- LOGIN
- MemberShip
- 2026-04-16 21:14:35
- Opinion
- [Reporter’s view] Unpredictable authorized generic policy
- by Lee, Tak-Sun Jul 01, 2020 05:54am
- The MFDS is planning to disclose the 'generic competitiveness strengthening plan' discussed through the public-private association in the near future. Some negotiated content has been reported. However, the main part of the generic policy seems to be known only when the final proposal is issued. The industry believes that the impact on the industry will also be enormous. These are tasks such as the introduction of INN (international nonproprietary names) in generic products. Currently, it is not possible to know whether the 'generic competitiveness strengthening plan' is a deregulation or a strengthening of regulations. The 'unification of authorized generics', which was first released to the media, was viewed as a deregulation in that the company does not need to undergo duplicate examinations. That is why the MFDS changed its policy after the co-biological equivalence limit policy failed at the Regulatory Reform Committee. However, the contents released afterwards are confused by strengthening regulations rather than deregulation. The challenge derived from the public-private councils, such as the development of quality indicators for livelihoods, disclosure of evaluation results, and enhancement of drug disclosure and information disclosure by pharmaceutical companies, is a policy of strengthening regulations to give generics a rank. As the policy direction of the MFDS is not shared, it is difficult for companies to pursue business. In particular, for companies seeking to expand the consignment manufacturing business, the method of limiting the co-biological equivalence test was frustrated, but the policy base was unpredictable, making it impossible to make an investment decision. This is explained by the fact that the contents of the discussion are shared only within the framework of the public-private council. The pharmaceutical industry points out that through the COVID-19 situation, the MFDS communicates in the course of policy making. In the case of the clinical reevaluation of recently announced Choline alfoscerate, it was difficult to know the exact contents until related companies were also announced. There seems to be no intention of policy communication. Press releases distributed to the media are everything The government's fate is to listen to as many opinions as possible and take criticism until the policy direction is decided. If policy promotion is inevitable, you can persuade them to fully understand. If this process is a reduced or deleted policy, the result will be bad. No matter how difficult it is to communicate with COVID-19, they have to disclose what they want to disclose and communicate with anyone who wants to communicate.
- Policy
- MFDS lifts nizatidine sales ban, Alvogen cancels license
- by Lee, Tak-Sun Jul 01, 2020 05:54am
- Alvogen Korea has reportedly cancelled the item license on its nizatidine drug, although its sales ban for containing the unacceptable level of cancerous NDMA was listed. The case proves lifting the sales ban and a company’s will to sell the product are two different matters. On June 25, Korea’s Ministry of Health and Welfare (MOHW) has announced the reimbursement suspension on Alvogen Korea’s seven nizatidine items including Zanitidine tablet 75 mg was listed as notified by Ministry of Food and Drug Safety (MFDS). But apparently Alvogen Korea has cancelled the sales license on Zanitidine tablet 75 mg as of June 24. Ironically, the company returned the license of the product cleared from sales ban. The license cancellation would take Zanitidine tablet 75 mg off the shelf, unless the company reapplies for the license. Technically, such odd situation occurred as the sales ban was lifted not because the responsible company followed through with the process to resume selling the product. Once the pharmaceutical company completes the suspended nizatidine product recall, MFDS allows the product sales to be resumed. But the company has to test NDMA level by each production serialization, and only the acceptable products can be released. The test results are not for MFDS submission, but to be archived by the company. The recall on Alvogen’s Zanitidine tablet 75 mg has been done, but the company’s action could be interpreted that it has no intention to immediately resume sales. Currently, the sales ban on eight out of 13 nizatidine products has been cleared and they can be prescribed normally. MFDS lifted the ban on the products as the responsible companies have fully recalled the products. The other five items cannot be prescribed as the process is unfinished.
