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- 2026-05-19 16:08:58
- Company
- SGLT-2 inhibitor combos drive sales in diabetes market
- by Kim, Jin-Gu Apr 30, 2021 06:10am
- The domestic sales of sodium-glucose transport protein-2 (SGLT-2) inhibitors in the diabetes treatment market have repeatedly marked rapid growth. The outpatient prescription sales of SGLT-2 inhibitors in Q1 this year increased by 14% from the previous year, continuing its double-digit growth. The growth is driven by combination therapies. Prescriptions of the two combo therapies ‘Xigduo’ and ‘Jardiance Duo’ have increased by 2.3 times over the past two years. ◆2.3 times increase in prescription of combo drugs… market share also jumps from 27%→39% According to pharmaceutical market research firm UBIST on the 29th, the SGLT-2 inhibitor class of antidiabetic treatments has recorded a total of 32.1 billion won in outpatient prescription sales in Q1 this year. This is a 14% increase from Q1 of the previous year. The SGLT-2 inhibitor market has been increasing quarter by quarter since AstraZeneca’s ‘Forxiga (dapagliflozin) was first introduced to the market in June 2014. Following AstraZeneca, Astellas Pharma’s ‘Suglat (ipragliflozin),’ Boehringer Ingelheim’s ‘Jardiance (empagliflozin),’ MSD’s ‘Steglatro (ertugliflozin),’ also entered the market. Prescription sales of SGLT-2 inhibitors for the last 2 years have been 20.9 billion won in Q1, 23 billion won in Q2, 24.2 billion won in Q3, and 26.1 billion won in Q4 of 2019, and 28.1 billion won in Q1, 29.2 billion won in Q2, 32 billion won in Q3 and 32.1 billion won in Q4 of 2020. The recent market growth has been driven by combination therapies. The SGLT-2 inhibitor combos, AstraZeneca’s ‘Xigduo’ and Boehringer Ingelheim’s ‘Jardiance,’ are in fierce competition. Both drugs are combination therapies that have added metformin to each company’s SGLT-2 inhibitor. At first, total prescription sales of the two products amounted to a mere 5.6 billion won in Q1 2019, with their combined market share being 27%. However, sales have increased over twofold over the next 2 years to reach 12.7 billion won, and their market share also expanded to reach 39%. By each product, Xigduo sold 7.7 billion won, and Jardiance Duo sold 5 billion won in Q1 of this year. The growth surge is more notable in Jardiance Duo, with a 58% increase from Q1 of the previous year. Xigduo also saw a 19% growth during the same period. ◆Forxiga·Jardiance both record ₩9.1 billion… market expected to increase with indication expansion Among monotherapies, Forxiga and Jardiance have recorded 9.1 billion won each. This is an 8% increase for Jardiance and a 4% increase for Forxiga compared to the previous year. Despite the market’s rapid growth, Suglat and Steglatro, however, has shown reduced performance. The prescriptions sales of Suglat and Steglatro recorded only 0.8 billion won and 0.5 billion won in Q1 this year. This was a 4% and 19% respective decrease compared to the Q1 of last year. Industry officials expect the growth of Forxiga and Jardiance to continue for a while. The biggest reason being their expanded indication. In December last year, Forxiiga succeeded in adding a chronic heart failure indication in Korea. As a result, the drug may be used for heart failure, with or without diabetes. Jardiance also has submitted an application for the same indication and is awaiting approval. One variable that might hinder this growth is the release of follow-on drugs by domestic pharmaceutical companies. Currently, Dong-A ST is the only company to have successfully avoided Forxiga's substance patent (to expire in April 2023). The second and third trial remains, however, the company has met the requirements to release a follow-on drug. If wishing to do so, Dong-A ST could release a follow-on drug within this year. Also, Daewoong Pharmaceutical has been speeding up the development of its new drug 'Enavogliflozin.' With Phase III clinical trials currently underway, Daewoong aims to roll out its drug in 2023.
