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
Venture Global Announces Final Investment Decision and Financial Close for Phase 2 of CP2 LNG13.3.2026 16:23:00 EET | Press release
Today, Venture Global, Inc. (NYSE: VG) is announcing a final investment decision (FID) and successful closing of an $8.6 billion project financing for the second phase of the company’s third project, Venture Global CP2 LNG (CP2). When combined with the Phase One financing for CP2 announced July 2025, this milestone represents the largest standalone project financing in the U.S. bank market.The transaction garnered enormous interest from the world’s leading banks, resulting in over $19 billion of commitments for Phase Two in addition to the previous $34 billion of commitments for Phase One, and required no outside equity investment. “We are extremely proud to have taken FID on the second phase of CP2, our third greenfield project, bringing Venture Global’s executed capital markets transactions to more than $95 billion,” said Venture Global CEO Mike Sabel. “The tireless dedication of our team has enabled us to reach five final investment decisions in less than seven years, positioning us
NIQ Launches Beta of New AI-Powered Analytical Capabilities in Ask Arthur13.3.2026 13:00:00 EET | Press release
NIQ (NYSE: NIQ), a global leader in consumer intelligence, has launched new AI-powered analytical capabilities in beta within Ask Arthur on the NIQ Discover platform. The expanded experience guides users through end-to-end analysis—helping them identify what matters in the data, understand why trends are occurring, and turn insights into clear, shareable narratives with recommended next steps. As organizations navigate increasing data complexity, the ability to move quickly from insight to action has become essential. Ask Arthur helps shorten analytical processes that once took days or weeks into minutes by surfacing the key drivers behind performance changes and generating decision-ready insights directly within Discover. By connecting analysis, explanation, and storytelling in a single experience, users can move seamlessly from understanding what is happening in the data to determining what to do next. “These new analytical capabilities represent an important step forward in how we b
Reply at NVIDIA GTC: Digital Twins and Physical AI Driving the Next Stage of Industrial Value Creation13.3.2026 12:24:00 EET | Press release
Reply [EXM, STAR: REY] will be present at NVIDIA GTC from 16 to 19 March 2026 in San Jose, California, showcasing how companies can optimise production and logistics processes, scale robotics and sustainably increase industrial performance using digital twin technology and physical AI. The conference is regarded as the most important international meeting point for AI developers, researchers and decision makers. This year, more than 30,000 participants from over 190 countries are expected to attend. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260313000399/en/ By attending NVIDIA GTC, Reply is showcasing how digital simulation and physical automation are already being integrated in practice. Projects for the Otto Group and the industrial edge domain show how physical AI and precise digital twins work together to create new opportunities for industrial value generation. The focus will be on two concrete use cases that demon
Klarna Board Chair Michael Moritz Acquires 3.47 Million Shares for $50 Million13.3.2026 12:05:00 EET | Press release
Klarna Group plc (NYSE: KLAR) today discloses the following transactions by the Chair of its Board of Directors and Chief Product & Design Officer, filed with the U.S. Securities and Exchange Commission on Form 3. Share Purchases Michael Moritz, Chairman, through an associated entity, purchased 3,472,845 ordinary shares between March 3 and March 11, 2026, at an aggregate consideration of $49,913,138.73. David Fock, Chief Product & Design Officer, purchased 27,000 ordinary shares on March 9, 2026, for an aggregate consideration of $388,552.14. Share Sales David Sandström, Chief Marketing Officer, sold 32,703 shares on March 9, 2026, pursuant to a Rule 10b5-1 trading plan, established in 2025. David Sykes, Chief Commercial Officer, sold 23,799 shares on March 13, 2026, pursuant to a separately established Rule 10b5-1 trading plan, established in 2025. Form 3 filings for all transactions are available on the SEC's EDGAR database atwww.sec.gov. Forward-Looking Statements This press release
Intertek Launches Comprehensive Digital Product Passport Services13.3.2026 11:00:00 EET | Press release
Intertek, a leading Total Quality Assurance provider to industries worldwide, has announced the launch of its enhanced Digital Product Passport (DPP) suite of services. This includes a comprehensive advisory service designed to help manufacturers, brands and retailers navigate the fast-evolving regulatory and sustainability landscape associated with digital product passports and circular economy compliance. Mark Thomas, Executive Vice President, Global Sustainability, Assurance, Agri World and Food at Intertek, said: “With the introduction of regulatory frameworks for improving the sustainability performance of products, companies are facing mounting pressure to implement robust systems for transparency, traceability and sustainability reporting globally. This shift marks a significant regulatory milestone, requiring organisations to strengthen data governance, engage suppliers more effectively and demonstrate credible, verifiable sustainability performance across the full product life
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