Stelara biosimilar of Dong-A ST succeeded in clinical trials

Introducing the top-line results of the global phase 3

Demonstrate safety and effectiveness equivalence

Dong-A ST announced on the 16th that the Stelara biosimilar DMB-3115 has confirmed its safety and effectiveness in clinical trials.

 

On the same day, Dong-A ST introduced the results of DMB-3115's global phase 3 clinical trial top line and announced that it would apply for item permission to the U.S.

 

and European health authorities in the first half.

 

Dong-A ST conducted a global phase 3 clinical trial of the Stelara biosimilar DMB-3115 on a total of 605 patients in nine countries, including the United States, Poland, and Estonia, from 2021 to the end of last year.

 

Developed by Janssen, Stelara is a treatment for inflammatory diseases such as plate psoriasis and psoriatic arthritis, Crohn's disease, and ulcerative colitis.

 

It is a blockbuster product that recorded sales of $9.134 billion in 2021.

 

In clinical trials, DMB-3115 has proven its validity for European and U.S.

 

item licensing.

 

As a result of evaluating psoriasis area and severity index, which are the primary evaluation variables for European EMA item licensing, DMB-3115 statistically demonstrated therapeutic equivalence with Stella.

 

In the US FDA evaluation index for item licensing, DMB-3115 confirmed the equivalent validity of Stelara.

 

The safety assessment also confirmed that DMB-3115 is equivalent to Stelara.

 

The proportion of subjects with even one new or worsening adverse reaction after administration of clinical trial drugs was about 54% in the group administered DMB-3115 and about 57% in the group administered Stelara.

 

At 28 weeks, about 55% of the group change from Stella to DMB-3115 occurred, and no clinically significant difference was observed.

 

The proportion of subjects with even one serious adverse reaction was similar, about 2% in the group administered DMB-3115 and about 3% in the group administered Stella.

 

It did not occur in the group that changed from Stelara to DMB-3115 at 28 weeks.

 

Dong-A ST said, "We plan to apply for DMB-3115 item permits in major overseas countries such as the United States and Europe in the first half of this year."