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- 2026-03-17 23:19:10
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- All 15 pharmaceutical unions gathered together
- by An, Kyung-Jin Oct 05, 2021 05:56am
- The chairmen of the union of 15 pharmaceutical companies constituting the consultative body (data: NPU) A labor union composed of workers from 15 domestic pharmaceutical and bio companies has begun in earnest to integrate. According to the industry on the 29th, representatives of labor unions from 15 pharmaceutical and bio companies currently active in Korea gathered to form the National Pharmaceutical & Bio Labor Union (NPU) and began official activities. NPU is a consultative body to launch labor unions by pharmaceutical and bio industries under the Federation of Korea Trade Union and The Federation of Korean Chemical Workers' Union. Currently, Novo Nordisk, Bayer Korea, Sanofi Aventis Korea, Alvogen Korea, Amgen Korea, Ipsen Korea, Novartis Korea, Merck Korea, Beringer Ingelheim Korea, Viatris Korea, AstraZeneca Korea, Janssen Korea, and Hyundai will participate. The total number of union members is about 2,500. The reason for the launch of NPU is because of the problem of recognizing the difficulties faced by pharmaceutical industry workers as common problems in Korea's pharmaceutical industry and finding solutions together. Although public interest in the pharmaceutical and bio industries is increasing in COVID-19 pandemic, industry workers point out that they are in danger of slowing industrial growth, job insecurity and income reduction due to changes in the business environment. However, it is known that the launch of the industrial union has been delayed in consideration of the COVID-19 pandemic situation. As strengthened "social distancing" measures continued and smooth communication between large-scale gatherings and members was restricted, the government decided to temporarily operate a consultative body, which is an intermediate level. According to Article 16 of the Trade Union and Labor Relations Adjustment Act and the conventions of trade unions by each company, more than two-thirds of the registered union members must agree with the resolution. As an alliance, NPU plans to strengthen solidarity and improve the working environment of workers in the pharmaceutical industry. It is predicted that the official industrial union will be launched as early as June next year, shifting the organization form sequentially from the organization where the union member vote was completed. The ambition is to work hard to raise the working level of 2,500 union members to the next level, led by Ahn Deok-hwan, chairman of the NPU. NPU Chairman Ahn Deok-hwan said, "Although it is launched as an intermediate consultative body, we will respect and solidarity with each other like the official industrial union," adding, "We will upgrade the wages and welfare of workers in the pharmaceutical industry through strategic and efficient bargaining support. We will also respond to problems such as employment insecurity caused by low growth and digital marketing by directly communicating with the National Assembly, the government, and civic groups."
- Company
- Liver cancer pioneer ‘Nexavar,' the star in its guidelines
- by Eo, Yun-Ho Oct 01, 2021 06:09am
- There are two reasons why new drug development is slow for a certain disease: its marketability is low or the development of the drug is difficult. When developed, new drugs developed in the latter situation attract more widespread attention. Liver cancer (hepatocellular carcinoma) is a typical example of this. And the only targeted anticancer therapy that was available in this difficult-to-develop field of liver cancer for over 10 years was ‘Nexavar (sorafenib).’ Of course, new drugs are now available, such as ‘Stivargar (regorafenib)’ as second-line treatment, and ‘Lenvima (Lenvatinib),’ which is used as first-line treatment like Nexavar. Also, an immunotherapy option was added in the field with the approval of the ‘Tecentriq (atezolizumab)+Avastin (bevacizumab)’ combination therapy. Still, Nexavar’s legacy remains strong ◆The liver treatment that was introduced for the first time in 30 years Nexavar, which was the first in the world to receive FDA approval for hepatocellular carcinoma, opened the door to targeted anticancer therapy in the field. At the time, Nexavar was a significant achievement that was made after a series of attempts and failures by pharmaceutical companies for around 30 years. In Korea, after receiving the first-ever approval for hepatocellular carcinoma from the Ministry of Food and Drug Safety in March 2008, the drug has accumulated the most amount of treatment experience as the only first-line targeted therapy for over a decade since then. And the drug kept on evolving. Data from the GIDEON study that was conducted on 3,371 liver cancer patients in 39 countries around the globe, the drug showed a consistent