- Policy
- There is no problem with AZ vaccine safety
- by Kim, Jung-Ju Apr 30, 2021 06:09am
- The government announced that it is concerned about the avoidance of the AstraZenega (AZ) COVID-19 vaccine due to the thrombosis side effect issue. It is said that there are no safety issues with side effects and solutions that appear around the world. Son Young-rae, Team Leader of Countermeasure Headquarters COVID-19 Social Strategy, answered this way through Q&A for regular briefings in the morning of today (28th). He said, "Recently, the amount of COVID-19 vaccine secured by purchasing additional Pfizer vaccines has increased to a total of 99 million this year. As the supply of vaccines from other companies is increasing, we are concerned about the phenomenon of avoiding AZ vaccination." He said, "In the case of the UK, half of the vaccination targets are AZ products. tens of millions of people are inoculated, so our government continues to monitor it." He said, "There is no problem with safety and rare thrombosis, which appears as a side effect, is also extremely rare, and because it is possible to treat it, the practical benefit of vaccination is high, so the Korean government also recommends vaccination." “Experts are also recommending AZ vaccination in common, and the Central Disaster Management Headquarters and the Central Disease Control Headquarters (employees) are also vaccinating AZ products. I hope that the people do not worry more than necessary, and that the AZ product candidates receive the vaccine as much as possible." The authorities forecast the completion of domestic vaccine development in the first half of next year. Five pharmaceutical companies have entered clinical trials through vaccine development, and it is expected to enter phase 3 as soon as possible in the second half of this year. He said, "It is the principle that domestic vaccines are supported until they are successful, and the government is actively supporting them with the aim of developing them in the first half of next year. It is difficult to recruit subjects due to the small number of domestic patients, but we will also review and apply for comparative clinical trials."
- Product
- The price of Rotarix has also increased
- by Moon, sung-ho Apr 30, 2021 06:09am
- As prices have increased for cervical cancer vaccines and rotavirus vaccines that prevent neonatal enteritis, the burden on hospitals and clinics is increasing. Some medical organizations are raising the issue of unilateral price hikes for global pharmaceutical companies, but there is currently no clear solution. The medical staff who have to deal with the complaints of the patients are worried a lot. According to the pharmaceutical industry on the 15th, from this month, MSD Korea increased its supply price by 15% for the cervical cancer prevention vaccine Gardasil 9 and 17% for the rotavirus vaccine Rotarix. The information has been guided to hospitals and clinics by HK inno.N, which is in charge of MSD sales since the beginning of this year. Rotarix produced by GSK is also expected to increase by 12% from May. Kwang Dong, which is in charge of Rotarix, recently guided this to hospitals and clinics. According to the HIRA, the currently nonreimbursement price of Gardasil 9 for hospitals and clinics is distributed between ₩107,928 and ₩202,524. Gardasil 9 is a vaccine that requires a total of 3 doses to complete the vaccination, so it costs up to ₩600,000. In the case of RotaTeq, the nonreimubursement price ranges from ₩48,100 to ₩130,000, which averages ₩92,473. Rotarix produced by GSK is distributed at ₩63,600 to ₩150,000, which is slightly more expensive than MSD's RotaTeq. The average price is ₩125,751. Gardasil 9 is up 15%, RotaTeq is up 17%, and Rotarix is up 12%. MSD's opposition to the Gardasil 9's impression eventually came to a medical organization to seek understanding, but it is an opinion that it is difficult for medical organizations to understand pharmaceutical companies. "We had a time to share the contents of the vaccine supply price increase with MSD," said Lee Ki-cheol, vice president of the Korean Association of Obstericians & Gynecologists. "There are many aspects that are difficult to understand from the standpoint of the medical community.” "The supply price is quite high, with a 15% increase. This is unusual and very burdensome. We are going to send a letter to protest against it," he emphasized. "Pharmaceutical companies say that the domestic supply price is not higher than the foreign supply price," said Ma Sang-hyuk, vice-chairman of The Korean Vaccine Society (Daegu Fatima Hospital, Pediatrics and Youth Division). He said, "It is difficult to adjust the price because even if the supply price of vaccines is raised, It depends on the pharmaceutical company in the case of non-reimbursement items. It is difficult to get involved legally, so it is only the doctor's role to get patient complaints." "This is because the related market operates exclusively," said Lee Ki-cheol, vice president of insurance at the KAOG. "As the related supply system has been improved, policy improvements are needed to prevent this from happening again," he argued. MSD believes that a price increase is inevitable because the price hikes of major non-reimbursement vaccines, including Gardasil 9, require production-specific complexity, long production periods, and quality control processes. In addition, MDS explained that it is working to reduce discomfort to medical staff and patients.
