EMA Accepts MAA for DMB-3115 of Dong-A ST, a Stelara Biosimilar
17.7.2023 16:00:00 EEST | Business Wire | Press release
Dong-A ST (President/CEO Min-young Kim, KRX:170900) announced on July 14 that the European Medicine Agency (EMA) confirmed acceptance of Marketing Authorization Application (MAA) for DMB-3115, a biosimilar of Stelara® (Ustekinumab).
Accord, a wholly owned subsidiary of Intas Pharmaceuticals Ltd, submitted the MAA to EMA on June 23rd, and the EMA accepted the MMA submission on July 14th in CET.
The MAA submission is based on the results of an extensive analytical similarity assessment of DMB-3115 with that US and EU-sourced STELARA using current ‘state-of-the-art’ methods. The MAA submission also comprised the results from the phase III multi-regional clinical trials in patients with plaque psoriasis (NCT04785326). The primary endpoint was the rate of change in the Psoriasis Area and Severity Index (PASI) for skin symptoms. As a result, the therapeutic equivalence between DMB-3115 and the reference product was verified, and no safety issues were observed.
DMB-3115 is a proposed biosimilar to Stelara®, a blockbuster drug developed by Janssen Biotech Inc., and for plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. It recorded 17.77 billion USD (IQVIA Accumulative Sales in 2022) and is one of the best-selling biologics.
Dong-A Socio Holdings and Meiji Seika Pharma began joint development for DMB-3115 in 2013, and the rights for R&D and commercialization were transferred to Dong-A ST in July 2020 for efficient project management. Since then, Dong-A ST and Meiji Seika Pharma worked together to develop the drug.
In July 2021, the worldwide distribution rights, excluding Japan, South Korea, and certain Asian regions, were licensed to Intas Pharmaceuticals, a multinational pharmaceutical company. Intas Pharmaceuticals will commercialize DMB-3115 with its global subsidiaries Accord BioPharma of the US and Accord Healthcare of the EU, UK, and Canada.
“We are delighted to reinforce our partnership with Dong-a & Meiji for Accord Healthcare to file for global rights to this critical drug, reinforcing our commitment to improving access to high-quality biosimilar drugs for patients globally,” said Mr. Paul Tredwell, Executive Vice President of Accord Healthcare.
“We will spare no effort to ensure DMB-3115 is supplied to the global market by leveraging a strong partnership between Dong-A, Meiji, Intas, and Accord,” said Mr. Jaehong Park, President & CSO (Chief Science Officer) of DongA ST.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230717954728/en/
Contact information
Shin-Hee Park
+82-32-610-2481
sh-park@donga.co.kr
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Calvin Klein Fragrances announces ROSALÍA as the face of new euphoria elixirs19.2.2026 15:30:00 EET | Press release
Calvin Klein, Inc., part of PVH Corp. [NYSE: PVH], and Calvin Klein Fragrances, a division of Coty Inc. [NYSE: COTY], today unveil GRAMMY® Award-winning singer-songwriter ROSALÍA as the face of euphoria elixirs, a new collection of three distinct parfum intense creations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260219549836/en/ Calvin Klein Fragrances announces ROSALÍA as the face of new euphoria elixirs. A daring new chapter of the iconic euphoria franchise, euphoria elixirs are a sensorial exploration of confidence, pleasure and sensuality. Embodied by global icon and Calvin Klein ambassador ROSALÍA, the campaign fuses movement and vivid color into a captivating exploration of freedom without limits. Known for her genre-defying sound and commanding visual artistry, ROSALÍA channels the fragrances’ modern femininity into an immersive journey that reflects the energy and individuality of the three distinctive scents.
ExaGrid Achieves Customer Milestone19.2.2026 15:00:00 EET | Press release
ExaGrid®, the leader in Tiered Backup Storage, today announced that over 5,000 customers are actively using its backup storage behind leading backup applications such as Veeam, Commvault, NetBackup, Rubrik, Arcserve, Acronis, SQL Dumps, Oracle RMAN Direct, HYCU, and many other backup applications and utilities. ExaGrid has achieved many milestones, including: +81 NPS score The highest in the backup storage industry 300+ published backup storage customer success stories on its website More than all competitors combined 200+ Gartner Peer Insights reviews With a high rating of 4.8/5 stars 24 Industry Awards in the last 3 years More than any other backup storage provider Over 20 consecutive quarters with positive: Free Cash Flow, P&L and EBITDA “ExaGrid realized that using standard primary storage behind a backup application is not a strong solution, and with any level of retention it’s very expensive as well as vulnerable to security attacks. Inline deduplication appliances such as Dell D
DCO Launches Global “Ctrl+Alt+Delete” Campaign to Combat Online Misinformation and Enhance Trust in Digital Economy19.2.2026 14:25:00 EET | Press release
The Digital Cooperation Organization (DCO) has announced the launch of the “Stop Online Misinformation: Ctrl+Alt+Delete,” global campaign to counter online misinformation and strengthen trust in the digital economy, calling for coordinated action by governments, media, the private sector, and digital platforms. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260218141056/en/ DCO Launches Global “Ctrl+Alt+Delete” Campaign to Combat Online Misinformation and Enhance Trust in Digital Economy - (Photo: AETOSWire) The campaign represents the culmination of a year of sustained multilateral and multistakeholder engagement led by DCO to address misinformation as a growing economic, societal, and trust-related challenge. Underpinned by DCO’s Online Content Integrity initiative, it will roll out in phased stages, anchored in stakeholder pledges and commitments, and advanced through policy dialogue, public engagement, and digital activa
Amazfit Announces the T-Rex Ultra 2: a Titanium GPS Watch Engineered for the Extreme19.2.2026 14:00:00 EET | Press release
Amazfit, a leading global smart wearable brand owned by Zepp Health, today announced the T-Rex Ultra 2, the latest and most advanced member of its rugged T-Rex lineup. As part of the T-Rex family, the T-Rex Ultra 2 is built for uncertainty—designed to remain reliable in conditions where plans, environments, and outcomes are never fully defined. Purpose-built for extreme environments, the T-Rex Ultra 2 combines premium materials, enhanced navigation capabilities, and extended battery life to support athletes and explorers tackling long, complex routes where preparation and reliability matter most. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260219679075/en/ Amazfit Announces the T-Rex Ultra 2: a Titanium GPS Watch Engineered for the Extreme “With the T-Rex Ultra 2, we focused on building a watch for people who rely on navigation, endurance, and on-watch decision-making in demanding environments,” said Scott Shepley, Head o
YolTech Therapeutics Announces Positive Interim Data on YOLT-202 for the Treatment of Alpha-1 Antitrypsin Deficiency19.2.2026 13:00:00 EET | Press release
YolTech Therapeutics, a late clinical-stage biotechnology company developing in vivo gene editing therapies, today announced positive interim data from an investigator-initiated trial (IIT) of YOLT-202, the Company’s investigational in vivo base editing therapy, for the treatment of Alpha-1 Antitrypsin Deficiency (AATD) that demonstrated positive safety and tolerability as well as meaningful increases in AAT levels in evaluated patients treated with the 35 mg and 45 mg dose levels. “These interim findings mark an exciting and important milestone for YolTech and for patients living with severe AATD. The rapid, robust, and dose‑dependent increases in functional AAT levels observed in this study—particularly among individuals with the PiZZ genotype—underscore the transformative potential of in vivo base editing as a one‑time treatment approach,” stated Yuxuan Wu, M.D., Founder and CEO of YolTech Therapeutics. “Equally encouraging is the favorable safety profile we have seen to date, which
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom