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
L&T Technology Services Global EI Hackathon Sparks the Next Wave of AI-Native Engineering Solutions11.7.2026 14:35:00 EEST | Press release
L&T Technology Services (BSE: 540115, NSE: LTTS), a global leader in Engineering Intelligence Solutions & ER&D Consulting Services successfully concluded Engineering Intelligence (EI) OpenHack 2026, a first-of-its-kind global innovation challenge conducted simultaneously across nine locations spanning India, the U.S. and Europe. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260711573331/en/ LTTS Global EI OpenHack at the Munich office The hackathon brought together nearly 4,000 engineers (770+ teams) from Bengaluru, Mysuru, Chennai, Hyderabad, Pune, Vadodara, Mumbai, Dallas and Munich to tackle complex engineering challenges through AI-led innovation. More than 500 challenge statements were aligned with company’s strategic growth priorities, spanning Software Defined Mobility, Plant Buildout & Modernization, Energy & Automation, Next-Gen Compute & AI Infrastructure, Digital Manufacturing, MedTech, and Software Platforms & A
Samos Energy Acquisition Corporation Announces Pricing of Initial Public Offering10.7.2026 16:32:00 EEST | Press release
Samos Energy Acquisition Corporation (the “Company”) announced today the pricing of its initial public offering (“IPO”) of 20,000,000 units at a price of $10.00 per unit. The units will be listed on the New York Stock Exchange (the “NYSE”) and trade under the ticker symbol “SAMO.U” beginning on July 10, 2026. Each unit consists of one Class A ordinary share and one-half of one redeemable warrant, with each whole warrant entitling the holder thereof to purchase one of the Company’s Class A ordinary shares at an exercise price of $11.50 per share. Once the securities comprising the units begin separate trading, the Class A ordinary shares and warrants are expected to be listed on the NYSE under the symbols “SAMO” and “SAMO.WS,” respectively. Cantor Fitzgerald & Co. is acting as the sole book running manager for the proposed offering. The Company has granted the underwriter a 45-day option to purchase up to an additional 3,000,000 units at the IPO price. The public offering is being made
Onera hPSG ® Wins Prestigious Red Dot Product Design Award10.7.2026 16:00:00 EEST | Press release
Onera Health, a leader in transforming sleep medicine, announces that its innovative product, Onera hPSG®, has been honoured with the prestigious Red Dot Product Design Award for 2026. This international recognition celebrates exceptional design quality and underscores Onera Health's commitment to excellence, creativity, and patient-centric innovation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260710266668/en/ Onera Health's patch-based home polysomnography solution, Onera hPSG®, wins Prestigious Red Dot Product Design Award 2026. The Red Dot Award, one of the most sought-after seals of quality for good design, attracted thousands of entries from around the globe. Onera hPSG® stood out for outstanding functionality, striking aesthetics, and thoughtful user experience. The expert jury praised the product for translating complex sleep diagnostics into a wearable, easy-to-use system that enables low-threshold application.
teamLab Biovortex Kyoto Welcomes Over 1 Million Visitors within 9 Months of Opening10.7.2026 10:00:00 EEST | Press release
teamLab Biovortex Kyoto has welcomed over 1 million visitors as of July 6, 2026, 9 months after its grand opening. (*1) These visitors arrived from more than 150 countries and regions. International visitors account for approximately 42% of the total. Many of these international visitors travel from distant countries and regions, including the United States, Australia, Canada, the United Kingdom, and Germany. Approximately 30% of these international visitors purchase their tickets at least 30 days in advance. teamLab Biovortex Kyoto is teamLab's largest museum in Japan, with an average visitor stay of over two and a half hours. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260709913938/en/ teamLab Biovortex Kyoto Welcomes Over 1 Million Visitors within 9 Months of Opening *1 According to ticket purchase data from the official teamLab Biovortex Kyoto website (survey period: October 7, 2025 – July 6, 2026) Visitors Comment (M
Robbyant Launches LingBot-VA 2.0 Built Natively for Embodied AI and Physical World Control10.7.2026 09:48:00 EEST | Press release
Robbyant, an embodied AI company within Ant Group, today announced the release of LingBot-VA 2.0, the industry’s first embodied-native video-action world model. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260709654440/en/ A robot powered by LingBot-VA 2.0 engages in a real-time tabletop air hockey match with a human This release marks a key transition in robotics foundation models, shifting from repurposing digital world models to designing them natively for the physical world. Instead of relying on fine-tuned digital content generation models, LingBot-VA 2.0 is built from scratch to meet the original demands of dynamic modeling, causal prediction, and real-time execution in physical environments. Integrating world models with embodied AI has been one of the major focuses of the AI industry. However, most mainstream approaches rely on video generation models designed for digital content, which are then fine-tuned for robo
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