- Company
- Complaint against the plan to reduce benefits of α-GPC
- by Chon, Seung-Hyun Jun 30, 2020 06:11am
- Pharmaceutical companies agreed to file a complaint against the government's plan to reduce the reimbursement of Choline alfoscerate. It is suggested that the co-payment rate be lowered for reasons such as high cognitive impairment and brain-related diseases with high prescription rates. According to the industry on the 29th, more than 100 executives from pharmaceutical companies with Choline alfoscerate had an emergency meeting on that day and sought a response strategy to the government's policy to reduce the benefit. Gliatamin byDaewoong Bio & Gliatilin by Chong Kun Dang At the meeting, which was conducted by online video conference, it was agreed that an appeal would be needed to reduce the coverage of Choline alfoscerate. The HIRA held the Pharmaceutical Benefits Advisory Committee on the 11th to deliberate the appropriateness of the choline alfoscerate formulation, and then decided positive list system according to efficacy and effectiveness. Choline alfoscerate is a drug that has three indications: ▲secondary symptoms and degenerative or degenerative cerebral stromal psychological syndrome ▲emotional and behavioral changes ▲senile pseudodepression. When a patient diagnosed with dementia uses this drug for the purpose of improving symptoms such as cognitive impairment, the copayment rate of 30% is maintained as before. However, dementia patients only pay 10% copayment. However, if a patient who has not been diagnosed with dementia is prescribed a Choline alfoscerate product, it increases from 30% to 80%. The prescription performance of choline alfoscerate last year was ₩352.5 billion. Among them, the diagnosis of dementia patients whose benefits are maintained as in the past was only ₩60 billion, only 17% of the total. More than 80% of the prescriptions for Choline alfoscerate drugs increase the patient's drug burden by 2.7%. Pharmaceutical companies shared a strategy to lead to a downward adjustment of the co-payment rate through appeals against areas where the drug cost burden rate will increase to 80%. To this end, it was reported that each area discussed the need for a response strategy that provides a basis for refuting the health authorities' decision. In the near future, the HIRA will notify pharmaceutical companies of the conversion of Choline alfoscerate formulations to a positive list system determined by the Pharmaceutical Benefits Advisory Committee. In response, pharmaceutical companies can appeal only once. In addition to dementia for which an increase in the co-payment rate has been announced, the strategy of pharmaceutical companies is to actively lead to a downward adjustment of the co-payment rate in the areas of mild cognitive impairment and other brain-related diseases in 'Secondary symptoms and degenerative or degenerative brain-based psychotic syndrome due to cerebrovascular defects'. The health authorities decided to re-evaluate the Choline alfoscerate product, taking into account its clinical usefulness, cost effectiveness, and social needs. However, pharmaceutical companies believe that in the case of mild cognitive impairment and other brain-related diseases, the 30% of copayment should be applied or lowered to 50%. There are not many drugs to replace for mild cognitive impairment and brain-related diseases of Choline alfoscerate and they said that it is unfair to increase the copayment rate under high social demand. In the case of mild cognitive impairment and brain-related diseases, which are serious diseases, it has been reported that despite the clinical usefulness, patients may be deprived of treatment opportunities if their drug burden increases. Pharmaceutical companies believe that mild cognitive impairment may increase the risk of dementia in the future, so treatment through drug administration is important. Studies have been reported that Choline alfoscerate is effective in mild cognitive impairment and brain-related disorders, but it has been reported that it has not been reflected in the re-evaluation of reimbursement. Last year, in mild cognitive impairment and other brain-related diseases, Choline alfoscerate formulations showed prescription performances of ₩252.8 billion, more than 70% of the total prescription amount. The pharmaceutical company believes that the positive list system of Choline alfoscerate formulations is confirmed, which can lead to a reduction in prescriptions if the patient's drug burden increases. The meeting did not discuss the clinical re-evaluation of Choline alfoscerate formulation recently announced by the MFDS. On the 23rd, the MFDS ordered 255 items from 134 companies to submit domestic clinical trial results. It was instructed to submit a clinical trial plan by December 23 if a clinical trial is conducted.