safety profile in Child-Pugh class B7 patients with liver damage (11%, n=359) and 에서 Child-Pugh class A patients (61%, n=1968). Based on this, Nexavar is currently the only drug recommended as a first-line systemic anticancer therapy in patients with Child-Pugh class B7 in the 2020 NCCN guidelines (Version 5). ◆The significance of reimbursement approval in Child-Pugh class B7 and the rising position of Nexavar By succeeding to expand its insurance benefit, Nexavar once again strengthened its position in the field. With Nexavar’s insurance benefit approved to Child-Pugh class B7 patients, or severe disease patients, the drug’s utility in liver disease has even more increased. Before then, Child-Pugh class B7 was a sort of ‘grey area’ in the field of liver cancer. With the approval, Nexavar can now be used with reimbursement in patients with advanced hepatocellular carcinoma (HCC, including pediatric patients) who cannot receive local treatment such as surgery or transarterial chemoembolization (TACE) that are: ▲Child-Pugh class A or B7; ▲at Stage Ⅲ or higher; or ▲ whose ECOG performance status (PS) is 0-2. Also, the biggest advantage of the first-line treatment Nexavar is that it has a second-line treatment Stivarga available for use in sequence with reimbursement. A clinical trial showed that the use of Nexavar in sequence with the second-line treatment Stivarga prolonged overall survival (OS). However, limitations still exist as Nexavar is the only systemic anticancer treatment reimbursed for Child-Pugh class B7 patients, and no sequential treatment is available for use with reimbursement after Nexavar. Also, there are unfavorable views on the limited reimbursement status of its competitor drug Lenvima. ◆Patent expiry, drug price cuts, and the entrance of competitor drugs However, in terms of sales, Nexavar is now on its descent. It's not about the prescription amount, but about the patent expiry and the resulting drug price cut. According to IQVIA, Bayer’s hepatocellular carcinoma treatment sold 5.6 billion won in the first half of the year. This is a 45% decrease from the 10.3 billion won that was sold in 1H last year. In the same period, sales of Eisai’s Lenvima increased 27% from 5.7 billion won to 7.2 billion won. With the steep fall in sales of Nexavar and a significant increase in sales of Lenvima, the position of the two drugs has changed. This is a first in 13 years since the drug started being used as a liver treatment and 3 years after the release of Lenvima. Nexavar took a hard blow in February this year with its insurance ceiling being reduced by 30%. The government cut Nexavar’s drug price 30% ex officio from 18,560 won to 12,992 won. This was because Hanmi Pharm’s released Nexavar’s generic after overcoming Nexavar’s patent.
- Company
- Only Taejoon’s succeeds in avoiding Simbrinza’s patent
- by Kim, Jin-Gu Oct 01, 2021 06:09am
- Taejoon Pharmaceutical succeeds in avoiding the patent for Novartis’s glaucoma treatment ‘Simbrinza eyedrops (brimonidine+ brinzolamide).’ Being the only company to successfully avoid Novartis’s patent, Taejoon Pharmaceutical will now be able to develop a generic version of Simbrinza Eye Drops in a relatively relaxed manner. According to industry sources on the 30th, Taejoon Pharmaceutical recently won the Passive Trial to Confirm the Scope of Patent Rights it filed against the composition patent of Novartis’ Simbrinza Eye Drops. Taejoon Pharmaceutical had filed the suit in July last year, and this is the only patent registered in Korea for Simbrinza Eye Drops. The patent will expire by June 2030, and its PMS has expired in June this year. With the victory, Taejoon Pharmaceutical prepared a foothold for the early release of its Simbrinza generic. If Taejoon Pharmaceutical succeeds in developing its generic and receives marketing approval, the company may immediately release its product. Currently Taejoon Pharmaceutical is the only company to succeed in avoiding its patent. Originally, Chong Kun Dang had challenged the patent with Taejoon Pharmaceutical, however, CKD had dropped its suit, and Taejoon continued on its challenge by itself. With no generic competitor, the company will be able to continue developing its generic in a relatively easier manner. Taejoon Pharmaceutical is currently selling other glaucoma treatments in the market. Its Xalost Eye Drops (latanoprost)’ is a generic of Pfizer’s ‘Xalatan Eye Drop,’ and its ‘Combisopt Eye Drops (timolol+dorzolamide’ is a generic of Santen Pham Korea’s ‘Cosopt Eye Drops.’ Taejoon Pharmaceutical plans to bring synergy into the glaucoma treatment market by adding a Simbrinza generic to its portfolio. According to the pharmaceutical market research institution IQVIA, its Xalost sold 6.5 billion won and Combisopt sold 0.2 bill won last year. Simbrinza Eye Drops have steadily sold around 2 billion won annually. The product has recorded 1.1 billion won in sales in the first half of this year.
