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
BM3EAC Corp. 2026 Semi-Annual Report12.8.2026 18:51:00 EEST | Press release
BM3EAC Corp. (the “Company”), a special purpose acquisition company incorporated under the laws of the Cayman Islands as an exempted company with limited liability and listed on Euronext Amsterdam, the regulated market operated by Euronext Amsterdam N.V., today published its semi-annual report for the period 1 January 2026 to 30 June 2026. The semi-annual report can be downloaded from the Company’s website via the following link: https://www.BrigadeM3EAC.com/documents IMPORTANT INFORMATION This press release contains information that qualifies as inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation. DISCLAIMER The Company’s semi-annual report referenced in this announcement may include forward-looking statements, which are based on the Company's current expectations and projections regarding a business combination, the business, the economy and other future conditions of the Company and speak only as of the date hereof. Forward-looking statements may
STL Selects Kinaxis Planning One to Strengthen Supply Chain Planning Across Global Operations12.8.2026 17:10:00 EEST | Press release
Kinaxis® Inc. (TSX:KXS), a global leader in supply chain orchestration, today announced that STL (NSE: STLTECH), a leading optical and digital solutions company, has selected Kinaxis Planning One to strengthen its supply chain planning capabilities and improve decision-making speed across its global operations. The deployment reflects Kinaxis' continued commitment to the Indian market and represents another milestone in expanding customer access through its growing network of value-added reseller (VAR) partners, and its first customer win through the company's Google Marketplace mid-market initiative. "Manufacturers are under increasing pressure to respond to volatility with faster, more coordinated decisions," said Ray Curbelo, SVP, Global Partner Organization at Kinaxis. "This engagement with STL reflects both the growing demand for modern supply chain planning in India and the role our partner ecosystem and Google Marketplace initiative are playing in expanding access to Kinaxis Pla
Azalea Vision Appoints Co-Founder Andrés Vasquez Quintero as Chief Executive Officer to Lead Next Phase of Clinical Development12.8.2026 17:00:00 EEST | Press release
Azalea Vision, a Belgian healthtech company, today announced that co-founder and CTO Andrés Vasquez Quintero will become Chief Executive Officer, effective immediately, while continuing as CTO. The transition marks the company’s next phase, advancing its smart contact lens platform into clinical development, following its selection for the European Innovation Council (EIC) Accelerator. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260812586109/en/ Andrés Vásquez Quintero, CEO & CTO of Azalea Vision As the inventor of Azalea Vision’s proprietary adaptive-optics platform, Vasquez Quintero has led its technology and clinical strategy since founding, keeping technical and corporate direction closely aligned. “This is an exciting milestone for Azalea Vision,” said Andrés Vasquez Quintero, co-founder, CEO and CTO of Azalea Vision. “Our focus is now on advancing clinical development, generating the evidence needed for regulatory a
Seoul Semiconductor Secures Permanent Injunction in India Following Rulings in Europe and the United States12.8.2026 16:00:00 EEST | Press release
Seoul Semiconductor Co., Ltd. (KOSDAQ: 046890, hereinafter 'Seoul') and its affiliate Seoul Viosys Co., Ltd. (KOSDAQ: 092190), global opto-semiconductor technology companies, have obtained a permanent injunction enjoining infringement of Seoul’s opto-semiconductor patents in India, following similar injunction rulings in Europe and the United States. The Delhi High Court extended the injunction to the managing director as well. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260812490873/en/ Patented opto-semiconductor light-output enhancement technology applied in the lawsuits (left) and WICOP technology (right) (Graphic: Seoul Viosys) These rulings are expected to significantly impact the global opto-semiconductor industry, a market worth roughly USD 200 billion that is expanding from automotive lighting and displays into optical communications for AI applications. In India, Seoul Viosys won a final judgment against Ornate
Brightfin Helps Federal Agencies Plan IT Finances Faster and Cut Telecom Costs Through Knox’s FedRAMP Platform12.8.2026 16:00:00 EEST | Press release
Brightfin today announced that its technology spend management solutions are now available to U.S. federal agencies through Knox’s FedRAMP Authorized cloud platform. Deploying on Knox gives public sector organizations a compliant path to faster financial planning cycles, more strategic decision-making, and lower IT and telecom costs, the same discipline commercial enterprises rely on. Brightfin is actively working with Knox toward achieving FedRAMP certification. Federal agencies have long struggled with IT spend data that is siloed and disconnected, limiting their ability to manage hardware and software assets and their associated costs. The result is a reactive posture, scrambling to keep pace with evolving government requirements rather than getting ahead of them. Built natively on ServiceNow, Brightfin turns fragmented IT spend data into actionable insight, operational efficiency, and reduced cost across the entire IT estate. The outcomes federal agencies can now realize Through th
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