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
Tanium Reappoints Co-Founder Orion Hindawi as CEO to Drive Next Chapter of Growth20.8.2026 22:10:00 EEST | Press release
Tanium, a leader in Autonomous IT, today announced that Co-Founder and Executive Chairman Orion Hindawi has been appointed Chief Executive Officer, effective immediately. Dan Streetman is stepping down as CEO and as a member of the Board after leading Tanium for the last three years, during which time Tanium scaled its go-to-market operations and secured strong industry analyst recognition for innovation within the Tanium platform. Streetman will continue to advise Tanium as part of the transition and co-founder David Hindawi will return to the role of Chairman of the Board. With this foundation in place, this transition positions Tanium to deepen its Autonomous IT capabilities and further expand AI offerings across its portfolio and strengthen customer and partner engagement. The Hindawis co-founded Tanium in 2007 to build the central nervous system of enterprise security, giving organizations unified visibility and control over their endpoints. During his prior tenure as CEO from 201
Perma-Pipe Secures More Than $67 Million in New Orders in the Second Quarter of 202620.8.2026 20:02:00 EEST | Press release
Perma-Pipe International Holdings, Inc. (Nasdaq: PPIH), a global leader in engineered piping and corrosion protection solutions, today announced that the Company secured more than $67 million in new orders during the second quarter of fiscal 2026, representing strong demand across its strategically important end-markets and geographies. The orders further strengthen Perma-Pipe's backlog and provide increased visibility into future revenue growth. The Company's backlog remains well diversified across geographies, customers and end-markets. The Company continued to see strong demand across its core Oil & Gas and infrastructure markets, while also securing important new business in emerging applications, including advanced leak detection and monitoring solutions. During the quarter, Perma-Pipe secured sizable Oil & Gas awards in both MENA and Canada, reinforcing the Company's position as a trusted supplier to customers undertaking significant energy infrastructure investments. The Company
Impartner Launches the First CPQ Built for Partners20.8.2026 16:00:00 EEST | Press release
Impartner, the leading partner revenue orchestration platform, today announced the launch ofImpartner CPQ, giving partners a direct path to create and advance quotes within the Impartner PRM platform. The new capability enables faster movement from opportunity to submission while giving vendors control over the rules, products, pricing, and approvals that govern each transaction. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260820479441/en/ Give partners a faster path from opportunity to quote with Impartner's CPQ. For many partnership programs, quoting remains a largely manual process. Partners often depend on vendor sales teams to prepare quotes because traditional CPQ systems are designed primarily for direct sellers or require additional licensing for external users. The result is a slower path from opportunity to revenue, increased administrative work for channel teams, and a partner experience that can limit the impa
Scientist.com Expands R&D Platform Capabilities with SciSure’s Integrated LabOps Inventory and Compliance Services20.8.2026 15:55:00 EEST | Press release
Scientist.com, the life sciences industry’s leading AI-enabled R&D orchestration platform and digital marketplace, today announced an expansion of its platform capabilities through an integration with SciSure’s lab management and EHS compliance tools. The partnership gives biopharma organizations a more unified workflow connecting scientific procurement directly with laboratory operations. “By bringing SciSure’s inventory management, safety, and compliance capabilities into the Scientist.com ecosystem, we are closing the gap between sourcing reagents and safely managing them in the laboratory,” said Jon Zibell, VP of Global Alliances at SciSure. “Together, our platforms connect product information, safety checks, and inventory management, giving research, lab operations, and EHS teams greater visibility from purchase request through disposal.” The integration connects procurement, safety, inventory, and compliance in a single connected workflow. SciSure enriches Scientist.com’s unified
NETFORCE Accelerates Its U.S. Industrial Expansion as a New Intermediate-Force Market Takes Shape20.8.2026 15:23:00 EEST | Press release
For the first time, major U.S. federal agencies are beginning to structure procurement around a new category of intermediate-force equipment, giving officers an additional option between verbal presence and higher levels of force. NETFORCE believes companies establishing themselves at this early stage will benefit from a significant first-mover advantage as this category expands nationwide. This is precisely the market NETFORCE anticipated years ago, having invested heavily in research, industrialization and international intellectual property well before the category attracted attention. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260820951658/en/ COPYRIGHT NETFORCE NETFORCE enters the U.S. market backed by two granted and active U.S. patents — US 11,236,973 B2 (granted 2022, protected through 2038) and US 12,222,193 B2 (granted 2025, protected through 2041). Together with the E-StunGlove® trademark, these assets form pa
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