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
Moore Nanotechnology Systems (Nanotech) Will Be Acquired by Shibaura Machine Group to Form a New Ultra-Precision Machine Tool Organization18.5.2026 22:36:00 EEST | Press release
MOORE NANOTECHNOLOGY SYSTEMS (“Nanotech”), today announced that it is being acquired by an affiliate of SHIBAURA MACHINE CO., LTD., an industrial machine-tool manufacturer headquartered in Japan. Founded nearly 30 years ago by Len Chaloux and Newman Marsilius III as a standalone subsidiary of the Moore Tool Company, Inc., Nanotech has become a global leader in the design, development and manufacture of state-of-the-art ultra-precision machine tools and associated processes for the production of advanced optical and reflective components. “As the world’s markets continue to develop, finding the right strategic partnerships is essential,” said Mark Boomgarden, President and CEO of Nanotech. “Partnering with Shibaura allows us to combine the true competencies of both organizations under one management team - affording both companies the ability to scale resources and invest on a global stage like never before.” Co-owner Newman Marsilius IV shared, “Moore Nanotechnology Systems grew to a p
First Guests Arrive at Four Seasons Resort and Residences Red Sea at Shura Island from 20 May, as Red Sea Global Launches First JV Resort18.5.2026 21:06:00 EEST | Press release
Red Sea Global (RSG), the regenerative tourism developer, has reached a major milestone as Four Seasons Resort and Residences Red Sea at Shura Island welcomes first guests from 20 May, marking the first joint venture-developed resort within its portfolio to enter the market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260518349628/en/ An aerial view of Four Seasons Resort and Residences at Shura Island, set along the shoreline with clear views of the Red Sea. Developed in partnership with Kingdom Holding Company (KHC), the launch represents a shared milestone for both organizations and marks a new phase in RSG’s development model, highlighting the growing role of institutional and private sector partnerships in scaling Saudi Arabia’s luxury tourism sector. “With Four Seasons preparing to welcome guests, we are significantly scaling the capacity and offering of The Red Sea destination in time for one of the busiest travel
Belkin Advances Towards Carbon Neutrality in Scope 3 Emissions18.5.2026 19:10:00 EEST | Press release
Belkin, a leading consumer electronics brand for 40 years, published its 2025 Impact Report, highlighting key achievements and reaffirming its commitment to corporate responsibility. Having achieved carbon neutrality in scope 1 and scope 2 emissions in 2025, the company continues to advance toward scope 3 carbon neutrality through enhanced life cycle assessment capabilities and improved supplier and logistics data collection. In 2025, Belkin calculated 131 product carbon footprints across its portfolio, surpassed 21.6 million PCR products sold, and has achieved a 95% reduction in single-use plastic packaging since 2019, reflecting continued progress in carbon reduction and responsible product design. “As we continue to make progress against our sustainability goals, we are taking deliberate steps to reduce our impact,” said Steven Malony, CEO of Belkin. “Over the past year, we expanded the use of post-consumer recycled materials, further reduced single-use plastic packaging, and streng
Infobip Named a Leader in the 2026 Gartner® Magic Quadrant™ for Communications Platform as a Service18.5.2026 17:25:00 EEST | Press release
Infobip is excited to share that global AI-first cloud communications platform Infobip has been recognized as a Leader in the 2026 Gartner Magic Quadrant for Communications Platform as a Service. Check back for a complimentary copy of the full report soon! In Infobip’s view, this recognition reflects what the company has spent 20 years building: a communications platform that stays focused on what customers actually need and evolves as markets change. Infobip believes that recognition in a fast-moving market comes not from chasing trends, but from disciplined execution and a clear long-term vision. As Infobip marks its 20th year of operations, the company thinks the shift to agentic AI represents the most significant transformation in customer communications in our history. Infobip believes enterprises need a partner that empowers them to move from campaigns and rigid workflows to autonomous, goal-driven interactions, while retaining the openness and flexibility to adapt as the technol
Seoul Design Foundation Announces ‘Seoul Design AI Film Festival’ Call for Entries18.5.2026 17:00:00 EEST | Press release
The Seoul Design Foundation (CEO Cha Kang Heui) is inviting visionaries worldwide to the Seoul Design AI Film Festival (SDAFF). This global competition aims to redefine the Dongdaemun Design Plaza (DDP)—the world’s largest atypical architecture—as a premier destination for AI-driven media art. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260518044745/en/ An official poster for Seoul Design AI Film Festival (Image: Seoul Design Foundation) The DDP’s 222-meter curved exterior wall, a Guinness World Record holder for the "World's Largest 3D Mapping on an Atypical Building," will serve as the digital canvas for the winners. ‘Seoul Light DDP’ has already achieved global acclaim by winning the world’s top three design awards: iF, Red Dot, and IDEA. Bridging AI Technology and K-Culture The festival seeks high-quality video works that blend artistic inspiration with cutting-edge AI technology. The competition features two main cat
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