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- 2026-04-10 23:45:49
- Company
- Paclitaxel copyright transfer
- by Kim, Jin-Gu Jan 19, 2023 05:58am
- Taxol & GenexolThe domestic copyright of Paclitaxel anticancer drugs has shifted one after another. Samyang Biopharmaceuticals' Genexol, the No. 1 item in the market, will be jointly sold by HK inno.N instead of Boryung. Boryung will jointly sell BMS Taxol, the original product, for the first time in seven years instead of Genexol. The annual sales of the two products are worth 21 billion won for Genexol and 9 billion won for Taxol. According to the pharmaceutical industry on the 16th, Boryung will jointly sell BMS Taxol in Korea from January 1 this year. Taxol is a cytotoxic anticancer drug composed of Paclitaxel. It is widely used for various cancers such as ovarian cancer, breast cancer, lung cancer, and gastric cancer. It has been nearly 30 years since it was approved in Korea in 1996, but it is still widely used. According to IQVIA, a pharmaceutical market research firm, Taxol's sales in 2021 are 9 billion won. In the case of last year, it generated 5.8 billion won in sales by the third quarter. Boryung is associated with Taxol. BMS and Taxol have been jointly sold for eight years from 2008 to 2015. The joint sales contract will bring Boryeong back to its original products for the first time in seven years. Boryung co-sold its rival Genexol until just before. Boryung jointly sold Samyang Biopharmaceuticals Genexol for six years from 2016 to last year. Since 2018, the second year after Boryung took charge of sales, Genexol has risen to the top market share of the Paclitaxel ingredient. Since then, Genexol has steadily maintained its No. 1 sales in the Paclitaxel market. In 2021, Genexol's sales were 21.7 billion won. Last year, it recorded cumulative sales of 16.5 billion won in the third quarter. From Boryung's point of view, there is a situation in which they have to compete with the products they have grown to be the No. 1 in the market. HKinno.N was in charge of Genexol, which Boryung was selling. HKinno.N and Samyang Biopharmaceuticals recently signed a joint sales contract for domestic sales and marketing. At higher general hospitals in Seoul and the metropolitan area, the two companies are jointly in charge of sales and marketing, while HKinno.N is in charge of other areas. HKinno.N also has a deep connection with Genexol. Samyang Holdings co-sold the product for 13 years from 2001 to 2013, when it developed Genexol with Paclitaxel Generics. The joint sales deal reunited the two companies for the first time in 10 years. For HKinno.N, the key is how solid Genexol's market share is. As Boryeong has recently put a strong drive into the anticancer drug business, a fierce competition is expected in this market. HKinno.N has CalmTOP, Aloxy, and Akynzeo in the anticancer field. Through this Genexol partnership, HKinno.N plans to further increase its status in the anticancer drug market and actively expand its pipeline. Kwak Dal-won, CEO of HKinno.N, said, "Just as the two companies have collaborated for a long time and made good results, we expect this Genexol to lead to positive results." Lee Young-Joon, CEO of Samyang Holdings, said, "HKinno.N has been selling Genexol for more than 10 years, so it has a high understanding of the product and has a professional anti-cancer drug sales organization." "We will firmly maintain our No. 1 position in the domestic market through a partnership with HKinno.N," he stressed.