- Company
- Otsuka recently signed a co-promotion contract with Boryung
- by Apr 30, 2021 06:09am
- Otsuka Otsuka will co-promote with Boryung to maintain IMD Mucosta SR in the Rebamipide market. The gastrointestinal drug Rebamipide market, worth ₩100 billion, has recently been fiercely competitive. In December of last year, Yuhan (Recomid SR), GC Pharma (Mucotect SR), Daewoong Pharmaceutical (Mucotra SR), and Daewon Pharmaceutical (Bidreba SR) were approved for IMD of Rebamipide. While Rebamipide is taken three times a day, these IMDs are taken twice a day. A competitive drug has been released in the existing market where generics have been the only so far. The launch of IMDs affected Mucosta's sales, which account for about 10% of Otsuka's total sales. Mucosta recorded ₩17.3 billion in outpatient prescriptions based on UBIST last year. It was down 5.5% from the previous year. Last year's prescription for Bamedin by Samjin was ₩4.6 billion. In order to maintain the No. 1 position in market share, Otsuka was also approved for an IMD Mucosta SR in January after 30 years. Four domestic companies, including Yuhan, are the same through joint development, but Otsuka, which was developed independently, shows a slight difference from the products of the four companies. Otsuka recently signed a co-promotion contract with Yuhan. The original Mucosta could be replaced with a company's product rather than IMD by other companies. The two companies' co-promotion contracts were announced later. In particular, Boryung is expected to play an active part in the highly competitive clinics. Boryung is also in charge of selling Otsuka's antithrombotic drug Pletaal. Domestic pharmaceutical companies were not interested in Rebamipide. This is because the growth trend was insignificant even after 30 years of launch. However, the situation has changed starting with the Ranitidine Incident in September 2019. After Ranitidine was expelled, it affected the growth of Rebamipide. The Rebamipide market, which was only growing at an annual average of around 4%, increased 14.8% year-on-year to ₩110.6 billion in 2020. Existing Rebamipide trend by item
- Policy
- MFDS added blood clots to the precautions for AZ vaccine
- by Lee, Tak-Sun Apr 29, 2021 07:21am
- A specific thrombosis with thrombocytopenia was added to the precautions for using the AstraZeneca COVID-19 vaccine. For this adverse reaction, the MFDS also recognized the causality with the vaccine. The MFDS announced on the 27th that it changed the precautions for use after consulting experts on the case of blood clots that occurred after vaccination with AstraZeneca COVID-19 vaccine. On the 8th, the MFDS issued a safety letter regarding a specific thrombosis with thrombocytopenia of the AstraZeneca COVID-19 vaccine. It is explained that additional necessary measures have been reviewed. Through the Central Pharmaceutical Affairs Review Committee meeting on the 20th, the MFDS received advice on the safety and action of the AstraZeneca COVID-19 vaccine against the occurrence of blood clots. As a result, vaccination did not increase the overall risk of thrombosis, and the unique thrombosis with thrombocytopenia, which has not yet occurred in Korea, is very rare outside the country. As in the evaluation, we received an opinion that it was judged that there was a possibility of a causal relationship with the vaccine. Accordingly, the Central Pharmaceutical Affairs Review Committee concluded that it is reasonable to change the information on unique thrombosis with thrombocytopenia in addition to the precautions for use. As a precaution for use, ▲people who have experienced major venous or arterial thrombosis with thrombocytopenia after vaccination of COVID-19 should not receive this vaccine.▲ It should be carefully administered to patients with a history of thrombosis in uncommon areas such as cerebral sinus thrombosis and visceral venous thrombosis, heparin-induced thrombocytopenia or antiphospholipid syndrome, and risk factors for thromboembolism and thrombocytopenia. ▲ After vaccination, serious cases of thrombosis with thrombocytopenia were observed very rarely, and ▲ people pay attention to the signs and symptoms of thromboembolism, thrombocytopenia and coagulation Accordingly, health care professionals should pay attention to the signs and symptoms of thrombosis and thrombocytopenia after vaccination so that patients can be treated promptly; and, after vaccination, severe or persistent headaches, blurred vision, confusion, and If symptoms such as seizures, shortness of breath, chest pain, leg swelling, leg pain, persistent abdominal pain, skin bruising or spotting bleeding other than the injection site appear, seek medical attention immediately. An official from the MFDS said, "We will continue to monitor abnormal cases after vaccination against COVID-19 in the future. In addition, we will promptly inform safety and whether or not measures are necessary through expert advice."