- Policy
- Korea Passing Novartis Xolair listed for reimbursement
- by Kim, Jung-Ju Jun 30, 2020 06:10am
- The Korean health authority has decided to grant healthcare benefit from next month on Xolair (omalizumab), the controversial ‘Korea Passing’ drug that withdrew the reimbursement application amid the pricing negotiation to avoid lowering the global price, from next month. The listing of the novel severe asthma treatment Xolair took three months from the first threshold, or the Drug Reimbursement Evaluation Committee (DREC). However, the benefit would be valid only for the Xolair injection first from next month due to the company’s internal supply issue. The 11th Health Insurance Policy Deliberation Committee (HIPDC) meeting was convened on June 26, where Korea’s Ministry of Health and Welfare (MOHW, Minister Park Neung-hoo) has deliberated and decided the approval on new drug reimbursement listing. An image of Xolair injection (Source: DrugInfo) The supplier of the drug Novartis Korea has abruptly withdrew from drug pricing negotiation with National Health Insurance Service (NHIS) on Dec. 20, 20218, after DREC has passed the drug. The company was apparently concerned of the drug pricing in the Chinese market. As the Chinese health authority tends to refer reimbursed drug pricing in Korea, the company unavoidably felt the pressure during the pricing negotiation. Novartis Korea withdrawing the reimbursement application on Xolair was recorded as the first case of ‘Korea Passing’ phenomenon, where a multinational pharmaceutical company discards drug reimbursement in Korea. Since then, the drug was listed for reimbursement in China and it repeated the economic evaluation procedure in Korea for reimbursement listing. In last March, the drug was approved by DREC and successfully completed the pricing negotiation. The maximum reimbursed price of Xolair injection and Xolair prefilled syringe injection in 150 mg dose would be at 271,700 won, and Xolair prefilled syringe injection in 75 mg dose at 143,000 won. But the reimbursement provision period would differ by doses due to the supply issue the company is going through. MOHW stated the reimbursement would be granted on Xolair injection from July 1, whereas the reimbursement on Xolair prefilled syringe injection 75 mg and Xolair prefilled syringe injection 150 mg would be provided from Jan. 1 and Oct. 1 next year, respectively. MOHW official said, “The latest decision on the healthcare benefit for patients with moderate to severe persistent asthma would improve their access to new drug treatment and lessen their medical expense.”
- Policy
- “KRW 10 bln COVID-19 vaccine budget plan unclear and vague"
- by Lee, Jeong-Hwan Jun 30, 2020 06:09am
- The voice of criticism is raised against weak and vague ‘budget plan on COVID-19 treatment and vaccine manufacturing facility establishment support (R&D)’ worth 10 billion won the Korean government included as a part of the third contingency budget plan. They point out a detailed business plan has to be set down first as the budget can be used differently depending on the development of the treatment vaccine. On June 29, the National Assembly Budget Office analyzed and made such comment on the third contingency budget plan of 2020. The treatment and vaccine manufacturing facility establishment support program mainly aims to financially boost the set up of the pharmaceutical manufacturing facility to respond against the COVID-19 pandemic. The program was not included in the original 2020 budget plan, and first and second contingency budget plans of 2020. The National Assembly Budget Office pinpointed the Ministry of Health and Welfare’s (MOHW) budget plan missing a specified business plan although the ministry plans to preemptively support setting up the manufacturing facility for the Korean-developed COVID-19 treatment and vaccine. The National Assembly officials also said the budget could be repurposed depending on the status of treatment and vaccine development. The 10 billion won budget plan appropriated 4.5 billion won and 5.5 billion won on constructing vaccine and treatment manufacturing facilities, respectively. The Budget Office claims the contingency budget plan lacks a clear basis of calculation for the budget appropriation. In detail, MOHW calculated 4.5 billion won would be needed for manufacturing 8.2 million doses of vaccine short from total 62.2 million doses of the two-dose vaccine required for immunizing 60 percent of the overall population (herd immunization threshold). The budget office stated the calculation only considered the required dose for herd immunity, and overlooked the feasibility of execution. The estimated treatment volume was also not properly projected, but apparently the ministry is to prepare it by the end of June. The Budget Office also commented the basis of calculation is weak as the specifics, such as the list of equipment to be funded or the number of pharmaceutical companies to be funded, were not decided. MOHW plans to allocate 2 billion won in constructing manufacturing facility for complete vaccine and 4.8 billion won on constructing treatment manufacturing facility. But the Budget Office sees these figures are inexact and the ministry has not made the decision on the subject pharmaceutical companies, yet. The contingency budget was reprimanded by the Budget Office as it could be used in other purposes besides the initial purpose, based on the development status of the COVID-19 treatment and vaccine. And the Budget Office was disapproving of MOHW suggesting the budget possibly reallocated to manufacture active pharmaceutical ingredient for symptomatic treatment in patients with COVID-19. Apparently, it is not clear if the ministry would withdraw the support plan depending on the high or low possibility of successfully finding COVID-19 treatment or vaccine within this year. The National Assembly Budget Office official stressed, “The ministry’s budget plan lacks a detailed business plan with the list of beneficiary, list of supported equipment, and subject designation standard,” and “The budget execution feasibility would be impacted significantly based on the development progress of the COVID-19 treatment and vaccine. The ministry should thoroughly draw out a business plan to achieve the objective of the program”