- Company
- Pfizer’s 2nd JAK inhibitor ‘Cibinqo’ to soon enter Korea
- by Eo, Yun-Ho Sep 30, 2021 05:57am
- Pfizer is planning to introduce a new JAK inhibitor after ‘Xeljanz’ to Korea. However, the new drug will target the ‘atopic dermatitis’ treatment market. According to industry sources, Pfizer Korea has recently submitted an application requesting marketing authorization for its Cibinqo (abrocitinib). The approval is expected to be made in the first half of next year. The drug, which is taken once daily, has been approved for the treatment of moderate-to-severe atopic dermatitis (AD) in adults and adolescents aged 12 years and over that are candidates for systemic therapy. The drug has not received marketing authorization in the U.S yet. Cibinqo is a selective Janus kinase (JAK)1 inhibitor that modulates multiple cytokines involved in AD including interleukin IL-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin (TSL). Xeljanz inhibits JAK3 rather than JAK1 or JAK2. With only Lilly’s ‘Olumiant (baricitinib)’ currently approved for the atopic dermatitis indication, more JAK inhibitors are expected to soon enter the market. Lilly is working to extend Olumiant’s insurance benefit to its atopic dermatitis indication Meanwhile, Cibinqo’s efficacy in atopic dermatitis was identified through the Phase III JADE Mono-1 trial. Study results showed that at Week 12, 62.7% of patients who received 200mg of Cibinqo showed improvement in their EASI (Eczema Area and Severity Index 75 response rate) score of 75% or higher, a significant improvement compared to the 11.8% in the placebo group. Also, the proportions of patients who achieved EASI-90 were 38.6% and 5.3% for Cibinqo 200mg and placebo, respectively Also, the proportion of patients achieving an Investigator Global Assessment (IGA) score of clear (0) or almost clear (1) skin was 43.8% and 7.9% for Cibinqo 200mg and placebo, respectively, indicating that around half of the Cibinqo-treated group showed response within 12 weeks of treatment. Recently, the FDA had issued a Dear Healthcare Professional Letter regarding the safety of JAK inhibitors such as Pfizer’s ‘Xeljanz (tofacitinib),’ Lilly's ‘Olumiant (baricitinib),’ Abbvie’s ‘Rinvoq (Upadacitinib),’ etc. Whether the drugs may resolve the issue and settle as a viable treatment option for atopic dermatitis remains to be seen.
- Company
- It does not affect sales of Rivaroxaban 2.5mg
- by Kim, Jin-Gu Sep 30, 2021 05:57am
- Xarelto 2.5mg Hanmi dismissed the possibility of legal disputes over the patent registration of the original company ahead of the launch of Xarelto's generic. The company said that the scope of validity of patents registered late does not affect Hanmi's new drug to be released. In addition, Hanmi emphasizes that it did not take issue when it sent certification of contents to Bayer, the original company. According to the pharmaceutical industry on the 29th, Hanmi is planning to release Riroxban, Xarelto's generic, on the 4th of next month. 133 items from up to 66 companies, including Hanmi, will be released simultaneously after the expiration of Xarelto's patents. Expected items to be released are Rivaroxaban 10mg and Rivaroxaban 15mg. On top of that, Hanmi's Riroxban 2.5mg is the only one to release. This is because Hanmi succeeded in overcoming the composition patent registered exclusively in Rivaroxaban 2.5mg, and first of all, it received generic for exclusivity. In the case of Rivaroxaban 2.5 mg, there may be legal disputes with the original company. This is because Bayer registered a patent for use of Xarelto 2.5mg in September 2019, more than two years after obtaining generic for exclusivity. The patent expires in June next year. Regarding Bayer's registration, the pharmaceutical industry said it was aimed at hindering the early launch of generic. In addition, the pharmaceutical industry predicted that if Hanmi pushes ahead with the sale of Riroxban 2.5mg, it will lead to a legal dispute between the two companies in the future. Hanmi said, "There will be no impact on the launch of the Riroxban 2.5mg product." This is because the scope of validity of the registered patent is different from that of Hanmi's Riroxban 2.5mg. According to the Korean Intellectual Property Office, the patent registered by Bayer is about "Oxazolidinone for combination therapy." Specifically, it explains, "It relates to a composite agent of Oxazolidinone and other active ingredients, the preparation method and use of the composite agent as a drug, and in particular, its use as a drug for the prevention and treatment of thromboembolic disorders." In other words, if it is a "combination drug" with Xarelto 2.5mg added with other ingredients, Aspirin is likely to be added as another active ingredient if it is recognized as a patent for use. Bayer is said to have tried to register a combination therapy with other ingredients as a patent as a single drug. Bayer did not release domestic combination drug and only patents are listed. Hanmi said that Riroxban 2.5mg is not a combination type, so it is not a problem. An official from Hanmi said, "Actually, the use of Rivaroxaban 2.5mg is limited to combination drugs, so it does not affect the single drug Riroxban 2.5mg. There will be no problem with the launch of Riroxban 2.5mg."