- Policy
- NDMA was detected again in Nizatidine
- by Lee, Tak-Sun Apr 29, 2021 06:10am
- NDMA (N-nitrosodimethylamine), a carcinogenic substance, was detected again. There is a possibility that the number of NDMA detection items will increase in self-test. The MFDS announced on the 27th that a business operator will recover some of the manufacturing numbers of four items, including Korea Pharma's Nizatide, Nexpharm Korea's Nitadin, Nex by Binex, and Ari's Artidine, which are used as GI drugs . All are products of Nizatidine. Nizatidine was temporarily banned from selling the item because NDMA was detected in 13 products in November 2019. The items to be recalled at this time are different from those found at the time. The MFDS explained that as NDMA is detected in the company's own product stability test, it is proceeding with recovery as a precautionary measure. All four items are consigned by Binex. Binex is consigning production of a total of 9 items, including its own. Therefore, NDMA was detected again in the product. It is known that this product recovery was triggered by an accelerated test conducted by the pharmaceutical company itself. The accelerated test is a test to find out the stability of a drug under conditions beyond the standard of storage for distribution. Nizatidine can be stored at room temperature between 1°C and 30°C, but NDMA was detected as a result of testing at higher temperatures and humidity. Dr. Reddy's Laboratories reported that NDMA was detected in the accelerated Nizatidine test and reported to the drug product company it trades. It is observed as a follow-up action by a drug product company starting from Dr. Reddy's Laboratories. The problem is Dr. Pharmaceutical companies that use Reddy's Laboratories' ingredients are not the only four pharmaceutical companies that are collecting items this time. All 13 items that were temporarily banned from sale and recalled in November 2019, when the MFDS discovered the NDMA problem in Nizatidine, all used raw materials from Solara Active Pharma Sciences. Dr. Reddy's Laboratories and Nizatidine products using domestic ingredients were able to sustain sales. Dr. It is known that among the items using Reddy's Laboratories raw materials, there are also items with relatively high sales. The pharmaceutical industry analyzes that Dr. Reddy's Laboratories raw materials can also cause problems, affecting other finished products using the same raw materials. An official in the pharmaceutical industry said, "There are a lot of domestic distribution items that use the ingredients of Dr. Reddy's Laboratories. However, it remains to be seen how many items NDMA is detected in the accelerated tests of finished products of these companies." The MFDS said, "The items in which NDMA was detected in this accelerated test are not commercially distributed items. As a precautionary measure, it recommended the drug company to recall." The MFDS added, "This issue is the company's action in accordance with the instructions for evaluating the likelihood of occurrence such as NDMA for all drugs. However, he added that there is a possibility that there may be more items to be recalled according to the results of the company's own test. "
- Policy
- Six more Arcoxia generics acquire generic exclusivity
- by Lee, Tak-Sun Apr 29, 2021 06:09am
- Six generic products of Arcoxia that received belated approval acquired generic exclusivity. Other Arcoxia generics that were previously approved will go on sale next month. On the 27th, the Ministry of Food and Drug Safety approved the generic etoricoxib products of 6 pharmaceutical companies - Theragen Etex, Guju Pham, Union Korea Pharm, Aju Pharm, Hana Pharm, Hutecs Korea Pharmaceutical. The products also obtained generic marketing exclusivity, applicable from the day after (28th) to December 25th. The 6 products will be produced by Theragen Etex under a consignment manufacturing agreement. Generics of Arcoxia from Arlico Pharm, Boryung Pharmaceutical, Reyon Pharmaceutical, and Samil Pharmaceutical was first approved last month. These companies also acquired generic exclusivity for their products until December 25th of this year. During this period, drugs of the same substances are not allowed to be sold in the market. Like the 4 products previously