MAA Approved: Dong-A ST’s Stelara Biosimilar DMB-3115 Now Available

On July 14, DONG-A ST, headed by CEO Min-Young Kim, celebrated a major milestone with confirmation of acceptance of their Marketing Authorization Application (MAA) for DMB-3115, a biosimilar of Stelara®, by the European Medicines Agency (EMA). This marked an important step forward for the company, set to be traded at KRX: 170900.

On June 23rd, Intas Pharmaceuticals’ wholly owned subsidiary, Accord, made the bold move of submitting an MAA to the European Medicines Agency (EMA). To the delight of the company, the EMA accepted the submission on July 14th in Central European Time (CET).

The efficacy and safety of DMB-3115 has been officially verified through the submission of its MAA! An extensive analytical similarity assessment of DMB-3115 with US and EU-sourced STELARA was conducted utilizing the most innovative methods currently available.

Moreover, the phase III multi-regional clinical trial results in patients with plaque psoriasis along with the primary endpoint of the Psoriasis Area and Severity Index (PASI) for skin symptoms ultimately granted therapeutic equivalence between DMB-3115 and the reference product, without any observed safety issues.

Developed by Janssen Biotech Inc., DMB-3115 is an exciting proposed biosimilar to Stelara®, a sought-after blockbuster drug for plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. This blockbuster drug has recorded an astounding 17.77 billion USD (IQIVA Accumulative Sales in 2022), making it one of the most popular biologics on the market.

In 2013, Dong-A Socio Holdings and Meiji Seika Pharma embarked on a collaborative journey to develop DMB-3115. After seven years of joint research and development, the rights for the project were transferred to Dong-A ST in July 2020, with the aim of streamlining the management of the drug development process. Together, Dong-A ST and Meiji Seika Pharma strive to bring the drug to completion.

In July 2021, a truly global moment occurred as Intas Pharmaceuticals, a multinational pharmaceutical company, acquired the worldwide distribution rights for DMB-3115, outside of Japan, South Korea, and certain Asian regions.

Through its global subsidiaries Accord BioPharma of the United States and Accord Healthcare of the EU, UK, and Canada, Intas Pharmaceuticals is now commercializing this groundbreaking product, creating opportunities to provide access to the masses.

Accord Healthcare is thrilled to strengthen its relationship with Dong-a & Meiji in order to seek global licensing to a vital medication. This shows our commitment to providing worldwide access to top-tier biosimilar drugs for patients. Paul Tredwell, Executive Vice President of Accord Healthcare, expressed his enthusiasm for this initiative.

Under Mr. Jaehong Park, President & CSO of DongA ST, an ambitious mission has been undertaken to ensure that DMB-3115 reaches the global market. With a powerful partnership between Dong-A, Meiji, Intas, and Accord, there will be no stone left unturned to make its success a reality.

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