- Company
- The cumulative sales of Biktarvy amounted to ￦60 billion
- by Sep 30, 2021 05:56am
- Gilead Science's Biktarvy dominated the AIDS tx market around the world, including Korea, two years after its launch. Biktarvy consists of Bictegravir Sodium, Emtricitabine, and Tenofovir Alafenamide Fumarate as Gilead's HIV treatment. Compared to conventional treatments, the effectiveness and safety are improved, the expression rate of resistance is low, the pill size is small, and it can be administered regardless of meal. After obtaining approval from the MFDS in January 2019, Biktarvy entered the market in earnest by applying benefit in July of the same year. According to IQVIA, a pharmaceutical market research firm, Biktarvy's sales increased to 4.6 billion won in the first quarter of its launch. In 2020, quarterly sales increased to 6.6 billion won, 7.9 billion won, and 9.8 billion won, respectively. It recorded 10.5 billion won in the first quarter of this year. Until the second quarter of this year, cumulative 24-month sales amounted to 59 billion won. In June 2019, just before the launch of Biktarvy, the HIV market had Genvoya and GSK's Triumeq. Genvoya and Triumeq accounted for 44.3% of cumulative market share over the year. Biktarvy recorded a cumulative market share of 19.4% over a year in June 2020, one year after its launch. In June this year, the market share was 38.3%, surpassing both Triumeq and Genvoya. As a result, Biktarvy topped the domestic HIV treatment market in the shortest time. This is because at the time of introduction in Korea, the time required from permission to notification was reduced to one-fifth, and permission and insurance benefit registration were completed in about 100 days. Gilead successfully made a replacement from Genvoya to Biktarvy. Biktarvy has already been a blockbuster in the global HIV treatment market. It posted about 8 trillion won in global sales last year, up 53.1% from about 5 trillion won a year earlier. Biktarvy ranked ninth in the world's most sold medicine last year. This is the first and only HIV treatment to be ranked in the top 10 in sales. Leading global HIV trends is analyzed as a factor in sales. Even in the COVID-19 pandemic, Biktarvy is recommended as a primary treatment. The BHIVA issued guidelines for ART to be applied to HIV-infected people in August last year, recommending Biktarvy as the only initial treatment drug among HIV treatments. It emphasized, "HIV infected people have a higher risk of COVID-19 death than the general population, so they should receive ART treatment, and it is important to use drugs that can effectively control the virus." Another HIV treatment trend is RapIT (Rapid Initation of Treatment). RapIT recommends major guidelines such as the WHO and IAS that treatment begins quickly within up to seven days of HIV diagnosis. Unlike other treatments, Biktarvy is considered a drug that meets the rapid treatment trend because it does not contain ABC and does not limit the virus level or CD4+ level of infected people. The DHHS recommends that acute and new HIV-infected people can start treatment through Biktarvy before confirming the results of genetic drug resistance tests. Biktarvy is the first and only HIV treatment to contain symptoms and emotional conditions that patients feel in their daily lives. In the PRO, patients evaluated that Biktarvy improved nausea, vomiting, sleep disorders, and fatigue compared to existing treatments, so patients' satisfaction was high. An official from Gilead Science Korea said, "Biktarvy has become the world's most prescribed HIV treatment, proving its strong and long-lasting virus suppression effect and long-term safety through the combination of upgraded integrated enzyme inhibitors and proven effective TAF drugs." He also said, "We will provide a good treatment experience for patients in need of drug switching and strengthen patient-centered marketing activities."