approved, the 6 products approved today also succeeded in avoiding Arcoxia’s patent by filing a defensive confirmation trial for the scope of right for Arcoxia’s crystalline patent. Applications for approval were submitted on December 22nd, at the time of the original PMS expiry. However, due to a delay in the review, the 6 products produced by Theragen Etex received approval a month later than the 4 products produced by Arlico Pharm. Thus, the release of the 6 products is expected to be delayed by a month. The 4 products produced by Arlico Pharm will be sold from the 1st of next month after completing the listing process. Being generic exclusivity products, the listing process for the said products was completed a month faster than general generics. According to UBIST, Arcoxia recorded outpatient prescription sales of 3.3 billion won last year. Arcoxia is a competitor to ‘Celebrex,’ which dominates the nonsteroidal anti-inflammatory analgesic market. As most of the pharmaceutical companies that will be releasing the Arcoxia generics also own their own generic versions of Celebrex, the industry expects the approval to create a synergistic effect of diversifying the prescription options in the analgesic market. Accordingly, further attention is being paid to whether the introduction of these Arcoxia generics may impact the Celebrex-dominant market.
- Company
- Will SK hand over Xarelto generic exclusivity rights to GC?
- by Kim, Jin-Gu Apr 29, 2021 06:09am
- Pic. of Xarelto SK Chemicals may decide to hand over the hard-won generic exclusivity for its generic version of ‘Xarelto (rivaroxaban) 2.5mg’ to GC Pharma. If GC Pharma takes over SK Chemicals’ generic exclusivity, the company will be able to enjoy market exclusivity for the low-dose Xarelto generic with Hanmi Pharmaceutical from this October to July next year. According to industry sources on the 28th, SK Chemicals and GC Pharma have been actively reviewing the possibility of making a deal for SK Chemicals’ generic version of Xarelto 2.5mg. Currently, SK Chemicals and Hanmi Pharmaceuticals own generic market exclusivity for Xarelto 2.5mg. The products that receive the benefit are Hanmi Pharmaceuticals’ ‘Riroxban Tab. 2.5mg’ and SK Chemicals’ ‘SK rivaroxaban Tab. 2.5mg.’ The exclusivity will apply from the date Xarelto’s substance patent expires, October 4th, to July 3rd next year. After successfully avoiding the formulation patent infringement for Xarelto 2.5mg in November 2015, the two companies obtained generic exclusivity by being the first to file for generic approval in July of the following year. The companies finally won the long patent dispute that went up to the Supreme Court in December 2020 and was allowed to exercise their right to generic exclusivity without the burden of a reversal ruling. However, the generic exclusivity owned by the two companies only applies to the 2.5mg dose, as Bayer had not registered a formulation patent for other doses of its Xarelto (10mg·15mg·20mg). In other words, from October, when Xarelto’s substance patent expires, all companies will be allowed to release 10mg·15mg·20mg generics of Xarelto. Still, experts interpret GC Pharm’s deal with SK Chemicals as an attempt to preoccupy the market and gain an advantage. For the other doses, 56 companies have obtained approval for 146 products and are awaiting their release in October. In this context, releasing the product 9 months earlier than the other competitors may provide an advantage in securing brand recognition, distribution, and positioning. Experts explain that the deal also meets the needs of SK Chemicals well. SK Chemicals has not applied for the approval of doses other than the 2.5mg, which suggests that SK Chemicals may not intend to enter the supersaturated market. Officials from GC Pharm and SK Chemicals have said that they cannot confirm or deny issues that are currently being discussed. According to the pharmaceutical market data research firm UBIST, the outpatient prescription sales of Xarelto recorded 50 billion won last year. This was a 1% decrease from the 50.8 billion won in 2019. In the first quarter of this year, Xarelto sold 11.9 billion won. In the new oral anticoagulant (NOAC) market, Xarelto stands in second place after Lixiana, and is followed by Eliquis and Pradaxa.
