EMA Accepts MAA for DMB-3115 of Dong-A ST, a Stelara Biosimilar
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
Usercentrics Acquires MCP Manager to Bring Consent and Trust to AI14.1.2026 12:15:00 EET | Press release
Usercentrics, the global leader in Privacy-Led Marketing solutions, announced today it has acquired MCP Manager, a next-generation governance platform for the Model Context Protocol (MCP), built by a team with deep expertise in AI infrastructure. The acquisition makes Usercentrics the first major global market leader in data privacy solutions to extend consent and data guardrails into AI-driven workflows. The combined platform will deliver a unified Privacy-Led Marketing Suite that manages consent, preferences, and data governance across websites, apps, internal systems, and consumer-facing AI agents. Because these agents increasingly shape personalization and customer engagement, extending consent into real-time, model-driven interactions applies the same rigor that exists at data collection. This keeps experiences transparent, trusted, and aligned with user choices, and turns compliance into a strategic differentiator and competitive edge. “With this acquisition, we are defining how
Blue Shift Report Highlights Systemic Vulnerabilities Caused by the Hidden Cost of AI14.1.2026 11:00:00 EET | Press release
Arthur D. Little’s Blue Shift institute has published its latest report, AI’s Hidden Dependencies. This in-depth report, involving more than 50 experts, explores AI’s resource dependencies and the consequent direct systemic vulnerabilities for businesses and lays out strategic actions in response. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260114966898/en/ Arthur D. Little’s Blue Shift Institute has published its latest report, AI’s Hidden Dependencies With AI’s adoption and usage expected to remain on its growth trajectory, so is its strain on resources. The report notably identifies three main areas of dependency: Environmental impacts, including emissions due to AI’s heavy energy usage and the manufacture of related hardware Energy supply, including increased electricity demand and strain on the grid Compute infrastructure, including supply chain choke points and dependencies on dominant providers As AI is now becomin
Klarna Expands Digital Bank Offer with Peer-to-Peer Payments14.1.2026 10:00:00 EET | Press release
Klarna, the global digital bank and flexible payments provider, has launched instant peer-to-peer payments in 13 European countries, marking the next step in its evolution as a digital bank. The new feature enables Klarna customers to send money to friends and family, whether splitting bills or gifting cash, directly from the Klarna app: as simple as handing someone cash, with the protection of a regulated bank. This launch takes Klarna deeper into everyday banking, turning Klarna into a central hub for day-to-day spending and money management. It comes on the back of the Klarna Balance accounts and the rapid adoption of Klarna Card, with over 4 million sign-ups just four months after launch. Sebastian Siemiatkowski, co-founder and CEO of Klarna commented: “Customers are sick of the friction and fees of traditional banking, which is why millions signed up to Klarna Card within a few months of launch. With peer-to-peer payments we’re making it even easier to manage all of your payments
Northern Trust Secures Expanded Mandate with Swedish Pension Provider AMF Tjänstepension AB14.1.2026 10:00:00 EET | Press release
Northern Trust (Nasdaq: NTRS) today announced that it has retained and expanded its mandate with AMF Tjänstepension AB (AMF), a leading Swedish pension provider. Under the renewed agreement, Northern Trust, which has serviced AMF for more than 20 years, will continue to serve as custodian for AMF’s global pension assets and add investment operations for trade services across AMF’s total portfolio, for both pension and fund company assets. AMF is one of Sweden’s leading pension companies, managing occupational pensions for millions of individuals. With a strong focus on delivering secure and sustainable retirement outcomes, AMF combines cost efficiency with long-term investment strategies to benefit its members. Petra Sjögerås, head of Nordic Region, Northern Trust said: “As a long-standing partner to institutions in the Nordic region, Northern Trust brings extensive experience and a solutions-oriented mindset to proactively support our clients to achieve their goals now and in the futu
Notice Concerning Change of Representative Executive Officer14.1.2026 09:14:00 EET | Press release
H.U. Group Holdings, Inc. (the Company) today announced that it has resolved, at a meeting of the Board of Directors held on January 14, 2026, to change the Company’s Representative Executive Officer as described below. 1. Name and job titles of newly appointed Representative Executive Officer Name New title Current title Goki Ishikawa Representative Executive Officer, President and Group CEO Managing Executive Officer 2. Name and job titles of retiring Representative Executive Officer Name New title Current title Shigekazu Takeuchi Director and Executive Officer Director, Representative Executive Officer, Chairman, President and Group CEO 3. Reason for change In May 2025, toward realizing its Vision for 2035, the Company announced its Medium-Term Management Plan “H.U. 2030” (MMP) as well as its CEO succession plan including the timing for the selection of the next CEO. As the succession plan progressed, the Company has recognized that Mr. Goki Ishikawa is the best to lead the executio
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