- Policy
- Generic for Dukarb to be released next month
- by Lee, Tak-Sun Jan 18, 2023 06:04am
- DukarbGeneric for Dukarb, a compound combined with Amlodipine in the new hypertension drug Kanarb developed by Boryung pharmaceutical, is expected to release in time for the expiration of the patent next month. Eight items from four companies approved last month will go to the market first, and they will be calculated at 53.55% of the initial price of every single ingredient. Among the same ingredient products approved this month, consignment items will be 15% cheaper depending on the standard requirements, and salary registration is expected to be possible only in March. According to industries on the 17th, as generics for Dukarb, which was approved in December last month, applied for benefits, the salary is expected to be applied from February 2, the day after the patent expires. Items licensed in December last month are Dunarb 30/2.5mg, Dunarb 60/2.5mg, Fimadipine 30/2.5mg, Fimadipine 60/2.5mg, Hana Pharmaceutical Fimaone-S 30/2.5mg, Fimaone-S 60/2.5mg, Aliko Pharmaceutical Ardewka 30/2.5mg, and Ardewa. All of these products are produced on consignment by Alico Pharmaceutical, and since they applied for drug prices in the same month, they are all considered data-submitted drugs, and the upper limit is expected to be 53.55% of the first price of a single ingredient. The original Dunarb, which was added as an innovative pharmaceutical company, is also expected to go down at the same price. Dunarb's first generic is different from amlodipine. The original Dunarb is Amlodipine Besylate, whereas the late drugs are S-Amlodipine Besylate 2.5. Since it is not the same ingredient as Dunarb, the drug price is calculated at the highest price according to the drug price standard. However, the drug price of the product approved in January is different. Products licensed in January are also 2.5 mg of S-Amlodipine Besylate, which are considered generics of the four products listed first, and consigned items without direct BA will be 15% cheaper as the standard requirements are applied. Of course, entrusted items with direct BA and DMF requirements are expected to be equally calculated at 53.55%. There was a difference in drug prices depending on the time of approval. None of the items released this time have the same active ingredients and content as Dukarb 30/5mg. This is because Dukarb 30/5mg is registered separately as a patent, and the composition patent lasts until August 8, 2031. Late pharmaceutical companies filed a passive trial to confirm the scope of rights to avoid the patent, but it was rejected in March last year. As a result, an appeal is currently underway in the Patent Court. Due to the failure of patent avoidance, the license of the capacity item is being delayed. Since Dukarb 30/5mg is the flagship capacity of about half of the market along with Dukarb 60/5mg, generic pharmaceutical companies are expressing regret over the failure of the first trial to evade patents. In addition to the approved generics, Fimasartan salt change generics are also reportedly preparing for approval.
- Opinion
- [Reporter’s View] Our expectations for ADC technology
- by Jan 18, 2023 06:04am
- Professor Park Yeon-hee of the Hematology and Oncology department at Samsung Medical Center who recently spoke at the press conference held to celebrate the launch of ‘Enhertu’ in Korea said, “I have never seen such data in breast cancer.” This goes to show the superior efficacy of Enhertu in breast cancer. She added, “During the Enhertu clinical trial, I was inspected by the Ministry of Food and Drug Safety due to the large number of patients enrolling in the trial. And during inspections, my sole concern was, ‘what if a fault I didn’t know about is found that disallows patients from using the drug?’ This was how essential Enhertu is to the patients.” At the American Society of Clinical Oncology meeting last year, Enhertu received a standing ovation from the audience. ASCO is one of the three major global academic conferences in oncology. At the meeting, Enhertu became the first drug to demonstrate an effect in HER2-low breast cancer patients that account for half of all breast cancer patients but have difficulty seeing an effect with existing drugs. The drug lowered the risk of disease progression and death by over 50% compared with chemotherapy and emerged as the star of the ASCO meeting last year. Enhertu is an antibody-drug conjugate (ADC). ADCs are drugs made by connecting antibodies that bind to specific target antigens on the surface of tumor cells to