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
IAMPHENOM Europe 2026 Registration Opens: HR’s Leading Conference for Agentic AI Learning Returns20.5.2026 14:00:00 EEST | Press release
Phenom, the leader in applied AI with an infrastructure built specifically to redesign work operations, today announced registration is open for IAMPHENOM Europe 2026, taking place 4-5 November in Paris, France. The only applied AI event dedicated to human resources on the continent, IAMPHENOM Europe gives HR and HRIT leaders the agentic AI strategies, instruction and proof points they need to build their AI-augmented workforce to address their biggest hiring, development and retention challenges. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260520683492/en/ Phenom today announced registration is open for IAMPHENOM Europe 2026. The only applied AI event dedicated to human resources on the continent is taking place 4-5 November in Paris, France. European organisations face pressure from every direction, including widening skills shortages, tightening EU AI Act compliance and competitors moving faster with AI than HR teams c
BeOne Medicines Launches One Save Changes Everything, a Global Cancer Care Awareness Campaign with Soccer Legend Tim Howard20.5.2026 13:00:00 EEST | Press release
BeOne Medicines Ltd. (“BeOne”) (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today launched One Save Changes Everything, a campaign that uses soccer as a lens to recognize the scientific, clinical, and human moments that matter in cancer care. The campaign launches with goalkeeping legends, including former U.S. Men’s National Team goalkeeper Tim Howard. The initiative is backed by a $300,000 community commitment for the installation of soccer mini-pitches near cancer treatment centers with the U.S. Soccer Foundation, and BeOne colleague‑driven charitable support across the world. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260520118614/en/ BeOne Medicines' One Save Changes Everything campaign uses soccer as a lens to recognize the scientific, clinical, and human moments that matter in cancer care. John V. Oyler, Co-Founder, Chairman, and CEO, BeOne Medicines, said: “Just like soccer is defined by sa
Chiesi Group Announces New Chair and Vice Chair20.5.2026 12:00:00 EEST | Press release
Chiesi today announced a planned leadership change in its Board of Directors: Maria Paola Chiesi has been appointed Chair of the Board, succeeding Alessandro Chiesi, who is completing his tenure after nearly three years in the role, and will now continue to serve as Vice Chair. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260520447292/en/ Maria Paola Chiesi is appointed Chair of Chiesi Board of Directors, the first woman in this role; aims to reinforce sustainability as an integral and enduring pillar of the Group’s strategy During his mandate, Alessandro Chiesi oversaw the Group through a phase of continued international development and governance strengthening, thereby further consolidating Chiesi’s long-term strategy as a research focused biopharmaceutical company and certified B Corp. “It has been my privilege to serve as Chair during a period of evolution for Chiesi,” said Alessandro Chiesi. “What has remained unchang
Insurance Investment Outsourcing Surpasses $5.5 Trillion as Private Markets and Global Expansion Reshape the Industry20.5.2026 10:00:00 EEST | Press release
Clearwater Analytics (NYSE: CWAN) today released the 2026 Insurance Investment Outsourcing Report (IIOR), produced in partnership with DCS Financial Consulting. The report captures $5.5 trillion in third-party general account insurance assets under management across 96 asset managers, a 23% increase year-over-year and a 65% increase since 2021, alongside $1.8 trillion in assets under advisement across 12 investment consultants. The findings point to an outsourcing market that has become larger, more global, and materially more complex. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260520780028/en/ The 2026 IIOR reveals defining trends reshaping insurance investment management: Private Markets Cross a Threshold. Third-party private insurance AUM has more than doubled since 2021, reaching $947 billion and approaching one-third of outsourced insurance allocations alongside public assets. Insurers have moved steadily beyond tra
Factbird Adds Quality & Compliance and Reports to its Manufacturing Intelligence Platform20.5.2026 09:00:00 EEST | Press release
Today, Factbird is announcing two major additions to its manufacturing intelligence platform: Quality & Compliance and Factbird Reports. Both address a problem that compounds as manufacturers grow. More sites mean more variation in how work gets done. More regulation means more documentation pressure on frontline teams. And more data, when fragmented across systems, often slows decisions rather than speeding them up. Solving this has traditionally meant large IT projects and months of deployment. “Enterprise manufacturers shouldn’t have to choose between capability and simplicity,” said Mogens Arne Hansen, Chief Technology and Product Officerat Factbird. “With Quality & Compliance and Reports, you can have standardized, audit-ready operations and automated performance reporting across every site, deployed in days, used by the people on the floor.” Quality & Compliance: standardized, compliant operations across every site Regulated manufacturers in food and beverage, pharma, and medical
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