FDA approves BLA for Dong-A ST’s Stelara biosimilar

Following success in Europe, DMB-3115 received FDA approval for BLA

Dong-A ST announced on the 5th that Accord Biopharma, a subsidiary of Intas Pharmaceuticals, has completed Biologics License Application (BLA) for Stelara biosimilar ‘DMB-3115’ to the U.S.

 

Food and Drug Administration (FDA).

 

The BLA, originally submitted in October 2023, has now been approved by the FDA.

 

FDA accepts BLA for DMB-3115 of Dong-A ST.

 

Dong-A ST and Meiji Seika Pharma will be responsible for R&D of DMB-3115 and exclusively distribute the product to Instas, Accord Biopharma, and Accord Healthcare.

 

The BLA submission was based on the results from quality equivalence testing between Stelara and DMB-3115 conducted in both the United States and Europe.

 

The global Phase 3 clinical trials enrolled patients with moderate to severe chronic plaque psoriasis, and the result demonstrated therapeutic equivalence between DMB-3115 and Stelara.

 

There were no clinically significant differences in safety.

 

Stelara, developed by Janssen, is a treatment for various inflammatory diseases, including plaque psoriasis, ulcerative colitis, Crohn’s disease, and ulcerative colitis.

 

Stelara is a blockbuster biomedicine and has recorded global sales of $17.77 billion (approx.

 

22 trillion won).

 

DMB-3115 has been under joint development by Dong-A Socio Holdings and Meiji Seika Pharma since 2013.

 

In July 2020, to facilitate more efficient global progress, the development and commercialization rights for DMB-3115 were transferred to Dong-A ST.

 

In July 2021, Dong-A ST finalized a technology transfer agreement with the multinational pharmaceutical company, Instas Pharmaceuticals.

 

Instas acquired exclusive rights for the approval and sales of DMB-3115 in global markets, except for several Asian countries such as Korea and Japan.

 

Instas plans to commercialize DMB-3115 globally via its subsidiaries, Accord Biopharma in the United States and Accord Healthcare in Europe, the United Kingdom, and Canada.

 

Meanwhile, Dong-A ST and Meiji Seika Pharma will be responsible for R&D of DMB-3115 and exclusively distribute the product to Instas, Accord Biopharma, and Accord Healthcare.

 

In July 2023, Accord Healthcare, a subsidiary of Instas, completed submission of BLA for DMB-3115 to the European Medicine Agency.

 

“Based on the proven therapeutic equivalence and safety between DMB-3115 and Stelara, we have successfully submitted the BLA in the United States following our success in Europe,” explained Park Jaehong, R&D President at Dong-A ST.

 

“To fast-track the entry of DMB-115 into global markets, including Europe and the United States, we are fully committed to efficiently completing the remaining procedure in close collaboration with Instas.”