Dong-A ST Reports P-III Study Results of Ustekinumab Biosimilar DMB-3115 for the Treatment of Chronic Plaque Psoriasis
Shots:
- The P-III therapeutic equivalence study evaluating the safety, efficacy, and immunogenicity of DMB-3115 vs Stelara in 605 patients with mod. to sev. chronic plaque psoriasis in the US & 9 other countries incl. Poland, Estonia, and Latvia. DMB-3115 has been jointly developed by Dong-A Socio Holding & Meiji Seika Pharma
- The results showed that ustekinumab biosimilar (DMB-3115) has similar safety and efficacy profiles to the reference Stelara, no clinically significant difference in safety were observed
- Dong-A ST received the commercialization and development rights to the biosimilar in July 2020. The company is expected to submit the MAA to the US FDA & EMA in H1’23
Ref: Businesswire | Image: Dong-A ST
Related News:- Meiji and Dong-A ST Sign an Exclusive License Agreement with Intas to Commercialize DMB-3115- Proposed Biosimilar to Ustekinumab
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