cytotoxic payloads with a linker. Although various ADC drugs existed in the past, Enhertu gained particular interest as it improved the shortcomings of existing ADC drugs by applying next-generation technology. Contrary to concerns that ADCs are highly toxic, Enhertu did not produce dose-limiting toxicity (DLT), and the drug's high cell membrane permeability also affected surrounding tumor cells, producing a bystander antitumor effect. With the spotlight on Enhertu, many Korean pharma and bio companies have also joined in the competition to develop ADC drugs. Biotechnology companies generally develop key platform technology, and large-scale companies pursue equity investments or joint development. Major biopharmaceutical CDMO companies in Korea have also set out to build ADC manufacturing facilities. Various biotechs and mid to large-sized pharma and bio companies including Dong-A Socio Group, LegoChem Biosciences, Lotte Biologics, Samsung Biologics, Samjin Pharm, Celltrion, Ahn-Gook Pharmaceutical, Yuhan Corp, Pinot Bio, Hanmi Pharmacuetical have started developing of ADCs. As in any field, not all of them will see good results. In areas like ADC where cutting-edge technology is applied, and many tasks remain unresolved, fierce technology-based competition is required. There was a time when Big Pharma's interest in ADC wavered after clinical trials were discontinued due to serious side effects such as toxicity that arose due to technical limitations. If these drugs fail to prove the effect equivalent to high cost, marketability for these drugs that apply cutting-edge technology is low even with approval. For example, the new ADC drug ‘Trodelvy,’ which was introduced at the same time as Enhertu, was evaluated to have fallen short of expectations. As a drug, Enhertu established itself as a success case where its company, Daiichi Sankyo set up a future-oriented strategy in the midst of a crisis and fully utilized its technology specialized in the development of small molecule drugs. Dae-Jung Kim, President of Daiichi Sankyo Korea, mentioned in a contributory article he sent to a paper last year that " We will be able to accumulate success stories in Korea by being true to the basics of 'solving unmet medical needs based on science and technology,’ showing persistence, and devoting ourselves to new drug development in the long run..” In the growing field of ADC technology, there is still room for the technology to leap to the next level with steady development. As Kim said, it is the reporter’s wish that the current wave of developing ADCs in the industry will continue to become greater waves in the future.
- Company
- The Canadian gov. has put the drug price system on hold
- by Kim, Jin-Gu Jan 18, 2023 06:04am
- Korea to add Canada to drug price reference country this year...The domestic drug price reduction variable disappears. The reorganization of the drug price system, which was promoted by the Canadian government, has been temporarily suspended. Analysts say that the Canadian Ministry of Health officially announced that it would come up with a new reform plan due to strong opposition from the local pharmaceutical industry and that the plan to reevaluate the prices of premium drugs has virtually been canceled. Canada's move is also expected to affect South Korea's decision on the price of salaried drugs. In Korea, Canada has been added to the drug price reference country since this year. ◆ Canada's Ministry of Health decided to temporarily suspend the implementation of the drug price reform plan According to the pharmaceutical industry on the 14th, Health Canada recently requested the PMPRB (Patented Medicine Prices Review Board) to suspend the implementation of the drug price guideline reform plan. PMPRB has pushed for a reform of the patented drug price system since 2019. The reform plan focused on lowering the price of excessively high patented drugs. The core of the reform plan is to give the authority to investigate and re-evaluate ex officio whether the price of previously listed patented drugs is not expensive. To this end, a new price regulation device was added. It adds pharmacoeconomic value, including cost-effectiveness analysis data, the size of the drug market in Canada, Canada's gross domestic product (GDP), and per capita GDP. 캐나다 보건부는 작년 6월 새로운 지침을 시행하겠다고 예고했으나(위), 최근 새로운 지침은 2023년 1월 1일에 시행되지 않는다고 밝혔다(아래). 