Shots :
- The US FDA has accepted the BLA for DMB-3115 based on the results from P-III multi-regional studies for treating plaque psoriasis having rate of change in the Psoriasis Area and Severity Index (PASI) for skin symptoms as its 1EP. The results showed similar quality, safety and efficacy between DMB-3115 vs Stelara
- Accord BioPharma (subsidiary, Intas Pharmaceuticals) holds US commercialization rights to DMB-3115 which was jointly developed by Dong-A Socio Holdings and Meiji Seika Pharma
- Additionally, the company has submitted 3 separate BLAs to the US FDA for its biosimilar versions of trastuzumab, pegfilgrastim, and filgrastim
Ref: Accord BioPharma| Image: Accord BioPharma| Press Release
Related News:- STADA and Alvotech’s Uzpruvo (Biosimilar, Stelara) Obtains EC’s Approval for Immune-Mediated Diseases
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