- Company
- SK C&C-GC Pharma, establish a big data platform for healthca
- by Chon, Seung-Hyun Sep 30, 2021 05:56am
- SK C&C announced on the 27th that it will carry out a project with GC Pharma Holdings to build a comprehensive healthcare big data analysis platform based on artificial functions (AI). During the project period, the two companies analyze and map various standard medical data based on the "cloud-type digital platform" and conduct AI convergence analysis activities based on domestic and foreign medical big data. "Cloud-type digital platform" is an all-in-one package platform that allows field practitioners to easily and quickly create necessary AI big data analysis models using AI, big data, cloud, and blockchain platforms and solutions without establishing a separate development environment. The company explains that cloud-type digital platforms allow users to freely develop various digital systems and services. The agreement was promoted with the aim of discovering new businesses related to digital healthcare through integration and analysis of data distributed to affiliates under GC. Starting with this agreement, the two companies will consider digital transformation for all affiliates under GC in the future. It plans to integrate distributed data from each company and collaborate closely in research and service solution development in the field of digital healthcare. Lee Jin-cheon, executive director of GC's Digital Transformation Office, said, "We will actively utilize domestic and foreign medical big data and DT technologies to strengthen our business capabilities in the digital sector and focus our capabilities on securing future competitiveness." Lee Ki-yeol, general manager of SK C&C's Digital Platform, said, "We will faithfully play a role as a digital transformation partner for GC Group, which plays a pivotal role not only in vaccine and new drug development but also in digital healthcare."
- Company
- Generic for Xarelto is about to be released.
- by Kim, Jin-Gu Sep 30, 2021 05:56am
- Bayer's new oral anticoagulant (NOAC) Xarelto (Rivaroxaban)' generic is imminent to be released. In particular, Hanmi, which received generic exclusivity, plans to release Xarelto 2.5mg exclusively, and Hanmi has a patent dispute with Bayer, drawing keen attention to the future response of the two companies. According to the pharmaceutical industry on the 24th, the Xarelto material patent will expire on the 3rd of next month. Generic for Xarelto will be released after the 4th of next month. In the case of the rest of the patents, Generic companies have succeeded through a Supreme Court ruling late last year. 133 generics for Xarelto are expected to be listed as starting next month. A total of 66 generic companies are expected to release generics for Xarelto 10mg and 15mg products, respectively. Hanmi's Riroxban 2.5mg was the only one to succeed in registering benefit. Hanmi is expected to release Riroxban 2.5 mg at the same time along with Riroxban 10mg and Riroxban 15mg. ◆ Bayer and Hanmi have registered their patents for use after obtaining generic for exclusivity In the case of Riroxban 2.5mg products, patent disputes still remain. This is because Bayer belatedly registered a patent for use in Riroxban 2.5mg after acquiring Hanmi's generic exclusivity. Hanmi and SK Chemicals challenged patent for Xarelto 2.5mg in March 2015. In November of that year, the two companies won the first trial. Then, as the two companies applied for permission for the first time, in July 2016, the two companies succeeded in obtaining generic for exclusivity. However, in September 2019, Bayer Xarelto 2.5 mg newly registered a patent for use. The patent expires in June next year, more than two years after acquiring generic for exclusivity. Since the new registration of the patent for use, the indication of Xarelto 2.5mg has also changed. Initially, Xarelto monotherapy was approved for the purpose of "reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation."However, after the registration of the patent for use, the combination therapy with Aspirin changed to "reduction of the incidence of atherosclerotic events such as myocardial infarction and stroke." ◆Will legal disputes continue? Riroxban's sales impact will be minimal The pharmaceutical industry predicts that it will lead to legal disputes between Bayer and Hanmi. Some predict that even if the two companies have legal disputes, sales of Riroxban 2.5mg will not be significantly disrupted. An official from the pharmaceutical industry said, "There was no problem with the approval of Riroxban 2.5mg after patent avoidance." However, if it is actually sold, there is a possibility that Bayer will raise the issue in the future, he said. ◆After the 4th of next month, it is predicted that generics for Xarelto such as Riloxvan will be released
- Company
- ST Pharm’s new cash cow ‘oligonucleotide’
- by Kim, Jin-Gu Sep 28, 2021 05:54am
