Dong-A ST said on Monday that it confirmed the therapeutic equivalence and safety of its Stelara biosimilar DMB-3115 compared to the original drug in the global phase 3 clinical trials.

Stelara (ingredient: ustekinumab) is a treatment for inflammatory diseases such as Crohn's disease, ulcerative colitis, plaque psoriasis & psoriatic arthritis. It is one of the highest-grossing biopharmaceuticals recording $16.8 billion (20.7 trillion won) sales worldwide in the third quarter of 2022. 

The phase 3 clinical trials began in the U.S. in 2021 and subsequently launched in nine other countries, including Poland, Estonia, and Latvia. The efficacy, safety, and immunogenicity of DMB-3115 and Stelara subcutaneous injections were compared in 605 patients with moderate to severe chronic plaque psoriasis over 52 weeks.

Dong-A ST’s candidate demonstrated therapeutic equivalence with Stelara via the psoriasis area and severity index (PASI) percentage change from baseline, the primary outcome measure, with no significant adverse effects at 8 and 12 weeks per the EMA and FDA standards.

DMB-3115 has been jointly developed by Dong-A Socio Holdings and Meiji Seika Pharma since 2013, with commercialization and development rights transferred to Dong-A ST in July 2020.

In July 2021, Dong-A ST signed a global license-out contract for DMB-3115 with Intas Pharmaceutical, a global pharmaceutical company. Under the contract, it transferred exclusive rights to Intas regarding permits and sales in global regions excluding Korea and Japan.

Accordingly, Intas will commercialize the DMB-3115 through Accord BioPharma in the U.S. and Accord Healthcare in Europe, the U.K. and Canada. Dong-A ST and Meiji Seika Pharma will be responsible for research and development of DMB-3115 and exclusively supplying products to Intas and Accord Healthcare.

"The deal between Dong-A ST and Meiji Seika Pharma underscores our commitment to lead the global pharmaceutical market," said Vice Chairman and Managing Director of Intas Pharmaceuticals Binish Chudgar.

"Based on the successful phase 3 results, we will apply for item licenses in the U.S. and Europe in the first half of this year and will do our best to supply DMB-3115 globally as quickly as possible together with Intas Pharmaceutical and Accord Healthcare,” Dong-A ST CEO Kim Min-young said.