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
GigaDevice Extends European Reach with SEMITRON Partnership for DACH region12.2.2026 11:52:00 EET | Press release
GigaDevice, a leading semiconductor company specializing in Flash memory, 32-bit microcontrollers (MCUs), sensors, and analog products, has entered into a distribution agreement with SEMITRON, a leading electronic component distributor that specializes with a focus on the DACH region. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260203746978/en/ Under the terms of the deal, SEMITRON is set to supply both GigaDevice's leading Flash, MCU, power and sensor lines in conjunction with field application engineering support to customers in the industrial, automotive and communication technology sectors. In particular, SEMITRON offers professional test house services, technical know-how and local on-the-ground expertise and support. The partnership further extends GigaDevice's reach into this major European market, with on the ground support in Germany, Austria, Switzerland. Jürgen Rohland, Managing Director of SEMITRON W. Röck Gmb
Samsung Ships Industry-First Commercial HBM4 With Ultimate Performance for AI Computing12.2.2026 11:48:00 EET | Press release
Samsung Electronics Co., Ltd., a global leader in advanced memory technology, today announced that it has begun mass production of its industry-leading HBM4 and has shipped commercial products to customers. This achievement marks a first in the industry, securing an early leadership position in the HBM4 market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260212674509/en/ Samsung Ships Industry-First Commercial HBM4 With Ultimate Performance for AI Computing By proactively leveraging its most advanced 6th-generation 10 nanometer (nm)-class DRAM process (1c), the company achieved stable yields and industry-leading performance from the outset of mass production — all accomplished seamlessly and without any additional redesigns. “Instead of taking the conventional path of utilizing existing proven designs, Samsung took the leap and adopted the most advanced nodes like the 1c DRAM and 4nm logic process for HBM4,” said Sang Joo
Sisvel Website Now Available in Chinese and Japanese12.2.2026 11:30:00 EET | Press release
Chinese and Japanese language versions of the Sisvel corporate website are now live, delivering an enhanced experience for users in two of the world’s key technology markets. The move also reflects the growing role of Asia-based innovators and implementers in Sisvel licensing programmes. The localised sites will enable more SEP licensing stakeholders to access patent pool information and programme details in their native languages. All versions of the website will be updated continuously to carry the full range of Sisvel news and insights. “Sisvel is deeply embedded in the markets where we operate,” says Sisvel Executive Head of Brand Giulia Dini. “Our expanded online presence in Asia, which also includes the recent launch of an official WeChat channel, aligns with our growing physical footprint in the region. We look forward to driving the global conversation on patent licensing and innovation.” In 2025, Sisvel appointed senior executives to run its operations in Japan and China. The
In the age of AI agents, Splio makes prediction the foundation of CRM and launches its AI-first CRM12.2.2026 10:30:00 EET | Press release
Splio announces the launch of its AI-first CRM powered by Tinyclues AI. Now integrated at the core of the platform, predictive AI helps brands orchestrate and personalize their communications at scale across every channel (email, SMS, RCS, WhatsApp...). Splio also unveils "Ask My CRM," its new AI agent designed as an intelligent marketing copilot that, plugged into each brand's customer data, makes customer knowledge easier to access, and speeds up day-to-day CRM management, from analysis to actionable recommendations. Splio made the strategic choice early on to invest in AI, especially with the acquisition of Tinyclues in 2023, to get ahead of rapid changes in the CRM Market. Today, the company runs an AI-first model with 30% of its annual recurring revenue coming from its AI offerings. Companies such as Air France, Fnac Darty, SNCF Connect, Samsung, as well as ETAM, Maisons du Monde, Mademoiselle bio, and Cyrillus in retail, already rely on Tinyclues AI on a daily basis. "We quickly
Stafford Capital Partners Announces New Renewable Energy Investment Strategy with Dedicated Team12.2.2026 10:00:00 EET | Press release
Stafford Capital Partners (“Stafford”), a leading international private markets investment and advisory firm, today announced the launch of a new strategy focused on the renewable energy sector. This initiative leverages the ongoing transformation and rapid growth within the renewables market, targeting the revamping and repowering of existing renewable assets to deliver compelling risk-adjusted returns while accelerating the transition to a low-carbon economy. This new strategic initiative further strengthens Stafford’s position in the global infrastructure investment market, providing institutions with access to a pioneering investment approach to renewable investing. This mirrors the differentiated approach Stafford has taken in developing its secondary market strategies across its real assets platform. The implementation of this strategy is driven by the integration of a dedicated 11-person team, based in Milan and Zurich, led by Angelo Prete. Stafford has worked successfully with
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