Intas and Dong-A ST Report EMA Acceptance of MAA for DMB-3115, a Proposed Biosimilar to Stelara (ustekinumab)
Shots:
- The EMA has accepted the MAA for DMB-3115, a biosimilar of Stelara. The MAA submission was based on the results of an extensive analytical similarity assessment evaluating DMB-3115 & was also based on the P-III multi-regional clinical trials in patients with PsO
- The 1EPs of the study was the rate of change in PASI for skin symptoms while therapeutic equivalence and safety were confirmed b/w DMB-3115 and Stelara
- Dong-A ST & Meiji Seika Pharma collaborated with Intas in July 2021 where Intas get an exclusive commercialization right globally excl. Korea, Japan & some Asian countries, commercialize DMB-3115 with its global subsidiaries Accord BioPharma of the US and Accord Healthcare of the EU, UK, and Canada
Ref: Businesswire | Image: Dong-A ST
Related News:- Dong-A ST Reports P-III Study Results of Ustekinumab Biosimilar DMB-3115 for the Treatment of Chronic Plaque Psoriasis
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