- Company
- Spravato, a nasal spray for TRD entered the domestic market
- by Eo, Yun-Ho Jun 30, 2020 06:09am
- Spravato is the first nasal spray medication, taken along with an oral antidepressant, for adults with treatment-resistant depression (TRD) and it enters the domestic market. According to the related industry, Janssen’s Spravato nazal spray (Esketamine HCl) as a treatment for moderate to severe major depressive disorder (treatment-resistant depression) in adults who do not adequately respond to at least two different oral antidepressants from the MFDS on the 23rd has been approved for oral antidepressant use in combination. Treatment-resistant depression refers to a case in which patients who are currently suffering from major depressive disorder (MDD) have taken two or more other antidepressants at appropriate doses for a sufficient period of time, but do not improve their symptoms due to inadequate response. In general, it is estimated that about one-third of patients with depressive disorder correspond to treatment-resistant depression. Spravato is a new mechanism of nasal spray treatment that first appeared in the field of treatment-resistant depression and 30 years in the major depressive disorder. The main component of Spravato, Esketamine, improves the symptoms of depression by regulating the activity of glutamic acid receptors called NMDA receptors in the brain to restore synaptic connections and increase neurotrophic signaling. The efficacy of the drug has been demonstrated in a phase III clinical trial consisting of short-term and long-term clinical trials in more than 1700 adult patients with treatment-resistant depression. In a short-term clinical trial of treatment-resistant depression between 18 and under 65 years of age, the combined group of patients with Spravato and oral antidepressants showed a decrease of 19.8 points on the Montgomery-Asberg Depression Assessment Scale (MADRS) over a 4-week treatment period. On the other hand, the group of patients receiving placebo and oral antidepressants in combination showed a decrease of 15.8 points, and statistically, it was confirmed that the symptoms of the group of patients receiving combination of Spravato and oral antidepressants were improved. In a long-term clinical study, patients who had stable remission by using Spravato and oral antidepressants were found to have a 51% reduction in the likelihood of recurrence of depressive symptoms compared to those who received placebo and oral antidepressants. Deok-in Jeon, Chairman of the Korean Society for Affective Disorders, said, "Resistant depression, which has a longer duration of disease and more severe symptoms than normal depression, causes serious pain to patients and their caregivers. Approval of Spravato is an innovative treatment option for new mechanisms in the field of depression that have not had new drugs in the past decades."
- Policy
- Insurance benefits of Dupixent PFS 300mg will be possible
- by Lee, Hye-Kyung Jun 30, 2020 06:08am
- After the approval of the MFDS on April 1, insurance benefits of 'Dupixent PFS 300mg (dupilumab)' will be possible when the adolescent patients are over 18 years old. As a patient with chronic severe atopic dermatitis who is over 18 years of age and has symptoms that persist for more than 3 years, ▲ it is not adequately regulated even after administration of a topical treatment agent (moderate or higher corticosteroid or calcineurin inhibitor) for 4 weeks or more. Reaction even after inhibitor (Cyclosporine or Methotrexate) was administered for 3 months or more (EASI (Eczema Area), and Severity Index) (over 50% reduction), or cannot be used due to side effects, etc. ▲ before starting the administration of the same drug, conditions such as EASI 23 or higher must be satisfied to receive benefits. The HIRA announced on the 26th QnA regarding the application of patient-related reimbursement criteria that began to administer Dupixent in youth. Dupixent has been reimbursed to adult atopic dermatitis since January 1st. Since April 1, the approval age of the MFDS expanded from 'adults' to 'adults and adolescents (over 12 years old)', and it is now possible for adolescent patients to administer drugs at their own expense. The HIRA said, "If adolescent patients over 12 years of age meet the administration target at the beginning of the first dose of Dupixent, they are judged to satisfy the administration target even when they become adults." "It is only possible to be reimbursed if it has been completed." Chronic atopic dermatitis, which persists for more than 3 years, means that the past history of atopic dermatitis diagnosed 3 years prior to the start date of Dupixent's administration is confirmed through the medical records. After the first topical treatment, if Dupixent is administered without systemic immunosuppressants, the patient must bear the full cost of the drug. However, if systemic immunosuppressive drugs cannot be administered due to medical contraindications such as renal failure, uncontrolled hypertension, uncontrolled infectious disease, malignant tumor, and severe liver disease, health benefit may be reimbursed if conditions such as EASI are satisfied. When re-administered after a drug break due to medical reasons, etc. ▲Re-administration of a patient who has been withdrawn prior to the first response evaluation (week 16) corresponds to the initial administration acceptance criteria. ▲ If the holiday period is less than 3 months, it is recognized as continuous administration, and if the holiday period is more than 3 months, the requirements such as the initial acceptance criteria must be met.
