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
Phenom Adds Major Headline Speakers as IAMPHENOM Europe Approaches Sold-Out Status6.10.2026 16:30:00 EEST | Press release
Phenom, the leader in applied AI built to redesign work operations for hiring faster, developing better and retaining longer, today announced the newest wave of speakers for IAMPHENOM Europe 2026, the only applied AI event dedicated to human resources taking place on 4-5 November in Paris, France. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261006714151/en/ Phenom announced the newest wave of speakers for IAMPHENOM Europe 2026, the only applied AI event dedicated to human resources taking place on 4-5 November in Paris, France. The two-day conference gives attendees what other HR events can’t: an inside look at AI agents already in production, automated workflows tailored to specific business contexts and the dramatic results they are already delivering. Across keynotes, customer sessions, hands-on experiences and peer networking with the continent’s top CHROs and HRIT decision-makers, guests can participate in discussion
European Firms Struggle to Keep Pace with Growing DSAR Demands, New Reveal Study Finds6.10.2026 16:00:00 EEST | Press release
New research published today byReveal, the provider of integrated AI-native platforms spanning the dispute resolution lifecycle, found that large European organisations complete fewer than half of data subject access requests (DSARs) within the one-month deadline required under the General Data Protection Regulation (GDPR), a shortfall the study ties directly to a near-universal absence of purpose-built technology. Nearly nine in 10 organisations still run DSARs on manual or general-purpose workflows, with no dedicated tooling in place. The report, based on a survey of 213 legal and privacy professionals at large European enterprises, is the first of its kind to benchmark how organisations across the region are managing DSAR compliance at scale. The findings expose structural inconsistencies between how organisations perceive their DSAR processes and how those processes perform. Ninety percent of respondents said they are confident their process would withstand scrutiny from an Informa
Rochester Electronics Launches Localized E-Commerce Experiences Across Key Global Markets6.10.2026 16:00:00 EEST | Press release
Rochester Electronics today announced the launch of fully enabled e-commerce capabilities across its regional websites, allowing customers in key global markets to search for, source, and purchase authorized semiconductors in their local language. While Rochester's regional sites previously offered localized content and product information, they now support a complete end-to-end purchasing experience. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261006914131/en/ Rochester Electronics Launches Localized E-Commerce Experiences Across Key Global Markets The newly upgraded platforms are now live in Portuguese (Brazil), Spanish (Mexico), French, German, Italian, and Polish, complementing Rochester’s existing full e-commerce platforms in English, Chinese, Japanese, and Korean (South Korea). Customers can now complete transactions directly through their local sites, simplifying sourcing, improving efficiency, and reducing process
Xsolla Shows Brand Owners How to Create Value for Video Players at Brand Licensing Europe With Rewarded Marketing6.10.2026 16:00:00 EEST | Press release
Xsolla, a global commerce company, today announced it will be at Brand Licensing Europe 2026 at ExCeL London, October 6 to 8, to show brand owners how to engage with video game players by creating quest-based programs and value new users actually value. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261006443167/en/ Graphic: Xsolla Video games are one of the largest categories of entertainment spending in the world, yet most brands still treat the category as an experiment: a one-off promotional stunt or a single media buy, not a lasting engagement program. The traditional formats brands default to were never built for players. Interstitial pop-ups disrupt gameplay, banner ads go unnoticed, and in-game activations remain cumbersome and expensive to execute. The idea is already proven in games, where players have purchased, collected, and valued digital items for years. The relationship between players and games is built on t
New Global Survey Finds Majority of VMware Users Are Choosing Alternative Paths for Cost Control, Roadmap Flexibility and Better Support6.10.2026 16:00:00 EEST | Press release
Rimini Street, Inc. (Nasdaq: RMNI), the Software Support and Agentic AI ERP Company™ and the leading third-party support provider for Oracle, SAP and VMware software, today announced findings from the 2026 IT Virtualization Survey – What’s Next for VMware Users, a new global survey of nearly 300 VMware user organizations conducted by Unisphere Research on behalf of Rimini Street. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261006014490/en/ New Global Survey Finds Majority of VMware Users Are Choosing Alternative Paths for Cost Control, Roadmap Flexibility and Better Support Cost Cited as the Number One Factor in Seeking Alternative VMware Solutions Key Findings: 90% of respondents said they are considering alternatives to VMware due to higher licensing costs, while 54% cited the end of perpetual license support as another reason to evaluate other options. The research shows that cost remains the leading driver of virtuali
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