Phase 3License out/inDrug ApprovalNDAClinical Result
SEOUL, South Korea--(BUSINESS WIRE)--Dong-A ST (President/CEO Min-young Kim, KRX:170900) announced that Accord BioPharma, Inc., a subsidiary of Intas Pharmaceuticals Ltd, in the United States has received a notification that the US Food and Drug Administration (“FDA”) has accepted its Biologics License Application (BLA) for DMB-3115, a proposed biosimilar to Stelara® (Ustekinumab), for substantive review.
'The DMB-3115 marketing application for the US has been submitted following the submission in the EU by leveraging therapeutic equivalence and safety data between DMB-3115 and Stelara\u00AE'
The BLA leverages the analytical similarity assessment data between EU and US sourced Stelara® and DMB-3115. A global clinical Phase III trial was performed on patients with moderate-to-severe chronic plaque psoriasis. DMB-3115 displayed therapeutic equivalence with Stelara and showed no statistically significant difference in safety.
Jae-Hong Park, CSO of Dong-A ST, stated, “The DMB-3115 marketing application for the US has been submitted following the submission in the EU by leveraging therapeutic equivalence and safety data between DMB-3115 and Stelara®,” adding, “We will spare no efforts in working with Intas Pharmaceuticals through the remaining application process to supply DMB-3115 to the global markets, such as the US and the EU.”
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