from the first month (June 2016) .The six-year-old was diagnosed with the same disease at 11-month-old and started administering the injection from 21st month (January 2016) .These patients were provided with the coverage on the continuous treatment as their clinical evaluation, blood test and radiological report after the administration improved, and they did not reach the administration suspension standards . Meanwhile, two out of three reimbursed administration applications on spinal muscular atrophy (SMA) treatment Spinraza were approved from last month .The health authority requested additional supplementary data .The 28 administration monitoring reports were all cleared . For this time, Soliris did not have anyone requesting for new administration in a patient with paroxysmal nocturnal hemoglobinuria (PNH), but only three out of six new applications on treating atypical hemolytic uremic syndrome (aHUS) have been cleared .The other three have been denied .
- Policy
- Generic for Xeljanz by Boryung was first approved
- by Lee, Tak-Sun Sep 01, 2020 06:12am
- PfizerBoryeong's generic for Xeljanz was first approved. On the 27th, the MFDS granted Boryung Tofacitinib 5mg (Tofacitinib aspartate) by Boryung as a drug for data-based re-evaluation. This product is a salt-modified product of the original product Gelzanz 5mg (Tofacitinib citrate), which was approved in April 2014, and is the first approved product among generics using Tofacitinib as an active ingredient. This product is expected to be available from November 23, 2025, when the materical patent ends. If the patent challenge had been successful as originally planned, it could be released from November 24th. The Intellectual Property Appeal Board ruled that the avoidance of extending the duration of a material patent through a salt-modifying drug was established in January 2018. The lawsuit was terminated due to the deprivation of generics, when the Supreme Court ruled that patent evasion was impossible in Vesicare’s salt change case. If it had avoided the extension of the duration of the material patent, it could be released on November 24 this year. It is the first drug for generics, but it is also impossible to obtain generic exclusivity. Boryung succeeded in evading the crystalline patent ending on November 24, 2027, but the patent was deleted on March 2 of this year due to the winning of Chong Kun Dang's patent invalidation trial. Because there was no registered patent before applying for permission, it became impossible to obtain generic exclusivity. Approval for generic release was possible after the expiration of the PMS on April 1. Accordingly, efforts to challenge patents to obtain generic exclusivity and early release were useless. It only worked to get rid of the crystalline patent. However, with the deletion of the patent list, the benefits of successful patent challenge companies have disappeared. Xeljanz is the first oral drug to be released on the market for rheumatoid arthritis drugs, mostly in the form of injections. Based on IQVIA, last year’s sales amounted to ₩14.7 billion, a 55.4% increase from the previous year. It is very unfortunate that the early release due to the patent challenge is unsuccessful as a generic.
- Policy
- Ongentys listed at ₩2,515 & Prevymis at ₩145,000
- by Kim, Jung-Ju Sep 01, 2020 06:12am
- SK Chemicals' parkinson's syndrome treatment, Ongentys 50mg (Opicapone) will be listed at ₩2,515 per capsule starting October 1st. MSD Korea's CMV infection and disease prevention drug Prevymis (Letermovir) 240mg was listed at ₩145,000, and Ferring Korea's infertility treatment, Rekovelle PFS (Follitropin delta) is applied at ₩71,494 per 12 μg/0.36 mL, starting next month (September 1). The MOHW announced that a partial revision of criteria for pharmaceutical reimbursed list & upper limit amount table' with the above contents was presented to the general meeting of the Health Insurance Policy Deliberation Committee on the evening of the 27th, and that the deliberation was passed and resolved at midnight. ◆Ongentys= Ongentys Capsule is a standard therapy for Levodopa/Dopa decarboxylase (DDCI), which is a drug approved by the MFDS as an adjuvant treatment for Parkinson's syndrome patients with movement agitation symptoms that do not improve symptoms. All. By taking it once a day, the number of target patients in Korea reaches about 78,000. The company received the application for insurance registration on November 29, as soon as it was approved, and was deliberated by the HIRA on May 7 this year. At that time, the committee recommended this drug as a treatment for the indication in textbooks and clinical practice guidelines, and determined that it had clinical utility, and that clinical trials proved non-inferiority to drugs of the same mechanism. The effect is non-inferior to that of alternative drugs, but the cost required increases based on the applied drug price. Accordingly, it was judged that there was a benefit adequacy when the drug rating was accepted below the evaluation amount (weighted average price of alternative drugs). Excluded countries are listed in the UK, Germany, and Italy among A7, with an adjusted average price of ₩4,957. The company accepted the level of the evaluation amount as recommended by the Drug Review Committee, and agreed to negotiate drug prices with the NHIS to July 27th of the same month. The drug price was agreed at ₩2,515, reflecting the price cuts of some alternative drugs. Considering the number of patients using drugs, the NHIS is expected to charge about ₩6.8 billion in the first year, and there will be no additional financial requirements as alternative drugs exist. The registration date and insurance coverage date were confirmed as of October 1, taking into account the domestic supply schedule of pharmaceutical companies.. ◆Prevymis= Previmis