캐나다 보건부 홈페이지 캡처 On top of that, the drug price reference countries were reorganized into 12 countries, including Korea, Japan, Australia, Belgium, the Netherlands, Norway, Spain, France, Germany, Italy, Sweden, and the United Kingdom. The existing U.S. and Switzerland were excluded. The intention is to lower the average price of foreign drug prices by excluding the U.S. and Switzerland, which have high drug registration prices. Ministry of Health estimated that $13.2 billion could be saved over the next 10 years by reforming the drug price system for the first time in more than 20 years. ▲Canada's Health Ministry announced in June last year that it would implement the new guidelines (above), but recently announced that the new guidelines will not take effect on January 1, 2023 (below). Capture Health Canada However, the implementation of such a reform plan has been delayed. It was originally scheduled to take effect in January 2020, but it was implemented on July 1 last year after four delays due to opposition from the Canadian pharmaceutical industry and the influence of COVID-19. The most strongly opposed part of the industry's re-evaluation of the price of such drugs was scheduled to take effect on January 1 this year after preparing a new plan with a grace period. The industry has consistently protested, and in the end, Canada's Ministry of Health has decided to suspend the reform of the drug price system, saying it needs more review. At the same time, he said he would come up with a completely new version of the reform plan. Temporary guidelines are expected to remain in place until a new reform plan is prepared. ◆The new drug price reference country Canada's drug price cut variable disappears There have been constant concerns in the domestic pharmaceutical industry that the implementation of the new drug price system in Canada will lead to a reduction in drug prices in Korea. Canada was added as a new drug price reference country this year. As of January 1 this year, the country subject to foreign adjusted average price calculation has been reorganized from A7 (Japan, France, Germany, Italy, Switzerland, the United Kingdom, and the United States) to A8 with Canada added. The government has expressed its willingness to refer to the drug prices of A8 countries for the reevaluation of quality medicines as well as the registration of new drugs. In this situation, concerns have been raised that if the Canadian drug price decreases, the Korean drug price referring to it will also decrease. However, as Canada's reorganization of the drug price system has been temporarily put on hold, it is interpreted that variables that will affect Korea's reduction in drug benefit prices have also disappeared. In response, a pharmaceutical industry official said, "It is welcome that the potential risk factors that will lead to a domestic drug price cut have disappeared," but added, "However, since the Canadian government is still willing to cut drug prices and has decided to come up with a new reform plan, we should carefully look at future changes."
- Policy
- MOHW-NECA issues notice on colorimetric assay
- by Kim, Jung-Ju Jan 18, 2023 06:04am
- The National Evidence-based healthcare Collaborating Agency (President: Kwang Hyub Han) announced the amendments to the notice on the new health technology, ‘colorimetric assay’ for anti-Xa apixaban testing, that had been deliberated as a safe and effective health technology at the 10th MOHW New Health Technology Assessment Committee meeting in 2022. The New Health Technology Assessment system was introduced in 2007 to assess the safety and clinical efficacy of new health technologies (acts of medical practice including treatment method, and testing method), and is implemented to prevent indiscriminate use of unverified medical technology and to protect the people's right to health. The anti-Xa apixaban assay technology, the ‘colorimetric assay, ‘is a test that quantifies the concentration of apixaban in plasma samples through colorimetric assay for patients that were administered apixaban and require monitoring for apixaban concentration. As it is safe as an in vitro test that uses patient samples and is recommended as a test to monitor the concentration of apixaban in patients that are administered apixaban when clinically necessary in textbooks and guidelines, the technology was determined to be a valid technique with an acceptable level of correlation to the current standard test method, liquid chromatography-tandem mass spectrometry. Meanwhile, the results of the new Health Technology Assessment were notified under Article 53-3 of the Medical Service Act and Article 4 of the Rules on New Health Technology Assessment and may be found on the MOHW and NECA’s Center for New Health Technology Assessment website.