- The oligonucleotide API business has become a major business of ST Pharm. The company has signed many deals over the past three years and the expansion and expectations for contract extensions have also greatly contributed to improving the company’s performance. Experts expect the oligonucleotide API business to stay as a cash cow for ST Pharm for a decade to come, with the global surge in demand for oligonucleotide API and the fact that most contracts signed by ST Pharm are long-term contracts. On the 27th, ST Pharm publicly announced that its oligonucleotide API supply contract with a biotech firm A in the U.S. has been expanded. In November 2019, ST Pharm had signed a contract with the company to supply 5 batches (150kg) of raw materials for clinical trials. The contract at the time was signed for ₩13.6 billion. Company A had requested to add 1 batch to its contract. With the request, the ST Pharm will be supplying a total of 6 batches (180kg) of its API to Company A. The contract amount also increased to ₩18.1 billion with the added ₩4.5 billion. With the addition, ST Pharm’s total contract for oligonucleotide has increased to ₩270 billion, which is more than twofold the sales made by the company last year. Since November 2017, the company had made a total of 14 deals to supply oligonucleotide API to companies, with most of the deals made in the past 3 years since 2019. ST Pharm had jumped into the oligonucleotide API business in 2018 after completing its Banwol plant in 2018. With its API business on track, the company’s performance has significantly improved. ST Pharm had recorded an operating loss for 9 consecutive quarters from Q2 2018 to 3Q 2020, then marked a turnaround in Q4 last year. The company e explained that its oligonucleotide API business was the cause of the turnaround. ST Pharm’s turnaround is drawing greater expectations as most of ST Pharm’s oligonucleotide API deals being long-term contracts. Industry experts foresee that its oligonucleotide business will contribute as a stable cash cow for 10 years at the most. The company has completed delivery of ₩80 billion’s worth of APIs from the ₩270 billion contracts. This means that the company still has around ₩190 billion left to be reflected in its performance from 2H this year to 2023. Also, expectations for additional sales being made from contract extensions exist. Most of the company’s contracts are for the supply of raw materials for clinical trials or initial commercialization. Therefore, if the drug succeeds in commercialization and enters full-scale production, this may lead to further requests for more supply of oligonucleotides.
- Company
- First progress to SGLT2i combo reimb. made in 3 years
- by Eo, Yun-Ho Sep 27, 2021 05:52am
- Patients in Korea have come one step closer to receiving reimbursement extensions to SGLT-2 inhibitor combos. This is the first progress that has been made in three years. According to industry sources, the diabetes expert committee that was convened by the Health Insurance Review and Assessment Service earlier this month concluded in the direction of integrating and allowing reimbursement for DPP-4 inhibitor and SGLT-2 inhibitor class and triple therapy combos. However, regarding TZD class drugs with cardiovascular issues, the committee decided to determine the combined use of each TZD class drug separately. Therefore, prescription restrictions on the use of TZD in combos are expected to continue. HIRA is currently discussing formal procedures, including when to put the agenda up for deliberation to the Pharmaceutical Benefit Assessment Committee. The issue has been ongoing for almost 3 years since 2018 when the government’s proposal to ‘amend the reimbursement standards to approve combined use of drugs by class’ to improve convenience and coverage for the patients. However, the amendment was put on hold due to the lack of efficacy data in some drugs that have no clinical studies conducted, and the academia’s opposition that reimbursement should be only allowed according to each drug’s indication. However, academia had first ignited the discussion on expanding reimbursement for diabetes drug combos as the different indications of drugs in the same class lead to confusion in the field and insurance cuts. The case was no different in 2013 when reimbursement was extended to DPP-4 inhibitor and thiazolidinedione class drug combinations. However, the end results were completely different. However, academia, which had always stressed the importance of clinical experience and expert judgment over indications or fiscal impact, had made a very different decision for the use of SGLT-2 inhibitor combos. As a result, the ‘class effect’ of SGLT-2 inhibitors were the only ones not recognized under the reimbursement standards among all oral diabetes drugs in Korea. However, academia had later submitted a statement recognizing the need for reimbursing SGLT-2 inhibitor combos, under which the MFDS had announced that it will ‘simplify’ the method of listing indications of diabetes treatments from ingredients to just ▲single or ▲combination therapy. And HIRA came to a positive conclusion this time. Currently, four SGLT-2 inhibitors - ‘Forxiga (dapagliflozin),’ ‘Jardiance (empagliflozin),’ ‘Suglat (ipragliflozin),’ and ‘Steglatro (ertugliflozin) – are being sold in Korea. For all 9 DPP-4 inhibitors in the Korean market to establish grounds for combined use according to principle, clinical studies on 36 combinations need to be conducted. In the same sense, 8 clinical studies are required to establish evidence for the combined use of 2 TZDs and 4 SGLT-2 inhibitors.