- Company
- Prevymis by MSD is noted whether it is listed
- by Eo, Yun-Ho Jun 29, 2020 06:13am
- It is noteworthy whether the coverage for prevention of cytomegalovirus, infection in allogeneic hematopoietic stem cell transplant patients will be expanded. According to related industries, 'Prevymis (Letermovir)', a preventive treatment for cytomegalovirus (CMV) infection in allogeneic hematopoietic stem cell transplant patients, which passed the Pharmaceutical Benefits Advisory Committee of the HIRA last month, will enter into drug price negotiations with the NHIS. It is interpreted that the evaluation of the adequacy of Prevymis is clinically useful and cost effective compared to the case which is not prevented. This is similar to the government's policy to strengthen health insurance coverage. Allogeneic hematopoietic stem cell transplantation is essential for the treatment of severe hematologic cancer patients such as acute myelogenous leukemia and acute lymphocytic leukemia The government has increased the age limit for the payment of hematopoietic stem cell transplants from under 65 to under 70 in 2019 as a policy to strengthen health insurance coverage. Efforts have been made to revitalize transplants and reduce costs, including recognizing primary allograft as a nursing care benefit. When cytomegalovirus (CMV) is reactivated in patients with hematopoietic stem cell transplantation, diseases such as pneumonia, hepatitis, myocarditis, gastroenteritis, and encephalitis develop. Even if the level of CMV is low, it has an effect on mortality. In the case of hematopoietic stem cell transplantation patients with CMV infection, there is a report that the mortality rate during initial hospitalization is 3.5 times higher than that of non-infected patients, and the risk of death is 2.6 times higher in patients with CMV viremia at the early stage of transplantation (within 60 days). However, CMV treatment in allogeneic hematopoietic stem cell transplantation patients is currently relying on pre-emptive administration of antiviral agents when the concentration of virus in the blood exceeds a certain level. Sung-Soo Yoon (SNU), Chairman of the Korean Society of Hematology said, "The limitations of current preemptive treatments that can only be started after the CMV blood level reaches the threshold are clear. In particular, the demand for treatment sites for Prevymis is increasing, as it is an important drug treatment option for survival of high-risk patients.." Prevymis clinically demonstrated the inhibition of CMV reactivation and the reduction of mortality. Also, no adverse reactions related to myelotoxicity and nephrotoxicity occurred. Previmis is recommended as a prophylactic agent for allogeneic hematopoietic stem cell transplant patients with CMV seropositivity in the 2019 guidelines of the National Comprehensive Cancer Network (NCCN) and the European Conference on Infections on Leukemia (ECIL).
- Company
- Boycott Japan: Drug import rather increased in a year
- by Kim, Jin-Gu Jun 29, 2020 06:13am
- During a year of the Koreans boycotting against Japanese-made products, the total imported Japanese pharmaceutical sales have increased even more. But the trade balance has improved as the Korean-made pharmaceuticals exporting to Japan surged as well. Daily Pharm analyzed Korea Customs Service today and found the Japanese-made pharmaceutical import volume has increased by 2.1 percent from the time before the boycott. From the start of the boycott against Japanese product in June last year to May this year, the overall USD 390 million (approximately 469.6 billion won) of Japanese-made pharmaceuticals were imported in the year. Compared to the year before (June 2018 to May 2019), the figure jumped 2.1 percent (approximately 459.9 billion won) from 382 million dollars. The pharmaceutical import contrasts greatly against the overall Japanese product import volume plummeting by 11.8 percent from 51.54 billion dollars to 45.48 billion dollars. However, the trade balance has apparently improved with a steep increase in Korean-made pharmaceutical export to Japan. A year prior to the boycott, the export to Japan generated 193 million dollars, but during the year of boycott the figure leapt by 56.1 percent recording 310 million dollars. Due to the boycott, the trade deficit with Japan was dropped by about 100 million dollars from 189 million dollars to 89 million dollars. The change in pharmaceutical import and export with Japan from a year before (June 2018 to May 2019) and after (June 2019 to May 2020) the boycott against Japan. The Japanese-made pharmaceutical import rose (left) slightly, whereas the overall Japanese product import plunged by over 10% (Unit: USD 1 million) Source: Korea Customs Service The statistics show Korea has made trade surplus with Japan in January, April and May this year. For last two years, the pharmaceutical trading