- Company
- Biktarvy, applies to the expansion of pediatric indications
- by Eo, Yun-Ho Jan 18, 2023 06:04am
- HIV treatment Biktarvy is aiming to expand pediatric indications in Korea. According to related industries, Gilead Science Korea recently submitted an application to expand indications for pediatric patients who weigh at least 14kg to 25kg of the HIV compound Biktarvy and have no experience in antiretroviral treatment or have been suppressed by existing antiretroviral treatment. The efficacy of Biktarvy in pediatric patients was confirmed through data from cohort 3 of clinical trials in a single clinical trial with phase 2/3 open markers. In the study, Biktarvy low-dose tablets were found to be generally drug-resistant and effective for 24 weeks in HIV-1-infected children with suppressed virus levels. Child patients enrolled in cohort 3 were continuously treated for 48 weeks and were able to continue receiving medication during the extended phase. 91% (20/22) of participants maintained virus level suppression at week 24 after switching to Biktarvy, with an average CD4% change of 0.2%. Biktarvy entered the market in earnest by applying salary in July of the same year after receiving approval from the Ministry of Food and Drug Safety in January 2019. According to IQVIA, a pharmaceutical market research firm, Biktarvy showed its potential from the first year of its launch, and its sales jumped from 400 million won to 4.6 billion won in just one quarter. In 2020, quarterly sales increased to 6.6 billion won, 7.9 billion won, and 9.8 billion won, respectively.
- Company
- Curing terminal cancer without treatment options
- by Jan 17, 2023 06:02am
- Mr. A, a 60-year-old Korean male patient, was diagnosed with gastric cancer several years ago. After struggling to treat the disease for several years, the hospital told A that there was no other treatment option available for him and that he may not be able to live for more than 6 months. As a last resort, A registered to enroll in the KOSMOS study and was told there was a breast cancer treatment available for the genetic mutation he was found with during genetic testing. The breast cancer drug stayed effective for over a year, and after seeing a significant reduction in tumor size, A left his hospital bed and was able to receive the outpatient treatment he had only dreamed of. The stage has been set to create a Korean-style precision medical ecosystem that can provide personalized treatment opportunities for cancer patients with terminal cancer who no longer have treatment options like Mr. A. A large-scale project involving academic societies, hospitals, research institutes including the Korean Society of Medical Oncology, Korean Cancer Study Group, Korea Health Industry Development Institute, National Cancer Center, Roche Korea, and Lunit Inc. is set to start this year. ◆Use without indication or approval ’OK’…brings new hope to terminal cancer patients The clinical project, KOSMOS2(KOrean precision medicine networking group Study of MOlecular profiling guided therapy based genomic alterations in advance Solid tumors II), will be recruiting 1,000 patients for 3 years. Subject patients are those with terminal-stage cancers that have a life expectancy of 6 months or less. In general, these patients are advised to leave the hospital because there is no other drug available for their use in the hospital. Therefore, their caregivers travel from hospital to hospital in search of one that can take care of their beloved’s illness just a little more. When left with no other option, most of them end up receiving hospice care. Enrolling in the KOSMOS2 study could open up new opportunities for these patients. First, patients who enroll in the KOSMOS2 study receive next-generation sequencing (NGS) to check for genetic mutations. Roche Korea provides an NGS-based comprehensive genomic profiling (CGP) Foundation Medicine Service. The results are stored on ‘Navify Tumorboard,’ Roche Diagnostic Korea’s multidisciplinary tumor board (MTBs) that was developed specifically for cancer treatment. It is a multicenter MTB that has been first attempted in the KOSMOS project that allows associated companies to share data. Academic specialists in pathology, oncology, and bioinformatics formed 6 teams to meet twice a week to analyze the patients' mutation status and discuss available drugs and treatment strategies. In the KOSMOS2 study, patients can attempt to be treated with drugs that are not approved in Korea or has no indication for their cancer if the doctors deem the drug appropriate. Therefore, the patient can receive treatment with a new drug that is not normally available, and the drug cost is borne by the pharmaceutical company. Of course, not all patients can receive treatment with new drugs. A drug that