is a drug that prevents cytomegalovirus (CMV) infection and disease in adult patients who have undergone allogeneic hematopoietic stem cell transplantation (HSCT), and has been approved by the MFDS on December 26, 2018. The company applied for insurance registration on April 30, 2019, and discussed two times on January 20 and April 17 at the Economic Evaluation Subcommittee under the HIRA. On May 7th, it was judged that it had the validity of reimbursement, and negotiated drug prices with the NHIS from the 27th of the same month to July 27th . At that time, the committee was judged that it was recommended as a CMV infection prophylaxis for patients with allogeneic hematopoietic stem cell transplantation in textbooks and clinical practice guidelines, clinical trials showed improved clinical usefulness compared to unpreventive therapy, and cost-effectiveness was also evaluated economically compared to non-prophylaxis therapy (cost-effectiveness analysis, ICER). Excluded Countries are listed in the A7 countries, and domestic fiscal impacts are expected to be claimed about ₩4.5 billion per year. In summary, the NHIS and the company agreed on the insurance listing price with a 240mg content of ₩145,000 and a 480mg content of ₩238,700. The registration date and insurance coverage date are September 1st. ◆Rekovelle PFS= This drug is a self-injectable pen used to induce superovulation for the purpose of infertility treatment, and was approved by the MFDS on December 27 last year. The company applied for insurance registration on January 8th of this year, and the the commitee decided on a conditional non-reimbursement decision that if it accepted the weighted average price or less of the alternative drug through a deliberation on May 7th. .The committee judged that it was published in related textbooks at that time, and it is recommended for inducing ovulation by stimulating follicle growth and development in clinical practice guidelines .However, in the case of cost-effectiveness, compared to the four components of the same family follicle stimulating hormone injections (follitropin-α, follitropin-β, follitropin, urofollitropin), which are alternative drugs, the clinical usefulness is specific, and the cost is determined to be expensive based on the applied drug price .It was recommended to accept the alternative drug at an amount below the weighted average price .Among the A7 countries, it is listed in France, Germany, Italy, and the United Kingdom .The adjusted average price is ₩133,497 for 12 µg content, ₩399,437 for 36 µg content, and ₩798,149 for 72 µg content .The company accepted this and agreed to list the health insurance through negotiations with the NHIS from June 9 to July 30 .Considering the expected market share based on clinical usefulness, the estimated billing amount for the first year was agreed at around ₩1 billion .The NHIS predicts that there will be no additional fiscal requirements because alternative drugs exist .The date of registration and coverage of this drug is September 1st .Vice Minister Kim Kang-rip said, "We expect to expand access to treatment as the burden of patient costs is eased by expanding the health insurance benefits for three medicines, including injections for inducing superovulation for infertility treatment."
- Policy
- 21 generics for Forxiga acquired the exclusivity from April
- by Lee, Tak-Sun Aug 28, 2020 06:17am
- ForxigaForxiga (Dapagliflozin), generic for SGLT-2 inhibitory diabetes treatment has obtained generic exclusivity that will be applied from April 2023. This is because the material patent ends in April 2023. Excluding this patent, the pharmaceutical companies that acquired the generic exclusivity succeeded in patent challenges. However, as a second trial decision is scheduled in the Patent Court of Korea next month, it is expected that Exercise of rights for generic exclusivity will be decided according to the conclusion. As of the 25th, the MFDS obtained generic exclusivity right for 21 single drugs containing Dapagliflozin as an active ingredient. The period of prohibition of the sale of the same drug is from April 8, 2023 to January 7, 2024. There are 21 generic exclusivity items are including Dongwha Dapagliflozin 10mg, Focidi M 5mg, Youngjin Dapagliflozin 5mg, Dongwha Dapagliflozin 5mg, Jepoga 10mg, Focigli 10mg, Dapor 10mg, Dapozin 10mg , Chongkundang Dapagliflozin 10mg, Genshiga 10mg, Dapalon 10mg, Zenciga 5mg, Dapalon 5mg, Dapazin 10mg, Focigli 5mg, Boryung Dapagliflozin 10mg, Hanwha Dapagliflozin 10mg, Youngjin Dapagliflozin 10mg, Hanwha Dapagliflozine 5mg, Focidi M 10mg, and Chongkundang Dapagliflozin 5mg. These are cases where the initial application for permission, the first request for trial (within ~14 days), and the success of the patent challenge are satisfied. In particular, it won a request for an invalidation trial against the second substance patent, which is scheduled to end on January 8, 2024. Currently, the case is an appeal from the patentee AstraZeneca, and a ruling is scheduled in the patent court on the 17th of next month. In this case, if the generic companies win, the exercise of the right is possible as planned, but if the conversely loses, there is a possibility that the right will not be properly exercised. In particular, the industry's analysis is that if the company loses it, it may fall under the effect of the ban on sales under Article 50 of the Pharmaceutical Affairs Act. The MFDS is in the position that it will closely review the provisions of the law after the decision. Currently, Dong-A ST is the only pharmaceutical company that has succeeded in challenging Forxiga's first substance patent. Dong-A ST is known to have succeeded in patent evasion by developing a prodrug. However, Dong-A ST's prodrug is currently in clinical development and has not yet been approved for product.