with Japan has never marked a monthly trade surplus. The pharmaceutical trade surplus with Japan generated 10 million dollars (exported 35 million dollars, imported 26 million dollars), 2 million dollars (exported 34 million dollars, imported 31 million dollars) and 3 million dollars (exported 24 million dollars and imported 21 million dollars) in January, April and May, respectively. The changes in trade balance with Japan in last two years. Korea made surplus in January, April and May this year (Unit: USD 1 million won) Source: Korea Customs Service The rare trade surplus aside, the Koreans boycotting against Japanese products does not seem to have brought a dire impact on the pharmaceutical sector. The monthly pharmaceutical import from Japan has been fluctuating from June to December last year, respectively marking 32 million dollars, 46 million dollars, 24 million dollars, 32 million dollars, 37 million dollars, 31 million dollars and 33 million dollars. The impact of boycotting was insignificant in pharmaceutical import this year as Korea imported 26 million dollars, 38 million dollars, 38 million dollars, 31 million dollars, and 21 million dollars of Japanese-made pharmaceuticals in January to May, respectively. Changes in Japanese pharmaceutical import from June 2018. Since June 2019 when the boycott movement started, the import volume fluctuated noticeably (Unit: USD 1 million) Source: Korea Customs Service The trend is also apparent in the outpatient prescription drug sales of top Japanese pharmaceutical companies in Korea until May. A pharmaceutical market research firm UBIST found Astellas Korea, Daiichi Sankyo Korea, Eisai Korea, Takeda Pharmaceutical Korea, Santen Pharmaceutical Korea and Korea Otsuka Pharmaceutical have generated total of 663.9 million won from outpatient sales within a year (June 2019 to May 2020). Compared to the outpatient drug sales performance in the year before (June 2018 to May 2019) at 662.7 million dollars, the figure only grew by 0.2 percent. Basically, the boycott has not affected the prescription drug sales. The change in prescription sales of Japanese pharmaceutical company product from a year before (June 2018 to May 2019) and after (June 2019 to May 2020) the boycott against Japan. Six companies did not demonstrate significant difference. (Unit: KRW 100 million) Source: UBIST The Koreans have revved up the boycott against Japanese products from June last year. When the Japanese government has reportedly decided to restrict the export of key material used in semi-conductor manufacturing, a large number of Korean consumers responded back by boycotting against Japanese-made beer, automobile, and consumer products. Regardless, the consumer boycott was unnoticeable in the pharmaceutical industry. The industry experts claim the boycott would have unlikely to target prescription drugs as they are, unlike OTC drugs, directly related to the people’s health. The majority of Japanese-made prescription drugs are original drugs with no alternative options used for highly severe diseases, which is why the switching drugs for the sake of boycotting would be unconvincing. In fact, Korean pharmacist groups have assertively participated in the boycott, but healthcare professionals did not openly join the movement.
- Company
- Dong-A ST is first to evade antidiabetic Forxiga patent
- by Lee, Tak-Sun Jun 29, 2020 06:13am
- For the first time in Korea, Dong-A ST has successfully evaded pharmaceutical patent on sodium-glucose co-transporter-2 (SGLT-2) inhibiting antidiabetic treatment Forxiga (dapagliflozin) by AstraZeneca. According to the pharmaceutical industry on June 25, Dong-A ST’s request for the negative scope confirmation on two Forxiga patents was accepted on June 23. The original drug has two substance patents to expire on Apr. 7, 2023 and Jan. 8, 2024, respectively. Following the legal proceeding, Dong-A ST would be the first company to knock on the follow-on dapagliflozin drug market. Dong-A ST is the only company that either evaded or nullified the original’s patent expiring on Apr. 7, 2023. The company would be able to launch a dapagliflozin product immediately after receiving the government’s approval. Other companies cannot launch a follow-on drug until Apr. 7, 2023 when the patent actually expires. The key to Dong-A ST’s patent evasion was modifying the original drug structure. For the patent-evaded dapagliflozin drug, the Korean company plans to conduct a Phase I trial and apply for item approval in the second quarter next year. If the product gets released next year, it would be two years earlier than other competitors. In the current antidiabetic treatment market dominated by DPP-4 inhibitor and SGLT-2 inhibitor, Dong-A ST would significantly expand its pie in the market with its independently developed new dipeptidyl peptidase 4 (DPP-4) inhibitor Suganon and the SGLT-2 inhibitor.