targets the patient’s mutation that had been identified through genetic testing has to first exist. The academic society estimated that around 30% of the patients will be able to receive treatment with new drugs. However, in the KOSMOS1 study, which became the basis for the KOSMOS2 study, more patients than expected were provided treatment opportunities. This was an unexpected achievement of precision medicine that even surprised the specialists. ◆Organic cooperation for Korean precision medicine...established a system for a virtuous cycle In the KOSMOS2 study, academic societies, research institutes, hospitals, and pharmaceutical companies organically work together to bring out the best results for each patient. The Korean Society of Medical Oncology and the Korean Cancer Study Group will lead the study, developing the specific design for the study and generating clinical and genomic data. As the Ministry of Food and Drug Safety’s designated national cancer data center, the National Cancer Center will be providing the technology and infrastructure required to build an integrated database for precision medicine. The NCC will also select and classify the collected data to provide a high-quality DB. Roche Korea will support pharmaceuticals and the optimal precision medical platform. To promote the project, the Korea Health Industry Development Institute will connect institutions, domestic and foreign pharmaceutical companies, and genome and software companies for collaboration. The first patient was recently enrolled in the KOSMOS2 study, which has been recruiting patients since the second half of last year. The study will enroll patients for 2 years, follow up for 1 year, and conclude the study after 3 years. The KOSMOS2 research project will provide patients with new treatment opportunities, and enable academia to realize precision medicine in the true sense regardless of their affiliation or region. Research institutes and industries can use high-quality genetic DB of cancer patients to conduct new research such as new drug development. In other words, a virtuous cycle of precision medicine and innovative new drug development will be created. Yong-Woo Kim, Lead of the Biopharmaceutical Industry Team at KHIDI, said, “It is important to build an integrated clinical genomic database as the basis for precision medicine and new drug development of pharma and bio companies in Korea. The organic cooperation between the government, academia, hospitals, and companies, will not only bring destructive innovation in precision medicine, but it will also mark the starting point for the revitalization of precision medicine in Korea."
- Product
- Dispensing drugs through text or KakaoTalk illegal
- by Kang, Shin-Kook Jan 17, 2023 06:02am
- If a patient takes a picture of his or her prescription and sends it via KakaoTalk or text message to the pharmacist, is it legal or illegal to dispense the drug? To Korean Pharmaceutical Association’s question, the Ministry of Health and Welfare recently replied that “Although the situation may differ by case, even with the patient’s consent, sending a prescription recorded on the patient’s mobile phone to the pharmacy and using it to prefill prescriptions in advance is not allowed under the current law unless there are special circumstances. The MOHW said, “According to the Supreme Court ruling and the Pharmaceutical Affairs Act, it is advised that drugs be ordered, delivered, and sold in pharmacies. Pharmacists must fill and dispense drugs according to prescriptions legally issued to patients under the Pharmaceutical Affairs Act and the Medical Service Act.” The MOHW added, “Pharmacists should receive the original prescription form from the patient and dispense the prescription after confirming the authenticity of the prescription and that the visitor is the patient or guardian of the patient specified the prescription." The issue arose with some pharmacies receiving a picture of a prescription through a pharmacist's personal cell phone or KakaoTalk message for dispensing. In other words, there were cases where patients voluntarily send a picture of their prescription using a text message or KakaoTalk to a pharmacist without any company intervention, and then visits the pharmacy with their paper prescription to receive the medicine. It is a sort of pre-booking system between patients and pharmacies.” This allows pharmacies extra time to fill long-term prescriptions for those that exceed 90 days while reducing the waiting time for the patients. Many have countered that there was nothing wrong with such acts as Kiosk-type prescription transmission between large hospitals and pharmacies is common. However, controversy is expected on-site with the MOHW concluding that it is illegal to send pictures of the prescriptions.