- Policy
- AZ vaccine vaccination is being reviewed in the 2nd quarter
- by Kim, Jung-Ju Apr 29, 2021 06:09am
- The quarantine authorities are considering expanding the age range for AstraZeneca COVID-19 vaccine. Although it is currently impossible to select a product, it will be reviewed after sufficiently diversifying the quantity while changing the inoculation institution for each product characteristic in the future. Thr KCDA Commissioner Jeong Eun-kyung responded in this way during the inquiry time for the COVID-19 Central Disease Control Headquarters Regular Briefing' during the day on the 26th. The quarantine authorities are considering expanding the possibility of a second quarter vaccination plan. The authorities currently supply 3.87 million doses of AstraZeneca and Pfizer vaccines, and are expected to supply a total of 18.09 million doses by the second quarter. She said, "Currently, we are considering expanding the age target to under the age of 65 as a plan to review changes to the vaccination plan for the second quarter including AstraZeneca to be additionally introduced through COVAX and AZ vaccination of 65-74 years old, including the amount of vaccination plan for under 30s ." In order to increase the vaccination rate of chronically ill and socially indispensable personnel, including health care workers, she said, "We will provide vaccination guidance through each institution and organization and strengthen the guidance so that vaccination can be administered." She suggested that although it is difficult at present as to the possibility that the public can choose and inoculate a vaccine, it is possible to some extent if the quantity is sufficiently diversified and expanded. She said, "It will be difficult in the third quarter to ensure that people can get the vaccine they want by guaranteeing the right to choose a vaccine." "However, in the third quarter, more vaccines such as Pfizer, Moderna, and Novavax will be available, so we are working on a vaccination plan accordingly." She added, "In this case, the medical institution will be different so that the vaccine can be vaccinated according to the characteristics of the vaccine. Because the vaccination is carried out through a consignment medical institution or a private primary medical institution, and as an alternative method, the vaccination center or a hospital of a certain size can be different, so the most suitable vaccine type, inoculation institution, and characteristics. We will proceed to guide the vaccination by matching the appropriate vaccination targets.”
- Policy
- First retinoid acne treatment in 20 years comes to Korea
- by Lee, Tak-Sun Apr 28, 2021 05:17pm
- Galderma’s Aklief cream (trifaortene), the first new retinoid molecule to receive U.S. FDA approval for the topical treatment of acne in more than 20 years, has finally set foot in Korea. On the 27th, the Ministry of Food and Drug Safety (MFDS) approved Galderma Korea’s ‘Aklief cream 0.005%’ as a new drug. The new drug is indicated for the topical (facial and truncal) treatment of moderate acne vulgaris that is characterized by comedones, papules, and pustules. In particular, Aklief cream is the only topical retinoid that selectively targets retinoic acid receptor (RAR) gamma, the most common RAR found in the skin. By stimulating RAR, the drug modulates target genes that are associated with various processes, including cell differentiation and mediation of inflammation. Retinoid is a vitamin A compound that is used to treat acne. For the first time in 20 years, the U.S. FDA had approved the new retinoid product, Aklief cream, in September 2019. Alief cream showed an improved effect on acne compared to existing creams in clinical studies. In a clinical trial on patients with moderate facial and truncal acne, 1,214 subjects who were treated with Aklief cream showed over 10% improvement in IGA (Investigator’s Global Assessment) for the face and PGA (Physician’s Global Assessment) for the trunk compared to the 1,206 subjects treated with vehicle cream. Galderma Korea has been leading the topical acne treatment market in Korea with its products, including its Epiduo gel. The Epiduo brand has recorded 2.3 billion won in sales last year according to IQVIA. With the approval of Aklief cream bringing a new treatment option into the acne market, Galderma Korea's influence in the market is expected to increase.
