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
euNetworks launches new quantum-safe private connectivity service powered by Adtran’s encrypted optical transport technology27.5.2026 11:00:00 EEST | Press release
Adtran and euNetworks today announced their collaboration on the launch of a new quantum-safe private connectivity service, Quantum Shield. euNetworks has developed Quantum Shield using Adtran’s optical transport technology to augment its broader architecture, which is designed to deliver secure, scalable data center connectivity across euNetworks’ pan-European network. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260526610601/en/ Adtran’s encrypted optical transport technology is helping euNetworks deliver the highest levels of protection for sensitive data moving across Europe. The new offering is built for enterprises with stringent security, performance and customer-controlled encryption requirements. The deployment combines high-capacity dedicated infrastructure with real-time fiber monitoring and enhanced optical-layer visibility to safeguard critical traffic. By integrating advanced encryption with continuous monito
National Bank of Greece in Cyprus Goes Live With Smartstream’s Air to Consolidate Reconciliations27.5.2026 10:55:00 EEST | Press release
Smartstream, the trusted data solutions provider for leading global financial institutions and enterprises, today announces that the National Bank of Greece (NBG) in Cyprus has successfully gone live with Air, the company’s AI-enabled reconciliation solution. The go-live marks a significant step forward in the bank’s operational efficiency, reducing daily manual processing effort and eliminating the complexity of working across multiple data formats. The bank has deployed Air’s Cash module, replacing both incumbent and consolidating four separate reconciliation systems for Instant, Cash, SEPA, and Nostro reconciliations, into a single, intelligent platform. Although transaction volumes were manageable, the fragmented landscape required significant daily manual effort to handle items individually across each system and to navigate multiple data formats. Following a market review, the bank committed to Smartstream’s Air, with self service model and AI-enabled automation being a distinct
Duco Launches the First Agentic Operations Platform for Financial Services27.5.2026 10:20:00 EEST | Press release
Duco, today launched the first agentic Operations platform for financial services. Built on the engine that already processes 20 billion transactions every month for more than 200 clients, including seven of the top 20 banks and ten of the top 20 asset managers, the platform brings together everything firms need to run post-trade Operations alongside autonomous agents, safely and at scale. The launch establishes a breakthrough the industry has been waiting for. A tool surface, purpose-built for agents. Duco has unbundled its platform into a new alternative agent layer that reconfigures its platform into hundreds of discrete capabilities servicing post trade. Model Context Protocol (MCP) gives capabilities covering reconciliation, data preparation, data access, audit trails, exception management, document creation and more. For the first time, agents have a verified, deterministic toolset built specifically for post-trade. Agents do not replace matching, rules or audit; they use them. P
Brenus Pharma Announces FDA Acceptance of IND Application for STC-1010 (BreAK-CRC001) in MSS Metastatic Colorectal Cancer (mCRC)27.5.2026 09:49:00 EEST | Press release
Brenus Pharma, a clinical stage biotechnology company developing novel in vivo immunotherapies for solid tumors, announced that the U.S. Food and Drug Administration (FDA) has accept the company's Investigational New Drug (IND) application for its first drug candidate, STC-1010, in microsatellite stable (MSS) metastatic colorectal cancer (mCRC). STC-1010 is designed to address a critical unmet need worldwide. Approximately 95% of mCRC patients have MSS tumors, which demonstrate minimal response to standard immunotherapies. The FDA validated Brenus Pharma's advanced regulatory and manufacturing capabilities. This operational readiness will accelerate patient access and data generation across both European and US sites for a Phase II program planned for 2027. "FDA's acceptance of our IND represents a major validation of our program and enables the full execution of our clinical strategy across Europe and the United States. Achieving regulatory alignment across multiple jurisdictions refl
Alfasigma presents first data on filgotinib from the Phase 3 OLINGUITO trial in axial spondyloarthritis at EULAR 202627.5.2026 09:00:00 EEST | Press release
Alfasigma S.p.A, a global pharmaceutical company with a focus on innovation in rare and specialty care where there is significant unmet patient need, presented positive results from the OLINGUITO Phase 3 clinical trial (NCT05785611iEudraCT 2022-501354-10-01ii) at EULAR 2026. In OLINGUITO filgotinib, an oral, once-daily JAK1 preferential inhibitor under investigation for the treatment of adult patients with active axial spondyloarthritis (axSpA), demonstrated sustained improvements in the signs and symptoms of axSpA, including disease activity and inflammation.iii Safety was consistent with the known profile of filgotinib, indicating a favourable benefit-risk profile for patients with active axSpA.iii The OLINGUITO trial consists of two international, randomised, double-blind, placebo-controlled studies (Study A and Study B), evaluating the efficacy and safety of filgotinib 200mg once-daily vs. placebo in patients with an established diagnosis of axSpA as per ASAS classification.i Eligi
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