- Company
- Despite the largest export of diagnostic kits ever, we canno
- by Kim, Jin-Gu Jan 17, 2023 06:02am
- Exports of domestic diagnostic kits broke the record last year. However, export performance in the second half of the year is on the decline. Analysts say that as the global COVID-19 situation calms down, exports of diagnostic kits, which have been on a high march, are returning to the level of previous years. According to the Korea Customs Service on the 16th, exports of diagnostic kits in Korea amounted to USD 3.34908 billion last year. It increased 63.6% from $2.047.32 billion in 2021. This is the highest performance ever. Domestic diagnostic kits have grown rapidly with the spread of COVID-19. Exports of diagnostic kits, which stood at only $253.26 million until 2019, rose vertically to $2.170.87 billion in 2020. It then recorded $2.047.32 billion in 2021. In the first half of last year, export performance increased further. Early last year, the average monthly exports soared to $435 million due to the simultaneous resurgence of COVID-19 around the world. Exports of diagnostic kits also plunged as the global COVID-19 crisis has subsided since the second half of last year. The average monthly export of diagnostic kits in the second half of last year was only $123 million. As the global pandemic is nearing an end, it is predicted that the export performance of diagnostic kits will also return to the level of previous years. Major diagnostic kit companies are also coming up with various measures to prepare for a decrease in global demand. SD Biosensor focused on expanding its appearance and entering the global market through mergers and acquisitions. In July last year, it announced that it would acquire Meridian Bioscience, a U.S. in vitro diagnostic company, for 2 trillion won. The acquisition will be jointly carried out by SD Biosensor and private equity fund operator SJL Partners. SD Biosensor and SJL Partners will take over at a rate of 60% and 40% respectively and invest in Columbus Holding Company, a special purpose corporation (SPC) jointly established in the United States. Madeira Acquisition and Meridian, SPC subsidiaries 100% of Columbus Holding Company, merge and enter Columbus subsidiary. SD BioSensor has been steadily expanding its global distribution network since last year. On top of that, the acquisition of Meridian made it official to enter the world's largest diagnostic market and focused on expanding the global distribution network. On top of that, the company plans to further expand its global territory through additional acquisitions. Seegene is focusing on developing diagnostic kits other than COVID-19. Seegene is developing reagents and equipment that diagnose diseases other than COVID-19 through massive R&D expansion. They include reagents for diagnosing cervical cancer (HPV), sexual intervention (STI), and respiratory diseases other than COVID-19.
- Company
- Stelara biosimilar of Dong-A ST succeeded in clinical trials
- by Chon, Seung-Hyun Jan 17, 2023 06:02am
- Dong-A ST announced on the 16th that the Stelara biosimilar DMB-3115 has confirmed its safety and effectiveness in clinical trials. On the same day, Dong-A ST introduced the results of DMB-3115's global phase 3 clinical trial top line and announced that it would apply for item permission to the U.S. and European health authorities in the first half. Dong-A ST conducted a global phase 3 clinical trial of the Stelara biosimilar DMB-3115 on a total of 605 patients in nine countries, including the United States, Poland, and Estonia, from 2021 to the end of last year. Developed by Janssen, Stelara is a treatment for inflammatory diseases such as plate psoriasis and psoriatic arthritis, Crohn's disease, and ulcerative colitis. It is a blockbuster product that recorded sales of $9.134 billion in 2021. In clinical trials, DMB-3115 has proven its validity for European and U.S. item licensing. As a result of evaluating psoriasis area and severity index, which are the primary evaluation variables for European EMA item licensing, DMB-3115 statistically demonstrated therapeutic equivalence with Stella. In the US FDA evaluation index for item licensing, DMB-3115 confirmed the equivalent validity of Stelara. The safety assessment also confirmed that DMB-3115 is equivalent to Stelara. The proportion of subjects with even one new or worsening adverse reaction after administration of clinical trial drugs was about 54% in the group administered DMB-3115 and about 57% in the group administered Stelara. At 28 weeks, about 55% of the group change from Stella to DMB-3115 occurred, and no clinically significant difference was observed. The proportion of subjects with even one serious adverse reaction was similar, about 2% in the group administered DMB-3115 and about 3% in the group administered Stella. It did not occur in the group that changed from Stelara to DMB-3115 at 28 weeks. Dong-A ST said, "We plan to apply for DMB-3115 item permits in major overseas countries such as the United States and Europe in the first half of this year."
